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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Moderna is still fending off patent challenges over the lipid nanoparticle delivery system used in its COVID-19 vaccine.
Today’s announcement from Seagen’s board of directors included difficult news regarding Clay Siegall, Ph.D. Until today, Siegall served as Seagen’s President, CEO and Chairman.
The U.S. SEC continues to tighten the screws on Chinese companies, adding more than 80 companies to its expanding list of companies that might be dropped from U.S. stock exchanges.
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Despite a growing product revenue, Beigene reported a net loss of $434.4 million for the first quarter of 2022, as well as updates to its audit from the SEC.
A post hoc analysis of data from the Phase II CENTAUR study showed a 10.6-month longer median survival duration for AMX0035 participants, Amylyx announced Thursday.
The FDA’s reaction came after Pfizer CEO Albert Bourla said that physicians may give a second five-day course of Paxlovid if patients see a spike in their SARS-CoV-2 viral load.
New studies suggest that the virus may aggravate childhood asthma after infection. For that and more COVID-19 news, continue reading.
The WHO issued an alarming statement that details a 79% increase in child measles outbreaks globally, as well as a warning that 11 countries have reported peculiar acute cases of hepatitis in children.
Three long-time FDA officials, Dr. Peter Marks, Dr. Janet Woodcock and Dr. Robert Califf wrote an op-ed in JAMA describing the reality that COVID-19 represents “the new normal.”