VRBPAC says Covid vaccines should be updated

FDA advisers voted unanimously that all Covid vaccines contain the formulation existing in the current booster shot. This is a step toward the goal of creating a single annual Covid shot for most Americans. The panel said Pfizer/BioNTech, Moderna, and Novavax should "harmonize" the first doses of their vaccines so they contain the original strain of the Covid-19 virus and a new Omicron strain. The VRBPAC also supported a single annual dose of a booster, and two doses for older people, the immunocompromised, and young children.

"I think this is a reasonable approach. We have to keep reminding ourselves that this is not influenza and we need to keep paying attention to that to make sure we don't just follow that dogma because we're used to doing it," one of the panel members said. "We'll try this this time. I don't think we're setting it in stone and we'll see how it goes. We may need to adjust along the way."

biosimilars

At long last, a biosimilar for Humira will be available

Despite AbbVie's considerable efforts to hang onto its lucrative monopoly, a biosimilar version of the bestselling autoimmune disease drug Humira will finally become available next week. Humira has been viewed as a test case for biosimilars, which offer the potential of substantial cost savings. In 2021, Humira sales exceeded $17 billion, so it's logical to think that cheaper facsimiles would surely cut health care costs dramatically.

But that's actually not a given: If the rebates linked to biosimilar versions aren't as lucrative to PBMs as those offered by AbbVie, formularies may end up preferring Humira to the copycats. Beyond that, physicians have long recognized the brand name of Humira and may want to stick with it. However, it seems as though physicians — who were once reticent to prescribe biosimilars — are now warming up to that idea.

podcast

Who needs an annual Covid jab?

Why did the FDA reject an Alzheimer's treatment? And what's in store for one of biotech's most highly respected executives now that he's stepping back from his CEO role? We cover all that and more this week on "The Readout LOUD," STAT's biotech podcast.

George Scangos, the CEO of Vir Biotechnology, joins us to discuss his retirement and offer some perspective and lessons from a remarkable, 40-year career in biotech. We also chat about the latest news in the life sciences, including an FDA advisory meeting debating the necessity for annual Covid vaccinations, and a surprising, but perhaps not, rejection of Eli Lilly's Alzheimer's disease treatment.

Listen here.

more covid-19

Covid antibody drug Evusheld loses its FDA sanction

The FDA has pulled its authorization for Evusheld, a Covid-19 antibody therapy that's become obsolete thanks to the ever-mutating nature of SARS-CoV-2. Notably, AstraZeneca's Evusheld was used as a pre-exposure prophylaxis for Covid-19, meant for immunocompromised people and others at risk for a severe form of the disease. The FDA has been warning since October that Omicron variants were rendering Evusheld ineffective; still, the move to rescind its authorization weakens the arsenal against Covid-19.

The FDA did say, however, that clinics that still have stores of Evusheld should hang onto them, in case variants susceptible to the drug emerge in the future. And AstraZeneca said that it has begun trials of another antibody that, in lab studies, have been able to neutralize all variants.

antitrust

Sen. Warren urges FTC to block two pharma mergers

Elizabeth Warren is urging the FTC to "closely scrutinize" two pending drug company mergers, saying that the "rampant consolidation" will raise health care costs for consumers. She's concerned by Amgen's potential $28.7 billion buyout of Horizon Therapeutics, as well as Indivior's $145 million deal to acquire fellow addiction medicine maker Opiant Pharmaceuticals.

"Given these companies' records of anti-competitive business practices, these acquisitions could cause further price increases on life-saving drugs and prevent affordable alternatives from entering the market," she wrote. "The FTC should carefully scrutinize these deals and oppose any Big Pharma acquisition that will threaten competition, reduce innovation, or increase costs for American families."

More around STAT