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Browse the latest news from BioSpace, and press releases from around the industry. Want to filter by date, keyword, and more? Search here.
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The U.S. Food and Drug Administration (FDA) approved AbbVie’s Dalvance (dalbavancin) for acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients as young as newborns.
Updated trial data show patients treated with BioMarin Pharmaceutical’s severe hemophilia A gene therapy expressed substantially lower factor VIII levels after five years compared with one year, calling into question the drug’s long-term benefits.
Novartis claimed the patents held by Plexxikon were invalid. Unfortunately for the company, the jury found it was unable to prove these claims.
It was another busy week for clinical trial updates. Here’s a look at some including Mesoblast Limited, CytoDyn, Magenta Therapeutics and more.
With COVID-19 resurging in the U.S., particularly in states with the lowest vaccination rates, additional news and research about the vaccines and the virus is coming out. Here’s a look.
Oramed Pharmaceuticals said that its majority-owned firm Oravax Medical would be spearheading the project, first in Israel and later in other international clinical locations.
Shares of Adverum Biotechnologies plunged more than 20% in premarket trading after the company announced it was revising its clinical development plan for investigational gene therapy candidate ADVM-022 based on safety concerns in patients with diabetic macular edema (DME).
Scientists at Gladstone discovered a molecular mechanism that can manipulate random fluctuations, or “noise,” when stem cells transform into different other cells in the body.
As disgraced Theranos founder Elizabeth Holmes awaits her day in court, a long-awaited documentary series focused on the Stanford dropout who became a billionaire before losing it all is set to air on streaming service Hulu.
Phase one launched last week after patients who had been on placebo in Biogen’s pivotal phase III VALOR study were transitioned to active therapy.
The company also issued an open letter to the Alzheimer’s disease community from Alfred Sandrock, which attempts to push back against negative media attention.
The FDA has now approved AstraZeneca’s convenient once-a-week glucose lowering drug for 10 to 17-year-olds with type 2 diabetes.
PRESS RELEASES
· Supporting the development of its proprietary MIC-Lx Modified Immune Cells technology as a novel approach to reduce lifelong systemic immunosuppression and improve long-term outcomes for transplant recipients · Strengthening MIC-Lx’s regulatory and commercial positioning in Europe
- EUR ~8M grant supports the late-stage clinical development of Omnix’s antimicrobial OMN6 - Leading European partners join forces to advance OMN6 for the treatment of life-threatening hospital-acquired infections