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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Erika Cheung testified that the data manipulation happened “frequently,” in order to make the company’s lead asset look good to investors.
Amylyx’s decision to submit the NDA, announced Wednesday morning, came on the heels of recent discussions with the FDA, including a pre-NDA meeting held on July 15.
Recently, the National Institutes of Health (NIH)'s removal of genetic data about the COVID-19 virus from its archive was brought into the spotlight.
A patient treated with Astellas Pharma’s experimental gene therapy for patients with X-linked Myotubular Myopathy (XLMTM) has died after a serious adverse event following treatment.
SENS Research Foundation released findings that confirmed the charges of inappropriate behavior raised by two former female employees against Aubrey de Grey.
A recent study suggests that about one-third of cancer indications with Accelerated Approval pathways are still on product labels without follow-up studies confirming their benefits.
September is turning out to be a busy month for the U.S. Food and Drug Administration. Here’s a look at this week’s schedule for PDUFA dates.
President Joe Biden took an aggressive step that mandates vaccination for 100 million Americans who are eligible for preventative medication.
Chin, 57, and Humad, 36, along with the company, were indicted on charges of paying surgeons to use their spinal implants in surgeries.
Elizabeth Holmes heads to court today to face multiple criminal fraud charges that could land the Theranos founder and CEO in prison for more than a decade.