Author: Michelle Dryden

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International & World

Saudi prince strongly criticizes Israel at Bahrain summit

FILE – In this Nov. 24, 2018 file photo, Saudi Prince Turki al-Faisal talks to The Associated Press in Abu Dhabi, United Arab Emirates. Turki harshly criticized Israel on Sunday, Dec. 6, 2020, at a Bahrain security summit that was remotely attended by Israel’s foreign minister. (AP Photo/Kamran Jebreili, File)

 

DUBAI, United Arab Emirates (AP) — A prominent Saudi prince harshly criticized Israel on Sunday at a Bahrain security summit that was remotely attended by Israel’s foreign minister, showing the challenges any further deals between Arab states and Israel face in the absence of an independent Palestinian state.

The fiery remarks by Prince Turki al-Faisal at the Manama Dialogue appeared to catch Israel’s foreign minister off guard, particularly as Israelis receive warm welcomes from officials in Bahrain and the United Arab Emirates following agreements to normalize ties.

Left unresolved by those deals, however, is the decades-long conflict between Israel and the Palestinians. The Palestinians view those pacts as a stab in the back from their fellow Arabs and a betrayal of their cause.

Prince Turki opened his remarks by contrasting what he described as Israel’s perception of being “peace-loving upholders of high moral principles” versus what he described as a far-darker Palestinian reality of living under a “Western colonizing” power.

Israel has “incarcerated (Palestinians) in concentration camps under the flimsiest of security accusations — young and old, women and men, who are rotting there without recourse to justice,” Prince Turki said. “They are demolishing homes as they wish and they assassinate whomever they want.”

The prince also criticized Israel’s undeclared arsenal of nuclear weapons and Israeli governments “unleashing their political minions and their media outlets from other countries to denigrate and demonize Saudi Arabia.”

The prince reiterated the kingdom’s official position that the solution lies in implementing the Arab Peace Initiative, a 2002 Saudi-sponsored deal that offers Israel full ties with all Arab states in return for Palestinian statehood on territory Israel captured in 1967.

He added: “You cannot treat an open wound with palliatives and pain killers”

Israeli Foreign Minister Gabi Ashkenazi, who spoke immediately after Prince Turki, said: “I would like to express my regret on the comments of the Saudi representative.”

“I don’t believe that they reflect the spirit and the changes taking place in the Middle East,” he said.

The confrontation and a later back-and-forth between Prince Turki and a confidant of Israeli Prime Minister Benjamin Netanyahu during the summit highlighted continued widespread opposition to Israel by many inside Saudi Arabia, despite some state-backed efforts to promote outreach with Jewish groups and supporters of Israel.

Ashkenazi, meanwhile, reiterated Israel’s position that it is the Palestinians who are to be blamed for not reaching a peace deal.

“We have a choice here with the Palestinians whether to solve it or not, or to go to this blame game,” said Ashkenazi, an ally of Netanyahu’s chief rival, Benny Gantz.

Dore Gold, a Netanyahu confidant and former U.N. ambassador in the audience, implied Prince Faisal’s remarks were “accusations of the past — many of which are false.” The prince later brought up Gold’s previous television appearances “denigrating the kingdom and using the most vile descriptions.”

“I think Mr. Dore Gold should be the last one to talk about having previous beliefs and positions here,” the prince said.

Prince Turki led Saudi intelligence for more than 20 years and served as ambassador to the U.S. and United Kingdom. Though he now holds no official position, his stance is seen as closely mirroring that of King Salman. However, the king’s assertive son, the 35-year-old Crown Prince Mohammed bin Salman, is seen having a greater willingness to quietly engage with Israel to counter common rival, Iran, and boost foreign investment in the kingdom.

Bahraini Foreign Minister Abdullatif al-Zayani, also on stage for the tense exchanges, sought to smooth over the differences in his remarks. Still, he too stressed the importance of a resolution to the Palestinian-Israeli conflict based on a two-state solution as envisaged by the Arab Peace Initiative.

“The path of peace is not an easy ride. There will be a lot of obstacles along the way,” he said. “There will be ups and downs. But the bedrock of that path, the path of peace, is the Israeli-Palestinian issue.”

In an apparent reference to Iran, al-Zayani added that a resolution to the conflict would also remove the pretext to justify some of the threats made to regional security.

 

— Associated Press

Categories
International & World

UK gears up for huge vaccination plan watched by the world

Nurses at the Royal Free Hospital, London, simulate the administration of the Pfizer vaccine to support staff training ahead of the rollout, in London, Friday Dec. 4, 2020. (Yui Mok/Pool Photo via AP)

 

LONDON (AP) — The coronavirus vaccine developed by American drugmaker Pfizer and Germany’s BioNTech was being sent to hospitals across the U.K. in super-cold containers on Sunday, two days ahead of the kickoff of Britain’s biggest-ever immunization program, one being closely watched around the world.

Around 800,000 doses of the vaccine are expected to be in place for the start of the rollout on Tuesday, a day that British Health Secretary Matt Hancock has reportedly dubbed as “V-Day,” a nod to triumphs in World War II.

“Despite the huge complexities, hospitals will kickstart the first phase of the largest scale vaccination campaign in our country’s history from Tuesday,” said Professor Stephen Powis, NHS England’s national medical director. “The first tranche of vaccine deliveries will be landing at hospitals by Monday in readiness.”

