BioPharma Dive

Celea, backed by investors such as RA Capital and Leaps by Bayer, is making what it says is an improved version of Roche's Esbriet.

The Phase 3 trial compared Roche’s divarasib with treatments sold by Amgen and Bristol Myers in patients with non-small cell lung cancer.

Elsewhere, Otsuka’s kidney drug hit the goal of a confirmatory trial and Vertex’s CRISPR sickle cell drug secured expanded approval.

The purchase hands Ipsen an experimental medicine in late-stage testing for a virus that often affects kidney transplant patients.

A group of coming decisions could provide important insights into how flexible the agency is willing to be under new leadership.

According to Abivax, fresh data suggest malignancy rates in its trials were no higher than "background" ones for people with ulcerative colitis, clearing a key safety concern.

The planned acquisition of Kartos Therapeutics would hand Ipsen a late-stage asset for myelofibrosis. Elsewhere, Sobi hit a regulatory setback and BeOne unveiled more positive Brukinsa data.

The FDA, through a new approval, gave Viridian's drug a label that some on Wall Street believe makes it well-positioned to compete against Tepezza in the thyroid eye disease market.

Biotechs aimed at eye diseases, autoimmune conditions and longevity medicine have pulled in some of the largest capital raises so far this year.

The company, which was built by Bain Capital, has now raised more than $426 million in its quest to advance a portfolio of Bristol Myers drugs.

Vedana Therapeutics emerged from stealth Wednesday with $46 million to support its mission of developing “anti-PACAP” therapies, an increasingly popular strategy for migraine prevention. 

It’s the latest in a string of deals for Lilly, which has sunk more than $18 billion into acquisitions over the past few years.

Express Scripts and the PBM lobby are following in CVS Caremark’s footsteps in filing complaints challenging the FAIR Rx Act, which was passed earlier this year despite vehement opposition from PBMs.

Ahead of a Thursday advisory panel meeting, agency scientists highlighted shortcomings in data accrued for a vaccine the FDA controversially refused to even review earlier this year. 

Still, the results leave somewhat unclear how different the company’s drug is than marketed hypertrophic cardiomyopathy medicines from Bristol Myers Squibb and Cytokinetics.

Neumora’s stumble is the latest setback for a once-promising class of brain drugs. Elsewhere, a cell therapy manufacturing specialist took steps toward an IPO and J&J made its latest U.S investment.

This podcast explores how leading Alzheimer’s experts are working to bridge the gap between clinical trial design and frontline care.

For 2029, a federal rule proposes closing a "loophole" that protects medicines transitioning from intravenous administration from price protection.

Acquired through its purchase of Ajax, the drug showed encouraging effects in patients with hard-to-treat myelofibrosis. To analysts, such results could lead to competition for Incyte’s Jakafi.

The latest results studying Talvey in combination with Darzalex Faspro support J&J’s efforts to expand the immunotherapy's use.