Policy
A renewal of the FDA’s pediatric rare disease voucher program is couched within a massive $1.2 trillion spending bill the House is set to vote on later this week.
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Only a handful of the top pharmas have signed Most Favored Nation drug pricing deals with the White House, while smaller biotechs continue to hang in limbo.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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Novartis’ Isturisa (osilodrostat) was approved for adults with Cushing’s disease who either can’t have pituitary gland surgery or who have had the surgery but still have the disease.
Although March looks to be a busy month for the U.S. Food and Drug Administration, several of the PDUFA dates for this week were for drugs under Priority Review.
Glaucoma is a progressive disease of the eye that can lead to irreversible vision loss and blindness.
On Tuesday, the European Commission gave the green light to the merger following the divestiture of an investigational autoimmune treatment.
The FDA granted the designation based on data from a mid-stage trial that examined the safety and efficacy of Esbriet in this indication.
This approval marks the first time in a decade Sanofi has had a wholly-owned cancer drug approved.
The U.S. Department of Justice charged New Jersey-based Sandoz with four counts of conspiring to rig bids and fix prices for generic drugs.
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 novel coronavirus that causes the disease COVID-19 continues to spread and has now been diagnosed in more than 50 countries.
The green light from the U.S. Food and Drug Administration marks the first approval for U.K.-based Acacia.