Last week the U.K. became the first country to authorize the Pfizer-BioNtech vaccine for emergency use. In trials, the vaccine was shown to have around 95% efficacy. Vaccinations will be administered starting Tuesday at around 50 hospital hubs in England. Scotland, Wales and Northern Ireland will also begin their vaccination rollouts the same day.

Governments and health agencies around the world will be monitoring the British vaccination program to note its successes and failures and adjust their own plans accordingly. The United States hopes to start vaccinations later this month. British regulatory authorities are also examining data on vaccines made by Moderna and AstraZeneca-Oxford University.

Russia on Saturday began vaccinating thousands of doctors, teachers and others at dozens of centers in Moscow with its Russian-made Sputnik V vaccine, which was approved over the summer after being tested in only a few dozen people.

The excitement in Britain, which has Europe’s highest virus-related death toll at more than 61,000, was palpable.

“This coming week will be an historic moment as we begin vaccination against COVID-19,” said Hancock.

Full Coverage: Coronavirus pandemic

Patients aged 80 and above who are already attending hospitals as outpatients and those being discharged after a stay in the hospital will be among the first to receive the jab in Britain. Hospitals will also start inviting over 80s in for a vaccine shot and will work with nursing homes to book staff into vaccination clinics. Any appointments not taken up will be offered to those health workers deemed to be at the highest risk of serious illness from COVID-19. Everyone who is vaccinated will need a booster jab 21 days later.

Buckingham Palace refused to comment on speculation that Queen Elizabeth II, 94, and her 99-year-old husband, Prince Philip, will be vaccinated within weeks and then make it public, a move that could reassure anyone nervous about getting a vaccination.

“Our goal is totally to protect every member of the population, Her Majesty, of course, as well,” Dr. June Raine, chief executive of Britain’s Medicines and Healthcare products Regulatory Agency, which authorized the vaccine, told the BBC.

The U.K. has secured 40 million doses of the Pfizer vaccine, which can cover 20 million people. Since the British government will only immunize people over 16, around 55 million people in the U.K. will be eligible.

Now that the first tranche of the vaccine has arrived from Pfizer’s manufacturing plant in Belgium, checks are being conducted by a specialist medical logistics company to ensure there was no damage in transit. This could take up to a day.

Each box containing the vaccines, which includes five packs of 975 doses, will need to be opened and unpacked manually at specially licensed sites. After that, the vaccines will then be made available to hospitals.

Delivering the Pfizer-BioNTech vaccine is complicated because it needs to be stored at super-chilled temperatures: about minus 70 degrees Celsius (minus 94 degrees Fahrenheit). Fortunately, the vaccine is stable at normal refrigerator temperatures, between 2 and 8 degrees Celsius (35.6 to 46.4 F), for a few days, meaning it can be stored locally. After defrosting the vaccine, which takes a few hours, additional time is required to prepare it to be given in a shot.

Public Health England has secured 58 special Twin Guard ultra-low temperature freezers that provide sufficient storage for approximately five million doses. The fridges, which are not portable, each hold around 86,000 doses.

The vaccine won’t just be provided by hospitals. Local doctors’ offices and other local health care centers are being put on standby to start delivering the vaccine, with a small number expected to do so the week of Dec. 14. More medical practices in more parts of the country will be phased in during December and in the coming months.

Vaccination centers treating large numbers of patients in sports areas and conference centers will subsequently emerge when further supplies of the Pfizer vaccine or other vaccines come on stream. Local pharmacies will later be able to offer the jabs as they do with annual influenza shots.

Although nursing home residents top the prioritization list given to the British government by the independent Joint Committee on Vaccination and Immunization, they won’t be getting the vaccinations straight away, as the vaccine packs of 975 doses cannot yet be divided.

The NHS hopes that authorities will soon approve a safe way of splitting up the dose packs so the vaccination shots can get to nursing homes during December.

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Follow AP coverage of the virus outbreak at https://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak

 

— Associated Press

Categories
Healthcare

Legend Biotech announces Phase 1b/2 study data of cilta-cel, an investigational BCMA CAR-T, showing early, deep, and durable responses in heavily pretreated patients with multiple myeloma

Combined Phase 1b/2 CARTITUDE-1 study presented at ASH 2020 Annual Meeting show 97 percent overall response rate and 12-month progression free survival rate of 77 percent at median follow up of 12.4 months

SOMERSET, N.J.–(BUSINESS WIRE)–Legend Biotech Corporation (NASDAQ: LEGN) (“Legend Biotech”), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today announced the latest data results from the combined Phase 1b/2 CARTITUDE-1 study (NCT03548207) of ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA) directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of patients with relapsed or refractory multiple myeloma (RRMM), sponsored by Janssen Research & Development, LLC. The data continued to show a very high overall response rate (ORR) that deepened over time, with 97 percent of patients achieving a response and 67 percent of patients achieving a stringent complete response (sCR) at a median follow-up of 12.4 months.1 The data were presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract #177) as an oral presentation.

“A 97 percent response rate is extraordinary when you consider the patient population who, prior to cilta-cel, have generally experienced low response rates,” said Deepu Madduri, M.D., Assistant Professor of Medicine, Hematology and Medical Oncology, Tisch Cancer Institute at Mount Sinai, New York, and principal CARTITUDE-1 study investigator. “Considering the early, deep and durable responses that we’ve seen at low-dose infusion of cilta-cel and its manageable safety profile, we look forward to further studying outpatient administration of cilta-cel in patients with multiple myeloma in earlier settings.”

