But the head of the FDA’s CBER office didn’t tip where the agency stands on potentially broadening use of Sarepta’s Duchenne gene therapy Elevidys.
The planned spending on constructing new facilities in Lebanon, Indiana, brings its total commitment to the site to $9 billion, the largest single investment in company history.
The U.K. drugmaker aims to catch up in developing new tumor-fighting technologies — areas where it has lagged behind leaders like Novartis and J&J.
Direct-to-consumer platforms can offer consumers an online path to sourcing popular medications, but some therapeutic areas may be better suited for the business model.
The German drugmaker is bolstering its MilliporeSigma business with a unit of Gamma Biosciences that specializes in so-called transfection reagents.
Rather than endorse the recommendation of the EMA, the commission called for a new review for Translarna that considers “the totality of the evidence” compiled to date.
The company, which previously announced plans to trim $4 billion in spending by the end of 2024, aims to save another $1.5 billion over the next three years.
Progentos says the money will go toward expanding its pipeline and pushing an experimental treatment for multiple sclerosis through "proof of concept” testing.
Imdelltra, a bispecific antibody targeting a protein called DLL3, is cleared for use following chemotherapy in treating extensive-stage small cell lung cancer.
The deal, only Biogen’s third since the start of 2018, is a sign the company is open to branching out beyond the neurological drugs that have long been its focus.
The collaboration, which gives Lilly access to Aktis’ technology in return for $60 million, adds to a flurry of dealmaking in the radiopharma field.
Since pivoting from oncology, the startup has raised close to $300 million and advanced an ulcerative colitis drug into mid-stage testing.