Drug Development
Vertex Pharmaceuticals commits $45 million upfront to leverage Enlaza Therapeutics’ War-Lock platform to create drug conjugates and T cell engagers for autoimmune diseases and gentler conditioning for sickle cell/beta thalassemia gene-editing therapy Casgevy.
FEATURED STORIES
Slashing adverse drug reactions through pharmacogenetics and advanced AI could help rehabilitate the pharmaceutical industry’s reputation amid mounting criticism.
Analysts believe that Gilead’s new PrEP drug Yeztugo could reach peak sales of $4.5 billion. Not if GSK has anything to say about it.
In the race to make the most tolerable obesity drug, there seems to be no clear winner—at least not according to analysts parsing the data presented at the American Diabetes Association annual meeting this week.
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Amid a season of regulatory and scientific advances, experts reveal a culture of data hoarding among cell and gene therapy developers that is reinforcing fragmentation, stalling innovation and delaying access to treatments.
Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based combination shot that targets both influenza and COVID-19. Now, the entire vaccine sector is sizing up a new regulatory world, companies’ next steps uncertain.
Despite the failure, BMS remains “encouraged” by Reblozyl’s clinical activity in myelofibrosis-associated anemia and will approach regulators to discuss potential submissions for this indication, for which few treatment options exist.
The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug conjugate in multiple myeloma.
The patient, who was being treated with an investigational gene therapy for limb-girdle muscular dystrophy, died of acute liver failure, the same complication responsible for the deaths of two boys taking Sarepta’s Duchenne muscular dystrophy treatment Elevidys.
In this episode presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses the evolving role of local qualified persons for pharmacovigilance with Ana Pedro Jesuíno, global head local QPPV network at IQVIA.
FDA reviewers flag “discordant results” in a briefing document published ahead of Friday’s advisory committee meeting for the partners’ application for the antipsychotic in post-traumatic stress disorder.
With venture funding tightening in the post-COVID landscape, efficiency has become more critical than ever. In this interactive webinar industry experts explored actionable strategies for maintaining quality under financial pressure. Watch now.
The antibody anselamimab, which AstraZeneca picked up in its 2021 purchase of Caelum Biosciences, failed to improve survival and reduce hospitalizations, but the company sees promise in data from an unspecified patient subgroup.
HIV pharma leaders are in Kigali, Rwanda for IAS 2025, touting their latest advancements in HIV and PrEP development on the heels of the landmark Yeztugo approval.