After Winning in Japan, Gefapixant Falls Short in U.S.
Merck’s investigational chronic cough drug, gefapixant, won Japanese approval last week, but this week didn’t make FDA’s approval cut. Source: Drug Industry Daily
Veklury Wins Accelerated Approval for Treatment of COVID-19 in Non-Hospital Settings
As the Omicron variant continues to spread rapidly, the FDA has granted accelerated approval to Gilead Sciences for Veklury (remdesivir), the first FDA-approved COVID-19 treatment for patients outside hospitals who…
FDA Lifts Clinical Hold on Kura Oncology’s AML Drug
Kura Oncology said Friday that the FDA has lifted a partial clinical hold placed on the company’s early-stage clinical trial of its drug candidate, KO-539, in patients with relapsed or…
UK’s Medicines Evaluation Body Adopts Sweeping Changes
The UK’s National Institute for Health and Care Excellence (NICE), the body that evaluates medicines for use by the National Health Service (NHS), is changing the way it makes judgments…
Pfizer, Moderna COVID-19 Booster Dose Effective Against Omicron, CDC Says
A Moderna or Pfizer/BioNTech COVID-19 booster dose was found to give highly effective protection against the Delta and Omicron variants, the Centers of Disease Control and Prevention (CDC) said Friday.…
FDA’s Maintains Stable Performance Across PDUFA and BsUFA Tasks During the Pandemic
Despite the pandemic, the FDA’s product review performance as it related to the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Amendments (BsUFA) remained relatively stable through…
FDAnews Webinar: On Challenges Facing the New FDA Commissioner
The next FDA commissioner — most likely Robert Califf, who is now awaiting a confirmation vote by the Senate — will face a tough 2022 on multiple fronts, beyond just…
European Parliament Endorses Plan to Strengthen EMA to Better Monitor Drug and Device Shortages
The European Parliament has endorsed a plan to strengthen the powers of the European Medicines Agency (EMA) to increase monitoring of the supply chain for drugs and medical devices. Source:…
Sanofi Seeks to Revive Antitrust Lawsuit Against Mylan Over EpiPen
In oral arguments held Wednesday, Sanofi urged a federal appeals court to reconsider its complaint against Mylan (now Viatris) over allegations the latter engaged in anticompetitive practices to maintain its…
FDA Again Delays In-Person Inspections Due to Omicron Concerns
The FDA has extended its delay on conducting in-person domestic surveillance inspections through Feb. 4 with the goal of restarting the activities as soon as safely possible. Source: Drug Industry…