BioSpace News Archive

Biogen and Eisai’s lecanemab win this week provides an opportunity to stop and consider whether science is closer to a cure or symptom management for Alzheimer’s disease.

Two years after receiving a Complete Response Letter for its hemophilia gene therapy, BioMarin is heading back to the FDA with stronger and more robust data for potential approval.

The HHS Office of Inspector General found that of 278 accelerated approvals between 1992 and 2021, 104 had incomplete confirmatory trials, according to a report issued Thursday.

The FDA had a busy week, approving drugs, greenlighting clinical trials and other regulatory activities for Immuneering, Amylyx, Sarepta, Sanofi, and Regeneron and more.

Solid Biosciences and AavantiBio – announced Friday they are merging to develop a portfolio of neuromuscular and cardiac programs, initially focusing on Duchenne muscular dystrophy.

In its ongoing battle against counterfeit drug rings, Gilead Sciences announced it has identified two “kingpins” behind the scheme to sell illegitimate HIV medications.

This week had a flurry of biopharma patent cases, from Novartis vs Gilenya, Merck vs Viatris, and Aligos vs Janssen, either filed or court decisions being made.

As it gears up to launch several new products, Moderna has created a new leadership role and onboarded an industry veteran.

Shares of Rocket Pharmaceuticals jumped Friday morning after the company announced positive clinical updates from a Phase I study of patients diagnosed with Danon disease.

Immuneering Corporation announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for IMM-1-104, paving the way for the company to initiate a Phase 1/2a clinical trial of this oral, once daily small molecule, in development for the treatment of advanced RAS mutant solid tumors.