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European pharma companies splashed billions of dollars into the U.S. biopharma sector in a matter of days, but there are differing views on whether the activity represents the rise of a new buyer class or a quirk of timing.
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New guidelines from two leading medical associations suggest that efforts to reduce bad cholesterol should focus on maintaining low levels of two key lipoproteins. Big pharma is all in, looking to improve on the standard statins to help vanquish America’s number one killer: heart disease.
The FDA’s decision last year to make complete response letters public provides new insight into why therapies sometimes fail to get the regulatory greenlight. Analysts say the information could help sponsors refine their regulatory strategies.
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
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Delaware Chancery Court Judge Paul Fioravanti on Tuesday ordered activist investor Carl Icahn to remove confidential information from his lawsuit against legacy Illumina board members.
Vertex Pharmaceuticals and CRISPR Therapeutics have secured another FDA approval for their Casgevy Cas9 gene-edited cell therapy, this time in treating transfusion-dependent beta thalassemia.
Disco Pharmaceuticals is taking to the biotech dance floor with seed funding from major players and pipeline programs in small cell lung cancer and colorectal cancer.
The biotech Tuesday announced a restructuring plan as its humanized IgG1 antibody lirentelimab failed two Phase II studies in atopic dermatitis and chronic spontaneous urticaria.
The snacks and confectionery giant has been seeking to enter the biopharmaceuticals space in recent years.
Alto Neuroscience and Kyverna Therapeutics are following in the footsteps of CG Oncology, Metagenomi and Arrivent in seeking initial public offerings this year.
Following the J.P. Morgan Healthcare Conference and other parallel meetings in San Francisco, it’s time to reflect on some of the significant deals secured last week.
After a quiet start to 2024, the FDA is expected to decide on three applications over the next two weeks, including one for a nasal powder migraine treatment.
The agency nevertheless said that it could not definitively rule out a small risk of suicidal ideation associated with GLP-1 receptor agonists, and that it will continue evaluating the evidence.
Dropping the potential Cytokinetics buy runs contrary to Novartis’ recent dealmaking frenzy, which included the acquisition of Calypso and three research collaborations.