Krystal Biotech wins second-ever FDA platform designation for viral vector
Krystal Biotech on Tuesday became the second company to land the FDA's prestigious platform technology designation, allowing the company to win faster approvals of products that incorporate its...
View ArticleJ&J CEO downplays any need for 'large' acquisition as it gears up for new...
As Johnson & Johnson faces increasing pressure from Stelara generics, the company's executives remain confident in their pipeline’s ability to fill in the gaps. On Tuesday’s third-quarter earnings...
View ArticlePfizer claims first-line success for Tukysa in breast cancer Phase 3 trial
Pfizer’s Tukysa succeeded as a first-line maintenance therapy in combination with other standard-of-care drugs for certain metastatic breast cancer patients, the company said Tuesday. In a Phase 3...
View ArticleReinventing mental healthcare in the age of AI
Headspace CEO Tom Pickett has been on the job for a little more than a year now. His focus during that time has been guiding the company through the “technology transition” brought on by generative ...
View ArticleTubulis snags $361M for clinical-stage ADCs
Tubulis is headed to one of the leading cancer R&D conferences with the fifth-largest private biotech fundraise of 2025. The Munich-based ADC biotech will present its first clinical data at the...
View ArticleHair loss biotech Pelage collects $120M for Phase 3 trials
In the span of three weeks, a seven-employee biotech focused on hair loss raised $120 million for Phase 3 trials that will begin next year. Los Angeles-based Pelage Pharmaceuticals announced the Series...
View ArticleMark Pruzanski joins Alentis as CEO after leading Intercept and Versanis
Mark Pruzanski has found another fibrosis drug developer to lead, and this time he's also venturing into oncology. The biotech industry veteran has joined Swiss startup Alentis Therapeutics as its new...
View ArticleWhich big pharma had the busiest M&A team? Q3 biopharma deal analysis
Biotech execs generally point to need as the biggest driver of dealmaking. Some of the biggest players — say Merck and Bristol Myers Squibb — are losing major franchises and have a limited time to fill...
View ArticleBexorg raises $23M to test drugs on ‘rebooted’ human brains from organ donors
Drugs that look promising in animals often prove ineffective in humans. That’s especially true for diseases that afflict the brain, our most complex organ, and the one that makes us most unique from...
View ArticlePost-Hoc Live: Are the good times in biotech … back?
The other day I went online and decided, for the first time in a while, to check the price of the {$XBI}. I blinked, rubbed my eyes, and blinked again. 100??? What year is it? Quietly, gradually and...
View ArticleFormer FDA deputy Bumpus to lead Charles River's new scientific advisory board
Namandjé Bumpus, the former FDA principal deputy commissioner, will lead a new scientific advisory board at Charles River to guide its approach to non-animal based research models that can help to...
View ArticleExclusive: Lipid nanoparticle startup emerges with $31M from Khosla for in...
The red-hot race to develop simple infusions that reprogram immune cells to fight cancer and other diseases just got another entrant. Liberate Bio has raised $31 million in seed funding exclusively...
View ArticleNovo Nordisk buys kidney, blood disorder drug from Omeros
Novo Nordisk is paying up to $2.1 billion for a mid-stage blood and kidney disorder drug just weeks after saying it would focus its pipeline on obesity and diabetes under a new CEO. The Danish ...
View ArticleBoehringer makes an ADC deal with AimedBio; EyePoint’s $150M stock sale
Plus, news about Scynexis, Step Pharma, Eradivir, J&J, Omnix Medical and Mission Therapeutics: 💼 Boehringer Ingelheim does another cancer deal: The German drugmaker will pay up to $991 million to...
View ArticleLilly’s oral GLP-1 racks up two more clinical wins in diabetes
Eli Lilly’s GLP-1 pill has succeeded in two more late-stage trials in type 2 diabetes. The company said Wednesday that orforglipron beat AstraZeneca’s Farxiga at lowering patients’ blood sugar levels...
View ArticleBioNTech to get up to €95M in EU funding for a mRNA vaccine site in Africa
Two EU bodies will fund BioNTech with up to €95 million ($110 million) to help build its mRNA vaccine factory in Kigali, Rwanda, which is designed to locally supply vaccines to Africa. The Mainz,...
View ArticleEx-FDA leaders take helm of new consultancy, discuss the state of the agency
The FDA's former chief medical officer Hilary Marston left the agency in June and has already teamed up with Michael Rogers, one of the FDA's former top inspectors, to be principals of a new...
View ArticlePeter Thiel-backed Peptilogics raises $78M for prosthetic joint infection...
A Pittsburgh-based biotech supported by PayPal co-founder Peter Thiel has secured $78 million in a Series B raise that will focus on advancing its candidate for prosthetic joint infections. The cash...
View ArticleAicuris' herpes drug succeeds in Phase 3 study, company says
A privately-held German biotech said its experimental herpes drug succeeded in a Phase 3 study, setting up plans to apply for US approval in 2026. Patients on Aicuris' drug, called pritelivir,...
View ArticleAdcytherix raises €104M Series A to back new ADC drug
A French team of researchers and biopharma executives is taking the wraps off a large Series A round that will help get its lead antibody-drug conjugate program into its first human trials. Adcytherix...
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