City and state officials are trying to recover millions from quick deals made during the worst weeks of the pandemic this spring.
— NYT: Top Stories
Author: Michelle Dryden
“Little People, Big World” star Jacob Roloff has accused producer Chris Cardamone of molesting him after “a long grooming process.”
— FOX News
Part of the Black Arts Movement in the 1960s, part of a Biden campaign ad in 2020, she has never stopped writing.
— NYT: Top Stories
The ruling reduced a four-year ban to two, but will keep Russian teams out of the next two Olympics and dozens of other global competitions.
— NYT: Top Stories
Application Based on Overall Survival and Progression-Free Survival Data Comparing KEYTRUDA Plus Chemotherapy to Chemotherapy Alone From Pivotal Phase 3 KEYNOTE-590 Trial
KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum and fluoropyrimidine based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus and gastroesophageal junction (GEJ). This sBLA is based on data from the pivotal Phase 3 KEYNOTE-590 trial, in which KEYTRUDA plus chemotherapy demonstrated significant improvements in the primary endpoints – overall survival (OS) and progression-free survival (PFS) – versus chemotherapy in these patients regardless of PD-L1 expression status and tumor histology. These data were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of April 13, 2021.
“Patients with newly diagnosed esophageal and GEJ cancer face an aggressive disease with a poor prognosis, despite the currently available treatment options,” said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories. “We look forward to working with the FDA to bring a new option to patients in the first-line setting.”
KEYTRUDA is currently approved in the U.S., China and Japan as monotherapy for the second-line treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10). Merck is continuing to study KEYTRUDA across multiple settings and stages of gastrointestinal cancer – including gastric, hepatobiliary, esophageal, pancreatic, colorectal and anal cancers – through its broad clinical program.
About KEYNOTE-590
KEYNOTE-590 is a Phase 3, randomized, double-blind trial (ClinicalTrials.gov, NCT03189719) evaluating KEYTRUDA in combination with platinum and fluoropyrimidine based chemotherapy versus placebo plus chemotherapy (cisplatin plus 5-fluorouracil [5-FU]) for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus and GEJ. The major efficacy outcome measures were OS and PFS. Additional efficacy outcome measures were objective response rate and duration of response. The study enrolled 749 patients who were randomized to receive either:
- KEYTRUDA (200 mg intravenously [IV] on Day 1 of each three-week cycle for up to 35 cycles); plus cisplatin (80 mg/m2 IV on Day 1 of each three-week cycle for up to six cycles); plus 5-FU (800 mg/m2 IV per day on Day 1 to Day 5 of each three-week cycle, or per local standard for 5-FU administration, for up to 35 cycles); or
- Placebo; plus cisplatin (80 mg/m2 IV on Day 1 of each three-week cycle for up to six cycles); plus 5-FU (800 mg/m2 IV per day on Day 1 to Day 5 of each three-week cycle, or per local standard for 5-FU administration, for up to 35 cycles).
About Esophageal Cancer
Esophageal cancer, a type of cancer that is particularly difficult to treat, begins in the inner layer (mucosa) of the esophagus and grows outward. The two main types of esophageal cancer are squamous cell carcinoma and adenocarcinoma. Esophageal cancer is the seventh most commonly diagnosed cancer and the sixth leading cause of death from cancer worldwide. Globally, it is estimated there were more than 572,000 new cases of esophageal cancer diagnosed and nearly 509,000 deaths resulting from the disease in 2018. In the U.S. alone, it is estimated there will be nearly 18,500 new cases of esophageal cancer diagnosed and more than 16,000 deaths resulting from the disease in 2020.
About KEYTRUDA® (pembrolizumab) Injection, 100 mg
KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,300 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.
Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.
Melanoma
KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.
KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
Non-Small Cell Lung Cancer
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
Small Cell Lung Cancer
KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Head and Neck Squamous Cell Cancer
KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) ≥1] as determined by an FDA-approved test.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
Classical Hodgkin Lymphoma
KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.
Primary Mediastinal Large B-Cell Lymphoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.
Urothelial Carcinoma
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (CPS ≥10), as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
Microsatellite Instability-High or Mismatch Repair Deficient Cancer
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
- solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
- colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.
Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer
KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).
Gastric Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Esophageal Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.
Cervical Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Hepatocellular Carcinoma
KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Merkel Cell Carcinoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Renal Cell Carcinoma
KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
Tumor Mutational Burden-High
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.
