Regulatory Recon: Drugmakers Fought State Opioid Limits FDA Approves Sarepta DMD Drug (19 September 2016)

Posted 19 September 2016 | By Michael Mezher 

Regulatory Recon: Drugmakers Fought State Opioid Limits FDA Approves Sarepta DMD Drug (19 September 2016)

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

In Focus: US

  • Sarepta Wins Controversial FDA Approval for First DMD Drug (Focus)
  • Drugmakers Fought State Opioid Limits Amid Crisis (AP)
  • Biosimilar User Fee Agreement Offers FDA Funding Boost, Fee Structure Overhaul (Pink Sheet-$) (PharmaLetter-$)
  • Sanofi accuses MSD of US patent infringement (Pharmafile)
  • J&J to Buy Abbott's Eye-Surgery Equipment Unit for $4.325 billion (WSJ) (MassDevice) (Crain's)
  • Adaptive Trial Design Can Save Device Makers Time and Money (MDDI)
  • Spectrum Pharma, FDA and the Buried Truth About a Bladder Cancer Drug Meeting (The Street)
  • US FDA Advisory Committees Discuss Development Plans for Opioid Use in Pediatric Patients – SEP 15-16, 2016 (PEDAC-AADPAC-DSRM) (Tarius) (MedPage)
  • Valeant says discount program for heart drugs on track (Reuters)
  • Final Rule on Clinical Trial Transparency: Will it be Enough to Encourage More Compliance? (Focus) (NIH Director's Blog) (NIH Press Release) (WSJ) (Reuters) (NEJM)
  • Evaluating FDA's Approach to Cancer Clinical Trials (FDA Voice)
  • The Hidden Toll of Drug-Resistant Superbugs (ProPublica)
  • Cancer Immunotherapy At A Crossroads (NPR)
  • Want a Zika Test? It's Not Easy (NYTimes)
  • Cancer-risk genetic testing reports can vary from lab to lab (Reuters)
  • Novartis intensifies Entresto push with new analysis (Reuters)
  • Novartis says MS drug cut risk of disability advance in study (Reuters)
  • Novartis says experimental drug helps chronic migraine sufferers (Reuters)
  • Microbiome Companies Attract Big Investments (WSJ)
  • When Information Storage Gets Under Your Skin (WSJ)
  • 17 and Going Blind: The High Stakes of Getting into a Gene Therapy Trial (MIT Technology Review)
  • Zombie Lab Company Sics Bill Collectors On Doctors Who Took Kickbacks (CardioBrief)

In Focus: International

  • EU Clinical Trials Delayed By Poor Reference Safety Information (Pink Sheet-$)
  • NICE says no to expanding scope of Roche's IPF drug (PharmaTimes)
  • GSK cuts vaccine price for refugees, bowing to pressure (Reuters)
  • U.N. To Take On Antibiotic Resistance At General Assembly (NPR)
  • Test new financial models for antibiotics (Financial Times)
  • Drug resistance in people and animals may push millions into poverty: World Bank (Reuters)
  • Global fund raises $12.9 billion to fight AIDS, TB and malaria (Reuters)
  • Promising Korea? CMO giant Samsung Biologics opens doors to Biopharma-Reporter (BioPharmaReporter)
  • CFDA Releases New Administrative Measures on Medical Device Recalls for Comment (InsideMedicalDevices)
  • GE Healthcare to invest €150m in Ireland biopharma campus (Financial Times) (Pharmafile)
  • Strengthening of the EU cooperation on Health Technology Assessment (HTA) (European Commission)
  •  Thermo Fisher Scientific opens new clinical services facility in Korea (BioSpectrum)

US: Pharmaceuticals & Biotechnology

  • S9 Nonclinical Evaluation for Anticancer Pharmaceuticals-Questions and Answers; International Council for Harmonisation; Draft Guidance for Industry; Availability (FDA)
  • Microbial Vectors Used for Gene Therapy: FDA Offers Final Guidance (Focus)
  • Chemicals in indoor dust tied to antibiotic resistance (Reuters)
  • A List of Biomarkers Used as Outcomes in Development of FDA-Approved New Molecular Entities and New Biological Therapeutics (October 2007 to December 2015); Establishment of a Public Docket (FDA)
  • International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; 4-Methylethcathinone and Eleven Other Substances; Request for Comments (FDA)
  • Biogen ties anti-LINGO miss to non-linear dose response (BioCentury)

