BioNTech, MediLink to resume trial enrollment for HER3 antibody-drug...
The FDA on Thursday lifted a partial clinical hold on an early-stage study of a HER3-targeting antibody-drug conjugate that BioNTech is developing with China-based MediLink Therapeutics. The hold,...
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Walgreens nabs $100M BARDA partnership to expand decentralized clinical trials
Walgreens has snagged US government funding to expand its clinical trial capabilities, continuing investment where others have dropped off. The retail pharmacy is partnering with the US Biomedical...
View ArticleLiquidia scores only tentative approval for Yutrepia due to Tyvaso exclusivity
Liquidia’s stock $LQDA plummeted nearly 30% on Monday following the company’s announcement that while the FDA had granted a tentative approval for its treprostinil inhalation powder, it won’t get final...
View ArticlePfizer brings Indian generics maker to court over Xeljanz patent
Pfizer filed suit against an Indian pharmaceutical company on Friday over its application to market generic versions of Xeljanz XR. Xeljanz XR is an extended-release version of Pfizer’s blockbuster JAK...
View ArticleHalf of IRA negotiation savings to come from three drugs, Brookings finds
For the first 10 drug prices negotiated under the Inflation Reduction Act, about one-half of the estimated $6 billion in Medicare savings is the result of negotiations for just three of those drugs,...
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Updated: Eli Lilly's tirzepatide wins in Phase 3 pre-diabetes trial
After recently reporting soaring sales of its diabetes franchise, Eli Lilly is back with more data on its GLP-1/GIP dual agonist tirzepatide. In a Phase 3 trial, the drug reduced the risk of developing...
View ArticleMerck exercises option on one Kelun ADC, returns another as it tweaks broad deal
More than two years into its partnership with China’s Kelun-Biotech, Merck has made further choices on which part of the sprawling early-stage pipeline it wants to move forward. The pharma giant will...
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J&J buys another medtech company, this time paying $600M upfront for...
In its fifth acquisition of the year, Johnson & Johnson is again tapping into the medical technology field, which has become a bigger part of its business. The New Jersey healthcare conglomerate...
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TCGX and JPM help Pathalys raise $105M to go up against Amgen in subset of...
North Carolina biotech Pathalys Pharma expects to do a rare thing with its nine-figure Series B: file for FDA approval. Whereas most Series B financing rounds get a biotech into Phase 1 or through...
View ArticleBig employers are spending even more money on pharmacy costs, driven by...
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Pharmacy costs are taking up a bigger chunk of employers’ total healthcare spending as popular GLP-1...
View ArticleKymera seeks to raise $225M; Adcendo, Multitude's new ADC deal
Plus, news about Talus Bioscience, Moleculin, Organon and Eli Lilly: Kymera Therapeutics aims to raise $225M: The public offering will be used to fund Kymera’s pipeline, and some funds could be used...
View ArticleHouse lawmakers call on FDA to investigate clinical trials run alongside...
A group of bipartisan representatives called on the FDA to play an “active role” in ensuring the US “remains ahead” of China in biotech and urged the regulator to investigate clinical trials conducted...
View ArticleEmergent joins broader efforts for mpox vaccine drive in Africa
Certain pharma companies, governments and public health agencies have separately pledged to help build up vaccine supply in Africa to address the mpox outbreak. Emergent BioSolutions on Monday said it...
View ArticleFTC 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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