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UniQure’s planned third-quarter submission for its Huntington’s disease gene therapy may be a harbinger of a more flexible FDA under acting commissioner Kyle Diamantas—but how long will it last? And how can companies be sure these positive decisions won’t just be reversed?
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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 and Kelun-Biotech’s antibody-drug conjugate achieved a 22% objective response rate and 80.5% disease control rate in heavily pretreated patients with gastric or gastroesophageal junction cancer.
Late-stage study results released Tuesday show YS Biopharma’s rabies vaccine candidate can induce twice the seroconversion rate at seven days versus a standard, globally marketed comparator.
A new Scandinavian study published Wednesday found no conclusive evidence to support the link between GLP-1 receptor agonists and an increased risk of thyroid cancer.
Many promising small molecules have lost significant investment appeal as a result of lopsided incentives favoring biologics in 2022’s Inflation Reduction Act.
Looking for a biopharma job in San Diego? Check out these top five companies hiring life sciences professionals like you.
A pair of biotechs burst onto the scene Tuesday, exiting stealth with $100 million in financing each and tapping executives who made their names at bluebird bio and Karuna Therapeutics.
After BrainStorm Cell Therapeutics withdrew its BLA in October 2023 for NurOwn, the company announced Tuesday that the FDA has agreed to the design of a Phase IIIb trial for its amyotrophic lateral sclerosis candidate under a Special Protocol Assessment.
AbbVie’s $10.1 billion takeover of ImmunoGen paces the cancer sector in early 2024, as ADCs and radiopharmaceuticals remain hot.
Pfizer’s respiratory syncytial virus vaccine Abrysvo is just as effective in younger adults aged 18 to 59 years as it is in the shot’s currently approved population of 60 years of age and older.
As part of its ongoing review, the European Medicines Agency this week is slated to examine the potential risks of suicidal ideation and self-harm associated with diabetes and weight-loss treatments.