Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Appili, BMS, F-star, Mustang, Obseva, Polypid, Viatris.
Two U.S. federal agencies at the Department of Health and Human Services (HHS) have finalized rules that affect how drug and device makers interact with the health care system, but under the Congressional Review Act, neither rule can go into effect until February 2021. This timeline comes up a couple of weeks after President-elect Joseph Biden is sworn in, thus raising the risk that the new administration at HHS will either modify or overturn these rules altogether.
When U.S. President Donald Trump and Health and Human Services (HHS) Secretary Alex Azar announced last week the Jan. 1 launch of a Medicare Part B most-favored nation (MFN) drug pricing model and a final rule to end Medicare’s safe harbor for the rebates that create a black box around the pricing of Part D drugs, they called the reforms “historic.”
An antibody cocktail developed by Regeneron Pharmaceuticals Inc. has received emergency use authorization (EUA) from the FDA for the treatment of mild to moderate COVID-19. Monoclonal antibodies (Mabs) such as Regeneron's, called casirivimab and imdevimab, "have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load," the company said.
Multiple companies have had their FDA reviews put on hold because coronavirus-related travel restrictions at the FDA has kept their manufacturing plants from being inspected.
Although Eiger Biopharmaceuticals Inc. sees more would-be opportunities with ultra-rare disease-targeting Zokinvy (lonafarnib), the company’s vice president of clinical and development operations, Colin Hislop, said that “at the moment, we’re very clearly focused on the population identified in the label, because it fits most closely with the mechanism of action.”
In what the FDA calls “an incremental step” in treating hospitalized COVID-19 patients, the agency has issued an emergency use authorization (EUA) for Eli Lilly and Co.’s baricitinib in combination with remdesivir.
Citing a lack of evidence that it improves survival, the need for ventilation or time to clinical improvement, the World Health Organization (WHO) has advised doctors against using Gilead Sciences Inc.’s antiviral Veklury (remdesivir) to treat COVID-19.
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