The trial included 97 patients treated with cilta-cel who received a median of six (range, 3-18) prior lines of therapy; 88 percent (n=85) were triple-refractory, 42 percent (n=41) were penta-refractory and 99 percent (n=96) were refractory to the last line of therapy.1 The median administered dose was 0.71×106 CAR+ viable T cells/kg and manufacturing of cilta-cel was successful for all patients. ORR per independent review was 97 percent, which included a sCR rate of 67 percent, very good partial response rate (VGPR) of 26 percent (VGPR or better, 93 percent) and partial response rate of 4 percent. Median time to first response was 1 month (range, 0.9-8.5) and responses were ongoing in 72 percent (n=70) of patients. Of 57 minimal residual disease (MRD) evaluable patients, 93 percent (n=53) were MRD negative at 10-5.1 Median progression-free survival (PFS) was not reached at median follow-up of 12.4 months (range, 1.5-24.9). The 12-month PFS rate was 77 percent (95 percent confidence interval [CI], 66-84) and the 12-month OS rate was 89 percent (95 percent CI, 80-94).1

The study also demonstrated a manageable safety profile for cilta-cel at the recommended Phase 2 dose.1 In the combined results, the most common hematologic adverse events (AEs) observed in the CARTITUDE-1 study were neutropenia (96 percent); anemia (81 percent); thrombocytopenia (79 percent); leukopenia (62 percent); and lymphopenia (53 percent).1 Cytokine release syndrome (CRS) of any grade was observed in 95 percent of patients, with a median duration of four days (range, 1-97), and 99 percent of which resolved within 14 days of onset. Of the 92 patients with CRS, most were Grade 1/2 (95 percent, n=87), 3 percent were Grade 3 (n=3), 1 percent was Grade 4 (n=1) and 1 percent was Grade 5 (n=1).1 The median onset of CRS was seven days (range, 1-12) post-infusion, with 89 percent (n=82) of patients experiencing CRS onset at day four or later, which is supportive of potential outpatient administration for cilta-cel. Total CAR-T cell neurotoxicity of any grade was observed in 21 percent (n=20) of patients, with Grade ≥3 neurotoxicity observed in 10 percent (n=10) of patients.1 Of these, Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) was observed in 16 patients and generally occurred concurrently with CRS; other neurotoxicities were observed in 12 patients and generally occurred after resolution of CRS and/or ICANS (eight patients experienced both ICANS and other neurotoxicities).1 ICANS events were resolved in all patients with a median time to recovery of four days (range, 1-12).1 Other neurotoxicities were resolved in six patients at a median time of 75 days (range, 2-160) and were not resolved in six patients (one with ongoing toxicity, one died from neurotoxicity and four died due to other causes).1 Fourteen deaths were reported during the study: five due to disease progression, three due to adverse events unrelated to treatment (acute myelogenous leukemia [n=2], pneumonia [n=1]) and six due to adverse events related to treatment (sepsis and/or septic shock [n=2], CRS/HLH [n=1], neurotoxicity [n=1], respiratory failure [n=1], and lung abscess [n=1]).1

“We are encouraged by the see strong results from the CARTITUDE-1 study showing the potential of our lead product candidate cilta-cel to be a transformative treatment option for patients living with relapsed or refractory multiple myeloma,” said Dr. Ying Huang, Chief Executive Officer and Chief Financial Officer of Legend Biotech. “We look forward to advancing this potentially life-saving treatment approach for patients in need.”

About CARTITUDE-1

CARTITUDE-1 (NCT03548207) is an ongoing Phase 1b/2, open-label, multicenter study evaluating the safety and efficacy of ciltacabtagene autoleucel in adults with relapsed or refractory multiple myeloma, 99 percent of whom were refractory to the last line of treatment; 88 percent of whom were triple-class refractory(to at least 1 immunomodulatory drug [IMiD], 1 proteasome inhibitor [PI] and 1 anti-CD38 antibody).

The primary objective of the Phase 1b portion of the study, involving 29 patients, was to characterize the safety and confirm the dose of ciltacabtagene autoleucel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2). The Phase 2 portion of the study, involving 68 additional patients, is evaluating the efficacy of ciltacabtagene autoleucel with overall response rate as the primary endpoint.

About Cilta-cel

Cilta-cel is an investigational chimeric antigen receptor T (CAR-T) cell therapy, formerly identified as JNJ-4528 outside of China and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and in earlier lines of treatment. The design consists of a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies. In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize cilta-cel. In addition to a Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a PRIority MEdicines (PRiME) designation from the European Commission in April 2019 and BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.2 Although treatment may result in remission, unfortunately, patients will most likely relapse. 3 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.4 Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy.5,6 While some patients with multiple myeloma have no symptoms until later stages of the disease, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.7 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options.8

About Legend Biotech

Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our team of over 800 employees across the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, provide us with the strong potential to discover, develop, and manufacture cutting-edge cell therapies for patients in need. We are engaged in a strategic collaboration to develop and commercialize our lead product candidate, ciltacabtagene autoleucel, an investigational BCMA targeted CAR-T cell therapy for patients with multiple myeloma. This candidate is currently being studied in registrational clinical trials. To learn more about Legend Biotech, visit us on LinkedIn, or on Twitter @LegendBiotech or at www.legendbiotech.com.

