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As industry leaders gather at the annual event in Phoenix, the cell and gene therapy space remains in a state of flux, with M&A activity and regulatory support signaling momentum while commercialization challenges continue to hinder broader investor interest.
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As AAV9 and CRISPR programs navigate safety, delivery and scalability hurdles, small molecules offer a deployable, scalable bridge, complementing genetic approaches and accelerating meaningful impact for patients with Duchenne muscular dystrophy.
It can cure deadly diseases, save long-term healthcare costs and transform lives. But the U.S. insurance system still isn’t ready to pay for it.
Blank check deals dwindled after a crazy 2021. Now, biotechs are starting to turn to special purpose acquisition companies again as an easy route to the public markets.
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Merck, known as MSD outside of the United States and Canada, will hold its second-quarter 2024 sales and earnings conference call with institutional investors and analysts at 9:00 a.m. ET on Tuesday, July 30.
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After Emma Walmsley steps down as GSK CEO in January, Vertex Pharma’s Reshma Kewalramani will be the sole female CEO at a top-20 pharma company. Still, there are many prominent women in pharma that could someday break through again.
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While last week’s recommended changes by CDC advisors to the MMRV vaccine schedule are unlikely to have a tangible effect on Merck’s business, the company said the removal of choice for healthcare providers is “concerning.”
In its rejection letter, the FDA flagged problems at a third-party fill-finish site owned by Novo Nordisk. Issues at this site have previously been investigated by the regulator.
The agency also pointed to the use of Tylenol and other acetaminophen products during pregnancy as being potentially linked to neurological and developmental defects in children, following a press conference Monday in which President Donald Trump did the same.
An advisory committee last year found that Zynquista’s benefit-risk profile in type 1 diabetes was unfavorable due to cases of diabetic ketoacidosis.
By improving gait stability, Ionis’ zilganersen could be “potentially disease modifying,” according to analysts at William Blair.
Small and large drugmakers alike have made big, proactive moves to secure the production capacity that will be vital to serving the weight loss market.
The company was expecting a decision from the FDA by Sept. 28 for its oral drug tolebrutinib, but an update to the drug’s application package convinced the agency to take more time to review.
The acquisition of breakout obesity star Metsera should pump new life into Pfizer’s portfolio, which over the last two years has suffered from three discontinued assets.
In an interview with German-language outlet Neue Zuercher Zeitung, Novartis CEO Vas Narasimhan said the company is exploring ways to remove or minimize the drug price gap between the U.S. and its other markets in similarly developed countries.
For the last two years, Keytruda has reigned as the world’s top-selling drug—a distinction under threat with key patent protections expiring in 2028.