J&J’s Abiomed and manufacturing partner Oscor warned of a bleeding risk from devices used to introduce catheters to the body.
FDA posts early alert over device used with Impella heart pumps Read More »
La evolución de la movilidad urbana en la era eléctrica En las últimas décadas, la movilidad urbana ha experimentado una transformación progresiva impulsada por la electrificación del transporte, la densificación de las ciudades y la necesida …
La evolución de la movilidad urbana hacia el uso compartido La movilidad urbana en Europa está entrando en una fase de transformación estructural impulsada por tres factores principales: el aumento de la congestión del tráfico, la reducción del espa …
Executives with Abbott, PercuSense and Biolinq spoke with MedTech Dive about what’s next with multi-analyte sensor technology.
4 diabetes tech execs on the future of multi-analyte glucose sensors Read More »
The drugmaker stopped paying 340B discounts to hospitals that didn’t comply with its new paperwork requirements late last week. Hospitals are urging HRSA to step in.
Hospitals irate after Eli Lilly follows through on 340B ultimatum Read More »
Formed by Sofinnova Partners and former Sanofi executive Frédéric Marrache, Bionyra Pharma emerged from stealth Monday with an initial focus in inflammatory bowel disease and atopic dermatitis.
Sofinnova, Sanofi alum unveil Bionyra with $165M and next-gen immunology assets Read More »
Results for Definium Therapeutics psychedelic candidate for major depressive disorder “exceeded expectations,” according to Stifel, while Jefferies called the efficacy data “profound.”
Definium’s LSD-based therapy elicits ‘profound’ efficacy in Phase 3 depression trial Read More »
The resubmission for RGX-121, expected in the third quarter, comes as the FDA has deemed REGENXBIO’s existing data “sufficient” to support an accelerated filing. It immediately follows a similar reversal of position regarding uniQure’s embattled Huntington’s disease gene therapy.
REGENXBIO to resubmit application for Hunter gene therapy after FDA’s most recent pivot Read More »
About two months into CEO Belén Garijo’s new tenure, Sanofi’s R&D chief has departed, with Xaira’s chief medical officer set to take charge of the pharma’s pipeline.
Sanofi’s R&D head exits, with AI biotech Xaira’s exec stepping in Read More »
As uniQure prepares its closely watched Huntington’s disease gene therapy for FDA review, the biotech is also making waves in chronic epilepsy with another gene therapy that Stifel says is off to a “promising start.”
UniQure’s chronic epilepsy gene therapy ‘should be on investors’ radar’ Read More »