Cautions Concerning Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s clinical efforts, its collaboration to develop and commercialize cilta-cel, and the data relating to the CARTITUDE-1 study. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the factors discussed in the “Risk Factors” section of the prospectus filed with the Securities and Exchange Commission on June 8, 2020. Any forward-looking statements contained in this press release speak only as of the date hereof, and Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

The safety and efficacy of the product candidates and/or uses under investigation have not been established. There is no guarantee that the product candidates will receive health authority approval or become commercially available in any country for the uses being investigated.

________________________________

1 Madduri, D et al. Cartitude-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel, a B-Cell Maturation Antigen–Directed Chimeric Antigen Receptor T Cell Therapy, in Relapsed/Refractory Multiple Myeloma. Abstract #177. Oral Presentation at 2020 American Society of Hematology Annual Meeting.

2 American Society of Clinical Oncology. Multiple myeloma: introduction. Available at: https://www.cancer.net/cancer-types/multiple-myeloma/introduction. Accessed November 2020.

3 Abdi J, Chen G, Chang H, et al. Drug resistance in multiple myeloma: latest findings and new concepts on molecular mechanisms. Oncotarget. 2013;4:2186–2207.

4 National Cancer Institute. NCI dictionary of cancer terms: relapsed. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=45866. Accessed November 2020.

5 National Cancer Institute. NCI dictionary of cancer terms: refractory. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=350245. Accessed November 2020.

6 Richardson P, Mitsiades C, Schlossman R, et al. The treatment of relapsed and refractory multiple myeloma. Hematology Am Soc Hematol Educ Program. 2007:317-23.

7 American Cancer Society. Multiple myeloma: early detection, diagnosis and staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Accessed November 2020.

8 Kumar SK, Lee JH, Lahuerta JJ, et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012;26:149-57.

Contacts

For Media and Investor Relations inquiries, please contact:
Jessie Yeung, Head of Corporate Finance and Investor Relations, Legend Biotech

jessie.yeung@legendbiotech.com or investor@legendbiotech.com

Surabhi Verma, Manager of Investor Relations and Corporate Communications, Legend Biotech

Surabhi.verma@legendbiotech.com or media@legendbiotech.com

For Medical Affairs inquiries, please contact:
Tonia Nesheiwat, Executive Director, Medical Affairs, Legend Biotech

tonia.nesheiwat@legendbiotech.com or medicalinformation@legendbiotech.com

Categories
International & World

UK and EU leaders to hold crunch talks on post-Brexit ties

European Commission’s chief negotiator Michel Barnier wears a face mask as he leaves his hotel to head back to Brussels, in London, Saturday, Dec. 5, 2020. With less than one month to go before the U.K. exits the EU’s economic orbit, talks have been paused due to “significant divergences.” (AP Photo/Alberto Pezzali)

 

LONDON (AP) — British Prime Minister Boris Johnson and the European Union’s top official are set to discuss the state of play of post-Brexit trade discussions later Saturday after negotiators paused talks in light of their inability to bridge an array of differences.

With the discussions stuck over the same issues for months, Johnson and Ursula von der Leyen, the president of the EU’s executive European Commission, will see if there is a route to a deal.

With the U.K.’s post-Brexit transition period due to conclude at the end of the year, the discussions are clearly facing a crunch point, not least because of the necessary approvals required from both sides. Without an agreement in place, tariffs will end up being imposed on traded goods at the start of 2021.

Months of negotiations have produced agreement on a swath of issues, but serious differences remain over the “level playing field” — the standards the U.K. must meet to export into the bloc — and how future disputes are resolved. That’s key for the EU, which fears Britain will slash social and environmental standards and pump state money into U.K. industries, becoming a low-regulation economic rival on the bloc’s doorstep.

EU chief negotiator Michel Barnier and his British counterpart, David Frost, agreed Friday to “pause” negotiations while they brief political leaders.

“We will keep calm as always and if there is a way, still a way, we will see,” Barnier said Saturday morning outside a hotel in London before heading off to Brussels.

Though the U.K. left the EU on Jan. 31, it remains within the bloc’s tariff-free single market and customs union until the end of this year. A trade deal by then would ensure there are no tariffs and quotas on trade in goods between the two sides, but there would still be technical costs, partly associated with customs checks and non-tariff barriers on services.

Though both sides would suffer economically from a failure to secure a trade deal, most economists think the British economy would take a greater hit, at least in the near-term, as it is relatively more reliant on trade with the EU than vice versa.

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Follow all AP stories about Brexit and British politics at https://apnews.com/Brexit

 

— Associated Press

Categories
For Edit

The rise and fall of Carl Lentz, the celebrity pastor of Hillsong Church

A charismatic pastor helped build a megachurch favored by star athletes and entertainers — until some temptations became too much to resist.

— NYT: Top Stories

Categories
For Edit

NFL further limits player access to facilities amid virus

New Orleans Saints quarterback Jameis Winston (2) passes under pressure from San Francisco 49ers defensive end Kerry Hyder (92) and defensive end Arik Armstead (91) in the second half of an NFL football game in New Orleans, Sunday, Nov. 15, 2020. A day after he started and played 40 snaps against the Saints, the 49ers placed Armstead on the reserve-COVID-19 list. (AP Photo/Butch Dill)

 

The NFL is further limiting player access to team facilities as it attempts to enhance safety measures during the COVID-19 pandemic.

In a memo sent to the 32 clubs and obtained by The Associated Press, teams must close their facilities for two days after games, with some exceptions.

Beginning Monday, that all teams playing on a Sunday must close those facilities the next two days — except for clubs playing on the subsequent Thursday. Only players needing medical attention for injuries or in rehab programs may enter the team complex.

