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Yet another therapy with FDA accelerated approval suffers a setback; Sage’s tough year continues; Sanofi drops $326 million in radiopharma while selling its consumer health unit; Novo Nordisk’s positive Rybelsus results in cardiovascular disease; and more.
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The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
At one point in merger negotiations with Novartis, Avidity CEO Sarah Boyce and her team walked, cutting off access to a data room and moving on to a capital raise.
Previous mega blockbusters took years to reach their peak sales. Lilly’s tirzepatide franchise is on course to exceed them just a few years in.
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Merck, known as MSD outside of the United States and Canada, announced positive top-line results from the pivotal Phase 3 STELLAR trial evaluating the safety and efficacy of sotatercept, an investigational activin receptor type IIA-Fc fusion protein being evaluated as an add-on to stable background therapy for the treatment of pulmonary arterial hypertension .
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Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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Thanks to strong sales of its blockbuster drugs Mounjaro and Zepbound, Eli Lilly on Tuesday reported nearly $8.77 billion in revenue in the first quarter of 2024, while raising its full-year revenue guidance by $2 billion.
A federal court issued a summary judgment saying that the IRA provision does not represent an unconstitutional taking of property but did not rule on suits by Novartis and Novo Nordisk.
Based on strong overall and progression-free survival data in its Phase III confirmatory study, Pfizer and Genmab’s antibody-drug conjugate Tivdak on Monday secured the FDA’s full approval for recurrent or metastatic cervical cancer that had progressed on or after chemotherapy.
AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu significantly improved progression-free survival in metastatic breast patients with low and ultralow HER2 expression levels who had received at least one line of systemic treatment.
On June 10, the FDA will convene its Peripheral and Central Nervous System Drugs Advisory Committee to discuss the New Drug Application for Lilly’s Alzheimer’s drug.
Pharma CEOs claim lifesaving drugs wouldn’t be possible without high prices — an assertion that doesn’t stand up to scrutiny.
Q&A: Development Scientist at AGC Biologics Sara Morlacchi analyzes the growth of the cell therapy industry and barriers for cost and accessibility.
Bristol Myers Squibb’s deal announced Monday will see the pharma pay $65 million upfront to Repertoire Immune Medicines, which will develop autoimmune disease vaccines using its Decode discovery platform.
Ono Pharmaceutical will pay $25.60 per share in an all-cash deal to buy Deciphera Pharmaceuticals for its potential blockbuster oncology drugs and U.S. sales infrastructure, the companies said Monday.
Johnson & Johnson and Addex Therapeutics’ epilepsy hopeful ADX71149 did not meet its primary endpoint of time to reach baseline seizure count in a mid-stage trial, as the partners look to determine the next steps for the program.