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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Pfizer and BioNTech requested the FDA authorize booster shots for their COVID-19 vaccine for all adults 18 years and older, presenting data not available in September.
Public Citizen urged NIH director Dr. Francis Collins to clarify the NIH’s role in Moderna’s vaccine publicly and explain what he plans to ensure that federal scientists are credited for their work.
The Oklahoma Supreme Court has overturned the landmark $465 million opioid verdict handed down against Johnson & Johnson in 2019.
Although Martin Shkreli continues to serve a prison sentence for fraud, the so-called “Pharma Bro” remains in legal hot water over antitrust charges.
Mid-November is a relatively quiet period for the U.S. Food and Drug Administration in terms of its scheduled PDUFA dates. Read on for more.
Ardelyx, Inc. is lacing up the gloves and preparing to wade into the ring with the U.S. Food and Drug Administration to dispute the July rejection of its chronic kidney disease drug, tenapanor.
The U.S. government canceled a contract with Maryland-based Emergent BioSolutions, which earlier in the year ruined about 15 million doses of the Johnson & Johnson COVID-19 vaccine.
Vaccinations will be required by January 4 under the new White House plan.
This agreement would cap out-of-pocket costs for insulin at $35 a month and all out-of-pocket medical costs for seniors at $2,000 a year.
Immunology expert Constance Cullen of Schering-Plough Corp. revealed that Theranos inappropriately attached Schering-Plough’s logo to data issued to potential investors.