Category: News Now!

Local news and beyond from diverse feeds and original sources.

Categories
Business Culture Economics Education Lifestyle News Now! Perspectives Programs & Events Regulations & Security

Affinity Federal Credit Union celebrates its first class of Certified Wellbeing Coaches

Coaches will support the wellbeing of Affinity members at each of its branches in NJ, NY and CT

 

 

BASKING RIDGE, N.J. — (BUSINESS WIRE) — Affinity Federal Credit Union (“Affinity”) proudly announces the graduation of its inaugural class of Certified Wellbeing Coaches. The program and its first graduates mark an important step in Affinity’s ongoing commitment to the financial wellbeing of its members.

 

The program’s 42 graduates represent various departments within Affinity. Each participant invested approximately 75 hours in training, learning about how to provide members with the best possible support in managing their personal finances and overcoming financial challenges. Course topics include credit, foreclosure, bankruptcy, taxes, insurance, identity theft, and the resources and tools available to support a member’s financial wellbeing. The program was inclusive of class attendance, presentations, homework, and tests.

 

“We are immensely proud to introduce our first class of Certified Wellbeing Coaches, who embody Affinity’s purpose of ‘people helping people’ within our communities,” said Kevin Brauer, CEO and President of Affinity Federal Credit Union. “By investing in the financial wellbeing of our members, we are not just helping them navigate financial challenges but are also empowering them to achieve their long-term goals. We look forward to the positive impact our Wellbeing Coaches will have on our members’ lives.”

 

Affinity also wants to highlight the work of four of its coaches who went above and beyond to meet the demands of the program. Top graduates of the inaugural class of Certified Wellbeing Coaches include Bedminster and Morristown Branch Manager Andrea Alfaro, Norwalk Branch Manager Juan Londono, Financial Services Accountant Lizandra Blanco, and Loss Mitigation Specialist Auria Torres.

 

Coaches are now available at all of Affinity’s branches in New Jersey, New York, and Connecticut, ensuring that every member has access to this invaluable resource. Appointments with Wellbeing Coaches can be made online at https://www.affinityfcu.com/financial-wellbeing/certified-wellbeing-coaches.

 

About Affinity Federal Credit Union

Affinity Federal Credit Union is a full-service financial institution, member-owned and community-focused, with a mission to nurture your financial wellbeing. With more than 20 branches across the tri-state area, Affinity is the largest credit union headquartered in the state of New Jersey, proudly ranking in the top 2% of all credit unions in terms of asset size1. The Affinity difference is about people helping people on a deeper level and understanding what YOU need to make your unique dreams a reality. For more information, please visit www.affinityfcu.com.

 

1 Source: NCUA.gov. Using the “Credit Union and Corporate Call Report Data” found here: https://www.ncua.gov/analysis/credit-union-corporate-call-report-data

Contacts

Rocco Aloe

Gregory FCA for Affinity Federal Credit Union

affinity@gregoryfca.com
610-860-2075

Categories
Culture Digital - AI & Apps International & World Lifestyle News Now! Perspectives Politics Regulations & Security Technology

Israel supporters use apps to mass report pro-Palestinian content; tech platforms question ‘citizen-led propaganda’

—  The apps raise questions for tech platforms over ‘citizen-led propaganda’ campaigns, experts say

 

 

Taylor Lorenz / Washington Post:

 

 

As the war in Gaza rages on, and both sides battle for support and public attention, supporters of Israel are making use of tools that allow them to mass report pro-Palestinian content as violating a platform’s rules.

 

The tools also generate AI-written suggested responses to posts online, allowing users to flood the comments of pro-Palestinian posts with pro-Israel messaging.

Experts who study communication online say the widespread use of such tools influences the online discussion of the war and is ushering in a new era of citizen-led propaganda campaigns. But the use of the tools does not appear to violate platform rules against what’s known as “coordinated inauthentic behavior,” or posts that appear to come from unrelated individuals but are really the result of an organized effort, often through automated accounts.

“Working in an orchestrated fashion can be violative, but it quickly becomes a gray area, and that’s why these apps exist,” said Nora Benavidez, senior counsel and director of digital justice and civil rights at Free Press, a nonpartisan organization that lists its goals as protecting free expression and civil liberties.

Researchers say it is difficult to determine which comments have been generated by such tools because there’s no way to publicly track a user’s private activity across multiple apps. Social media companies would have to come up with ways to detect their use, which is challenging because the apps operate on their own platforms, not those of the social media companies. If the apps were automatically posting, they would likely violate rules against inauthentic activity. But third-party apps that simply encourage legitimate users to report posts escape that sanction.

There’s also no way to know with precision that actions taken against someone’s account or posts are in response to activity from these apps. Anecdotally, some users report that after their Instagram and TikTok posts were mentioned on the apps, the posts were either removed or heavily downranked, making them less accessible to a large audience.

Meta, which owns Instagram and Facebook, did not respond to a request for comment. TikTok also did not respond to requests for comment.

“I’ve had many posts taken down, I’d say upwards of 15 to 20 posts removed,” said Nys, a content creator who posts on TikTok under the handle @palestinianpr1ncess and spoke on the condition that she be referred to by first name only because she’s worried about repercussions when traveling to the West Bank. Nys said that each of her posts that has been surfaced on one of the apps has received a flood of pro-Israel, seemingly AI-generated comments. The post is also usually removed after many users report it for bullying or hate speech. “I’m not using hate speech,” Nys said. “I’m just doing commentary on everything happening in Palestine.”

Laura Chung, a content creator and podcaster, said that she believes a mass reporting campaign facilitated by one of the apps is what led to her TikTok account being removed in December. “I was creating pro-Palestine content for education purposes and I was going massively viral,” she said. “I believe it’s these apps that got me banned on TikTok.”

Joan Donovan, a noted disinformation expert who is an assistant professor of journalism at Boston University, said the apps are a new development in the propaganda battle being waged on the internet over Israel’s offensive in Gaza and that social media companies need to find ways to monitor their use.

“Social media is a terrain of warfare, not just for cyber troops, but also for citizen battalions armed with AI-enhanced bots and the ability to generate endless unique posts that evade current content moderation tools,” she said. “It is incumbent on tech companies to defend against such abuses.”