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

  • Teva Announces Results from Exploratory 52-Week Phase 2 PRIDE-HD Study of Pridopidine in Huntington Disease (Press)
  • SELLAS™ Life Sciences Receives FDA Fast Track Designation of Galinpepimut-S for the Treatment of Malignant Pleural Mesothelioma (Press)
  • BioMarker Strategies Awarded Phase I National Cancer Institute Contract to Develop Novel Predictive Test for Response to Immunotherapies for Patients with Non-Small Cell Lung Cancer (Press)
  • Seattle Genetics Initiates Phase 1 Trial of SGN-CD123A for Patients with Relapsed or Refractory Acute Myeloid Leukemia (Press)
  • Akebia Announces Publication of Phase 2b Data for Vadadustat in Non-Dialysis Patients with Anemia Related to Chronic Kidney Disease (Press)
  • CORRECTING and REPLACING OptiNose Presents Data from Phase 3 Trials with Investigational Product Using Exhalation Delivery System Technology for Treatment in Patients with Chronic Rhinosinusitis (CRS) with and without Nasal Polyps (Press)
  • Oral Ozanimod Efficacy and Safety Results at 2 Years from Phase 2 RADIANCE Trial of Patients with Relapsing Multiple Sclerosis Presented at 32nd ECTRIMS (Press)
  • NovaBay Pharmaceuticals' Auriclosene® Demonstrates Statistically Significant and Clinically Meaningful Results in Phase 2b Study for the Prevention of Urinary Catheter Blockage and Encrustation (Press)

US: Medical Devices

  • Med-El USA wins FDA nod for Synchrony EAS hearing implant (MassDevice) (Press)
  • OptiNose touts Phase III data for exhaled breath drug delivery (MassDevice)
  • Shockwave Medical wins FDA clearance for peripheral vessel Lithoplasty device (MassDevice)
  • Regulatory Missteps Threaten Medical Device Innovation (MDDI)
  • Varian wins FDA clearance for Nexus DR digital X-ray (MassDevice)
  • U.S. FDA approves Bayer contraceptive device Kyleena (Reuters) (Press)
  • Medeon Biodesign Receives FDA 510(k) Clearance for Abclose(TM) - Laparoscopic Port Site Closure Device (Press)
  • FDA-Cleared Bed Linens Engineered to Reduce Development of Pressure Ulcers (Press)

US: Assorted & Government

  • Causation Issues in Failure-To-Report Cases – Post-Stengel Precedent (Drug and Device Law)
  • As Polls Tighten, Clinton's Senate Allies Push Bernie's Public Option (Forbes)
  • Kratom Movement Draws Attention From Congress, And More On The DEA's Plan To Schedule 1 (Forbes)
  • In Re Reglan Litigation: New Jersey Supreme Court Holds that Failure to Timely Update Claims against Generic Drug Manufacturers Are Not Pre-Empted by Federal Law (National Law Review)

Upcoming Meetings & Events


  • Boston Scientific wins CE Mark for Lotus Edge heart valve (MassDevice)
  • Paediatric Committee re-elects chair (EMA)
  • 17-year-old is first minor to be granted euthanasia in Belgium (Reuters)
  • Baxter Launches NUMETA G13E in Europe: Only Ready-To-Use IV Nutrition for Vulnerable Preterm Newborns at Risk for Malnutrition (Press)


  • Glenmark, Particle Sciences to develop generic cancer drug (Economic Times)
  • Suresh Subramanian to head Biocon's branded formulations biz Economic Times)


  • Australian Government Accepts Proposals for Multiple Market Pathways for Medical Devices (Emergo)


  • A Mosquito Killer, Unwelcome to Many (NYTimes)
  • Cuba Fights Off Zika (NPR)
  • Florida expands Zika zone in Miami Beach after five new cases (Reuters)

General Health & Other Interesting Articles

  • Eliminating out-of-pocket costs for birth control boosts use (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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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