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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The DSMB for Ocugen’s Phase I/II trial of OCU400, a gene therapy in development for Retinitis Pigmentosa (RP), recommended the study proceed with enrolling more patients.
Shares of Axsome Therapeutics have fallen more than 20% in trading this morning after the company announced the FDA is unlikely to approve its acute migraine treatment AXS-07 due to unresolved quality control issues.
Final analysis of the Himalaya trial demonstrated safety as well as a statistically relevant 22% improvement of overall survival (OS) without exposing the patient to an increase in liver toxicity.
Patient deaths associated with Astellas Pharma’s gene therapy candidate underscore the risks of developing potential one-and-done treatment options for serious diseases.
WHO is raising flags against the concerns surrounding a mysterious illness (related to pediatric liver disease) that is increasing following a reported death.
One of the most common types of leave is family leave, and navigating it can be a long, arduous process. To help, we’ve created a guide to answer your questions about family medical leave.
Nkarta announced that two of its therapies have shown complete remission in patients with blood cancer. These results are the latest development in the treatment of difficult-to-treat blood cancers.
Ardelyx announced the FDA’s OND, CDER, provided an interim response to the company’s second level of appeal for tenapanor. Here’s what you need to know.
Today, Astellas announced that after evaluating its gene therapy for patients with X-linked Myotubular Myopathy, it revised its eligible treatment population and any likely future product label.
Louisiana Attorney General Jeff Garland sued UnitedHealth Group over Medicaid fraud. In a lawsuit filed earlier this week, Garland alleged the insurance company overinflated drug charges.