Archive for December 2020
GSK’s Benlysta Approved to Treat Active Lupus Nephritis
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 common form of lupus. The inflammation can lead to end-stage kidney disease, requiring dialysis or a kidney transplant. Source: Drug Industry Daily
Read MoreCOVID-19 Vaccine Developers Adjust Phase 3 Trial Protocols to Allow Authorized Vaccines
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 hinder the collection of meaningful trial data. Source: Drug Industry Daily
Read MoreITC Imposes 21-Month U.S. Ban on Botox Competitor, a Reduction From Initial Ban of 10 Years
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: Drug Industry Daily
Read MoreSackler Family, Current Purdue CEO Condemned in House Oversight Hearing
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 by Purdue’s former flagship product, the painkiller OxyContin (oxycodone), in the opioid abuse crisis that has killed thousands of Americans. Source: Drug Industry Daily
Read MoreNovartis to Pay Up to $770 Million for Cadent Therapeutics, Enhancing Neuropsychiatric Pipeline
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
Read MoreEU to Begin COVID-19 Inoculations With Pfizer/BioNTech Vaccine on Dec. 27
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 Industry Daily
Read MoreFDA Advisory Panel Gives Big Thumbs Up for Moderna’s COVID-19 Vaccine
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 authorization is widely expected to come today. Source: Drug Industry Daily
Read MoreSponsors of CID Trials Should Discuss Plans With the FDA, Guidance Says
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 on the kinds of information to bring to an agency meeting. Source: Drug Industry Daily
Read MoreFDA Tells Devicemakers Denied an Export Permit How to Reapply
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 a new FDA guidance. Source: The GMP Letter
Read MoreMedTech Europe: Class D Diagnostics Vulnerable Under EU IVDR
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 Commission for help with the transition process for high-risk devices. Source: The GMP Letter
Read More