Cutaneous Squamous Cell Carcinoma
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
Triple-Negative Breast Cancer
KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Selected Important Safety Information for KEYTRUDA
Severe and Fatal Immune-Mediated Adverse Reactions
KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment.
Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. 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 KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, 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 adverse reactions are not controlled with corticosteroid therapy.
Immune-Mediated Pneumonitis
KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.
Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients, 42% of these patients interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.
Immune-Mediated Colitis
KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus 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. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.
Hepatotoxicity and Immune-Mediated Hepatitis
KEYTRUDA as a Single Agent
KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.
KEYTRUDA with Axitinib
KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen, which was at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT ≥3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT ≥3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT ≥3 ULN subsequently recovered from the event.
Immune-Mediated Endocrinopathies
Adrenal Insufficiency
KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.
Hypophysitis
KEYTRUDA can cause immune-mediated hypophysitis. 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 indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.
Thyroid Disorders
KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.
Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism.
Type 1 Diabetes Mellitus (DM), Which Can Present With D
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Peter Billingsley is dishing on a little-known secret from the set of “A Christmas Story.”
— FOX News
Surrounded by Army cadets, President Donald Trump watches the first half of the 121st Army-Navy Football Game in Michie Stadium at the United States Military Academy, Saturday, Dec. 12, 2020, in West Point, N.Y. (AP Photo/Andrew Harnik)
WASHINGTON (AP) — President Donald Trump is considering pushing to have a special counsel appointed to advance a federal tax investigation into the son of President-elect Joe Biden, setting up a potential showdown with incoming acting attorney general Jeffrey Rosen.
Trump — angry that out-going Attorney General William Barr didn’t publicly announce the ongoing, two-year investigation into Hunter Biden — has consulted on the matter with White House chief of staff Mark Meadows, White House counsel Pat Cipollone and outside allies.
That’s according to several Trump administration officials and Republicans close to the White House who spoke to The Associated Press on condition of anonymity to discuss private matters.
Beyond appointing a special prosecutor to investigate the younger Biden, the sources said Trump is interested in having another special counsel appointed to look into his own baseless claims of election fraud. But if he’s expecting his newly named acting attorney general to go further than Barr on either matter, he could end up quickly disappointed.
Barr on Monday evening announced he will resign effective next week, revealing his plans about a week after Hunter Biden publicly disclosed that he was under investigation related to his finances. It is generally Justice Department policy not to disclose investigations that are in progress, though the subjects of those investigations can.
Rosen, the deputy attorney general, will step into the Justice Department’s top job in an acting role. A longtime litigator, he has served as Barr’s top deputy since May 2019 but largely shies away from the spotlight. He said in a statement Tuesday he was “honored” to serve and “will continue to focus on the implementation of the Department’s key priorities.”
Trump is still weighing his options, considering whether to pressure Rosen to make the special counsel appointment or, if needed, to replace the acting attorney general with someone more likely to carry out his wishes. He has even asked his team of lawyers, including personal attorney Rudy Giuliani, to look into whether the president has the power to appoint a special counsel himself.
A key question will be whether Rosen can stand up to presidential pressure — and potentially withering attacks — in the waning weeks of the Trump administration. If not, Rosen could be cast aside in favor of others more willing to do Trump’s bidding.
Believing that a special counsel probe could wound a Biden administration before it even begins, Trump aides have urged the president to push for one, which would make it so the investigation can’t be easily stopped by the incoming president. No firm decision has been made.
Trump announced that Barr would be stepping down from his position on Dec. 23, amid lingering tension between the president and the attorney general over the Hunter Biden investigation. Trump was angry for days after learning that Barr knew of the Hunter Biden tax investigation before the election but did not disclose it.
He also was unhappy that Barr said in a widely reported interview with the AP that the Justice Department had not uncovered widespread election fraud that would have affected the results of the election.
For much of his tenure, Barr was perceived as one of the president’s most loyal Cabinet members, especially after he framed the results of Robert Mueller’s Russia investigation in a manner favorable to Trump even though the special counsel did not exonerate the president of obstruction of justice. It was Barr who first appointed a U.S. attorney to review the case against former national security adviser Michael Flynn and then sought to dismiss the criminal charges against Flynn, who twice pleaded guilty to lying to the FBI.
