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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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Merck is eyeing a quick review for its lipid-lowering drug candidate enlicitide, which in December was awarded a Commissioner’s National Priority Voucher.
Serial biotech investor Kevin Tang previously unsuccessfully tried to buy Kezar Life Sciences via Concentra Biosciences, a biotech consolidation company owned by the venture capital firm he runs.
Takeda’s layoffs include cutting 247 people in Massachusetts. The workforce reduction is meant to help offset investments in areas including a product launch for oral drug candidate zasocitinib, for which the pharma today announced positive Phase 3 data.
While tonlamarsen missed one of two co-primary endpoints, Kardigan says the drug has shown a clinically meaningful effect on blood pressure, supporting advancement into Phase 2b.
The FDA rejected the high-dose regimen of Spinraza in September last year due to manufacturing concerns.
William Blair hailed a positive readout in cutaneous lupus erythematosus as a turning point for Biogen, while RBC Capital analysts called the results “another derisking step” for the company’s immunology and inflammation pipeline.
The lack of a dose-response effect could be due to the high number of dropouts in the higher-dose Winrevair arm and the relatively small study population, a discussant for Merck explained.
The Insilico Medicine agreement plays into Eli Lilly’s recent AI push, anchored by a partnership last year with NVIDIA to build a supercomputer to optimize drug discovery and shorten the development timeline.
AbbVie’s Skyrizi appears to have stronger efficacy than Johnson & Johnson’s newly approved pill Icotyde, as well as a less frequent dosing schedule that patients could prefer, according to analysts at BMO Capital Markets.
The FDA has some big verdicts lined up in the second quarter, including one for a closely watched obesity drug that many anticipate will further intensify competition in weight loss.