Drug Development
The FDA’s busy week ahead involves three decision dates for potential industry firsts and a highly anticipated advisory committee meeting for two CAR-T therapies.
FEATURED STORIES
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.
The cholesterol-lowering drug is part of a suite of medicines that also includes MariTide and that Amgen Chief Medical Officer Paul Burton hopes will make the company the “undisputed leader in the management of cardiometabolic risk for patients” by 2030.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
Preliminary trial results show the GSK five-in-one meningitis vaccine is immunologically effective against the most common strains, as the FDA decision date for Pfizer’s candidate looms.
Nirsevimab lowered hospitalizations due to RSV-related lower respiratory tract disease by 83.21%. Friday’s data drop comes ahead of next week’s advisory committee meeting for Pfizer’s RSV hopeful.
The FDA has four events lined up this week, including a target action date for Krystal Biotech’s gene therapy for a rare skin disease and an adcomm meeting for Pfizer’s RSV vaccine candidate.
The approval of Reata Pharmaceuticals’ Skyclarys for Friedreich’s ataxia highlights progress being made in the treatment of rare mitochondrial diseases.
Developers of psychedelics-based therapies say the industry is poised to explode, with several reporting strong clinical trial results and the FDA granting breakthrough status for two hallucinogenic drugs.
The layoffs come as the company posts nearly $300 million in net losses and just over $80 million in revenue during the first quarter of 2023.
The deal with BlissBio is the latest in a cascade of multi-million- and billion-dollar acquisitions and collaborations centered on antibody-drug conjugates.
The German biotech is trying to deepen its pipeline in cancer and other infectious diseases as COVID-19 markets contract and the international public health emergency comes to an end.
After a brief slump, interest in ADCs is at an all-time high, highlighted by a handful of recent multi-million- and billion-dollar acquisitions.
The FDA’s new guidance on decentralized clinical trials clarifies how investigators and trial sponsors can use digital health technologies and involve primary healthcare practitioners.