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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U.S. Food and Drug Administration(FDA) has granted Orphan Drug designations to Editas Medicine and Neurocrine Biosciences.
On Thursday at the White House, President Biden paid tribute to the 1 million American lives lost due to COVID-19.
AbbVie and Teva are reportedly ready to pay over $5 billion to quiet the over 3,500 opioid liability lawsuits filed against them over their painkillers.
Police documents reveal a May 2 dated TRO against Siegall concerning a fourth degree domestic violence gross misdemeanor charge.
With regulatory approvals beginning to break through, attendees at ISCT’s annual meeting set out along the translational pathway. Organizers shared their findings with BioSpace.
Usama Malik, the former chief financial officer of Immunomedics, has been indicted for insider trading, five months after the U.S. Securities and Exchange Commission leveled charges.
Less than one month after he was appointed as chief financial officer of Moderna, Jorge Gomez abruptly departed the company due to an ongoing investigation at his former company.
An investigation conducted by the U.S. House of Representatives shows Emergent was forced to destroy nearly 400 million doses of the vaccine. The company disputes the report’s claim.
The revised PDUFA action date for miglustat is August 29, 2022, while the new date for cipaglucosidase alfa is October 29, 2022. Amicus expects the agency to approve the applications together.
Could big pharma buy out much of the biotech industry? Yes, according to analysts. But that’s not likely to happen anytime soon.