FDA
An unnamed pharma filed a citizen petition in April seeking reforms to the way the FDA publicly releases rejection letters, alleging that the policy “contravenes decades of agency practice.”
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
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Five years after Martin Shkreli rose to infamy for acquiring the toxoplasmosis treatment Daraprim from Impax Laboratories for $55 million and then jacking the price by 5,000%, the U.S. FDA approved the first generic for the medication.
The green light from the U.S. Food and Drug Administration marks the first approval for U.K.-based Acacia.
Nexlizet is expected to be on the market in the U.S. in July 2020.
Seqirus snagged approval for Fluad Quadrivalent, the first-and-only quadrivalent adjuvanted influenza vaccine developed to help protect adults 65 years and older against seasonal influenza.
H. Lundbeck A/S is making a statement with its newly approved treatment for migraine, the first intravenous medication approved for the preventative treatment of migraine.
The company is planning for its drug for cholesterol lowering medications to hit the streets by the end of March. It will provide a new option to all the patients.
The approval marks the first once-per-day 24-hour, intravenous COX-2 preferential NSAID, the company said.
Here’s a look at the two drugs that had dates this week but were approved early and are now on the market.
The U.S. Food and Drug Administration has a busy week planned for drug review. Here’s a look at this week’s schedule.
A number of new medications stand a shot at early regulatory approval thanks to the U.S. Food and Drug Administration’s priority review program.