“This level of organization only exists on one side of the conflict,” said Emerson T. Brooking, a former cyber policy adviser to the Defense Department who studies disinformation and propaganda campaigns as a resident senior fellow at the Atlantic Council’s Digital Forensic Research Lab. “It exists for pro-Israel voices, and it exists because there are government ministries in Israel that support these tools and encourage their use.”

Brooking and other experts said they aren’t aware of any similar tools for Palestinian supporters.

At least one of these apps is directly tied to Israel. The app, called Moovers, encourages users to “Advocate for Israel, One Click at a Time.” It pulls in allegedly pro-Palestinian content from Instagram, TikTok, Facebook and X in a never-ending feed, allowing users easily to take action on that content, reporting it for review or commenting on it. It also provides pre-written pro-Israel scripts to respond to such posts.

In early December, a representative from Leaders, a Tel Aviv-based Israeli influencer marketing firm, began contacting creators in the United States, offering to pay them to promote Moovers to their audiences on Instagram. In emails viewed by The Washington Post, a representative from Leaders touted content on the Moovers app as “endorsed by Israel’s Government Advertising Agency.”

 

Read More

 

 

— Techmeme

Categories
Healthcare Lifestyle Local News News Now! Science

Opdivo (nivolumab) plus Yervoy (ipilimumab) reduced the risk of disease progression or death by 79% versus chemotherapy in patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer in CheckMate -8HW trial

First presentation of data from the Phase 3 randomized trial shows statistically significant and clinically meaningful improvement in progression-free survival with Opdivo plus Yervoy compared to chemotherapy as first-line treatment in this patient population

 

Opdivo plus Yervoy is the first dual immunotherapy regimen to demonstrate significant efficacy benefit compared to chemotherapy as first-line treatment in MSI-H/dMMR mCRC

 

Late-breaking data to be featured in oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium and highlighted as part of official Congress press program

 

 

PRINCETON, N.J. — (BUSINESS WIRE) — $BMY #ASCO—Bristol Myers Squibb (NYSE: BMY) on Monday announced results from the Phase 3 CheckMate -8HW trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to investigator’s choice of chemotherapy (mFOLFOX-6 or FOLFIRI with or without bevacizumab or cetuximab) as a first-line treatment for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC).

 

The dual immunotherapy combination of Opdivo and Yervoy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR), with a reduction in the risk of disease progression or death by 79% (Hazard Ratio [HR]: 0.21; 95% Confidence Interval [CI]: 0.14-0.32; p<0.0001) compared to chemotherapy in patients with centrally confirmed MSI-H/dMMR mCRC.

These late-breaking data (Abstract #LBA768) will be featured in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium on Saturday, January 20 at 9:15 a.m. Pacific Time and will be highlighted as part of the Congress’ official press program.

 

Improvement in PFS was noted beginning at approximately three months and was sustained throughout. Median PFS was not yet reached in the Opdivo plus Yervoy arm (95% CI: 38.4-NE) vs. 5.9 months in the chemotherapy arm (95% CI: 4.4-7.8). Consistent PFS benefit was observed across all pre-specified subgroups, including patients with KRAS or NRAS mutations, and those with baseline liver, lung, or peritoneal metastases.

 

The safety profile for the combination of Opdivo plus Yervoy remained consistent with previously reported data and was manageable with established protocols, with no new safety signals identified. Grade 3/4 treatment-related adverse events (TRAEs) occurred in 23% of patients in the Opdivo plus Yervoy arm and 48% of patients in the chemotherapy arm. Any grade TRAE-related discontinuation was 17% in the Opdivo plus Yervoy arm and 32% in the chemotherapy arm.

 

“Patients with MSI-H/dMMR metastatic colorectal cancer are less likely to benefit from chemotherapy,” said Thierry Andre, M.D., Head of the Medical Oncology Department, Sorbonne University and Hospital Saint-Antoine, Paris, France. “An impressive improvement in PFS and sustained benefit beginning at three months was observed with nivolumab plus ipilimumab versus chemotherapy in this trial. These results demonstrate the meaningful efficacy of this combination with practice-changing potential for this patient population.”

 

Opdivo plus Yervoy is the first dual immunotherapy regimen to demonstrate significant efficacy benefit compared to chemotherapy as first line treatment in MSI-H/dMMR mCRC.

 

“With research from the full CheckMate clinical development program, BMS has revolutionized the oncology landscape and helped change survival expectations for people with cancer. Today, with these data from CheckMate -8HW, we showed that Opdivo plus Yervoy reduced the risk of disease progression or death by an unprecedented 79%,” said Dana Walker, M.D., M.S.C.E., vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb. “These results build on the benefit of Opdivo and Yervoy in MSI-H/dMMR metastatic colorectal cancer as previously demonstrated in CheckMate -142 and reinforce our commitment to exploring the potential of these therapies to help more patients in need.”

 

CheckMate -8HW is ongoing to assess the second dual primary endpoint of PFS in patients receiving Opdivo plus Yervoy compared to Opdivo alone across all lines of therapy, as well as secondary endpoints, including overall survival (OS).

 

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -8HW clinical trial.

 

About CheckMate -8HW

CheckMate -8HW (NCT04008030) is a Phase 3 randomized, open-label trial evaluating Opdivo plus Yervoy compared to Opdivo alone or investigator’s choice chemotherapy (mFOLFOX-6 or FOLFIRI with or without bevacizumab or cetuximab) in patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC).

 

Approximately 830 patients were randomized to receive either Opdivo monotherapy (Opdivo 240 mg Q2W for six doses, followed by Opdivo 480 mg Q4W), Opdivo plus Yervoy (Opdivo 240 mg plus Yervoy 1 mg/kg Q3W for four doses, followed by Opdivo 480 mg Q4W), or investigator’s choice of chemotherapy. The dual primary endpoints of the trial are progression-free survival (PFS) per blinded independent central review (BICR) for Opdivo plus Yervoy compared to investigator’s choice of chemotherapy in the first line setting and PFS per BICR for Opdivo plus Yervoy compared to Opdivo alone across all lines of therapy. The trial also includes several secondary safety and efficacy endpoints, including overall survival (OS).

