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.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
Lawmakers on Thursday voted 18–3 to increase oversight of pharmacy benefit managers and limit their practice of spread pricing, when PBMs charge payers for drugs more than they pay pharmacies.
The FDA has four events lined up this week, including a target action date for Krystal Biotech’s gene therapy for a rare skin disease and an adcomm meeting for Pfizer’s RSV vaccine candidate.
The regulator in a Complete Response Letter rejected ImmunityBio’s bladder cancer hopeful due to deficiencies with the company’s third-party contract manufacturer.
The Chapter 11 bankruptcy was driven by increasing generic competition, declining profits and the unrelenting legal woes of its head Martin Shkreli, dubbed “Pharma Bro” in the media.
As insulin prices skyrocket, pharmas and PBMs faced pointed critique from the Senate HELP Committee, led by Sen. Bernie Sanders (I-VT).
A federal judge compelled Merck to release confidential information on its HPV vaccine as a part of discovery in a series of lawsuits spanning states dating back to 2020.
The FDA set a new action date of June 22 for Sarepta’s gene therapy for the neuromuscular disease, approximately three weeks after the original date of May 29.
Developers of psychedelics-based therapies say the industry is poised to explode, with several reporting strong clinical trial results and the FDA granting breakthrough status for two hallucinogenic drugs.
The biopharma company scored two major wins on Tuesday: a court victory over HIV patent claims and an acquisition deal to expand its pipeline in cancer and inflammatory diseases.
The FDA’s new guidance on decentralized clinical trials clarifies how investigators and trial sponsors can use digital health technologies and involve primary healthcare practitioners.