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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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Two days after winning FDA approval, Orchard Therapeutics on Wednesday provided its U.S. launch plans for metachromatic leukodystrophy gene therapy Lenmeldy, which has a wholesale acquisition cost of $4.25 million for the one-time treatment.
Under the European Union’s proposed regulations, companies will have data protection for at least seven-and-a-half years preventing competitors from accessing their product data.
Novo Nordisk’s investment of more than half a billion dollars is meant to expand its production capabilities in China and help it meet the global drug demand.
Takeda on Tuesday secured another label expansion for the kinase inhibitor, this time in the first-line setting for the treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia.
President Joe Biden has made drug pricing a cornerstone of his campaign, but former President Donald Trump also plans to target drugmakers if he reenters the White House.
The FDA took center stage last week as it approved the first-ever MASH therapy and considered additional approvals for CAR-T therapies, whose safety the agency has been investigating since last year.
The past year saw the slowest year-over-year growth in biopharma salaries in the past five years, according to the BioSpace 2024 Life Sciences Salary Report.
Bayer bagged another late-stage victory for its menopause drug candidate Tuesday, setting up a potential showdown with Astellas’ Veozah which was approved last year by the FDA for the treatment of hot flashes.
Engrail Therapeutics’ latest financing round will give it enough funds to advance its candidates for neuropsychiatric and neurodevelopmental disorders through clinical development.
GenAI, the youngest of the AI family, is evolving quickly. The global life sciences industry is attempting to evolve with it. However, as a keynote session at DIA’s MASC suggests, taking a pause to understand AI risks and to prepare to comply with the EU AI Act is what is needed.