As Barr exits, the biggest thing by far hanging over the Trump Justice Department is its investigation into Hunter Biden, which involves multiple U.S. attorney offices and FBI field offices. Appointing a special counsel could prove to be complicated, requiring consolidating different investigatory angles and bringing in someone new to run the probe and get up to speed.
Under federal regulations, a special counsel can be fired only by the attorney general and for specific reasons such as misconduct, dereliction of duty or conflict of interest — reasons that must be spelled out in writing. Appointing a special counsel for the Hunter Biden probe would also signal a more prolonged and complicated investigation than the current inquiry, so far largely centered on his taxes. A subpoena seeking documents from the younger Biden asked for information related to more than two dozen entities, including Ukraine gas company Burisma.
Either way, the probe is complicating Joe Biden’s pick for attorney general, upon whose shoulders this probe would land. Any nominee for attorney general is likely to face a mountain of questions at a confirmation hearing about how they would oversee the probe.
It could be that Rosen is left in the position for a few weeks after Biden is sworn in on Jan. 20. If Trump doesn’t fire him, that is.
Rosen has been the public face of some of the Justice Department’s biggest actions, including its antitrust case against Google and the criminal case against opioid maker Purdue Pharma. Before joining the Justice Department, he worked at the Department of Transportation as general counsel and then deputy secretary.
At Rosen’s confirmation hearing in 2019, he suggested that he was willing to rebuff political pressure from the White House, if necessary. He told legislators that criminal investigations should “proceed on the facts and the law” and that prosecutions should be “free of improper political influences.”
“If the appropriate answer is to say no to somebody, then I will say no,” he said at the time.
— Associated Press
Election-related falsehoods have subsided, but misleading claims about the coronavirus vaccines are surging — often spread by the same people.
— NYT: Top Stories
The guard tower stands near the Colorado Department of Corrections Denver Reception and Diagnostic Center Tuesday, Dec. 8, 2020, in east Denver. Amber Johnson of Fayetteville, Ark., is fighting for vaccination against the coronavirus for her 63-year-old father, Ronald, who is an inmate in the prison. (AP Photo/David Zalubowski)
DENVER (AP) — Amber Johnson is terrified her 63-year-old father will get the coronavirus. He has high blood pressure, asthma and is pre-diabetic, and she worries he’s especially vulnerable as an inmate in Colorado, where outbreaks in prisons are raging.
Prisons across the U.S. have been hit hard by COVID-19. Social distancing is virtually impossible behind bars: inmates sleep in close quarters and share bathrooms. Masks, hygiene supplies and safety protocols are often lacking, and many inmates have health problems that make them susceptible to the virus.
Johnson believes a vaccine might be the only hope for her father, Ronald Johnson, who is serving time for theft, forgery and drug possession.
But in Colorado and most other states, prisoners aren’t near the front of the line for initial doses of COVID-19 vaccine now being distributed. Health care workers and nursing home residents are getting the first wave of shots, and many argue that those who break the law — despite living in conditions that put them at risk — shouldn’t be a priority when many others are vulnerable.
“To think about him dying in prison is an awful thought because from what I’ve heard, if you have a loved one who dies in prison, you just kind of get the remains in a box. They cremate them and send them home,” Amber Johnson said. “You don’t have the opportunity to sit by them and hold their hand.”
Initially, Colorado had inmates in the second phase of vaccine distribution, set for the spring, behind health workers and first responders but ahead of other adults over 65 with health conditions. Prisoners were to be treated like others in group housing, including homeless shelters and college dorms.
But an outcry followed. Suburban Denver prosecutor George Brauchler said the plan would have allowed two men convicted of killing the son of 66-year-old state Sen. Rhonda Fields to be vaccinated before her.
“The people who murdered her son would get it before she would,” Brauchler said.
Democratic Gov. Jared Polis bowed to criticism last week, updating the plan to prioritize age and health risks over where people live. Jail staffers will still get the vaccine in the second phase, along with first responders.
“Whether you’re in prison or not, if you’re 67 years old or at risk, wherever you are, you’ll have access to the vaccine when 67-year-old’s have access to vaccines,” Polis said.
Though Colorado changed course, California, North Carolina, Maryland, Delaware, Utah, New Mexico, Nebraska, Montana and Massachusetts have prisoners among the first to get the vaccine this winter. Some states also have taken steps to reduce COVID-19 risks behind bars by releasing nonviolent offenders early.
