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Fallout from the resignation of FDA Commissioner Marty Makary continues as several other senior regulators are removed from their posts; pharma’s top paid CEOs make up to 358 times more than their employees; Revolution Medicine’s pancreatic cancer results highlight movement in the deadly disease space; more.
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Biotech is increasingly financed, governed and regulated as though it were a mature pharmaceutical industry rather than a discovery system built around scientific uncertainty. Structural changes are needed to sustain the sector’s strategic innovation.
BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
Nusano will bring a massive new radioisotope facility in Salt Lake City online by the end of the year, establishing a supply of starting materials for the next generation of radiopharmaceuticals.
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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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Industry advocates argue price negotiation via the IRA may jeopardize the prices relied upon by biosimilar manufacturers to recoup their investments.
The company also terminated a Phase III trial of its TGFB inhibitor as a treatment for metastatic pancreatic ductal adenocarcinoma, though that drug will continue to be tested as a treatment for colorectal cancer.
Tuesday’s partnership will dig into Flagship’s deep ecosystem of companies and technologies to discover medicines in line with Pfizer’s core strategic areas.
Less than two years after launch, the startup posts positive Phase II results and heads into Phase III trials for major depressive disorder with a new CEO.
Following the full approval of Leqembi, the CMS suggests expanding its coverage of beta-amyloid PET scans, which could improve the uptake of novel Alzheimer’s disease treatments.
The Netherlands-based immunology company said Wednesday it brought in $1.1 billion by selling more than two million shares in the U.S. and Europe.
The U.S. regulator Monday approved the Beyfortus single-dose monoclonal antibody, developed jointly by the two companies, for the pediatric prevention of respiratory syncytial virus.
Part B of the study, cleared to proceed in Canada, remains on hold in the U.S. due to findings from non-clinical chronic toxicology studies.
The Swiss pharma is expanding its neuroscience pipeline with an upfront $500 million payment to DTx Pharma and additional payments of up to $500 million upon completion of certain milestones.
Following disappointing topline data, BridgeBio’s acoramidis has scored a late-stage win in transthyretin amyloid cardiomyopathy, leading to significant survival and quality of life benefits.