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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Pfizer is lining up a potential New Drug Application for an ulcerative colitis treatment for patients who are not seeing an improvement in their condition from currently available options.
Moderna reported positive interim results from the Phase II/III KidCOVE trial of its mRNA COVID-19 vaccine for children six months to under two years and two to six years of age.
Like Elizabeth Holmes, Ramesh Balwani faces multiple counts of fraud related to the business practices of Theranos.
Teva Pharmaceuticals and AbbVie will pay the state of Rhode Island a combined $28.5 million to settle opioid-related claims against the companies.
Takeda faces yet another setback by the U.S. Food and Drug Administration for its parathyroid hormone, natpara.
Who is to thank for the COVID vaccine? Many major biopharma companies are asking that question after a series of lawsuits over patent rights to the vaccine and its associated technology.
An FDA Investigational New Drug application has been approved for NeuroSense Therapeutics Ltd.’s PrimeC, a potential therapeutic targeting amyotrophic lateral sclerosis (ALS).
Russia’s continued assault on Ukraine threatens a supply of chemicals and compounds that drug researchers and developers use across the globe.
Provention Bio has announced that the FDA has accepted its biologics license application resubmission for teplizumab, a drug intended to delay clinical Type I Diabetes (T1D) in at-risk individuals.
Albert Bourla, Pfizer’s CEO, took home a salary of $1.69 million in 2021. To Pfizer, he’s undoubtedly worth it, having led the company to its COVID-19 vaccine success.