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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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With an advisory committee meeting slated for Friday, the regulator has posted briefing documents in which it has raised concerns about early deaths in patients treated with Bristol Myers Squibb’s Abecma and Johnson & Johnson’s Carvykti.
Staffing agencies say contract work is a great way to break into an industry and avoid a resume gap.
The FDA will close out a hectic month of March with a flurry of target action dates, including ones for lymphoma and CKD anemia treatments.
The biotech announced Wednesday that patients on ION224 had histologic improvement in the liver disease without worsening of fibrosis. Ionis’ mid-stage win comes as the FDA is set to decide whether to approve rival Madrigal’s resmetirom by Thursday.
IFM Therapeutics announced Wednesday its subsidiary IFM Due has been acquired by Novartis. The acquisition provides the Swiss pharma with full rights to IFM Due’s portfolio of STING antagonists targeting inflammation-driven diseases.
Heather, Greg and Tyler discuss a busy news week including Wegovy’s label expansion, biosimilars, surprise donanemab delays for Eli Lilly and speculate on election impact.
Eli Lilly has partnered with Amazon Pharmacy to help fill online orders of its obesity drug Zepbound—as well as migraine and diabetes medicines—placed through the pharma’s online portal LillyDirect.
This is the latest rundown of people coming and going from executive positions at biopharma companies that BioSpace covers. This regular column highlights the hired, fired, retired, promoted or resigning, as well as those personally named in lawsuits.
Allogene Therapeutics and Arbor Biotechnologies will use their allogeneic CAR T and next-generation gene-editing platforms to develop novel off-the-shelf CAR-T therapies for autoimmune diseases.
In a briefing document for Thursday’s advisory committee meeting, the FDA pointed to efficacy and safety issues with Geron’s New Drug Application for imetelstat in myelodysplastic syndromes.