Current Industry Articles

The world of biotech is constantly evolving, with breakthroughs happening seemingly every week. Metis strives to stay on top of and provide this information to it’s clients and colleagues.

The Pharmaceutical and Biotech industries are constantly buzzing with innovation and breakthroughs, and this week is no different! Let’s take a quick peek at some of the most intriguing headlines:

• Oncology Accelerated Approval Confirmatory Trials: When a Failed Trial Is Not a Failed Drug – via Journal of Clinical Oncology / American Society of Clinical Oncology (ASCO). FDA authors Gautam Mehta, MD, and Richard Pazdur, MD
• FDA rejected MDMA-assisted PTSD therapy. Other psychedelics firms intend to avoid that fate. Lykos Therapeutics’s failure to win approval may trigger a strategic shift in psychedelic medicine  by Kai Kupfeerschidt, Aug 2024
• Trouble for ecstasy? What MDMA’s FDA setback could mean for psychedelics by Will Stone, June 2024
• In strengthening Spravato sales, a positive sign for psychedelic drugs by Ned Pagliarulo, Lead Editor Biopharmadive, July 23, 2024
• PharmaVoice interviews Psilera’s Jackie von Salm by Taren Grom, Editor-in-Chief, Emeritus, Pharma Voice, March 29, 2023
• McKinsey Is Under Criminal Investigation for Its Opioid Work, The New York Times, April 24, 2024
• The 2024 RIC Annual Meeting, ric NEWS, REMS Industry Consortium, April 2024
• AI oversight is top challenge facing global device regulators: FDA official
  Ricky Zipp, Editor, Medtechdive.com, March 8, 2024
• ChatGPT Misdiagnosed Most Pediatric Cases— Older version of the chatbot was wrong in 83% of kids’ clinical scenarios
  Jennifer Henderson, Enterprise & Investigative Writer, MedPage, January 2, 2024
  
• Deep Flaws in FDA Oversight of Medical Devices, and Patient Harm, Exposed in Lawsuits and Records
  Fred Schulte and Holly K. Hacker, December 21, 2023
• FDA findings at Moderna’s Massachusetts facility don’t reflect quality, safety concerns, company says
  Lia DeGroot, Reporter, EndpointsNews, December 21, 2023
  
• FDA rejects Checkpoint Therapeutics’ PD-L1 drug cosibelimab over manufacturing issues
  Ayisha Sharma, News Reporte, Endpoints News, December 18, 2023
  
• Artificial Hips Snapped in Half; Obesity Drug Windfall for Docs; Clinicians Unionize
  Michael DePeau-Wilson, Enterprise & Investigative Writer, MedPage, December 6, 2023
• Proposed Artificial Intelligence Law for India 
  Dr. Karnika Seth, via LinkedIn, December 2, 2023
  
• Sonesta Medical AB – Warning Letter – Medical Devices
  U.S. Food & Drug Administration, September 22, 2023
  
• Vanessa’s Law makes it mandatory to share information on harmful side effects
  Annie Burns-Pieper, September 15, 2023