News
Ralph Abraham, a vocal vaccine skeptic who served at the agency for just three months, has stepped down due to “unforeseen family obligations,” according to the CDC.
FEATURED STORIES
The first gene therapies approved to treat sickle cell disease in December 2023 are struggling on the market. But there are glimpses of forward momentum as Vertex and Genetix Bio provide updates.
After last year’s ‘stampede’ for FGF21 assets, the focus for the metabolic dysfunction-associated steatohepatitis space has shifted toward differentiated approaches, such as THR-β agonists and combination treatments, that seek to mirror the commercial success of Madrigal’s Rezdiffra.
Maintaining America’s momentum demands that policymakers resist policies that undermine research and development incentives.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
THE LATEST
A controversial decision by the Alabama Supreme Court temporarily chilled IVF before igniting nationwide pushes to protect access to this type of fertility treatment, leaving drugmakers with questions.
Vertex and CRISPR Therapeutics are setting up treatment centers for patients with beta thalassemia and sickle cell disease to compete with bluebird’s established infrastructure.
Synthetic biology company Pearl Bio announced Tuesday it has entered into a license and collaboration agreement with Merck to discover biologic therapies comprising non-standard amino acids.
The FDA plans to convene an advisory committee meeting to discuss the safety profile and efficacy of Eli Lilly’s Alzheimer’s candidate, the company announced Friday.
Bristol Myers Squibb has pulled the plug on a more potent version of its cancer immunotherapy Yervoy. However, the two companies will continue to work on other collaborative programs for T-cell engagers.
Plus, tips on applying to multiple jobs at the same company, making new work friends, and how to ask for more time at the offer stage.
Antibody-drug conjugate Adcetris, when used with rituximab or lenalidomide, improved overall survival in patients with relapsed or refractory diffuse large B-cell lymphoma. Pfizer secured access to Seagen’s ADC in March 2023.
The regulator’s new draft guidance, released on Monday, provides additional details regarding the use of surrogate and biomarker endpoints to support accelerated approvals.
In Monday’s neurology update for investors, Roche touted data from a small Ib/IIa trial for trontinemab, an investigational therapy for Alzheimer’s disease which demonstrated “rapid and robust” amyloid plaque reduction.
Acadia Pharmaceuticals is terminating development of its antipsychotic drug pimavanserin, which did not demonstrate a statistically significant improvement over placebo in the late-stage study’s primary endpoint.