But even in states with the biggest prison outbreaks, inmates often weren’t on early vaccine distribution plans.
The five states with the highest number of coronavirus cases in their prisons, according to data compiled as part of a joint project by The Associated Press and The Marshall Project — Texas, California, Florida, Michigan and Wisconsin — did not include details about how they would prioritize prisoners in their October draft reports to the Centers for Disease Control and Prevention.
Michigan has decided to treat prisoners like everyone else, vaccinating them based on their age and health problems and not prioritizing them as a group. Jail and prison workers, however, are set to be vaccinated along with other essential workers before people 65 and older or those 16 and 64 with conditions like heart disease and diabetes that can worsen COVID-19, according to a state plan updated Sunday.
Wisconsin is still deciding which groups should get shots after its first wave of vaccinations. Texas likely will consider prisoners along with other vulnerable populations, but plans are unclear.
Iowa, another state with high prison infection rates, plans to put inmates and those who live in state institutions for the disabled ahead of others but behind health care workers and nursing-home residents and staff.
The federal prison system — one of the first government agencies to receive the vaccine — plans to administer initial vaccines to staff, not inmates, according to documents obtained by the AP.
For families of inmates, the uncertainty is gut-wrenching. They’re pleading with state officials to consider the transmission risks behind bars. Medical experts also have suggested that living arrangements in prisons call for higher priority.
“From a public health perspective, it’s also really important because what we’ve seen is they are hot spots,” said Maria Morris, senior staff attorney at the American Civil Liberties Union’s National Prison Project. “And people are coming and going out of prison. There’s no way to avoid that.”
That includes officers, administrative staff, lawyers and medical and mental health workers.
More than 249,000 inmates have tested positive and nearly 1,700 have died from COVID-19 nationwide. At a prison in Colorado last week, nearly three-quarters of inmates caught the virus.
Meanwhile, the ACLU of Colorado has been fighting for early release for some prisoners to lower their risk. Ronald Johnson has served 22 years and got his parole moved up to 2027, but his daughter worries that’s still too far away.
Amber Johnson said her father is a nonviolent offender who has sobered up, tutors other inmates, helps in the prison church and coordinates mental health courses. She says he deserves a chance to live — and that, for her, means a vaccine.
“The time is now,” said Johnson, who lives in Fayetteville, Arkansas. “It needs to be done urgently before somebody else dies — and somebody else will.”
— Associated Press
Environmental goals build on previously announced D&I commitments to enhance the company’s enterprise ESG efforts
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced it is strengthening its commitment to environmental sustainability on a global basis by setting new 2030 and 2040 goals. By 2030, the company will purchase 100% of the electricity it uses from renewable sources, and by 2040, it will be carbon neutral in its Scope 1 (direct) and Scope 2 (indirect) emissions and reach the targets of equitable water use, zero waste to landfill and 100% electric vehicles in its fleet.
These new environmental goals are in line with Bristol Myers Squibb’s strategy to leverage sustainability to drive innovation, build resiliency and manage non-financial risks across its operations and portfolio. Today’s announcement builds upon this year’s $300 million combined investment by Bristol Myers Squibb and the Bristol Myers Squibb Foundation in a series of commitments to Diversity & Inclusion and Health Equity, further enhancing the company’s efforts on environmental, social and governance (ESG) issues.
In addition to setting new 2030 and 2040 goals, Bristol Myers Squibb commits to set approved science-based emissions reductions targets in alignment with the Science Based Targets Initiative as a key step in the roadmap to delivering these environmental commitments.
“As a leading global biopharma company dedicated to transforming patients’ lives through science, we understand our responsibility to create maximum positive impact while minimizing our environmental footprint. Now, after 20 years of setting global sustainability goals, we are honing our focus to continue to reduce our energy consumption and greenhouse gas (GHG) emissions, improve water use and reduce waste,” said Danielle Menture, vice president of Sustainability, EHS and Occupational Health. “Along with announcing these goals, we commit to increased transparency in reporting our progress to internal and external stakeholders.”
Bristol Myers Squibb has a longstanding commitment to environmental sustainability. The company has been a signatory to the UN Global Compact (UNGC) for more than a decade, and has been reporting in alignment with the Global Reporting Initiative (GRI) framework since 2010. As part of its enhanced focus on transparency, the company will expand its reporting to include additional validated ESG frameworks such as SASB and TCFD, and publish ESG updates annually beginning in 2021.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram.
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