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Under Friday’s final ruling anti-obesity medications for weight-loss will remain ineligible for Medicare coverage.
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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.
Experts suggest the FDA’s Advanced Manufacturing Technologies designation could be a lifeline for improving production processes for approved cell and gene therapies.
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Pfizer (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved TALZENNA (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI (enzalutamide), for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
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Read our takes on the biggest stories happening in the industry.
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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According to the World Health Organization, GLP-1 receptor agonists are currently being used in a highly medicalized manner. Healthcare systems need to enact more holistic solutions, focusing on health promotion, disease prevention and policy interventions.
While layoffs have slowed in the second half of the year, according to BioSpace data, companies including Bayer, Bristol Myers Squibb and Johnson & Johnson are cutting hundreds or even thousands of employees in 2024.
Following an appeal by the Danish Medicines Agency, the European Union’s drug regulator will review two new studies that have strengthened the link between Novo Nordisk’s blockbuster GLP-1 and a rare eye disease.
Photys is eligible for up to $186 million from Novo Nordisk for its PHICS small molecules that pair a kinase to a disease-causing protein for phosphorylation.
BioSpace Senior Editor Annalee Armstrong reflects on the year that was, and what’s to come in 2025.
Suddenly the hottest thing in biopharma isn’t a new indication, disease target or modality—it’s manufacturing, and all of pharma is going to be vying for capacity and talent.
AbbVie’s blockbuster Humira held 105 patents, shielding the anti-inflammatory drug from biosimilar competition for more than 20 years. Proposed reforms could help prevent companies from extending exclusivity with such patent thickets.
The Hansoh deal will let Merck compete in the crowded oral GLP-1 space alongside fellow pharma giants Eli Lilly, Novo Nordisk and Roche.
Gratitude, a key part of stoicism, can benefit those working in—and being served by—the pharmaceutical industry.
The letters come amid the Outsourcing Facilities Association’s ongoing lawsuit against the FDA over the regulator’s decision to end the shortage for tirzepatide.