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Denali Therapeutics is the latest company to sell a priority review fast pass for an elevated price after the program was renewed earlier this year.
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While agents like AbbVie’s Humira have transformed the treatment landscape, not all patients benefit equally from the drug. Better biomarker analysis and more investment in mechanistic trials can inform the development of more effective therapies with broader clinical value.
Precision science is ruling the M&A scene as pharmas prepare for loss of exclusivity on key products, PwC says in a new report. Biotechs should be prepared with a dual-track process with the IPO window now open.
While biopharma’s overarching mission is to develop innovative medicines to improve patient outcomes, for these six people, the motivation came from much closer to home.
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FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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Novo Nordisk’s etavopivat elicited a 27% drop in vaso-occlusive crises and 48.7% hemoglobin response after 24 weeks, creating “separation amongst PK class candidates,” Truist analysts said on Monday. Novo plans to seek FDA approval in the back half of 2026.
While Merck’s PD-1/VEGF asset appears to match the performance of Summit Therapeutics’ ivonescimab, the pharma’s Phase 1/2 readout in non-small cell lung cancer still leaves analysts with some questions moving into later-stage development.
The acquisition of Neurona will put UCB in both the epilepsy and cell therapy space, even as many of its fellow pharmas move away from the latter modality.
A new executive order could usher in psychedelics as the “key next wave” of mental health therapies, according to analysts at RBC Capital Markets.
While Novo Nordisk’s Wegovy pill reached more than 3,000 patients in its first week on the market, analysts at RBC Capital Markets said a direct comparison of the two figures could be misleading given the shorter data collection time for Foundayo.
Obesity-focused Kailera Therapeutics debuted on the Nasdaq Friday after raising a record $625 million, beating Moderna’s $600 million from 2018.
The pharma industry “own Congress, they own the media,” Health Secretary Robert F. Kennedy, Jr. told lawmakers by way of explaining the bad press against FDA Commissioner Marty Makary following the second rejection of Replimune’s advanced melanoma drug.
More patients on Eli Lilly’s tirzepatide lost over 5% of their lean mass versus those on Novo Nordisk’s semaglutide, according to a study that has yet to be peer reviewed.
After Replimune’s advanced melanoma drug was rejected for a second time, CEO Sushil Patel slammed the FDA for failing to exercise regulatory flexibility, while other experts bemoaned the agency’s lack of consistency. With new safety guidelines for gene editing therapies, the FDA has taken a first step toward fixing both problems.
The Merck update, which will shed light on a $588 million bet to succeed Keytruda, is part of a roster of presentations that could shape the future of ADCs, protein degraders and KRAS-targeted therapies.