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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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Axsome clinched a late-stage victory for its chronic sleep disorder candidate AXS-12, which demonstrated significant improvement in cataplexy—the sudden loss of muscle tone while a person is awake—after five weeks.
The National Institutes of Health claims BioNTech is in default regarding alleged royalty payments the agency contends it is owed in connection with the company’s COVID-19 vaccine Comirnaty.
Join us in this discussion on how you can optimize your chances of landing a new role despite a highly competitive job market.
Regeneron’s bispecific antibody odronextamab was hit with Complete Response Letters from the FDA noting issues with the enrollment status of its confirmatory trials.
Monday’s announced buyout of Virginia-based Landos Biopharma adds a mid-stage, oral NLRX1 agonist for ulcerative colitis and Crohn’s disease to AbbVie’s growing portfolio.
Esperion bagged broader-than-expected FDA labels for its cholesterol-busting drugs Friday, allowing the biotech to target seven times as many people in the U.S. compared to the old labels.
Just weeks after Wegovy won FDA approval for cardiovascular disease, Novo Nordisk has bought mid-stage biotech Cardior Pharmaceuticals and its miRNA-targeting candidate for heart failure.
The regulator has allowed for emergency use of Invivyd’s monoclonal antibody Pemgarda as a COVID-19 pre-exposure prophylaxis for moderately or severely immunocompromised patients.
Johnson & Johnson’s Opsynvi has been approved by the FDA for the treatment of pulmonary arterial hypertension, combining macitentan, which cuts the risk of clinical worsening and hospitalization, while tadalafil boosts patients’ exercise capacity.
AbbVie’s antibody-drug conjugate Elahere on Friday won the FDA’s full approval for the treatment of FRα-positive, platinum-resistant ovarian, fallopian tube and primary peritoneal cancers.