Policy
Leerink analysts hailed the deals as a sign that President Trump “is unlikely to attack the industry in 2026.”
FEATURED STORIES
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.
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
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Eli Lilly has filed lawsuits in several states seeking to prevent unauthorized selling of products that claim to contain tirzepatide, the active ingredient in its blockbuster type 2 diabetes drug Mounjaro.
Though it received backing from the Pulmonary-Allergy Drugs Advisory Committee in May, the FDA on Tuesday rejected ARS Pharmaceuticals’ neffy as a nasal spray for allergic reactions.
After facing regulatory roadblocks, Novartis is returning the anti-PD-1 antibody to the cancer-focused biotech, which regains global rights to develop, manufacture and commercialize tislelizumab.
The consent agreement struck between the FTC and Amgen and Horizon Therapeutics could have significant implications for ongoing and future M&A challenges, experts told BioSpace.
Nearly three years after European approval, the U.S. regulator has accepted Orchard Therapeutics’ BLA for its gene therapy OTL-200, being proposed for metachromatic leukodystrophy.
The legal battle over the Inflation Reduction Act’s price negotiation program moved to federal court in Ohio with the Department of Justice and U.S. Chamber of Commerce sparring about the law.
In the largest biotech Series C financing so far this year, Generate:Biomedicines raised $273 million, while Neumora and RayzeBio announced IPO pricing valued at more than $560 million combined.
The FDA will finish September with three action dates and one of the year’s most highly-anticipated advisory committee meetings.
After nearly seven years, the company’s rare diseases arm Alexion has reached a settlement in an investors’ lawsuit over alleged unethical sales practices for its hemoglobinuria therapy Soliris.
As researchers face delayed project timelines and inflated costs, industry leaders are offering an alternative option for sourcing nonhuman primates.