Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Altimmune, Basilea, Bio-Thera, Janssen, Liquidia, Pfizer, Polaryx, Reata, Revance, Rhovac, Sirtex.
The Pharmaceutical Research and Manufacturers Association (PhRMA) filed suit Nov. 23 in U.S. district court challenging the Trump administration’s final rule allowing the import of prescription drugs from Canada.
Four days after receiving European approval, the FDA has followed suit for Alnylam Pharmaceuticals Inc.’s Oxlumo (lumasiran), the first treatment for primary hyperoxaluria type 1, an ultra-rare genetic disorder that contributes to kidney stones and deposits.
SHENZHEN – To accelerate the development of cell therapies, China’s NMPA has introduced a dual-track regulatory pathway that allows companies to seek an IND with data from investigator-initiated trials.
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.
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