Policy
A controversial decision by the Alabama Supreme Court temporarily chilled IVF before igniting nationwide pushes to protect access to this type of fertility treatment, leaving drugmakers with questions.
FEATURED STORIES
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
Having seen Congress spend money to onshore semiconductor production, pharma groups are pushing for similar incentives for domestic drug manufacturing.
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The FDA on Monday gave the greenlight to Pfizer’s RSV vaccine for expectant mothers, given during the third trimester of pregnancy, designed to protect newborn babies through the first six months of life.
The German pharmaceutical giant is the latest pharma company to challenge the constitutionality of the Inflation Reduction Act’s drug price negotiation program.
The biopharma’s acute myeloid leukemia hopeful is on partial clinical hold, affecting two Phase III AML studies, Gilead announced Monday. The CD47 candidate also spent four months on hold in 2022.
Following a prior rejection due to manufacturing problems, Regeneron’s higher-dose Eylea won the FDA’s approval Friday, allowing for more infrequent dosing for the treatment of various eye diseases.
The regulator’s greenlight on Friday for Regeneron Pharmaceuticals’ monoclonal antibody Veopoz (pozelimab) makes it the first and only treatment indicated for children and adults with CHAPLE disease.
Boehringer Ingelheim will launch three Phase III studies for its obesity drug candidate; third time is a charm for Ipsen as it gets FDA approval; and Pfizer takes multiple myeloma battle to J&J.
Some experts question the value of recently issued FDA guidance that aims to address gaps in the quality of unapproved laboratory tests for cancer.
Mifepristone’s legal saga continues as the U.S. 5th Circuit Court of Appeals ruled for steep restrictions on the drug’s access, though its effectivity is pending the Supreme Court’s review.
The regulator informed bluebird bio that it will not convene an advisory committee meeting to discuss the company’s application for the gene therapy being developed for sickle cell disease.
The legal complaint, filed with the Scripps Research Institute, alleges that Dexcel Pharma Technologies’ plan to sell a generic version of Pfizer’s Vyndamax (tafamidis) infringes on three patents.