News
In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA’s decisions in 2024.
FEATURED STORIES
A tale of two multi-billion schizophrenia deals, AstraZeneca touts strong sales while deflecting questions about an investigation into China exec, the Huntington’s pipeline builds momentum and layoffs continue with Sana Biotechnology and 23andMe.
Suggestions that the U.S. should emulate other countries on drug price controls or patents obscure how our present policies have allowed drug development to flourish.
Novo Holdings’ acquisition of Catalent has ignited concerns from industry stakeholders, who fear that the consolidation could limit competition, but there is also the possibility that the deal could represent an opportunity for smaller-scale CDMOs to find new partners.
TRACKERS
Follow along as BioSpace keeps you up-to-date on the latest pharma and biotech layoffs.
In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA’s decisions in 2024.
FROM OUR NEWS EDITOR
Every week, BioSpace’s Greg Slabodkin offers his take on the biggest stories happening in our industry.
With Novo Holdings’ $16.5 billion buyout of Catalent being reviewed by regulators, what work the contract drug manufacturer may or may not be performing for Eli Lilly remains a point of contention.
THE LATEST
Allogene is ceasing enrollment in a Phase I trial of cema-cel for patients with relapsed or refractory chronic lymphocytic leukemia after Bristol Myers Squibb’s Breyanzi was approved in the indication earlier this year.
Despite recent enthusiasm around the PD-1/VEGF space, BMO Capital Markets analyst Evan Seigerman noted that Merck’s pact with LaNova Medicines is more “conservativism” on the pharma’s part than confirmatory of recent data in the drug class.
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GSK is carving out a niche for Blenrep in the second-line multiple myeloma setting, for which it projects multi-blockbuster potential for the antibody-drug conjugate.
Following strong treatment response data for Adaptimmune’s lete-cel, the biotech is planning to initiate a rolling BLA submission to the FDA, set to start by the end of 2025.
The FDA has followed in the footsteps of its European counterparts and granted accelerated approval to PTC Therapeutics’ gene therapy Kebilidi for AADC deficiency. It is the first approved gene therapy to be delivered directly to the brain.
Following patient deaths in a lupus trial that led to the termination of that program, Kezar’s autoimmune candidate zetomipzomib faces a partial clinical hold barring four trial participants from continuing treatment in the open-label portion of the trial, though the trial itself will continue as planned.
Despite crowding in the next-gen weight loss space, Metsera has raised over $500 million since its April launch, indicating a continued appetite for these drugs.
A slow launch for Alzheimer’s medicine Leqembi, a lackluster pipeline and a challenging drug launch environment are just a few of the factors that have sent Biogen’s shares down this year.
The acquisition will give BioNTech full ownership of an investigational bispecific antibody targeting the PD-L1/VEGF-A pathways, a hot area in oncology that could potentially replace standard checkpoint inhibitors for cancer treatment.