 

The study is ongoing to assess the second dual primary endpoint of PFS in patients receiving Opdivo plus Yervoy compared to Opdivo alone across all lines of therapy, as well as secondary endpoints.

 

About MSI-H or dMMR Colorectal Cancer

Colorectal cancer (CRC) is a cancer that develops in the colon or the rectum, which are part of the body’s digestive or gastrointestinal system. CRC is the third most commonly diagnosed cancer in the world. In 2020, it is estimated that there were approximately 1,931,000 new cases of the disease; it is the second leading cause of cancer-related deaths among men and women combined.

 

Mismatch repair deficiency (dMMR) occurs when the proteins that repair mismatch errors in DNA replication are missing or non-functional, leading to microsatellite instability-high (MSI-H) tumors. Approximately 5-7% of metastatic CRC patients have dMMR or MSI-H tumors; they are less likely to benefit from conventional chemotherapy and typically have a poor prognosis.

 

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research programs uniquely position the company to approach cancer from every angle.

 

Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

 

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

 

Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

 

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In September 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

 

About Yervoy

Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types.

 

INDICATIONS

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.

OPDIVO® is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.

OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

 

IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune- mediated adverse reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

Immune-Mediated Pneumonitis

OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune- mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune- mediated pneumonitis occurred in 7% (31/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune- mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%). In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune- mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis.

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO, including Grade 3 (n=1) and Grade 2 (n=12).

Immune-Mediated Colitis

OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%).

In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in 25% (115/456) of patients, including Grade 4 (0.4%), Grade 3 (14%) and Grade 2 (8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated colitis occurred in 9% (60/666) of patients, including Grade 3 (4.4%) and Grade 2 (3.7%).

Immune-Mediated Hepatitis and Hepatotoxicity

OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%).

In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%).

OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in 11% of patients.

Immune-Mediated Endocrinopathies

OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.

In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, adrenal insufficiency occurred in 8% (35/456), including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, adrenal insufficiency occurred in 7% (48/666) of patients, including Grade 4 (0.3%), Grade 3 (2.

Contacts

Bristol Myers Squibb

Media Inquiries:
media@bms.com

Investors:
investor.relations@bms.com

Read full story here

Categories
Business Economics Environment Government Lifestyle News Now! Science

New Jersey American Water files rate request driven by over $1.3 billion in investment

Request reinforces company’s commitment to providing safe, clean reliable and affordable service

 

CAMDEN, N.J. — (BUSINESS WIRE) — New Jersey American Water filed a petition Monday with the New Jersey Board of Public Utilities (BPU) requesting new rates, driven by more than $1.3 billion in capital investments through December 2024, to continue providing safe and reliable service.

 

The company continues to make needed investments to replace aging infrastructure, meet water quality and environmental regulations, provide resiliency of operations, increase fire protection, and meet customers’ other water and wastewater service needs.

 

“Our approach to long-term, efficient and consistent investments in our water and wastewater systems helps us continue to deliver high-quality, reliable service and fire protection for the more than 2.8 million people in 18 counties we serve. As the state’s largest water and wastewater utility, we believe it is essential that the service we provide is safe, complies with state and federal water quality regulations; reliable, so that it is resilient in the face of floods, droughts, and other weather-related impacts; and affordable,” said Mark McDonough, president of New Jersey American Water.

 

“One of the steps we are taking to address affordability is proposing a universal affordability tariff to expand our customer assistance program.”

 

If the company’s proposed rates are approved as requested, the water bill for the average residential customer using 5,640 gallons per month would increase about $11.30 per month. The average monthly residential wastewater bill would increase about $6.16 per month. The new affordability tariff, if approved by the BPU, would provide a 20 to 80 percent monthly bill reduction for income-eligible customers.

 

New Jersey American Water’s investment in replacing or rehabilitating nearly 176 miles of aging water mains is included in this rate request. Additional critical infrastructure projects included in the rate request are improvements to the company’s seven surface water treatment plants serving nearly all customers statewide; investments in its treatment facilities to comply with regulations for PFAS; replacement of aging, critical, large-diameter transmission mains and several large-scale pipeline replacement projects throughout the state to improve system reliability; replacement of thousands of utility-owned lead and galvanized service lines statewide; additional advanced leak detection technology; replacement or upgrades to improve reliability and efficiency at dozens of wells, pumping stations and other critical facilities statewide; and sewer system upgrades to meet environmental regulations throughout the company’s service areas.

 

The company’s rate request undergoes extensive public scrutiny by the BPU, the New Jersey Division of Rate Counsel, and the Office of Administrative Law. This process includes numerous interrogatories, public hearings and evidentiary hearings and can take nine months or more. To increase transparency of the process, the company’s petition and its associated exhibits are being posted to the Company’s website, newjerseyamwater.com, under Customer Service & Billing, Your Water and Wastewater Rates.

 

New Jersey American Water is seeking a total annual revenue increase of approximately $161.7 million. The increased rates proposed in the petition are a request only. The BPU will make the final decision regarding the actual increase. Once a final decision has been made, customers will receive information on the new rates in the mail and on the company’s website.

 

About American Water

American Water (NYSE: AWK) is the largest regulated water and wastewater utility company in the United States. With a history dating back to 1886, We Keep Life Flowing® by providing safe, clean, reliable and affordable drinking water and wastewater services to more than 14 million people with regulated operations in 14 states and on 18 military installations. American Water’s 6,500 talented professionals leverage their significant expertise and the company’s national size and scale to achieve excellent outcomes for the benefit of customers, employees, investors and other stakeholders. For more information, visit amwater.com and join American Water on LinkedIn, Facebook, X (formerly Twitter) and Instagram.

 

About New Jersey American Water

New Jersey American Water, a subsidiary of American Water, is the largest investor-owned water utility in the state, providing high-quality and reliable water and wastewater services to approximately 2.8 million people. For more information, visit www.newjerseyamwater.com and follow New Jersey American Water on Facebook, X (formerly Twitter), Instagram, and LinkedIn.

