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The U.K.'s drug regulator has authorized a coronavirus vaccine from AstraZeneca and the University of Oxford, the first clearance for a shot viewed as critical to global immunization efforts but whose exact effectiveness is uncertain...The Medicines and Healthcare Products Regulatory Agency based its decision on positive data from studies in the U.K., Brazil and South Africa, which showed the shot was able to prevent symptomatic COVID-19 in a majority of vaccinated participants and protect against severe disease. The authorization comes less than a year after a team of Oxford researchers adapted pre-existing work on different coronaviruses to develop a shot for SARS-CoV-2...READ MORE

Novavax Inc has begun a large late-stage study of its experimental COVID-19 vaccine in the United States, the drug developer said on Monday, after delaying the trial twice due to issues in scaling up the manufacturing process...It will enroll up to 30,000 volunteers across about 115 sites in the United States and Mexico, with two-thirds of them receiving the shot 21 days apart and the rest getting placebo, the company said...READ MORE

More than a decade ago, Purdue Pharma pleaded guilty to marketing the powerful painkiller OxyContin in a way that illegally downplayed its addictiveness and abuse potential. This past October, the company again admitted criminal wrongdoing for misleading doctors, regulators and the public regarding the drug’s dangers...Last Thursday’s congressional opioid hearing was the first time in years that the family behind Purdue, the Sacklers, would have a chance to take responsibility for it all. But instead of accepting blame for that reckless promotion, two of the family members, who appeared voluntarily under penalty of subpoena, did little more than murmur words of regret for the harmful commercial tactics that made their company’s lead product the poster child for the opioid crisis...While both apologized, neither acknowledged personal (or familial) fault or error...READ MORE

Scientists are eyeing a potential culprit causing the allergic reactions to the Pfizer Inc. and BioNTech SE Covid-19 vaccine: the compound polyethylene glycol, also known as PEG...Six severe allergic reactions to the vaccine have been reported in the U.S., according to the Centers for Disease Control and Prevention, out of 272,001 doses administered through Dec. 19. At least two cases of anaphylaxis have also occurred in the U.K. People in the U.S. began receiving Moderna Inc.’s vaccine Monday, and no allergic reactions to it have been reported so far...READ MORE (full story behind pay wall)

The amount of money flowing into the biopharma industry via grants and collaborations with nonprofit and government entities is a 272% increase over last year, with efforts to fight the COVID-19 pandemic accounting for 84% of the total for 2020...BioWorld has tracked 855 bio/nonprofit deals worth $14.66 billion and 630 grants awarded to the industry and valued at $12.72 billion for a combined total this year of 1,485 and $27.4 billion. Companies developing therapeutics and vaccines for the SARS-CoV-2 virus are the recipients of about $23 billion of those funds through 628 deals (42%)...READ MORE

Jocelyn Konrad, Rite Aid’s executive vice president and chief pharmacy officer, said the mission of RxEvolution and the new store format is to unlock the value of its pharmacists to support its customers and communities...“The Store of the Future highlights the RxEvolution strategy as the whole store is reimagined and remodeled,” she said. “Whether it be the front-end merchandise and, in particular, the way we have reintroduced the pharmacist to our customers in a very different way that has never been done before. Historically, the industry kept that pharmacist back in the production end of the pharmacy and what we have literally done is pulled that pharmacist out to be front and center for our customers, so there’s always a connection every time the customer is in our stores.”...READ MORE

The new brand name for Pfizer and BioNTech's COVID-19 vaccine, Comirnaty mashes up community, immunity, mRNA and COVID—pretty much everything that could fit into the moniker for the world's most high-profile product at the moment...How did those concepts become a brand? We asked the naming agency behind both Comirnaty and its non-proprietary name, tozinameran—industry heavyweight Brand Institute, which began working with BioNTech in April. Pfizer joined the effort shortly after, when the duo’s vaccine collaboration was announced...READ MORE

The Trump administration...finalized a rule meant to make it easier for state Medicaid programs, commercial insurers and drugmakers to enter into "value-based" arrangements tying prescription drug payments to clinical outcomes... The rule overhauls existing regulations...Under these types of deals, payers negotiate prices with drugmakers based on outcomes and evidence-based measures like reduced hospitalizations or lab visits, and aren't accountable for the full price if those measures aren't met...CMS estimates that value-based drug deals emerging in the wake of the final rule could save federal and state governments up to $228 million through 2025...READ MORE

Will mRNA vaccines continue to protect the public against COVID-19 as mutant strains emerge? Pfizer and Moderna have set out to answer that question...After a mutated, fast-spreading variant of COVID-19 in the U.K. disrupted global travel over the weekend, a troubling question emerged: Will the new vaccines from Pfizer and Moderna work against this scary new strain of the virus?... They’re launching new studies designed to prove their mRNA-based shots will fend off the new coronavirus strain, while simultaneously expressing confidence this new vaccine technology is ideal for protecting against rapidly mutating viruses...READ MORE

The U.S. government has reached a deal to acquire 100 million more doses of Pfizer and BioNTech's coronavirus vaccine, giving the U.S. enough of a stockpile to vaccinate 100 million total residents. The vaccine is administered via two shots...Under the deal, Pfizer will deliver 70 million doses by the end of June and another 30 million by July 31 The U.S. also retains an option to acquire an additional 400 million doses of the vaccine. As with the original supply deal the two struck in July, Pfizer will receive $1.95 billion, suggesting a per-dose price of about $20...READ MORE