Coaches can access the facility but must work in their own offices and can’t conduct meetings except virtually.

Teams playing on Monday nights can next have players in their facilities on Thursday, and teams with Thursday night games must close the complex to players until Sunday.

“There are no exceptions to this prohibition,” the league wrote. “Approvals previously received for in-person meetings will not apply on these two days.”

Locker rooms and cafeterias must be closed during those days.

Tryouts will be permitted on those days with only “essential football personnel” attending. Players trying out for a team are subject to current testing rules.

Such arrangements were agreed to by the players’ union.

USA Today first reported the memo being sent to the clubs.

The NFL also is lifting the 62-player game travel limit for teams. Each team can determine how many players to take to road games, including practice squad players. That takes effect for this week’s games, and should help with filling out the 48-man roster in case of issues with the coronavirus on game days.

All players who attend games for both home and visiting teams and will be on the sideline or in a designated stadium space with other players and personnel must stay at the team hotel the night before the game.

NFL protocols have been adjusted constantly since training camps, with stiffer restrictions put in place in recent weeks as the nation undergoes a surge in the novel coronavirus.

The league had its second major outbreak in the last two weeks, with the Baltimore Ravens having at least two dozen people testing positive. That led to shuffling Baltimore games at Pittsburgh from Thanksgiving night to last Sunday, then to Tuesday and again to Wednesday, when the Steelers won 19-14.

“Finally,” the league wrote in the memo, “please remind all players and staff that gatherings among players and/or club staff of any number outside of the club facility are prohibited at all times pursuant to the intensive protocol.”

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More AP NFL: https://apnews.com/NFL and https://twitter.com/AP_NF

 

— Associated Press

Categories
For Edit

Pence comes to Georgia as calm before potential Trump storm

ATLANTA (AP) — Vice President Mike Pence is trying to help Republicans project a unified front in two high-stakes Senate runoffs as he campaigns in Georgia a day ahead of President Donald Trump’s potentially volatile visit to the state that will determine which party controls the Senate in January.

The vice president is campaigning Friday with Sens. David Perdue and Kelly Loeffler, with the GOP roiled by Trump’s continued denial of his own defeat and his baseless attacks that Republican officials in Georgia, including the governor and secretary of state, enabled widespread voter fraud on behalf of President-elect Joe Biden.

Pence navigated Trump’s refusal to concede as he rallied Republicans two weeks ago alongside Perdue and Loeffler. At two north Georgia rallies, he promised to fight for “every legal vote” but spent more time emphasizing the stakes of Senate control. But this time, Pence arrives as Georgia completes another recount of presidential ballots and with some of the president’s supporters – including lawyers once considered allies of the president’s re-election campaign – urging a boycott of Perdue’s and Loeffler’s Jan. 5 runoffs.

The vice president’s visit also comes on the same day that former President Barack Obama will appear in a virtual rally with the Democratic challengers, Jon Ossoff and Raphael Warnock, in a show of the kind of party unity that Republicans have difficulty fashioning with the president calling Gov. Brian Kemp “hapless” and dubbing Secretary of State Brad Raffensperger “an enemy of the people.”

Perdue and Loeffler have attempted to steer clear of the intraparty divide, calling for Raffensperger’s resignation but generally focusing more on the consequences of Senate control rather than questioning the outcome of the first round. But Republicans in Washington and Georgia nonetheless voiced concerns that Trump on Saturday will continue those lines of attack rather than focus his efforts on GOP enthusiasm in the second round.

“They are hyper aware of Trump’s latest comments and latest tweets and the negative impact it could be having,” said Republican donor Dan Eberhart of the senators’ advisers. “And those folks go to bed every night hoping there’s no Trump tweet while they sleep.”

White House press secretary Kayleigh McEnany dismissed any such concerns, though she certainly embraced the idea that Trump can make or break the runoffs for Republicans.

“The president’s presence in Georgia will push Sens. Loeffler and Perdue over the finish line,” she said Friday, noting that Republicans enjoyed their own turnout boost this fall to narrow House Democrats’ majority and defend Senate Republicans who’d been seen as vulnerable.

Republicans need one more seat to command a Senate majority that could counter a Biden presidency. Democrats need a sweep to force a 50-50 Senate and set up Vice President-elect Kamala Harris to tilt the chamber to Democrats as the tiebreaking vote.

Trump has tweeted in support of Perdue and Loeffler, but has spent more energy blasting Kemp and Raffensperger and suggesting, falsely, that the two officials have the legal authority to reverse Biden’s victory in Georgia. State law gives them no such option. Initial returns showed Biden with a lead of more than 14,000 votes out of about 5 million cast. An initial hand recount put Biden’s margin at about 12,500. As Pence arrived in the state, Georgia officials were in the final stages of a third count requested by Trump’s campaign.

Perdue and Loeffler greeted Pence together late Friday morning at Dobbins Air Reserve Base north of Atlanta before a scheduled event at the U.S. Centers for Disease Control and Prevention, where the vice president and the senators discussed the coronavirus pandemic and the development of vaccines. The trio will appear Friday afternoon at a rally in Savannah.

Demonstrating of Friday’s unity efforts, U.S. Rep. Doug Collins, Loeffler’s erstwhile GOP opponent in the Senate race, flew to Georgia with Pence and participated in a roundtable at CDC headquarters along with the two senators. Before the CDC roundtable, Collins, Loeffler and Perdue huddled in front of a bank of television cameras and photographers.

