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Novavax goes before FDA’s Vaccines and Related Biologics Advisory Committee this week, seeking Emergency Use Authorization of its COVID-19 vaccine. Read More
The company will continue to work with the FDA to complete the review of the BLA and will be “ready to launch upon approval,” said TG Therapeutics CEO Michael S. Weiss. Read More
The companies said they are “assessing the FDA’s comments” in the Complete Response Letter and considering what they will need to gain approval for the indication. Read More
Pfizer and BioNTech hit back against Alnylam Pharmaceuticals’ claims alleging their COVID-19 vaccine infringed on Alnylam’s patent for lipid-nanoparticle delivery (LNP) technology. Read More
Nephron Pharmaceuticals of South Carolina has issued a voluntary recall of about 2 million doses of its medicines after an FDA inspection found a “lack of assurance of sterility” across 20 of the company’s mostly injectable medicines manufactured at its West Columbia, S.C., compounding facility. Read More
As of Wednesday night, the Federal Trade Commission (FTC) had received a whopping 24,113 comments in response to its February notice soliciting input on how pharmacy benefit manufacturer (PBM) practices affect patients and payers. Read More
The FDA has withdrawn its approval of TG Therapeutics’ flagship lymphoma drug, Ukoniq (umbralisib), citing the possibility of increased risk of death in those taking the drug — and the company has voluntarily withdrawn the drug from market. Read More
In the latest move in the ongoing feud over their cholesterol-fighting monoclonal antibodies, Regeneron has filed a new antitrust suit against Amgen, accusing the drugmaker of carrying out an “unlawful, anticompetitive bundling scheme” to harm the market for Regeneron’s Praluent (alirocumab) in order to increase sales of Amgen’s competitor product, Repatha (evolocumab). Read More