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The delay is largely “benign” for Praxis Precision Medicines, according to Jefferies, which emphasized that the FDA did not flag safety or manufacturing issues.
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Recent approvals for Corcept Therapeutics and Merck have injected momentum into the space, where GSK, Allarity Therapeutics, OSE Immunotherapies and others are advancing their own candidates.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
Dealmaking across biopharma is shifting dramatically as the SEC rolls out new regulations to ease burdens on newly public companies and antitrust review is replaced by drug pricing as the policy concern du jour.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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The five-year investment will go toward the construction of a new R&D facility in Beijing to develop innovative therapies and integrate the world’s second most populated country into the company’s global strategy.
Following two layoffs in less than three months, Viracta Therapeutics may have around 18 employees left to advance its efforts to bring lead product candidate nana-val to market.
While Moderna’s Spikevax beat Wall Street estimates in the third quarter, William Blair analyst Myles Minter in a Thursday note to investors said sales of the company’s respiratory syncytial virus vaccine mRESVIA was significantly lower than expected.
Novo said supply of Wegovy and Ozempic is in good shape after the drugs were removed from the FDA’s shortage list last week. But Eli Lilly reported slower than expected sales in the third quarter due to wholesaler destocking.
The investigational therapy, vesleteplirsen, had been positioned as an updated version of Sarepta’s original exon 51-skipping Duchenne muscular dystrophy drug Exondys 51.
In this episode of Denatured, BioSpace’s Head of Insights Lori and guests from Teva Pharmaceuticals and TOWER Capital discuss the opportunities, regulatory challenges and uncertainty surrounding AI.
Driven by copycat versions of Bristol Myers Squibb’s Revlimid and Novo Nordisk’s Victoza, Teva’s generics business was again a top-performer in the third quarter, with U.S. sales growing 30% and bringing in $1.1 billion in sales.
BMO Capital Markets analyst Evan Seigerman in a note to investors called Gilead’s third-quarter performance “consistent” and “steady,” while noting the company continues to demonstrate “reliable strength” in its human immunodeficiency virus business.
Year-over-year BioSpace data shows there are fewer job postings live on the website and far more competition for them.
Novo Nordisk’s total revenue in the third quarter missed analysts’ expectations but sales of weight loss drug Wegovy exceeded the consensus forecast. Still, the Danish drugmaker narrowed its full-year guidance for revenue and operating profit.