BioSpace News Archive

Josh Ludwig is global commercial director at ScaleReady, where he leads a team of scientists that drives new business through technical expertise.

A ripple effect of the NIH’s slashed 2026 budget will be felt throughout the biopharma ecosystem. Young companies must act now to weather the storm.

After decades of limited progress—owing to the difficulty of treating the disease and resultant market risk—glioblastoma research is entering a new phase spurred by smarter trials, targeted funding and renewed interest from companies like Merck and Jazz Pharmaceuticals.

This year, LOTTE BIOLOGICS has ramped up its CDMO business expansion with the completion of an ADC (Antibody-Drug Conjugate) facility expansion at its Syracuse Bio Campus in the U.S. and the signing of its first production contract.

Earlier this year, the Centers for Medicare and Medicaid Services scrapped a previous proposal, from the Biden administration, to include anti-obesity medications in Medicare Part D coverage.

The pivotal Phase II trial is testing Allogene’s CAR T candidate cemacabtagene ansegedleucel for large B-cell lymphoma. ALLO-647 was being used as a preparative lymphodepletion therapy.

The company expects that the U.S. COVID-19 vaccination rate will be “maybe a couple of points lower” than the prior level of around 20% but that pricing and Comirnaty’s market share will hold steady.

Sarepta and Capricor learned of key regulatory decisions from the media and investors, and Duchenne muscular dystrophy families have turned to the news for answers. Meanwhile, the FDA insists it remains committed to notifying companies of any regulatory action before sharing information with the media or public.

According to reporting from multiple outlets, Richard Pazdur, head of the Oncology Center of Excellence at CDER, opposed the consensus opinion of CBER staff to approve the drug. Replimune’s stock has dropped precipitously since the rejection.