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.
FEATURED STORIES
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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Gilead Sciences scored a legal victory regarding fraudulent HIV reimbursements, securing a court order against a number of clinics, labs and prescribers in Florida that were engaging in the alleged fraud.
The FDA has issued a Complete Response Letter (CRL) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) to Teva Pharmaceuticals and MedinCell.
More than two years into the COVID-19 pandemic, some experts, business leaders and government agencies are starting to prep for the next potential pandemic.
Axsome Therapeutics received good news regarding its NDA for AXS-05, a treatment for depression, and Aytu BioScience received Fast Track designation for its VEDS treatment.
Pharma giant Moderna has shared data on the development of a new bivalent COVID-19 booster vaccine that performs better than its first booster that is currently on the market.
There are very few ongoing clinical trials on treatments for Long COVID and there has been what appears to be a successful treatment using Pfizer’s Paxlovid. Read on for more details.
TG Therapeutics voluntarily withdrew its pending BLA and supplemental NDA for its treatment dubbed U2 for adults with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
McKinsey & Company is under fire for allegedly allowing its employees to work simultaneously for big pharma companies and serve as consultants for the U.S. Food and Drug Administration.
The SEC added 12 China companies to their delisting watchlist this week. The companies will need to release evidence by May 3 to remain listed.
The FDA issued new guidance urging drugmakers to submit racial and minority recruitment plans when designing their studies.