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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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The vaccine maker’s fourth-quarter revenue and earnings on Wednesday missed Wall Street expectations, while providing full-year 2024 sales guidance of flat to lower than last year.
Plus, last week Richard Gonzalez announced his retirement from AbbVie, PhRMA appointed Gilead’s O’Day to chair its board and Joseph Papa became president and CEO of Emergent.
AbbVie continued its dealmaking spree Wednesday by partnering with OSE Immunotherapeutics to develop its early-stage, first-in-class antibody for chronic and severe inflammation.
This week Lori, Greg and Tyler discuss AbbVie: how longtime CEO Richard Gonzalez navigated Humira’s LOE, his victorious retirement announcement, and the future of biosimilars.
The Canadian biotech’s regulatory setbacks continued on Tuesday with an FDA Refusal to File letter for its intramuscular formulation of the humanized monoclonal antibody Trogarzo.
More than two years after an FDA rejection, AstraZeneca has given back to FibroGen U.S. and rest-of-world rights to the HIF-PH inhibitor, though the companies will maintain their contract in China and South Korea.
Amid the dual crises of worsening medicine quality and growing drug shortages, the FDA plans to increase inspections of Indian manufacturing facilities this year, Reuters reported Tuesday.
The FDA has rejected Minerva Neurosciences’ treatment for negative symptoms in schizophrenia, noting a lack of data and other factors that led to the Complete Response Letter.
From entering college in China at just 15 to co-inventing a drug for Bayer, Mei’s career journey has been far from average. Now CMO at Editas, he’s not done yet.
The biopharma industry in Nigeria takes a hit as GSK and Sanofi shut down their commercialization efforts in the country.