AWK-IR

Contacts

Media Contact:
Denise Venuti Free

Senior Director of Communications & External Affairs

New Jersey American Water

Denise.Free@amwater.com

Categories
Business Culture Digital - AI & Apps Economics Lifestyle News Now! Perspectives Regulations & Security Technology

Apple’s commissions from third-party iOS apps seemingly confrontational stance at odds with regulatory pressure

As of Thursday, developers can begin exercising their court-established right to tell US customers about better prices on the web. These awful Apple-mandated confusion screens are over and done forever.

 

John Gruber / Daring Fireball:

 

 

—  That take didn’t last long.

 

Sweeney, on Wednesday at 7 p.m., after Apple released the details of its intended compliance with the anti-steering (anti-anti-steering?) mandate from the Epic v. Apple case:

 

A quick summary of glaring problems we’ve found so far:

  1. Apple has introduced an anticompetitive new 27% tax on web purchases. Apple has never done this before, and it kills price competition. Developers can’t offer digital items more cheaply on the web after paying a third-party payment processor 3-6% and paying this new 27% Apple Tax.

[Sweeney’s points 2–4, complaining about Apple’s stringent design, presentation, and privacy demands regarding external links, omitted.]

 

Epic will contest Apple’s bad-faith compliance plan in District Court.

 

Sweeney’s description makes it sound as though Apple is demanding its commission from all web sales for apps and services that have an iOS app. They’re not. They’re only demanding the commission from web sales that occur within 7 days of a user tapping through to the web from the new External Purchase Links entitlement in an app. Any app or service that already sells over the web, without paying a cent to Apple, can continue to do so in exactly the same way.

 

 

Also, Apple has done this before: what they announced yesterday is almost exactly in line with their compliance with Netherlands regulations pertaining to dating apps in 2022.

 

Before yesterday:

  • iOS app developers could sell digital content and subscriptions over the web, without paying Apple any commission.
  • iOS apps outside the “reader” category could not link to, nor even tell users about, those web purchases from within their apps.

After yesterday:

  • Apps that wish to link to — or, I think, even inform users about — web purchasing options from within their iOS apps must (a) still offer Apple’s IAP for those items; (b) pay Apple its adjusted 27/12 percent commissions on web sales that come from inside iOS apps; (c) send Apple sales data monthly and submit to audits of their sales; and (d) follow Apple’s stringent design edicts for these in-app links to the web.
  • Apps that do not link out to their web stores from within their iOS apps using Apple’s new External Purchase Links entitlement can continue whatever they were doing before yesterday. For apps that do nothing new, Apple is collecting nothing new.

 

I’m only surprised that Sweeney was seemingly surprised by any of this. He genuinely seemed to think that Apple not only would, but had to allow links from within apps to the web for purchases without collecting any commission on those sales, and that developers could present those links however they chose.

 

I’m glad that Sweeney and Epic plan to contest this, because I’m genuinely curious whether Judge Yvonne Gonzalez Rogers sees Apple’s solution as complying with her injunction against their prior anti-steering rules. But I think it does comply.

 

To be clear, I think Apple should allow apps other than games to just tell users they can pay/buy/subscribe/whatever on the web, without any commission. That the rules which have applied only to “reader” apps since early 2022 should be extended to all apps other than games, perhaps alongside a requirement (which doesn’t apply to “reader” apps) that apps taking advantage of this also offer in-app purchasing.

 

I’d draw an exception for games — an exception that surely Sweeney would disagree with completely, given that he’s in the games business — because games are different, and hefty un-circumventable revenue commissions to platform owners are clearly standard for the video game industry. The iPhone and iPad are not PCs; they’re consoles for games and apps.

 

But I’m not sure at all that Apple is doing anything contrary to the law. Sweeney (and other critics of Apple’s stewardship of iOS as a tightly controlled console) believe Apple both shouldn’t and legally can’t comply with the anti-steering injunction this way. I only believe Apple shouldn’t, not that they legally can’t.

 

Most critics of Apple’s control over all iOS software are seemingly of the view that iPhones and iPads should, on principle, be largely like the Mac, where the App Store is an option, not the only game in town for software distribution. Personally, I am on the record wishing that Apple would allow some sort of “expert” or “developer” mode — chock full of warnings, perhaps even requiring a developer account to enable — that would basically offer the same options for installing third-party software on iOS as there are on the Mac. That’s me, personally, an expert user. But even setting aside every penny of revenue generated by the App Store,1 I see and understand many of the reasons why Apple wouldn’t want to do this. There are a lot of Mac users whose Macs are overrun by adware and other scammy software. I’m not talking about viruses or malware, even — but apps that just abuse the largely free-for-all nature of the Mac platform.

 

Basically, there’s an argument that iOS devices should be more like traditional PCs (including the Mac), on ethical or moral grounds. The “it’s my device, I should decide and control what software runs on it” argument. I get it. But I also get that most consumers’ Windows PCs, and many Macs,2 are riddled with bad software (privacy invasive, resource hogging, and all sorts of anti-user shenanigans you’d never think of) that App Store policies forbid. App Store review is far from perfect — I mean come on, that should go without saying — but it is undeniable that adversarial software is not a problem for any typical users on iOS. Nothing you install from the App Store can damage your iPhone or iPad experience. Nothing you install from the App Store is difficult to uninstall if you don’t like it. The same is true of dedicated game consoles like Switch, PlayStation, and Xbox — and to a lesser degree (because Google’s Play Store review seems comparatively lax) for Android.

 

But the cynical take is that it’s all about the money for Apple. Maybe the cynics are right! Let’s just concede that they are, and that Apple will only make decisions here that benefit its bottom line. My argument remains that Apple should not be pursuing this plan for complying with the anti-steering injunction by collecting commissions from web sales that initiate in-app. Whatever revenue Apple would lose to non-commissioned web sales (for non-games) is not worth the hit they are taking to the company’s brand and reputation — this move reeks of greed and avarice — nor the increased ire and scrutiny of regulators and legislators on the “anti-Big-Tech” hunt.

