FTC backs FDA plan to remove switching study requirement for interchangeable...
The Federal Trade Commission is backing a recent FDA proposal to officially remove the requirement that biosimilar developers must run switching studies to obtain interchangeability designations....
View ArticleLawsuit alleges Biogen schemed with PBMs to preserve Tecfidera market
A lawsuit filed against Biogen last week alleges the company participated in a kickback scheme with pharmacy benefit managers to promote its blockbuster multiple sclerosis drug Tecfidera instead of...
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J&J scores approval for Rybrevant combo in first-line lung cancer, stoking...
Johnson & Johnson scored a label expansion for Rybrevant in combination with the newly-approved Lazcluze to treat certain first-line lung cancer patients, putting it in direct competition with...
View ArticleWuXi Biologics’ ADC spinout reports revenue jump despite Biosecure risk
ADCs are so hot that WuXi Biologics’ specialist company has so far appeared immune to the Biosecure threat as it unveiled a rise in revenues, manufacturing build momentum and an upsurge in workforce...
View ArticleSemaglutide may come with a higher risk of suicidal thoughts, JAMA study finds
A new observational study has found an increased risk of suicidal ideation among patients who take Novo Nordisk’s flagship weight loss drug semaglutide compared to other drugs, adding to a mixed bag of...
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After Pfizer layoffs, Array chemists regather at next-gen obesity biotech...
A small piece of the multibillion-dollar restructuring at Pfizer has a light at the end of the tunnel, and it’s in Boulder, CO. Just a few months after research operations ended at the home of Array...
View ArticleAadi axes 80% of staffers as it winds down Phase 2 solid tumor trial that’s...
Not even a year since it named Dave Lennon as CEO, Aadi Bioscience is facing major headwinds as it pulls back from a series of trials of its only cancer asset and cuts a majority of its staffers. The...
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Dr. Reddy's and Stanford spinout Kainomyx partner up on anti-malarial program
Dr. Reddy’s Laboratories, its CRDMO arm Aurigene and Stanford spinout Kainomyx are teaming up to develop an anti-malarial drug with a new mechanism of action. In the partnership, Kainomyx will develop...
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BridgeBio forms another offshoot with $300M in commitments
BridgeBio is again offloading pieces of its pipeline as it stares down a November drug approval decision that could spark competition with Pfizer and Alnylam. The California biotech has formed a new...
View ArticleVandria raises another $10M; Nykode ends Phase 2 trial in cervical cancer
Plus, news about Retension Pharmaceuticals: Vandria tops up Series A with another $10M: The Swiss biotech increased its round total to $30.7 million after getting a new investment from the Hevolution...
View ArticleFDA rejects Regeneron’s multiple myeloma bispecific antibody over...
The FDA rejected linvoseltamab, Regeneron’s experimental antibody for multiple myeloma, the company announced Wednesday morning. In an earnings call earlier this month, Regeneron CEO Leonard Schleifer...
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Indian CDMOs unlikely to see sudden surge in clients if China bill passes,...
Although CDMOs based in India continue to see an uptick in inquiries because of the Biosecure Act, executives have tempered expectations on how soon queries will convert to financial tailwinds for the...
View ArticleTimber Pharmaceuticals' candidate for rare skin disorder flunks all endpoints...
Dermatology biotech Timber Pharmaceuticals’ Phase 3 trial investigating its treatment in a rare inherited skin disorder missed all primary and secondary endpoints, the company announced Wednesday. In...
View ArticleWuXi Bio spotlights new US contracts, but profits are down as Biosecure brews
WuXi Biologics said Wednesday that it’s still signing on new US customers despite much of the public discussion about the company concerning a bill designed to discourage biopharmas from working with...
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BioMarin shakes up executive team, tapping notable dealmaker James Sabry
BioMarin is bringing prominent dealmaker James Sabry onto its executive team, along with Amgen rare disease veteran Greg Friberg. Hank Fuchs Sabry will start on Oct. 7 as chief business officer,...
View ArticleFDA warns hospitals against using Pfizer's remaining potassium injections for...
In an update to a warning issued last year, the FDA said Wednesday it remains concerned about the risk of aluminum toxicity associated with a Pfizer subsidiary’s unapproved potassium phosphate...
View ArticleChinese government indicts Japanese Astellas employee for espionage — report
A Japanese employee of Astellas Pharma who was detained in March 2023 in Beijing by Chinese authorities has now been indicted on suspicion of espionage, according to reporting by Reuters and other...
View ArticleBiogen, Eisai’s Leqembi wins UK approval, but NHS coverage may be unlikely
Biogen and Eisai’s Leqembi has been authorized by the UK’s Medicines and Healthcare products Regulatory Agency for Alzheimer’s disease, but a negative opinion from the country’s cost-effectiveness...
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Versant, Novartis launch Borealis Biosciences for RNA therapies in kidney...
Five years to the day after launching Chinook Therapeutics, Versant Ventures is back with a second generation of that kidney disease biotech and has a partner in Chinook’s acquirer, Novartis. The...
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Digital health startup Sesame starts offering compounded weight loss shots
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Customers of Sesame, a digital marketplace that connects patients to doctors in person and online, can...
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