Calley Means joins White House as a special government employee
A close ally of HHS Secretary Robert F. Kennedy Jr. is joining the administration as a special government employee, according to a source familiar with the decision. Calley Means, an entrepreneur and...
View ArticleNovo Nordisk lays out new structure for early R&D unit
Novo Nordisk is reorganizing its research and early development unit in an effort to “future-proof the organization” and “significantly increase” the number of projects it brings into clinical trials,...
View ArticleMany rare disease drugs rely on just one trial for approval, FDA authors find
New research published by FDA authors found that 67% of non-oncologic rare disease marketing applications approved between 2020 and 2023 used only one clinical trial plus confirmatory evidence to...
View ArticleAkero exec calls MASH accelerated approval guidance 'bizarre'
NEW YORK — Akero Therapeutics may not have adequate data for accelerated approval of its MASH drug, despite showing it may reverse cirrhosis in patients with severe liver disease. The problem, chief...
View ArticleACIP meeting, delayed earlier this year, is rescheduled
A meeting of CDC vaccine advisors that’s been in limbo for almost a month is slated to take place around the middle of April, two sources familiar with the planning told Endpoints News. A spokesperson ...
View ArticleBridgeBio, Editas finance chiefs depart; Former FDA No. 2 joins Recursion's...
→ Brian Stephenson has stepped down after more than five years as CFO of BridgeBio, and president Tom Trimarchi will take over. Trimarchi was promoted to president and COO last July. “It has been an ...
View ArticleExclusive: VantAI builds AI model Neo-1 for molecular glues
A Roivant Sciences spinout says it has made the first AI model, to its knowledge, that simultaneously predicts biomolecule structures while generating new molecules. The diffusion-based model, called...
View ArticleJohnson & Johnson earmarks $55B to boost US capacity
Johnson & Johnson is planning to invest $55 billion to build up its US footprint over the next four years, becoming the latest pharma company to pour billions into the country. As a part of ...
View ArticleAstraZeneca broadens presence in China, promising $8B+ to Harbour and Syneron
AstraZeneca is further investing in China, opening an R&D center in Beijing and inking a pair of majorly backloaded R&D deals with Chinese drug developers. The Harbour BioMed and Syneron Bio...
View ArticleAstraZeneca puts $2.5B toward first vaccine factory and second R&D site in China
AstraZeneca is again boosting its manufacturing footprint in China, this time making a $2.5 billion investment to build its first vaccine plant and second R&D facility in the country. As a part of...
View ArticleGenfit's up to €185M royalty deal; J&J’s Tremfya gets a Crohn's approval
Plus, news about Akeso, Pulmatrix, Autolus, MacroGenics and BlissBio: Genfit completes up to €185M royalty deal: Per the agreement with HealthCare Royalty, the company gets €130 million ($141 million)...
View ArticleFDA approves Novartis’ Fabhalta in C3 glomerulopathy
Novartis’ Fabhalta notched another FDA approval, this time in adults with an ultra-rare kidney disease called C3 glomerulopathy. Fabhalta is the first drug approved specifically to treat C3...
View ArticleThe buildup to Chimerix's $935M cash exit to Jazz
Chimerix began attracting deal interest in its experimental brain tumor treatment about 18 months before it signed a $935 million cash exit to Jazz Pharmaceuticals earlier this month, according to a...
View ArticleBARDA cancels annual Industry Day
An annual gathering of industry and government officials focused on biomedical countermeasures and pandemic response has been canceled. The two-day event hosted by the Biomedical Advanced Research and...
View ArticleAlnylam hopes its ATTR-CM label will give Amvuttra an edge
Alnylam will likely face challenges in turning a profit this year, despite executives promising to do so. But the label for its newly-approved Amvuttra indication may give it an advantage over its...
View ArticleTrump think tank resurrects international drug pricing policy
President Donald Trump appears poised to bring back one of the drug pricing policies from his first term, as part of efforts to go after other countries "freeloading" on US pharma innovation. A
View ArticleLiver cancer drug combo gets its second FDA rejection
The FDA has once again rejected HLB and Jiangsu Hengrui Pharmaceuticals' drug combination to treat the most common form of liver cancer. Korean biotech HLB and China-based Hengrui were applied to...
View ArticleTeenager dies after receiving Sarepta therapy; Immunovant gets Phase 3 win,...
Hello and welcome back to the new Endpoints Weekly. It was another busy week in the biopharma world and we’ve got all of the headlines for you below. We also had an
View ArticleTwo biotechs fail to beat or match Regeneron's Eylea in key trials
Opthea and Unity Biotechnology, which are both developing new drugs for eye diseases, were unable to beat or match aflibercept, the standard-of-care treatment that Regeneron markets as Eylea, in two...
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