Policy
Acadia Pharma’s Catherine Owen Adams has formed a group of small- to mid-cap biotechs to advocate against a ‘peanut butter blanket’ approach to drug pricing for small companies.
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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.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
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Kite Pharma, a subsidiary of Gilead, announced that its Yescarta® has been approved by the U.S. Food and Drug Administration (FDA).
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After wrapping up March with a flurry of PDUFA dates, the U.S. Food and Drug Administration has a more leisurely calendar for the first three weeks of April, at least in terms of drug approvals.
Ishtiaq Ali Saaem is sentenced to three years of probation following a guilty plea to charges he obstructed a federal investigation into his efforts to acquire the deadly toxin ricin.
In a meeting of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, six members voted not to approve the NDA for Amylyx’s ALS candidate, AMX0035, while four voted in favor.
Although it looks that we’re on the downside of the COVID-19 pandemic in the U.S., biopharma companies are still working on developing better treatments and preventions.
Without holding a meeting of its vaccines advisory committee, the U.S. Food and Drug Administration (FDA) authorized a fourth booster shot for everyone 50 years of age and older.
Antares Pharma has announced that the U.S. Food and Drug Administration has granted approval to its therapeutic Tlando intended for testosterone replacement therapy (TRT).
Pfizer stated that etrasimod patients achieved statistically significant improvements in primary endpoints of clinical remission and attained all secondary endpoints vs. placebo.
When ImmunoGen announced top-line results from the Phase III SORAYA trial in November 2021, the primary endpoint - confirmed objective response rate - was met at 32.4%.