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The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
FDA
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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?
Job Trends
Follow along as BioSpace tracks job cuts and restructuring initiatives.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
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.
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Digitization enables each drug to have a software-enhanced version optimized for individual patients.
Leqembi’s sales continue to be underwhelming, according to analysts, who contend the companies’ Alzheimer’s disease therapy is being held back by barriers such as coverage, infusion centers and time to diagnosis.
With Novo Holdings’ $16.5 billion buyout of Catalent being reviewed by regulators, what work the contract drug manufacturer may or may not be performing for Eli Lilly remains a point of contention.
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.