 

Apple should have been looking for ways to lessen regulatory and legislative pressure over the past few years, and in today’s climate that’s more true than ever. But instead, their stance has seemingly been “Bring it on.” Confrontational, not conciliatory, conceding not an inch. Rather than take a sure win with most of what they could want, Apple is seemingly hell-bent on trying to keep everything. To win in chess all you need is to capture your opponent’s king. Apple seemingly wants to capture every last piece on the board — even while playing in a tournament where the referees (regulators) are known to look askance at blatant poor sportsmanship (greed).

 

Apple’s calculus should be to balance its natural desire to book large amounts of revenue from the App Store with policies that to some degree placate, rather than antagonize, regulators and legislators. No matter what the sport, no matter what the letter of the rulebook says, it’s never a good idea to piss off the refs.

 

 

    1. That’s a metric buttload of pennies to set aside, to be sure. ↩︎
  2. iOS App Store policy critics often point to the Mac as all the evidence they need that Apple could open up software distribution on iOS with no ill effects to users. I wrote about this back in 2021, in a piece titled “Annotating Apple’s Anti-Sideloading White Paper”. Quoting from that column, which begins with a quote from Apple’s white paper:

    Page 9:

    iPhone is used every day by over a billion people — for banking, to manage health data, and to take pictures of their families. This large user base would make an appealing and lucrative target for cybercriminals and scammers, and allowing sideloading would spur a flood of new investment into attacks on iPhone, well beyond the scale of attacks on other platforms like Mac.

     

    Here Apple dances around the elephant in the room — the question of why iOS shouldn’t just work like the Mac with regard to non-App Store software. Apple’s deft argument is that there are far fewer Macs than iOS devices, making the Mac a less enticing target for scammers and crooks (including privacy crooks). That’s more or less the argument Windows proponents used to explain the profound prevalence of malware on Windows compared to the Mac back in the day, whilst Apple (and Mac proponents) argued otherwise, that the Mac actually was far more secure at a technical level.

     

    But the truth Apple won’t come out and say is that it’s both. The Mac was more secure by design, but also a far less enticing target because of how many more users were (and still are) on Windows. And, today, iOS is more secure and private than the Mac. That’s the nature of the Mac as a full PC platform.

     

    I’ll admit it: if Mac-style sideloading were added to iOS, I’d enable it, for the same reason I enable installing apps from outside the App Store on my Mac: I trust myself to only install trustworthy software. But it doesn’t make me a hypocrite to say that I think it would be worse for the platform as a whole.

     

    The Mac is fundamentally designed for users who are at least somewhat technically savvy, but tries its best to keep non-savvy users from doing things they shouldn’t. But you can always hurt yourself, sometimes badly, with any true power tool. The iPhone is the converse: designed first and foremost for the non-savvy user, and tries to accommodate power users as best it can within the limits of that primary directive.

     

 

— Techmeme

Categories
Education Healthcare Lifestyle Local News News Now! Programs & Events Science

Bristol Myers Squibb Data at ASCO GU 2024 showcase transformative research in genitourinary cancer treatment

First presentation of results from Phase 3 CheckMate -67T trial with subcutaneous formulation of Opdivo (nivolumab and hyaluronidase) to be shared in a late-breaking oral presentation

Four-year data from CheckMate -9ER and unprecedented eight-year data from CheckMate -214 will confirm durable outcomes with Opdivo-based combinations for patients with advanced renal cell carcinoma

First disclosure of clinical outcomes from Phase 1 trial with BMS-986365 (CC-94676), the company’s first androgen receptor ligand-directed degrader in solid tumors from its targeted protein degradation platform, in metastatic castration-resistant prostate cancer

 

 

PRINCETON, N.J. — (BUSINESS WIRE) — $BMY #ASCO—Bristol Myers Squibb (NYSE: BMY) today announced the presentation of data at the American Society of Clinical Oncology 2024 Genitourinary Cancers Symposium (ASCO GU) to be held from Jan. 25 to 27 in San Francisco, Calif., highlighting the company’s progress in making long-term survival outcomes a possibility for more patients with genitourinary cancers, as well as showcasing potential new options and therapeutic platforms that may transform treatment paradigms across tumor types.

 

Data from 14 company-sponsored studies, investigator-sponsored studies and collaborations will be presented at the meeting.

The first presentation of data from the CheckMate -67T study will highlight the potential of a subcutaneous formulation of nivolumab co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) in advanced or metastatic clear cell renal cell carcinoma (RCC). Research to be shared will also add to the evidence supporting the use of Opdivo (nivolumab)-based combinations in patients with advanced RCC, including four-year follow-up data from the CheckMate -9ER trial and eight-year results from the CheckMate -214 trial. In addition, data will be presented on an investigational androgen receptor (AR) ligand-directed degrader (LDD; BMS-986365) in metastatic castration-resistant prostate cancer (mCRPC), providing validation for the targeted protein degradation platform in solid tumors and representing one of the company’s next waves of potential registrational assets.

 

“We are excited to present our research at ASCO GU 2024, which will demonstrate not only our long-standing leadership in oncology with our work in immunotherapy, but also our commitment to developing new assets and approaches to treating cancer from our differentiated research platforms such as targeted protein degradation in an effort to provide patients with better, long-term outcomes,” said Samit Hirawat, M.D., executive vice president and chief medical officer, Drug Development, Bristol Myers Squibb.

 

“These results simultaneously showcase the ongoing success of Opdivo-based combinations in metastatic disease and our contributions to the future of cancer treatment and research. We are especially eager to share data for the first time showing the potential of our subcutaneous formulation of a proven agent, and a new mechanism of action in a difficult-to-treat tumor type – both of which could have a tremendous impact on existing standards of care and the patient experience.”

