Regulatory Recon: FDA’s Califf Calls for Sarepta Trial Retraction Alzheimer’s Drug Fails in Phase III Study (22 September 2016)

Posted 22 September 2016 | By Zachary Brennan 

Regulatory Recon: FDA’s Califf Calls for Sarepta Trial Retraction Alzheimer’s Drug Fails in Phase III Study (22 September 2016)

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

In Focus: US                                      

  • How the FDA Manipulates the Media (Scientific American)
  • Value: Can We Afford To Think Long-Term While Ignoring Budget Impact? (Health Affairs Blog)
  • Lundbeck says Alzheimer's drug fails in late-stage study (Reuters) (Endpoints)
  • U.S. lawmakers blast Mylan CEO over 'sickening' EpiPen price hikes (Reuters) (Bloomberg) (WSJ)
  • Amid controversial Sarepta approval decision, FDA head calls for key study retraction (Retraction Watch) (Stat)
  • Sarepta Preps For Sales As Insurers Unlikely To Deny Duchenne Drug (Xconomy)
  • The Pediatric Voucher Program and Its Impending Renewal Deadline (Focus) (FDA Law Blog)
  • US FDA Agrees To CLIA Waiver Process Reforms, But More Is Needed, Coalition Says (MedTech Insight)
  • Chan Zuckerberg Initiative announces $3 billion investment to cure disease (In the Pipeline) (Nature News) (Press) (TechCrunch) (NY Times)
  • FDA May Push Back Release of Biosimilar Interchangeability Draft Guidance (Focus)
  • MAPP on Good Review Practices: Clinical Pharmacology Review of New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs) (FDA)
  • FDA Warning Letter for Chinese Manufacturer (FDA)
  • New Diptheria and Tetanus Treatment Approved by FDA (FDA)
  • Prioritizing Public Health: The FDA’s Role in the Generic Drug Marketplace (Senate Appropriations)

In Focus: International

  • Breaking Taboo, Swedish Scientist Seeks To Edit DNA Of Healthy Human Embryos (NPR)
  • Hard to swallow: emerging markets get tougher for drugmakers (Reuters)
  • China’s bid to be a DNA superpower (Nature News)
  • Japan weighs further clampdown on drug pricing, with Opdivo and Repatha in its sights (FiercePharma)
  • United Nations pledges to fight drug-resistant superbugs (Reuters)
  • European Regulatory Roundup: UK to Increase Regulatory Oversight of Antibiotics (Focus)
  • Worldwide brain-mapping project sparks excitement — and concern (Nature News)
  • NICE backtracks on its 'no' for Strensiq, but Alexion still isn't satisfied (NICE) (Fierce)

US: Pharmaceuticals and Biotechnology

  • Secret trove reveals bold ‘crusade’ to make OxyContin a blockbuster (Stat)
  • Big Pharma, Biotech Attack NASH Liver Illness From All Sides (Bloomberg News)
  • The pill mill doctor who prescribed thousands of opioids and billed dead patients (Washington Post)
  • Valeant avoids double-digit price hikes with 9.9 percent increases (Stat)
  • Colorado is latest state to be sued for restricting access to hepatitis C drugs (Stat)
  • Freeze-Dried Molecules Can Be Used to Whip Up Medicines Anywhere (MIT Tech Review) (Stat)
  • Alexion's Managed Access Agreement Only Partially Quashes Strensiq Cost Concerns (Pink Sheet-$)
  • Extending EpiPen shelf life could be a relief for patients, costly for Mylan (Modern Healthcare)

US: Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • German next-gen checkpoint inhibitor startup reels in €40M (FiercePharma)
  • Ligand stands to earn $150 million from licensing deal with Seelos (PharmaLetter-$)
  • Gilead scraps a PhII/III study early as drug flops against ulcerative colitis (Endpoints)
  • Teva Announces Positive Top-Line Data from Second Phase III Study of SD-809 in Tardive Dyskinesia (Press) (Endpoints)
  • The next Sage? Shkreli partner Ligand puts together another sweet startup package deal for Seelos (Endpoints)
  • Potential Genetic Link Between Platelet Activity and Cardiovascular Disease Identified (tctmd)

Medical Devices

  • NEST Update: Recommendations for Early-Phase Projects of US Medical Device Evaluation System (Emergo)
  • GOP Senator Blasts FDA’s Plans for Regulating Lab Tests (BNA)
  • Gore touts 1-year data from Japanese study of Viabahn stent graft (Mass Device)
  • K2M receives FDA clearance for pediatric spinal deformity system components: 5 key points (Beckers)

US: Assorted and Government

  • McConnell unveils stopgap spending bill that includes anti-Zika funds (The Hill) (AP)
  • ‘Manhattan Project-Level' of Money Needed to Fight Cancer (BNA)
  • 21st Century Cures Act: Pork Or Promise? (Forbes)
  • Extortion scam (FDA Video)

Upcoming Meetings and Events             


  • Glenmark takes aim at Celgene's Abraxane with complex generic deal (Fierce)


  • Healthcare professionals’ working party elects co-chair (EMA)

General Health and Other Interesting Articles

  • Cost hampers drive to double number of children treated for starvation: hunger experts (Reuters)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

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