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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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Gilead Sciences is ending the development of magrolimab for the treatment of blood cancer following the FDA’s placement of a clinical hold on all its programs related to the drug.
Kyowa Kirin’s dealmaking continued on Wednesday when BridgeBio Pharma granted the Japanese company an exclusive license to develop and commercialize infigratinib.
BioNTech will pay $50 million in cash and purchase $200 million of Autolus Therapeutics’ shares to progress the companies’ respective CAR-T candidates to commercialization.
On Thursday, Kyverna Therapeutics is debuting on the Nasdaq with an upsized initial public offering which the biotech will use to support its pipeline of anti-CD19 CAR T therapy candidates.
Thursday’s full-year financial results from AstraZeneca showed a revenue crash of more than 90% for COVID-19 medicines, while cancer, cardiovascular and rare diseases all generated double-digit revenue growth.
The European Medicines Agency is looking into how Novo Holdings’ recently announced $16.5 billion acquisition of contract manufacturer Catalent might affect the availability of drugs.
Under the FDA’s compassionate use program, an eyedrop formulation of Krystal Biotech’s Vyjuvek restored the vision of a teenager with the rare genetic disease dystrophic epidermolysis bullosa.
A proposed class-action lawsuit accuses Johnson & Johnson of failing to negotiate fair prescription drug prices for its employees, but experts note that the company is also on the hook for benefits costs.
Takeda, AbbVie and Moderna are among the companies with open positions.
Jazz Pharmaceuticals is acquiring Redx Pharma’s KRAS inhibitor program including preclinical-stage drug candidates, with the companies working to advance assets through IND-enabling studies.