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Kailera’s lead asset, KAI-9531, elicited an average weight loss of more than 17% in a Phase III study in China. The biotech expects to launch a global late-stage program for the drug this year.
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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.
Some of the biggest SPACs from the industry’s pandemic-fueled heyday are no longer on the market.
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MorphoSys AG announced that the company has entered into a delisting agreement with Novartis BidCo AG and Novartis AG following the successful closing of the acquisition of MorphoSys by Novartis in May 2024.
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Following restricted vaccine approvals and changes to CDC immunization schedules, Merck, Pfizer, GSK and Sanofi are all suffering revenue hits to their vaccine programs.
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Already approved in Japan, China and other Asian countries, Crystalys’ dotinurad works to lower serum uric acid levels.
Without naming Aurinia Pharmaceuticals, the CDER director in a now-deleted LinkedIn post claimed that for lupus nephritis, companies have not conducted post-approval studies “to demonstrate a benefit on hard clinical endpoints.”
Companies are moving from using AI for distinct operations to applying the technology for control and optimization of the whole production process.
Reshoring generic pharmaceutical production is essential in today’s era of geopolitical instability and heightened awareness surrounding national health security. And it is possible—if done right.
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.
Chief Commerical Officer Luke Miels will replace outgoing GSK CEO Emma Walmsley at the U.K. pharma next year.
The AAV pullback comes amid Biogen’s aggressive cost-cutting campaign, which put some 1,000 jobs on the chopping block with the goal of generating $1 billion in savings by 2025.
Applied Therapeutics has yet to confirm whether the study, posted on Clinicaltrials.gov on Thursday, means it has indeed aligned with the FDA on govorestat’s development.
The centerpiece of the acquisition is petosemtamab, Merus’ bispecific antibody targeting EGFR and LGR5, which in May demonstrated best-in-class potential for head-and-neck cancer.
The FDA in September issued two rejections for spinal muscular atrophy therapies—both linked to manufacturing problems—and granted approvals in Barth syndrome and for a subcutaneous version of Merck’s Keytruda that could be key to the blockbuster’s future earnings.