Regulatory Recon: Clinton Looks to Increase Fines for Drug Price Gouging (2 September 2016)

Posted 02 September 2016 | By Michael Mezher 

Regulatory Recon: Clinton Looks to Increase Fines for Drug Price Gouging (2 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

  • Biogen's Alzheimer's Therapy Granted FDA Fast-Track Status (WSJ) (Fierce) (Press)
  • FDA Chief Scientist Post A Chance For Califf To Make Mark (Pink Sheet-$) (USA Jobs)
  • Hillary Clinton to Unveil Plan to Address 'Excessive' Increases in Drug Prices (NYTimes) (Reuters) (The Guardian) (The Street) (Washington Post)
  • Rising Drug Prices Put Big Pharma's Lobbying to the Test (NYTImes)
  • Diabetes Outcomes Trial Requirement Looks 'Increasingly Wise' – FDA's Temple (Pink Sheet-$)
  • Takeda joins effort to develop Zika vaccine with $300m in US funding (Reuters) (Fierce) (WSJ)
  • Merck scraps development of osteoporosis drug due to stroke risk (Reuters) (Fierce) (Press)
  • FDA OKs paediatric use of Amgen's Blincyto (PharmaTimes) (Press)
  • Departing Pharma CEOs Leave Waning Sales for Successors to Solve (Bloomberg)
  • For a 6-year-old with cancer, a future staked on medicine's hottest field (Washington Post)
  • Weak Mylan board fosters EpiPen 'debacle': New York comptroller (Reuters)
  • Third U.S. patent on Teva's MS drug Copaxone invalidated (Reuters)
  • FDA Makes Drug Safety Labeling Change Information Easier to Access (Focus)
  • Drugmakers may face more legal action over opioid epidemic (CBS)
  • Six teams seek to identify biological factors that influence neural regeneration (NIH)
  • Medtech mergers still the driving force behind jobs changes (EP Vantage)
  • FDA To Hold Two-Day Hearing on Off-Label Communications (FDALawBlog) (Focus)

In Focus: International

  • Proton therapy demand wave drives expansion of Belgium's IBA (Reuters)
  • Fresenius acquires 85 per cent stake in Sandor Nephro Services (Economic Times)
  • Europe's biggest science centre opens in the UK (Financial Times)
  • EMA to Revise Herbal Medicines Guideline (Focus)
  • UK Decision Soon On Pfizer/Flynn's "Excessive" Phenytoin Price Rises (SCRIP-$)
  • NICE recommends Bayer's Xofigo for prostate cancer treatment (Pharmafile) (PharmaTimes)
  • Regulators And Pharma Lock Horns On Pricing In India (SCRIP-$)
  • GSK dials up value of MolMed gene therapy pact to support growing operation (Fierce) (Reuters)

US: Pharmaceuticals & Biotechnology

  • ESC: Arrivederci Roma! (Medpage)
  • PTAB Life Sciences Report (Patent Docs)
  • Induced pluripotent stem cells, past and future (Science)
  • Sterility Assurance and Cross Contamination (FDAZilla)
  • Study leads to insulin injection recommendations (Reuters)
  • Therapy focus – Clinging to options in Friedreich's ataxia (EP Vantage)
  • Cancer surgeons hesitant to tell patients the odds of a cure (Reuters)
  • Four out of five pharma cos will meet serialization deadlines; poll (Securing Industry)
  • Expectations may influence side effects of breast cancer hormone therapy (Reuters)

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

  • Genentech takes on BMS, Merck with positive I/O lung cancer PhIII data (Fierce)
  • Amgen moving omecamtiv mecarbil into Phase III (BioCentury)
  • Sensorion Obtains FDA Approval to Initiate a Clinical Study of SENS-111 in Acute Severe Vertigo (Press)

US: Medical Devices

  • FDA Issues Safety Communication for Sciex Mass Specs (GenomeWeb) (FDA)
  • Pivotal trial pits St. Jude Medical's Amplatzer Amulet anti-stroke device against Boston Scientific's Watchman (MassDevice)
  • Bonesupport touts high infection eradication rate in prospective trial (MassDevice)
  • Site selection – What to look for? (MassDevice)
  • B. Braun Renal Therapies Division to Launch New Class of Kidney Dialyzer (Press)
  • Stryker acquires Ivy Sports Medicine and its meniscus repair device (MassDevice)
  • Medtronic Announces Approval of Enlite® Sensor for iPro®2 Professional Continuous Glucose Monitoring System in the U.S. (Press)
  • Vascu-Guard Peripheral Vascular Patch by Baxter International: Letter to Health Care Providers - Potential Risk of Severe Bleeding and Hematomas (FDA 1, 2)

US: Assorted & Government

  • Allergan OKs Generic Of Alzheimer's Drug Namzaric For 2025 (Law360-$)
  • "I Am Not an Expert" (Drug and Device Law)
  • Bayer Shakes Majority Of Essure Twin Pregnancy Suit (Law360-$)

Upcoming Meetings & Events


  • Use of biosimilars in oncology in France (GaBI)
  • Medicines and Healthcare products Regulatory Agency board member expenses from January to March 2016 (MHRA)


  • Cipla gets USFDA nod for overactive bladder treating drug (Economic Times)


  • Health Canada moving to control chemicals used to make fentanyl (PharmaLetter-$)


  • Florida finds first local mosquitoes with Zika virus (Reuters)
  • U.S. fights Zika mosquitoes with limited arsenal (Reuters)
  • Hurricane Hermine will complicate Florida's Zika fight: experts (Reuters)
  • Singapore Zika outbreak a concern for Formula One (Reuters)
  • Singapore says Zika infections spread, nearly 190 cases (Reuters)

General Health & Other Interesting Articles

  • An Even Deadlier Opioid, Carfentanil, Is Hitting The Streets (NPR)

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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