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Moderna will not commit to previous 2028 breakeven guidance as the ripple effects of the FDA’s refusal-to-file decision spread through its pipeline.
FEATURED STORIES
The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
A rapturous response to data published last year for Pelage’s hair loss candidate overwhelmed the biotech. Now, the company is ready to show the world the science behind the breakthrough.
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Read our takes on the biggest stories happening in the industry.
Novo Nordisk and Eli Lilly have been battling head-to-head in an exploding obesity market. They should never have been compared apples to apples.
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Following a controversial Rett Syndrome trial last year, Anavex Life Sciences’ blarcamesine has claimed another clinical victory—this time in an Alzheimer’s disease Phase IIb/III study.
After nearly seven years, the company’s rare diseases arm Alexion has reached a settlement in an investors’ lawsuit over alleged unethical sales practices for its hemoglobinuria therapy Soliris.
Bristol Myers Squibb’s pipeline cuts, announced Thursday during its R&D Day, include a mid-stage drug candidate for nonalcoholic steatohepatitis and an anti-TIGIT solid tumor program.
As researchers face delayed project timelines and inflated costs, industry leaders are offering an alternative option for sourcing nonhuman primates.
The FDA has issued more than 30 guidance documents related to drug development so far this year. BioSpace takes a closer look at six of them.
AlveoGene has licensed the U.K. Respiratory Gene Therapy Consortium’s InGenuiTy platform for all uses excluding the CTFR gene, which is already licensed to Boehringer Ingelheim for cystic fibrosis.
The company declined to exercise the license option for Harpoon Therapeutics’ TriTAC HPN217 program for multiple myeloma, which targets B cell maturation antigen, or BCMA.
During Wednesday’s annual R&D Day, Moderna said it is culling four programs from its pipeline, including two molecules that had been discontinued last year by AstraZeneca.
The Cardiovascular and Renal Drugs Advisory Committee voted 9-3 in favor of Alnylam’s patisiran on whether its benefits outweigh its risks for patients with cardiomyopathy induced by transthyretin amyloidosis.
The company plans to launch up to 15 new products and bring up to 50 new candidates to the clinic over the next five years as part of its growth plan, while scaling down COVID-19 manufacturing.