 

Key data being presented by Bristol Myers Squibb at ASCO GU 2024 include:

  • First disclosure of pharmacokinetics, efficacy and safety results from the Phase 3 CheckMate -67T trial with subcutaneous nivolumab (nivolumab and hyaluronidase) being presented in a late-breaking oral session. This marks the first presentation of data evaluating subcutaneous nivolumab compared to its intravenous formulation.
  • Eight-year data from the Phase 3 CheckMate -214 study with Opdivo plus Yervoy (ipilimumab) showing ongoing survival and response benefits over sunitinib among intermediate- and poor-risk patients with advanced RCC, as well as among all randomized patients. These data represent the longest survival benefit vs. sunitinib reported in patients with previously untreated advanced or metastatic RCC.
  • Four-year follow-up data from the Phase 3 CheckMate -9ER trial evaluating Opdivo in combination with Exelixis’ CABOMETYX (cabozantinib). These data demonstrate meaningful, long-term efficacy benefits seen with the combination therapy over sunitinib and reinforce it as a standard of care for previously untreated advanced RCC.
  • First presentation of clinical outcomes from the company’s targeted protein degradation platform in solid tumors with Phase 1 data from BMS-986365 (CC-94676), an oral drug selectively targeting AR. BMS-986365 induces effective and durable suppression of AR signaling, overcomes resistance to existing AR pathway inhibitors (ARPI) therapies and shows promising clinical activity in heavily pre-treated patients with mCRPC across wildtype, amplified and mutant AR status, highlighting this asset as the potential best-in-class AR-ligand directed degrader that may help overcome resistance to standard of care ARPIs in patients with mCRPC, a difficult-to-treat tumor type.

 

Summary of Presentations:

Abstract Title

Author

Presentation

Type/#

Session Title

Session

Date/Time (ET)

Prostate Cancer

First-in-human phase 1 study of CC-94676, a first-in-class androgen receptor (AR) ligand-directed degrader (LDD), in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).

Dana Rathkopf

Poster

Abstract #134

Poster Bd. #F5

Poster Session A: Prostate Cancer

Thursday, January 25

2:30 PM – 4:00 PM

Renal Cell Carcinoma

Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T.

Saby George

Oral

Abstract #LBA360

Oral Abstract Session C: Renal Cell Cancer

Saturday, January 27

11:10 AM – 12:45 PM

Nivolumab plus cabozantinib (N+C) vs sunitinib (S) for previously untreated advanced renal cell carcinoma (aRCC): Results from 55-month follow-up of the CheckMate 9ER trial.

Maria Teresa Bourlon

Rapid Oral

Abstract #362

Rapid Oral Abstract Session C: Renal Cell, Adrenal, and Testicular Cancers

Saturday, January 27

4:00 PM – 5:15 PM

Nivolumab plus ipilimumab (NIVO+IPI) vs sunitinib (SUN) for first-line treatment of advanced renal cell carcinoma (aRCC): Long-term follow-up data from the phase 3 CheckMate 214 trial.

Nizar Tannir

Rapid Oral

Abstract #363

Rapid Oral Abstract Session C: Renal Cell, Adrenal, and Testicular Cancers

Saturday, January 27

4:00 PM – 5:15 PM

Adjuvant nivolumab monotherapy vs placebo for localized renal cell carcinoma at high risk of relapse after nephrectomy: Results from Part B of the randomized, phase 3 CheckMate 914 trial.

Robert Motzer

Oral

Abstract #LBA358

Oral Abstract Session C: Renal Cell Cancer

Saturday, January 27

11:10 AM – 12:45 PM

Treatment patterns and costs among patients with metastatic renal cell carcinoma (mRCC) in the United States: A real-world study using integrated claims and clinical data.

Daniel Geynisman

Poster

Abstract #398

Poster Bd. #F22

Poster Session C: Renal Cell Cancer; Adrenal, Penile, and Testicular Cancers

Saturday, January 27

10:00 AM – 11:00 AM

Urothelial Carcinoma

Estimating the impact of adjuvant treatment with nivolumab on long-term survivorship rates compared with surveillance: Analyses of disease-free survival (DFS) from the phase 3 CheckMate-274 trial.

Daniel Geynisman

Oral

Abstract #528

Role of Immunotherapy in Advanced Urothelial Carcinoma: Sequencing, Pairing, Rechallenging

Friday, January 26

5:30 PM – 6:45 PM

Characteristics of patients (pts) with muscle-invasive urothelial carcinoma (MIUC) who received adjuvant nivolumab (NIVO) or adjuvant platinum-based chemotherapy (CHEMO) in the real-world (RW) setting.

Alex Chehrazi-Raffle

Poster

Abstract #565

Poster Bd. #E14

Poster Session B: Urothelial Carcinoma

Friday, January 26

2:30 PM – 4:00 PM

 

 

All abstracts except late-breaking abstracts will be available on ASCO’s digital program at 5:00 PM Eastern Time (ET) on January 22, 2024. All late-breaking abstracts will be available on ASCO’s digital program at 10:00 AM ET on their day of presentation at the meeting.

 

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle.

 

Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

 

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

 

Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

 

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In September 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

 

About Yervoy

Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types.

 

INDICATIONS

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years of age and older with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years of age and older with unresectable or metastatic melanoma.

OPDIVO® is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.

OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

 

IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune- mediated adverse reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

 

Immune-Mediated Pneumonitis

OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune- mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune- mediated pneumonitis occurred in 7% (31/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune- mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%). In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune- mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis.

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO, including Grade 3 (n=1) and Grade 2 (n=12).

 

Immune-Mediated Colitis

OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%).

In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in 25% (115/456) of patients, including Grade 4 (0.4%), Grade 3 (14%) and Grade 2 (8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated colitis occurred in 9% (60/666) of patients, including Grade 3 (4.4%) and Grade 2 (3.7%).

Immune-Mediated Hepatitis and Hepatotoxicity

OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%).

In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%).

OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in 11% of patients.

 

Immune-Mediated Endocrinopathies

OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis.

Contacts

Bristol Myers Squibb

Media Inquiries:
media@bms.com

Investors:
investor.relations@bms.com

Read full story here

Categories
Business Culture Economics Government Lifestyle Local News News Now!

AACCNJ welcomes new management for two of its boards in 2024

TRENTON, N.J. —  The AACCNJ announced that Gary Mann, CEO of Jasfel Analytics, and Viviana Lamm, CEO of Risk Strategies, will serve as Chairman and Chair of the AACCNJ Board of Directors and Foundation Board of Directors, respectively.

 

Tammeisha Smith, CEO, Dunbar Center will serve as Vice Chair of the Board of Directors. The appointments were effective Jan. 1, 2024.

 

“I am truly honored and humbled to step into the role of Chairman of the Board. Stan Prater has been an exemplary steward and leader, and I extend my sincere gratitude to him,” said Gary Mann, CEO, Jasfel Analytics.

