Food and Drug Administration (FDA)
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Three of Vivek Ramaswamy’s companies reported activity today including corporate changes, a licensed therapy and investment of $100 million.
A betting man may have placed a pretty strong wager on the U.S. Food and Drug Administration’s approval of Akcea Therapeutics’ Waylivra (volanesorsen), a treatment for the rare lipid disorder familial chylomicronemia syndrome (FCS).
Shares of AbbVie are inching up this morning after the company announced it had secured regulatory approval for Imbruvica as a treatment for patients with a rare blood disease.
Ann Arbor, Mich.-based Esperion Therapeutics is starting off the week with several positives. The company first reported final results from a long-term safety study of bempedoic acid 180 mg versus placebo in high-risk patients with atherosclerotic cardiovascular disease (ASCVD) whose disease is inadequately controlled by statins.
Transthyretin Cardiomyopathy is a rare heart disease that can lead to heart failure. This weekend Pfizer presented data that shows its Phase III tafamidis therapy reduced the risk of death in patients with a distinct form of the disease by 30 percent, giving the drug the chance to become the first approved medication for these patients.
Janssen Pharmaceutical and Bayer saw the good, the bad and the potential for ugly this week with their blockbuster blood-thinner Xarelto (rivaroxaban). The drug gained approval for a new indication in Europe, failed a late-stage trial and is staring down the barrel of patent loss in 2023 while battling legal threats.
This week has several action dates by the U.S. Food and Drug Administration (FDA) for a range of indications, including acne, intra-abdominal infections, and rare liver diseases. Here’s a look.
In a new draft guidance released Thursday, the U.S. Food and Drug Administration is questioning whether or not the use of a placebo in a double-blind, randomized clinical trial is always necessary.
San Diego-based Rakuten Aspyrian nabbed $150 million in a Series C financing round. The funding provides the company with a total of $238 million in equity. Rakuten Aspyrian will use the funds to drive its lead therapy into Phase III trials.
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