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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Here’s a look at mRNA vaccines and their effectiveness and more COVID-19 news.
Litigator Block & Leviton is launching an investigation into Ginkgo Bioworks after short seller Scorpion Capital released a report alleging that Ginkgo is running a fraudulent operation.
Attorneys for Holmes have speculated that the lab failures at Theranos are the fault of Rosendorf and not Holmes herself.
Moderna seeks to invalidate two patents of Arbutus Biopharma Corp. The company hopes to appeal a preemptive challenge to the patents upheld by the U.S. Patent Trial and Appeals Board.
Henrietta Lacks’ family accuses Thermo Fisher Scientific of profiting off the first cell line that had been shared and replicated in a lab for the development of countless medical innovations.
After serving three presidential administrations, Dr. Francis S. Collins is stepping down as director of the National Institutes of Health at the end of the year.
The DOL’s Office of Federal Contract Compliance Programs found that AstraZeneca paid a much lower base salary than similar employees to 23 Hispanic female staff and 295 female employees.
The U.S. FDA is kicking off the month of October with a number of PDUFA dates and an advisory committee meeting. Read on for more details.
Catalyst Pharmaceuticals received a positive decision from the 11th Circuit Court of Appeals over a suit against the U.S. FDA’s approval of a competitor’s amifampridine product.
The Pfizer-BioNTech booster shot is now authorized for people over 18 and 65 who are immunocompromised, at high risk due to their work or living situation and front-line healthcare workers.