 

“As I assume this responsibility, I am mindful of the extraordinary work of John Harmon, Founder and CEO. Standing on the shoulders of both Stan and John, I am committed to building on their incredible legacy. Together, with the continued guidance of John, we will further advance and expand revenue generating opportunities and strategic relationships for African American businesses in New Jersey and beyond,” said Viviana Lamm, CEO, Risk Strategies.

 

“I am beyond honored, grateful and inspired to be a part of a forward moving organization that is driven by the triumph of a collective team of individuals that recognize diversity and difference yet having the ability to bring people together and create bridges between them. I intend to ensure active participation, encourage and give back to meet the commitment and common goals of our organization. I look forward to learning from our directors and board members as we forge forward.”

 

“As we look ahead, I am inspired by the collective strength and diversity of talent within our membership. I firmly believe that our success is interlinked with the success of every member,” said Tammeisha Smith, CEO, Dunbar Center.

 

“Therefore, I encourage active participation, constructive feedback, and a shared commitment to our common goals. Together, we will chart a course that not only sustains our present momentum but also paves the way for a brighter, more prosperous future.”

 

“We are grateful to former Chairman Stan Prater for his leadership to excellence, growth and sustainability over his tenure, he definitely made an impact on our organization,” said John E. Harmon, Sr., IOM, Founder, President, & CEO, AACCNJ.

 

“And to our incoming Chairman, Gary Mann, and Foundation Board Chair Lamm, and Vice Chair Smith, there remains a tremendous amount of work to be done and each of you possess the commitment and unique skills necessary to get the job done with excellence. I look forward to working with each of you to design strategies that will derive value for our members and those that invest in the mission of AACCNJ while concurrently contributing to the competitiveness of New Jersey.”

 

The official Changing of the Guard ceremony/reception will take place on Jan. 18th from 6 p.m. to 8 p.m. at the Lobby Club in Trenton, N.J. Members only, may register at www.aaccnj.com.

Categories
Business Culture Economics Education Environment Healthcare International & World Lifestyle News Now! Perspectives Science

Beauty Hype: World’s most expensive bird droppings better than Botox!

Better than Botox: Many celebrities swear by it – over 400 years old recipe

NEW YORK — It’s supposed to work better than Botox, and after just a few minutes, you look 10 years younger. The story about it from “Asami Geisha” goes back to the 17th century and comes from Japan.

 

On special farms, nightingales produce valuable feces. The songbirds are fed exclusively with plant seeds. The feces contain the urea known in cosmetics and the enzyme guanine.

 

The nightingales’ feces are disinfected by ultraviolet light and then ground into a fine powder. The effect on the skin is instantaneous, and you’re left with a peachy complexion.

 

More than 300 years ago, geishas used “Asami Geisha” very successfully to regenerate and rebuild their skin bleached with lead and zinc.

 

Numerous celebrities all over the world admire the radiant skin of Japanese women. “Asami Geisha” is a pure natural cosmetic and does not require any chemical additives.

 

But if you want to enjoy these valuable cosmetics, you have to dig deep into your pocket. 50 ml of “Asami Geisha” costs an incredible  Euro 490. This makes “Asami Geisha” by far the most expensive bird droppings in the world.

 

British journalist Claudia Cornell tested the cosmetics for Mail Online. Her conclusion: “Even after two days, my skin looked radiant, and my girlfriend thought I had had Botox injections. I’m more than satisfied with the result.”

Source:

https://www.dailymail.co.uk/femail/article-2641957/The-cringe-inducing-facial-The-good-news-beats-Botox-The-bad-news-birds-mess.html

 

More information can be found at: www.asamigeisha.com

Categories
Culture Entertainment News Lifestyle News Now! Perspectives

Whew lawd! The hottest celebrity thirst traps of the week include your faves

New year, new traps

 

Source: Jeff Kravitz/FilmMagic

 

Back at it again with the hottest thirst traps of the week amid trending celebrity headlines including Katt Williams’ internet-shattering interview with Shannon Sharpe, Halle Bailey and DDG revealing their baby boy “Halo,” Jonathan Majors getting roasted for calling Meagan Good his “Coretta,” and much more.

 

As promised, we’ve compiled swoon-worthy stunners (and our thirst-trappin’ celebrity faves) with Lori Harvey making her return to the series after seemingly rekindling her baeship with Damson Idris.

View this post on Instagram

A post shared by Lori Harvey (@loriharvey)

The soon-to-be 27-year-old shared photos from her latest tropical getaway on social media where super nosy fans noticed that the background in her photos was very similar to that in pics recently posted by Idris.

 

View this post on Instagram

Rumors of a reconciliation come just a couple months after the former couple confirmed their split to The Hollywood Reporter via a joint statement in November.

 

“We are at a point in our lives where our individual paths require our full attention and dedication,” the statement began. “We part ways remaining friends with nothing but love and respect for each other and the time we shared together.”

 

Just three weeks after announcing their breakup, the former couple was spotted at the Renaissance: A Film by Beyoncé premiere in Los Angeles.

 

According to reports from PEOPLE at the time, a source saw the two stars leaving the premiere “side by side.” They went on to say that “they didn’t look happy but looked together and exited that way.”

 

This week’s thirst trap compilation features Ashanti delivering heat along with Chlöe Bailey and Saweetie giving what needs to be gave.

 

There’s also big baddie energy from Daalischus, Jada Kingdom, and Kris Summers so we invite you to enjoy our latest collection of top-tier thirst traps on the flip.

 

 

— Bossip

Categories
Culture Government International & World News Now! Politics Regulations & Security Technology

Critics and tech firms worry UK’s Investigatory Powers Bill,  surveillance law undermines user privacy

—  Despite the protestations of industry and campaigners, ministers are whisking a new bill through parliament.

 

 

Laurie Clarke / Politico:

 

 

LONDON — The U.K. already has some of the most far-reaching surveillance laws in the democratic world. Now it’s rushing to beef them up even further — and tech firms are spooked.

 

Britain’s government wants to build on its landmark Investigatory Powers Act, a controversial piece of legislation dubbed the “snooper’s charter” by critics when introduced back in 2016.

