Policy
Incoming PhRMA Chair Paul Hudson, a day before the White House announcement, pledged to work with the administration as the president turns to insurers as a source of cost savings for prescription medicines.
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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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Jose Luis Casero Sanchez took advantage of his position in Goldman Sachs’ “control room” to gain insider knowledge of upcoming transactions, including those for several biopharma companies.
Teva Pharmaceuticals reached a $15 million agreement with the state of Louisiana to settle claims against the company over its marketing of opioid products.
The announcement came following independent FDA analyses of inspections conducted at the two CROs in November 2019.
Biogen agreed to pay $22 million in response to allegations that it violated the False Claims Act, and now, life insurance company Humana is suing Biogen over a similar scheme.
Pfizer and BioNTech share data with FDA on COVID-19 vaccines for younger children as Sanofi pivot on its mRNA COVID-19 vaccine, shifting focus toward other infectious diseases instead.
Peter Marks will serve as acting director of the Office of Vaccines Research and Review at the U.S. FDA following the resignation of two top officials at the agency.
Industry watchers question why Elizabeth Holmes has been singled out for failing to deliver what she promised while other tech executives are given a pass.
Diabetes player Novo Nordisk cut a deal this week, announcing a settlement agreement to put an end to a lawsuit filed in January 2017 by American Depository Receipt investors.
The U.S. Food and Drug Administration is wrapping up the end of September and beginning October with two PDUFA dates. Here’s a look.
Aside from the fraud trial of Theranos founder Elizabeth Holmes, other court-related cases are taking place, including between Takeda and AbbVie over cancer drug, Lupron.