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If ultimately confirmed, Makary’s planned departure, broken by The Wall Street Journal Friday afternoon, would follow a controversial tenure in which his deputy and constant co-author Vinay Prasad riled biopharma feathers with myriad unexpected drug rejections. Prasad stepped down as biologics chief last week.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
In Salt Lake City, biotech founders new and seasoned reflect on ways to ride out the industry’s challenges, such as sending cold emails to investors and learning to address leadership weaknesses.
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With Eisai and Biogen’s Leqembi and Eli Lilly’s Kisunla launching onto the market, the 2024 Clinical Trials of Alzheimer’s Disease conference focused on the role these drugs might play, as well as combination therapies and innovative new treatment options.
The past four years have brought disappointment for the Huntington’s community, but optimism is growing as companies including Prilenia and Wave Life Sciences eye paths to approval of therapies that could address the underlying cause of the disease.
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.