 

PHOTO: The new legislation is triggering fresh alarm among both industry execs and privacy campaigners | Scott Barbour/Getty Images

 

That law — introduced in the wake of whistleblower Edward Snowden’s revelations of mass state surveillance — attempted to introduce more accountability into the U.K. intelligence agencies’ sprawling snooping regime by formalizing wide-ranging powers to intercept emails, texts, web history and more.

 

Now new legislation is triggering a fresh outcry among both industry execs and privacy campaigners — who say it could hobble efforts to protect user privacy.

 

Industry body TechUK has written to Home Secretary James Cleverly airing its complaints. The group’s letter warns that the Investigatory Powers (Amendment) Bill threatens technological innovation; undermines the sovereignty of other nations; and could unleash dire consequences if it sets off a domino effect overseas.

 

Tech companies are most concerned by a change that would allow the Home Office to issue notices preventing them from making technical updates that might impede information-sharing with U.K. intelligence agencies.

 

TechUK argues that, combined with pre-existing powers, the changes would “grant a de facto power to indefinitely veto companies from making changes to their products and services offered in the U.K.”

 

“Using this power, the government could prevent the implementation of new end-to-end encryption, or stop developers from patching vulnerabilities in code that the government or their partners would like to exploit,” Meredith Whittaker, president of secure messaging app Signal, told POLITICO when the bill was first unveiled.

 

The Home Office, Britain’s interior ministry, remains adamant it’s a technical and procedural set of tweaks. Home Office Minister Andrew Sharpe said at the bill’s committee stage in the House of Lords that the law was “not going to … ban end-to-end encryption or introduce a veto power for the secretary of state … contrary to what some are incorrectly speculating.”

 

“We have always been clear that we support technological innovation and private and secure communications technologies, including end-to-end encryption,” a government spokesperson said. “But this cannot come at a cost to public safety, and it is critical that decisions are taken by those with democratic accountability.”

 

Encryption threat

Despite the protestations of industry and campaigners, the British government is whisking the bill through parliament at breakneck speed — risking the ire of lawmakers.

 

Ministers have so far blocked efforts to refine the bill in the House of Lords, the U.K.’s upper chamber. But there are more opportunities to contest the legislation coming and industry is already making appeals to MPs in the hopes of paring it back in the House of Commons.

 

PHOTO: Some companies including Apple have threatened to pull their services from the UK if asked to undermine encryption under Britain’s laws | Feline Lim/Getty Images

 

“We stress the critical need for adequate time to thoroughly discuss these changes, highlighting that rigorous scrutiny is essential given the international precedent they will set and their very serious impacts,” the TechUK letter states.

 

The backdrop to the row is the fraught debate on encryption that unfolded during the passage of the earlier Online Safety Act, which companies and campaigners argued could compel companies to break encryption in the name of online safety.

 

The bill ultimately said that the government can call for the implementation of this technology when it’s “technically feasible” and simultaneously preserves privacy.

 

Apple, WhatsApp and Signal have threatened to pull their services from the U.K. if asked to undermine encryption under U.K. laws.

 

Since the Online Safety Act passed in November, Meta announced that it had begun its rollout of end-to-end encryption on its Messenger service.

 

In response, Cleverly issued a statement saying he was “disappointed” that the company had gone ahead with the move despite repeated government warnings that it would make identifying child abusers on the platform more difficult.

 

Critics see a pincer movement. “Taken together, it appears that the Online Safety Bill’s Clause 122 is intended to undermine existing encryption, while the updates to the IPA are intended to block further rollouts of encryption,” said Whittaker.

Beyond encryption

In addition to the notice regime, rights campaigners are worried that the bill allows for the more permissive use of bulk data where there are “low or no” expectations of privacy, for wide-ranging purposes including training AI models.

 

Lib Dem peer Christopher Fox argued in the House of Lords that this “creates an essentially new and essentially undefined category of information” which marks “a departure from existing privacy law,” notably the Data Protection Act.

 

Director of campaign group Big Brother Watch, Silkie Carlo, also has issues with the newly invented category. With CCTV footage or social media posts for example, people may not have an expectation of privacy, “[but] that’s not the point, the point is that that data taken together and processed in a certain way, can be incredibly intrusive.”

 

Big Brother Watch is also concerned about how the bill deals with internet connection records — i.e. web logs for individuals for the last 12 months. These can currently be obtained by agencies when specific criteria is known, like the person of interest’s identity. Changes to the bill would broaden this for the purpose of “target discovery,” which Big Brother Watch characterizes as “generalized surveillance.”

 

Members of the House of Lords are also worried about the bill’s proposal to expand the number of people who can sanction spying on parliamentarians themselves. Right now, this requires the PM’s sign-off, but under the bill, the PM would be able to designate deputies for when he is not “available.” The change was inspired by the period in which former PM Boris Johnson was incapacitated with COVID-19.

 

PHOTO: The bill will return to the House of Lords on January 23, before heading to the House of Commons to be debated by MPs | Tolga Akmen/AFP via Getty Images

“The purpose of this bill is to give the intelligence agencies a bit of extra agility at the margins, where the existing Rolls Royce regime is proving a bit clunky and bureaucratic,” argues David Anderson, crossbench peer and author of a review that served as a blueprint for the bill. “If you start throwing in too many safeguards, you will negate that purpose, and you will not solve the problem that bill is addressing.”

 

Anderson proposed the changes relating to spying on MPs and peers are necessary “if the prime minister has got COVID, or if they’re in a foreign country where they have no access to secure communications.”

 

This could even apply in cases where there’s a conflict of interest because spies want to snoop on the PM’s relatives or the PM himself, he added.

 

Amendments proposed by peers at the committee stage were uniformly rejected by the government.

 

The bill will return to the House of Lords for the next stage of the legislative process on January 23, before heading to the House of Commons to be debated by MPs.

 

“Our overarching concern is that the significance of the proposed changes to the notices regime are presented by the Home Office as minor adjustments and as such are being downplayed,” reads the TechUK letter.

 

“What we’re seeing across these different bills is a continual edging further towards … turning private tech companies into arms of a surveillance state,” says Carlo.

 

 

 

— Techmeme