Regulatory Focus™ > News Articles > Regulatory Recon: Fitbit's Move Risks FDA Notice; WHO Backs Sanofi's Dengue Vaccine (15 April 2016)

Regulatory Recon: Fitbit's Move Risks FDA Notice WHO Backs Sanofi's Dengue Vaccine (15 April 2016)

Posted 15 April 2016 | By Michael Mezher 

Regulatory Recon: Fitbit's Move Risks FDA Notice WHO Backs Sanofi's Dengue Vaccine (15 April 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

  • Health Officials Split Over Advice on Pregnancy in Zika Areas (NYTimes)
  • Cancer drug labels rarely reflect patient experiences (Reuters)
  • After Gaffe, Biotech Firm Emphasizes Women (Not Just at Parties) (Bloomberg)
  • Fitbit's Move Into Medical Gadgets Risks Attracting FDA Scrutiny (Bloomberg)
  • It's Not Cancer: Doctors Reclassify a Thyroid Tumor (NYTimes) (JAMA)
  • NYTimes Editorial Board: On Zika, Congress Is Failing to Do Its Job (NYTimes)
  • Depomed Abandons Plans to Reincoporate in Delaware (WSJ-$)
  • Repros to drop testosterone drug in US if key study fails (Reuters)
  • Patient advocates urge action on clinical trials reporting (STAT)
  • S&P Downgrades Valeant After Default Notice From Shareholder (WSJ-$)
  • Why our peer review system is a toothless watchdog (STAT)

In Focus: International

  • Pfizer fined by UK regulator amid pricing probe (STAT) (Pharmafile)
  • WHO group backs Sanofi's vaccine in areas with high dengue rates (Reuters)
  • Glaxo probing bribery accusations in Yemen (STAT)
  • Report of the International Regulatory Forum of Human Cell Therapy and Gene Therapy Products (PMDA)
  • Justin Trudeau Seeks to Legalize Assisted Suicide in Canada (NYTimes) (Reuters)
  • European Regulatory Roundup: EMA Sets Up Antimicrobial Monitoring Program (Focus)
  • Brazil Updates Label Requirements for Wireless Products (EMERGO)
  • Chinese biopharma companies set down roots in Boston area (STAT)
  • India's Alkem Labs accused of fudging trial data by German regulator (Reuters) (Focus)
  • CFDA Medical Device Software Regulation Undergoes Major Revision (GxP Lifeline)
  • Listening to the public's views on the safety of medicines (EMA)
  • WHO Issues Updated Guidelines for Treatment of Hepatitis C Infection (ICT) (WHO)
  • EU extends safety review of chronic Hep C treatments (Reuters)

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US: Pharmaceuticals & Biotechnology

  • Rheumatoid arthritis: current and future trends (Nature)
  • FDA Offers Specific Guidance on Bioequivalence Trials for Next Generation of 38 Generic Drugs (Focus)
  • Verily, Alphabet's medical business, is profitable, Sergey Brin tells Googlers (Re/Code)
  • FDA, Senators Seek To Keep USP Standards From Hindering Biosimilar Development (IHP-$) (USP)
  • Faster Approval of Combination Drug Products Via the 505(b)(2) Pathway (The 505(b)(2) Blog)
  • Biosimilars: management of clinical issues (GaBI)
  • FDA Collates GMP Data Integrity Advice Into New Guidance (Pink Sheet-$) (Focus)
  • Drugs for your gut bugs are on the horizon (STAT)
  • Merck won't seek U.S., EU approval of omarigliptin (BioCentury)
  • Pfizer and IBM join forces to develop remote monitoring solutions (Outsourcing-Pharma)
  • FDA Official Warns of Bioequivalence Deficiencies in ANDAs (FDANews-$)
  • Infograph: What new drugs will be approved by 2020? (MedCityNews)
  • PTAB Rejects AIA Challenge To Amgen Drug Patent (Law360-$)
  • Good Clinical Practice: From Review To Application (imarc)
  • Orphan drugs provide unique opportunity for manufacturers (DSN)
  • FDA panel to discuss Merck's bezlotoxumab (BioCentury)
  • IDSA/SHEA Release New Antibiotic Stewardship Guidelines (MPR)

