Regulatory
The Centers for Medicare and Medicaid Services indicated it would cover the cost of these drugs and any necessary scans — but only “if they are enrolled in qualifying clinical trials.”
The U.S. averages more than 700,000 new COVID-19 cases per day. As of Saturday, there were 4.91M cases, more cases in seven days than in April, May, June, and July 2021 combined.
Evidence continues to accumulate suggesting that Omicron, although significantly more infectious than previous COVID-19 strains, causes less severe disease.
Janssen Pharmaceutical has recently applied for Biologics License Application for its relapsed or refractory (r/r) multiple myeloma drug. Here’s all about it.
Reuters alleges Johnson & Johnson knew of the ketoacidosis risk of its diabetes drug Invokana but covered it up.
Shares of Reata Pharmaceuticals have plunged nearly 40% in premarket trading after an FDA advisory panel recommended against the approval of its Alport syndrome disease treatment, bardoxolone.
In the staff documents, the FDA scientists expressed concerns over the Reata clinical data that was submitted.
The U.S. Food and Drug Administration is wrapping up 2021 with a fairly busy schedule for the month of December. Here’s a look at the first half of the month.
In the CRL, the FDA indicated that the single registrational trial (106 Phase III) did not provide sufficient proof of efficacy to demonstrate benefit.
The FDA’s Antimicrobial Drugs Advisory Committee voted 13 to 10 to recommend emergency authorization of molnupiravir. Read more about the authorization here.
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