GlaxoSmithKline has received FDA approval for Benlysta (belimumab) to treat active lupus nephritis, a serious inflammation of the kidneys that appears in about four in 10 patients with the most…
COVID-19 vaccine developers are faced with an ethical quandary — whether to let phase 3 trial participants become “unblinded” and to receive authorized vaccines as they become available, which could…
The import, sale and marketing of a competitor to AbbVie’s Botox wrinkle treatment must be stopped for nearly two years, the U.S. International Trade Commission (ITC) ruled this week. Source:…
In a Thursday hearing of a congressional committee, two members of the Sackler family and Purdue Pharma’s current president and CEO, Craig Landau, dutifully expressed sorrow for the role played…
Novartis has agreed to buy Cambridge, Mass.-based Cadent Therapeutics for a possible $770 million, expanding its pipeline of treatments for cognitive and mood disorders. Source: Drug Industry Daily
With COVID-19 cases surging across Europe, EC President Ursula von der Leyen announced yesterday that EU countries will start vaccinations with the two-dose Pfizer/BioNTech vaccine on Dec. 27. Source: Drug…
The FDA’s vaccines advisory committee voted almost unanimously on Thursday in favor of Emergency Use Authorization (EUA) for Moderna’s COVID-19 vaccine, with all but one abstaining member supporting clearance, and…
Before proceeding with trials that use complex innovative designs (CID), sponsors should meet with the FDA to discuss their plans, according to a final guidance released Wednesday that provides details…
Device manufacturers that have been denied a Certificate to Foreign Government (CFG) to export a product may file for a review of the decision in a process laid out in…
The EU’s implementation of the new In Vitro Medical Device Regulation (IVDR) “has ground to a halt in the wake of the COVID-19 outbreak,” MedTech Europe said, pressing the European…