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

  • Gilead Sciences says Phase III trials for chronic HBV drug meet primary endpoints (Pharmafile) (Press)
  • Studies confirm benefit of plasma genotyping to predict treatment benefit in patients with non-small-cell lung cancer (MNT) (Press)
  • ARIAD Presents Updated Phase 1/2 Clinical Data on Brigatinib in Patients with ALK+ Non-Small Cell Lung Cancer (Press)
  • Corbus gets FDA rare disease trial blessing as shares soar (Boston Business Journal)
  • Controversial Houston Clinic to Launch Phase II Study in DIPG (Background: Houston Chronicle, USA Today) (Press)
  • Asana BioSciences, LLC to Provide First Presentation of Pre-Clinical Data on its Novel ERK 1/2 Inhibitor Program at the American Association for Cancer Research Annual Meeting (Press)
  • Enanta Announces that AbbVie's Investigational, Pan-Genotypic Regimen of ABT-493 and ABT-530 Shows High SVR Rates in Genotype 1 Hepatitis C Patients Who Failed Previous Therapy with Direct-Acting Antivirals (Press)

US: Medical Devices

  • US FDA Describes Device Emergency Use Authorization Process In Draft Guidance (SCRIP-$)
  • cryoFORM Cryoablation Probe for Cardiac Arrhythmias FDA Cleared (medGadget)
  • Number of Mass. medical device firms doubles in 20 years (Boston Business Journal)
  • Fresenius rebrands dialysis division to Fresenius Kidney Care (MassDevice)

US: Assorted & Government

Upcoming Meetings & Events


  • Promoting high-quality clinical research to develop more and better medicines for children (EMA)
  • Mistakes by both sides led to Vidaza NICE rejection, says Celgene (PharmaPhorum)
  • Confirmation of names for influenza strains (CBG-MEB)
  • Trade secret laws adopted by MEPs create legal uncertainty for pharma whistleblowers says HAI (In-PharmaTechnologist)
  • EMA, EUnetHTA to Continue Collaboration on Drug Assessments (Focus)
  • Cipla partners with non-profit body FIND to increase detection of Hepatitis C (Economic Times)
  • Clinical trial initiated to help Paris attacks victims with PTSD (Pharmafile)
  • Lonza would add drug delivery tech through Catalent merger, analyst (Outsourcing-Pharma)
  • Five-Year EU Benefit-Risk Project Bearing Fruit, Says EMA (SCRIP-$)
  • Mixed Results For EMA's Early Pediatric Advice Pilot (SCRIP-$)
  • Fractyl Announces CE Mark Approval for Revita DMR at EASL 2016 (Press)


  • DNDi Adds Affordable Ravidasvir Combo To Asian HCV Trials (PharmasiaNews-$)


  • Two Indian generics makers end battle to copy drugs amid patent debate (Reuters)
  • India denies patent on novel HIV/AIDS medicine (PhRMA)
  • Despite being on rough end, annual report from US FDA's OGD shows Indian firms won key approvals in 2015 (Economic Times)
  • Recruitment rules for technical positions in DoP ambiguous: IPA (PharmaBiz)
  • Advent, Baxter set to submit bids for India's Gland Pharma: Sources (Economic Times)
  • CRO Lambda appoints Tausif Monif as Global President (Economic Times)
  • Health ministry launches e-health & m-health initiatives to rope in youth to combat lifestyle diseases (PharmaBiz)


  • Zika vaccine-blocker candidate being tested in animals (Outsourcing Pharma)
  • Zika Virus Can Be Transmitted Through Anal Sex, C.D.C. Says (NYTimes)
  • Colombia confirms two microcephaly cases linked to Zika virus (Reuters)

General Health & Other Interesting Articles

  • The Drugs That Built a Super Soldier (The Atlantic)
  • Why aren't millions of Americans getting preventive care? (STAT)
  • Follow-up eye visits at preschools not cost-effective (Reuters)
  • These hospitals are doing something shocking: Giving refunds to unhappy patients (Washington Post)

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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