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Analysts are cautiously optimistic about an IPO rebound for biopharma. BioSpace is keeping track of companies that seek to trade on the public markets this year.
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The first gene therapies approved to treat sickle cell disease in December 2023 are struggling on the market. But there are glimpses of forward momentum as Vertex and Genetix Bio provide updates.
After last year’s ‘stampede’ for FGF21 assets, the focus for the metabolic dysfunction-associated steatohepatitis space has shifted toward differentiated approaches, such as THR-β agonists and combination treatments, that seek to mirror the commercial success of Madrigal’s Rezdiffra.
Maintaining America’s momentum demands that policymakers resist policies that undermine research and development incentives.
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Read our takes on the biggest stories happening in the industry.
Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
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The regulator’s approval on Friday of Vyloy for gastric or gastroesophageal junction cancer makes it the first and only claudin 18.2–targeted therapy approved in the U.S. for these indications, according to Astellas.
United States Pharmacopeia is recruiting expert volunteers from academia, industry, regulatory and healthcare to develop, revise and approve medicine, dietary supplement and food ingredient standards and solutions used in more than 150 countries to improve global public health. The volunteers will serve from 2025 to 2030.
Massachusetts residents voted Tuesday against the Natural Psychedelic Substances Act, which would have seen some psychedelics, including psilocybin and dimethyltryptamine, legalized in the state.
In the wake of Pfizer’s voluntary market withdrawal of the popular sickle cell disease therapy, BioSpace looks at five investigational drugs currently making their way through the pipeline.
Pharmaceutical companies are combining antibodies with radioisotopes in a bid to more precisely deliver radiation to cancers and tumors.
This week marked the start of the third-quarter earnings season, with Johnson & Johnson exceeding Wall Street’s expectations. Pfizer is projected to have a strong quarter, while Eli Lilly could pull ahead of Novo Nordisk in the obesity space. Moderna, by contrast, has a decidedly negative outlook.
The move is a blow to Gilead’s cancer portfolio. Trodelvy, an antibody-drug conjugate granted accelerated approval for bladder cancer in 2021, failed its confirmatory trial earlier this year.
Pressure has been mounting for the Federal Trade Commission to take action, with Senator Elizabeth Warren last week urging FTC Chair Lina Khan to block the merger if it violates antitrust laws.
The regulator has delayed its respective decision dates on whether to grant full approval to Amgen’s Lumakras in metastatic colorectal cancer and Intercept Pharmaceuticals’ Ocaliva for primary biliary cholangitis.
Merck’s investigational antibody clesrovimab demonstrated more than 60% effectiveness in reducing some types of respiratory syncytial virus-associated infections in infants, while Pfizer’s RSV vaccine Abrysvo showed 90% effectiveness at preventing the most severe RSV cases in adults 60 years and older.