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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The United States’ relatively high costs have become a political issue on both sides of the aisle. Here’s how international pharmaceutical prices stack up.
Aldeyra Therapeutics is planning to run another trial, in line with the regulator’s requirements, and is expecting top-line data and a New Drug Application resubmission in the first half of 2024.
Pfizer and BioNTech scored a win over Moderna on Tuesday as the European Patent Office decided that a key patent held by the Massachusetts biotech related to its COVID-19 vaccine is invalid.
Both the White House and Congress have proposed legislation for the appropriate use of AI while the FDA continues to serve as the gatekeeper for patient privacy and safety.
The regulator has decided to hold an advisory committee meeting regarding BMS and 2seventy bio’s bid to move the CAR-T cell therapy into earlier lines of treatment, missing its previous target action date of Dec. 16.
The U.K.’s conditional marketing authorization for Vertex Pharmaceuticals and CRISPR Therapeutics’ gene-edited therapy exa-cel raises some potential safety concerns with the risk of off-target effects.
In a 12-1 tally, the FDA’s Pulmonary-Allergy Drugs Advisory Committee determined that the data does not establish a clinically meaningful benefit in this indication.
The U.K.’s Medicines and Healthcare products Regulatory Agency on Thursday provided conditional marketing authorization for Vertex Pharmaceuticals and CRISPR Therapeutics’ gene-edited therapy exa-cel.
After a Phase III trial did not meet its primary endpoint, Bayer will voluntarily withdraw Aliqopa (copanlisib) from the U.S. market following discussions with the FDA.
In today’s challenging environment, here are some creative ways biotechs have found to survive and thrive.