Drug Development

Bristol Myers Squibb and 2seventy bio published positive results Friday from a pivotal Phase III trial of Abecma in multiple myeloma patients who had received two to four prior lines of therapy.
FEATURED STORIES
Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
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Janssen’s COVID-19 vaccine is now limited to certain individuals ages 18 years and up after the FDA downgraded its emergency use authorization (EUA).
With a robust pipeline, Vertex is moving beyond its market dominance in cystic fibrosis and laying claim to multiple markets in diabetes, pain, kidney disease and sickle cell disease.
A post hoc analysis of data from the Phase II CENTAUR study showed a 10.6-month longer median survival duration for AMX0035 participants, Amylyx announced Thursday.
Novartis announced on Thursday that it will be temporarily and voluntarily suspending the production of its cancer therapeutics Lutathera and Pluvicto at facilities in Italy and New Jersey.
Researchers at the University of Illinois at Chicago have uncovered the possibility of utilizing gene editing to reverse a cause of anxiety and alcohol use disorder (AUD).
AstraZeneca and Daiichi Sankyo’s breast cancer therapeutic Enhertu received supplemental approval for an earlier form of breast cancer from the U.S. Food and Drug Administration.
Intellia’s first-quarter financial conference call and report focused on the ongoing Phase I trial of NTLA-2001 in transthyretin (ATTR) amyloidosis with polyneuropathy patients.
Two biologic therapeutic candidates have met their primary endpoints in phase III trials, including AstraZeneca’s Champion-NMOSD trial and Argenx’s Advance trial.
AstraZeneca’s proposed treatment for heart disease delivered positive high-level results from its Phase III DELIVER trial of Farxiga. Here’s more about this drug.
The FDA’s reaction came after Pfizer CEO Albert Bourla said that physicians may give a second five-day course of Paxlovid if patients see a spike in their SARS-CoV-2 viral load.