Kemp, a Trump supporter and at one time staunch ally, was not part of Pence’s public itinerary. But separately, the governor noted that Friday marked one year since he named Loeffler as his choice to fill the Senate vacancy created by Republican Sen. Johnny Isakson’s retirement.

“I’m proud of what Kelly has accomplished but there’s more work to be done,” Kemp said via his official Facebook page. “Let’s unite as Georgia conservatives and send Kelly Loeffler and David Perdue back to Washington.”

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Associated Press reporter Deb Riechmann contributed from Washington.

 

— Associated Press

Categories
Weather & Environment

California fire danger remains high even as winds ease

A firefighter battles a mulch and pallet fire burning out of control, fanned by Santa Ana winds in and around a recycling yard near Wilson Street and Fleetwood Drive in Riverside, Calif., Thursday, Dec. 3, 2020. Firefighters from both Riverside and San Bernardino County, along with assistance from Colton, Rialto and Riverside City Fire fought the blaze. (Will Lester/The Orange County Register via AP)

 

LOS ANGELES (AP) — Fire danger remained high Friday amid unpredictable wind gusts and dry conditions in Southern California, as crews made progress against blazes that burned several homes and injured two firefighters.

The region’s notorious Santa Ana winds decreased slightly but red flag warnings of extreme wildfire risk were in place into the weekend because of low humidity. After the weather calms in the southern part of the state, winds are expected to increase in Northern California starting Sunday, forecasters said.

Firefighters were still busy trying to contain a number of blazes south and east of Los Angeles. The biggest began late Wednesday as a house fire in Orange County’s Silverado Canyon that spread to dry brush by fierce winds. Some 25,000 people were ordered to flee their homes, although some evacuations orders were later lifted.

The fire grew to 10 square miles (26 square kilometers) and blanketed a wide area with smoke and ash. It was 10% contained as calmer conditions helped hundreds of firefighters who fought the flames on the ground and by air.

Two U.S. Forest Service firefighters were hospitalized after being hurt while battling the blaze, though it wasn’t known how the injuries occurred. One was treated for a leg injury and the other suffered bruising and both were released Wednesday night, the Forest Service said on Twitter.

Some residents said they didn’t receive evacuation alerts because Southern California Edison had shut off power as a precaution before the fire erupted, leaving them without cellphone service.

The fire was not far from the site of October’s Silverado Fire, which also forced thousands from their homes and left two firefighters critically burned.

Crews mostly tamed two small fires that prompted evacuations in Riverside County east of Los Angeles.

And to the south, a small blaze in San Diego County that threatened about 200 residences was fully contained Thursday after destroying one home and damaging six others in a neighborhood near El Cajon.

Santa Ana winds hit 50 mph (80.5 kph) to 85 mph (137 kph) at times throughout the region beginning Wednesday night.

Numerous studies have linked bigger wildfires in America to climate change from the burning of coal, oil and gas. Scientists have said climate change has made California much drier, meaning trees and other plants are more flammable.

The fires erupted as Southern California utilities cut the power to more than 100,000 customers to avoid the threat of winds knocking down or fouling power lines and causing wildfires — something that has sparked devastating fires in recent years.

Southern California Edison cut power to nearly 50,000 homes and businesses, including those in the area where the Bond Fire started, but as winds eased the utility began restoring electricity.

San Diego Gas & Electric’s precautionary blackouts affected around 73,000 customers at the peak.

California already has experienced its worst-ever year for wildfires. More than 6,500 square miles (16,835 square kilometers) have been scorched, a total larger than the combined area of Connecticut and Rhode Island. At least 31 people have been killed and 10,500 homes and other structures damaged or destroyed.

The latest fire threat comes as much of California plunges deeper into drought. Virtually all of Northern California is in severe or extreme drought while nearly all of Southern California is abnormally dry or worse.

___

Associated Press reporter Amy Taxin contributed from Orange County, California.

 

— Associated Press

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For Edit

Native Americans helped flip Arizona. Can they mobilize in Georgia?

Very few of Georgia’s more than 100,000 voting-age Native Americans cast ballots in November. Even a small increase could make a difference in the Senate runoffs.

— NYT: Top Stories

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Business

AM Best affirms credit ratings of Anthem, Inc. and its subsidiaries

OLDWICK, N.J.–(BUSINESS WIRE)–AM Best has affirmed the Financial Strength Rating (FSR) of A (Excellent) and the Long-Term Issuer Credit Ratings (Long-Term ICR) of “a+” of the core Blue Cross Blue Shield-branded insurance subsidiaries of Anthem, Inc. (Anthem) (Indianapolis, IN) [NYSE:ANTM]. Concurrently, AM Best has affirmed the Long-Term ICR of “bbb+”, the Long- and Short-Term Issue Credit Ratings (Long-Term IR; Short-Term IR) of Anthem and the Long-Term IR on the existing surplus notes of Anthem Insurance Companies, Inc. (Indianapolis, IN).

Furthermore, AM Best has affirmed the FSR of A- (Excellent) and the Long-Term ICRs of “a-” of the UNICARE Life & Health Group (UNICARE) and AMERIGROUP Health Companies (AMERIGROUP).

The outlook of these Credit Ratings (ratings) is stable. See below for detailed listing of the companies and Long-Term IRs.

