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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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Orna Therapeutics announced Thursday it is acquiring ReNAgade Therapeutics, which launched in May 2023 with $300 million in Series A financing and is on BioSpace’s NextGen Class of 2024 startups to watch this year.
Riding the growing wave of interest in molecular glue degraders, Takeda has partnered with Chinese biotech Degron Therapeutics to develop novel therapies for oncology, neuroscience and inflammation.
An appellate court ruled on Tuesday that pharmaceutical companies can lawfully impose restrictions on covered drugs under the 340B Drug Pricing Program.
In advance of Friday’s Endocrinologic and Metabolic Drugs Advisory Committee meeting, the FDA has raised concerns about hypoglycemia linked to Novo Nordisk’s insulin icodec, according to a briefing document.
Amid its ongoing efforts to trim $4 billion in spending in 2024, Pfizer in an SEC filing on Wednesday said it is looking to save an additional $1.5 billion over the next several years.
BioSpace’s Lori Ellis discusses the risks and challenges of cell and gene therapy combination products with DIA speakers James Wabby, AbbVie and Rob Schulz, Suttons Creek, Inc.
SixPeaks Bio emerged from stealth Wednesday with up to $110 million, a deal with AstraZeneca and plans to take weight-loss candidates designed to preserve muscle mass toward the clinic.
Otsuka Pharmaceuticals announced Wednesday it is ending development of drug candidate AVP-786 after failing to improve agitation associated with dementia due to Alzheimer’s disease.
Looking for research associate jobs in the biopharma industry? Check out these five top companies hiring life sciences professionals like you.
Days after backing out of two Ionis-partnered neuro programs, Biogen has inked a potential $1.8 billion buy of Human Immunology Biosciences and boosting its late-stage immunology pipeline.