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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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About a year after cutting staff by 29%, Sana Biotechnology will trim its workforce as it increases investment in its type 1 diabetes program and looks to extend its cash runway.
Not everyone who completes a life sciences Ph.D. wants to continue working in a laboratory or in research. If this is the case for you, here are 12 careers for Ph.D. life scientists outside of the lab.
Despite the PDUFA date being extended by three months for Merus’ zenocutuzumab, Truist Securities analyst Asthika Goonewardene in a Tuesday note to investors said the delay is not a cause for concern with an approval expected.
A suit against Novartis and Vitaris by Henrietta Lacks’ estate hinges on questions about the morality and legality of using the line for biopharmaceutical research.
While expected and seen as largely incremental, Jefferies analyst Peter Welford in a Tuesday note to investors said the detailed data for three early-stage assets support moving them into Phase IIb studies and creates a “foothold” for AstraZeneca in the weight loss space.
Coming off of a strong third quarter, Vertex Pharmaceuticals is nearing several important milestones, including the potential approvals of vanzacaftor triple in cystic fibrosis and the non-opioid therapy suzetrigine in pain—both slated for January 2025.
In a deal worth up to $285 million initially for the lead program, Novo Nordisk will gain access to Ascendis’ TransCon technology platform in an effort to find novel GLP-1 candidates with reduced dosing frequency.
Driven by the early approval of its updated COVID-19 vaccine, BioNTech far exceeded analysts’ expectations in the third quarter and reported its first quarterly profit in 2024. However, the German biotech also cut its outlook for the year.
Multiple players are exploring whether modalities designed to combat B cell malignancies can be repurposed against lupus, myasthenia gravis and other conditions traced to misdirected immune response.
The Big Pharma companies made a last-ditch effort asking a U.S. appeals court to reconsider their lawsuits against the Inflation Reduction Act’s Medicare drug price negotiations, which they contend infringe on their constitutional rights.