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The FDA is looking at a slew of label expansions this month, including one that could open up home-based treatments for Alzheimer’s disease.
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We must treat drug resistance as a central scientific priority rather than an unavoidable complication.
Altitude Labs, an offshoot of AI-focused techbio Recursion, is teaching scientists to build companies, one founder at a time.
With six acquisitions already this year, Eli Lilly’s business development shows no signs of stopping as executives make good on a promise to spend their GLP-1 gains.
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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.
By publishing complete response letters as soon as they are issued to drug sponsors, the FDA is expanding transparency in a way that, while positioned as a public health measure, also grants investors greater visibility into regulatory decisions. Experts question whether this is the agency’s proper remit.