The Blue Cross Blue Shield-branded entities, also referred to as Anthem Health Group (Anthem Health), are part of the core subsidiaries of Anthem. The ratings of Anthem Health reflect its balance sheet strength, which AM Best categorizes as very strong, as well as its strong operating performance, favorable business profile and appropriate enterprise risk management (ERM).

Anthem Health’s risk-adjusted capitalization is viewed as strongest, as measured by Best’s Capital Adequacy Ratio (BCAR). The Anthem Health entities comprise the main source of earnings and dividends for the parent organization, Anthem, with dividends from subsidiaries exceeding $3 billion in each of the past two years, and projected to be in line with these levels in 2020. The Anthem Health entities generally have been able to grow capital despite these dividend payments. Anthem Health’s reported underwriting results and net income in aggregate have been favorable with some fluctuations at the product and entity level. The Anthem Health entities have reported underwriting income of approximately $4 billion per year and net income of approximately $3 billion to $4 billion annually, with return on revenue in the 5-6% range and return on equity of approximately 30% in the past few years. The group has good product and geographic diversity, as Anthem operates Blue Cross Blue Shield plans in 14 states with excellent brand recognition and leading market share in the majority of its states. While there is geographic limitation to its business, based on the Blue Cross/Blue Shield licenses, the companies have a solid presence across its various product offerings, including small-mid-large and national accounts and the fully insured and self-insured segments, as well as through BlueCard.

Anthem Health’s ERM is managed by Anthem­ in conjunction with local oversight and involvement. Anthem has a well-established, developed ERM program that has a formalized governance structure and is considered appropriate for its risk profile. Risk identification and reporting are completed on a regular basis throughout the year and incorporated into the organization’s strategic planning process.

Anthem has strong and well-diversified revenue and earnings through its Blue Cross Blue Shield-branded entities in 14 states, as well as its non-Blue-branded entities under AMERIGROUP and UNICAREs, and has developed its integrated medical and pharmacy benefit management organization, Ingenio RX, which provides additional nonregulated income. Financial leverage at Anthem declined to approximately 38.5% as of the end of third-quarter 2020 and AM Best expects financial leverage to moderate slightly through a combination of eliminating existing debt and increases in shareholders’ equity. Earnings before interest and taxes interest coverage was adequate at 8.9 times for 2019, improving in each of the past two years. The holding company maintains ample liquidity with access to a $2.5 billion revolving-credit facility, a $1 billion, 364-day senior revolving credit facility, a $3.5 billion commercial paper program and access to the Federal Home Loan Bank through several of its insurance subsidiaries. However, AM Best considers Anthem’s goodwill plus intangibles to equity as high, at over 92%, through September 2020. Furthermore, AM Best acknowledges that a portion of the intangibles is the Blue Cross Blue Shield trademarks, which are required to operate as a Blue Cross Blue Shield-branded entity.

The ratings of Anthem Life Insurance Group (Anthem Life) reflect its balance sheet strength, which AM Best categorizes as strongest, as well as its strong operating performance, neutral business profile and appropriate ERM. Anthem Life has ample capital with all members adequately capitalized, and AM Best has assessed its risk-adjusted capital at the strongest BCAR level. While Anthem has taken dividends, none were taken in 2019, and capital expansion overall has not been hindered significantly. Anthem Life has produced favorable operating results, with some fluctuations, but the organization has typically reported double-digit returns on equity in the midteen range. The business written by this group is not a main focus for the overall organization and its product offerings complement those offered by Anthem Health, specifically in the employer group market.

The ratings of AMERIGROUP reflect its balance sheet strength, which AM Best categorizes as weak, as well as its strong operating performance, favorable business profile, appropriate ERM and its strategic importance to Anthem. On a consolidated basis, capitalization for the AMERIGROUP operating entities has increased to nearly $2 billion. Risk-adjusted capital, as measured by BCAR, improved in 2019, but remained weak. Capital measures improved incrementally in 2019, mainly due to retained earnings exceeding large dividends to the parent; however, these companies still have a weak level of risk-adjusted capital in support of their current business and investment risk. AM Best notes that Anthem is in a good capital position for the size of its operations and its financial flexibility, and has supported AMERIGROUP as needed. Additionally, the group produces very favorable operating results and is a material contributor to revenue, earnings and cash flow for its parent. AMERIGROUP has built excellent brand awareness and has solid enrollment in its core markets, and allows Anthem access to Medicaid markets outside of its core Blue Cross Blue Shield states.

The ratings of UNICARE reflect its balance sheet strength, which AM Best categorizes as adequate, as well as its adequate operating performance, limited business profile, appropriate ERM and support from as well as strategic importance to Anthem. On a consolidated basis, capital for the UNICARE operating entities increased significantly in 2019 due to a sizeable contribution from its parent combined with positive operating results. As a result, the companies’ risk-adjusted capital has improved dramatically in support of their current growing business and investment risk. Investments are conservative and provide sufficient liquidity to the group. UNICARE has produced good operating results in aggregate, although premiums and earnings have fluctuated widely. Earnings increased again through year-end 2019, as did business growth, mainly from assumed business. UNICARE is one of Anthem’s brands in the Medicaid market and has a limited scope of business, writing primarily Medicaid and dual Medicare-Medicaid business. Through UNICARE, Anthem has licenses in all 50 states, Washington DC and Puerto Rico; nevertheless, premiums are generated predominantly from 10 states.

The FSR of A (Excellent) and the Long-Term ICRs of “a+” of the following subsidiaries of Anthem, Inc. have been affirmed with a stable outlook:

  • Anthem Blue Cross Life and Health Insurance Company
  • Anthem Health Plans of Kentucky, Inc.
  • Anthem Health Plans of Maine, Inc.
  • Anthem Health Plans of New Hampshire, Inc.
  • Anthem Health Plans of Virginia, Inc.
  • Anthem Health Plans, Inc.
  • Anthem Insurance Companies, Inc.
  • Anthem Kentucky Managed Care Plan, Inc.
  • Anthem Life & Disability Insurance Company
  • Anthem Life Insurance Company
  • BlueCare Health Plan
  • Blue Cross Blue Shield Healthcare Plan of Georgia, Inc.
  • Blue Cross Blue Shield of Wisconsin
  • Blue Cross of California
  • Community Insurance Company
  • Compcare Health Services Insurance Corporation
  • Empire HealthChoice Assurance, Inc.
  • Empire HealthChoice HMO, Inc.
  • Greater Georgia Life Insurance Company
  • HealthKeepers, Inc.
  • Healthy Alliance Life Insurance Company
  • HMO Colorado, Inc.
  • HMO Maine
  • HMO Missouri, Inc.
  • Matthew Thornton Health Plan, Inc.
  • Rocky Mountain Hospital and Medical Service, Inc.

The FSR of A- (Excellent) and the Long-Term ICRs of “a-” of the following subsidiaries of Anthem, Inc. have been affirmed with a stable outlook:

  • UNICARE Life & Health Insurance Company
  • UNICARE Health Plan of West Virginia, Inc.
  • AMERIGROUP Community Care of New Mexico, Inc.
  • AMERIGROUP Maryland, Inc.
  • AMERIGROUP New Jersey, Inc.
  • AMERIGROUP Tennessee, Inc.
  • AMERIGROUP Texas, Inc.
  • AMGP Georgia Managed Care Company, Inc.
  • AMERIGROUP Washington, Inc.
  • AMERIGROUP Insurance Company
  • AMERIGROUP Kansas Inc.
  • Community Care Health Plan of Louisiana, Inc.
  • Community Care Health Plan of Nevada, Inc.

The following Long-Term IRs have been affirmed with a stable outlook:

Anthem, Inc.—

— “bbb+” on $700 million 3.70% senior unsecured notes, due 2021

— “bbb+” on $850 million 3.125% senior unsecured notes, due 2022

— “bbb+” on $750 million 2.95% senior unsecured notes, due 2022

— “bbb+” on $1 billion 3.3% senior unsecured notes, due 2023

— “bbb+” on $800 million 3.50% senior unsecured notes, due 2024

— “bbb+” on $850 million 3.35% senior unsecured notes, due 2024

— “bbb+” on $1.25 billion 2.375% senior unsecured notes, due 2025

— “bbb+” on $1.6 billion 3.65% senior unsecured notes, due 2027

— “bbb+” on $1.25 million 4.101% senior unsecured notes, due 2028

— “bbb+” on $825 million 2.875% senior unsecured notes, due 2029

— “bbb+” on $1.1 billion 2.25% senior unsecured notes, due 2030

— “bbb+” on $499 million 5.95% senior unsecured notes, due 2034

— “bbb+” on $900 million 5.85% senior unsecured notes, due 2036

— “bbb+” on $800 million 6.375% senior unsecured notes, due 2037

— “bbb+” on $300 million 5.80% senior unsecured notes, due 2040

— “bbb+” on $900 million 4.625% senior unsecured notes, due 2042

— “bbb+” on $1.5 billion 2.75% senior unsecured convertible debentures, due 2042

— “bbb+” on $1.0 billion 4.65% senior unsecured notes, due 2043

— “bbb+” on $800 million 4.65% senior unsecured notes, due 2044

— “bbb+” on $600 million 5.10% senior unsecured notes, due 2044

— “bbb+” on $1.4 billion 4.375% senior unsecured notes, due 2047

— “bbb+” on $850 million 4.55% senior unsecured notes, due 2048

— “bbb+” on $825 million 3.70% senior unsecured notes, due 2049

— “bbb+” on $1.0 billion 3.125% senior unsecured notes, due 2050

— “bbb+” on $250 million 4.85% senior unsecured notes, due 2054

Anthem Insurance Companies, Inc.—

— “a-” on $25.1 million 9.0% surplus notes, due 2027

The following Short-Term IR has been affirmed:

Anthem, Inc.—

— AMB-2 on commercial paper program

The following indicative Long-Term IRs have been assigned with a stable outlook to its new shelf registration. The ratings on the previous shelf registration have been withdrawn:

Anthem, Inc.—

— “bbb+” on senior unsecured debt

— “bbb” on subordinated debt

— “bbb-” on preferred stock

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper media use of Best’s Credit Ratings and AM Best press releases, please view Guide for Media – Proper Use of Best’s Credit Ratings and AM Best Rating Action Press Releases.

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in New York, London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

Copyright © 2020 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

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Joseph Zazzera, MBA
Director
+1 908 439 2200, ext. 5797
joseph.zazzera@ambest.com

Christopher Sharkey
Manager, Public Relations
+1 908 439 2200, ext. 5159
christopher.sharkey@ambest.com

Sally Rosen
Senior Director
+1 908 439 2200, ext. 5280
sally.rosen@ambest.com

Jim Peavy
Director, Communications
+1 908 439 2200, ext. 5644
james.peavy@ambest.com