Regulatory Recon: FDA Rejects New Indication for Merck's Vytorin, India's Pharmacovigilance Program Struggles With Growth (16 February 2016)

Posted 16 February 2016 | By Michael Mezher 

Regulatory Recon: FDA Rejects New Indication for Merck's Vytorin, India's Pharmacovigilance Program Struggles With Growth (16 February 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

  • Pfizer OKs $785M FCA Deal Over Wyeth Drug Charges (Law360-$) (SEC Filign)
  • FDA expands use of Gilead's Harvoni to rare subset of patients (Reuters) (Press)
  • FDA Rejects Expanded Use for Merck's Cholesterol Drug Vytorin (Reuters) (PharmaLetter-$) (Press)
  • 3D 'bioprinter' produces bone, muscle, and cartilage (Reuters) (STAT)
  • With drug costs rising, it's time for pharma companies to open their books (STAT)
  • For the National Institutes of Health, an Infusion of Cash (WSJ)

In Focus: International

  • Russian plant inspections will cost foreign drugmakers ~$38,000 (PharmaLetter-$)
  • Many EU HTA Bodies Wary Of Involvement In 'ADAPT SMART' MAPPs Project (SCRIP-$)
  • Biocon and Mylan Team Up for Biosimilar Regulatory Filings (BigMoleculeWatch)
  • European Pharmacopoeia looks to international experts to help harmonization (In-PharmaTechnologist)
  • India Waives Large-Scale Trials For Sanofi's Dengue Vaccine (PharmAsiaNews-$)
  • India drug monitoring programme struggles to grow fast enough (Reuters)

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US: Pharmaceuticals & Biotechnology

  • When Quality Beats Quantity: Decision Theory, Drug Discovery, and the Reproducibility Crisis (PLOS)
  • Do We Have What It Takes To Put Patients At The Center? (LifeSciVC)
  • Real-world data studies could 'revitalize' productivity, says analyst (In-PharmaTechnologist)
  • Study Finds No Improvement In Quality Of Life With ESAs (CardioBrief)
  • More Support for Osteoporosis Drugs (WSJ)
  • What do you do when you have one of the rarest diseases around? (Washington Post)
  • CDC Flu Update: Localized Pockets of High Activity in the US (ICT)
  • Gene editing: The next frontier in America's abortion wars (Politico)
  • FDA Opioid Action Plan Means More Advisory Committees And A New Look At REMS, PMRs (RPM Report-$)
  • Gastric reflux drugs may be tied to dementia risk (Reuters)
  • API report: outsourcing preferred, market to reach $119.7bn (Outsourcing-Pharma)
  • Novartis On Payer Contracts, Other Updates From BIO CEO & Investor Conference (PinkSheet-$)
  • Clovis' Rociletinib May Get Back On Track With FDA Panel Review in April (PinkSheet-$)
  • First robotically driven experimentation system reduces drug discovery costs (Outsourcing-Pharma)
  • South Boston's newest life sciences firm wants to make animal testing obsolete (Boston Business Journal)
  • Expert View: Combatting Antibiotic Resistance - Protect the Gut while Targeting Disease (PharmaLetter-$)
  • CTI Biopharma confirms a CRO is involved in Ph III trial halted after deaths (Outsourcing-Pharma)
  • Johnson & Johnson next to suffer from the rise of biosimilars (EP Vantage)

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

  • Study Highlights Effectiveness of a Herpesvirus CMV-Based Vaccine Against Ebola (ICT)
  • Phase III trial success for Amgen's Aranesp (PharmaLetter-$) (EPR)
  • Allergan Says FDA Accepts SNDA For TEFLARO (Press)
  • Novaliq Begins Phase 2 Clinical Trial of CyclASol for the Treatment of Moderate to Severe Dry Eye Disease (Press)
  • Biofrontera AG pivotal Phase III data demonstrate significant efficacy and excellent safety for BF-200 ALA treatment of superficial skin cancer (MNT)
  • Remedy Pharmaceuticals Announces FDA Orphan Drug Designation in Two CNS Indications (Press)

US: Medical Devices

  • Scientist helps NASA develop medical device (PhysOrg)
  • Compassionate Use vs. Planned Protocol Deviation - What is the Difference? (Medical Device CRO Blog)
  • Experts Fear Wearables Going Down Path Of Misguided User Research (Forbes)
  • Use of Transvaginal Mesh Fell After Strongly-Worded FDA Safety Alert, Study Finds (Focus)
  • Mentor Receives FDA IDE Approval for its ATHENA Clinical Trial (Press)
  • Talking Medical Exoskeletons with CEO of US Bionics (Live Hangout Today @ 1 pm EST) (medGadget)

US: Assorted & Government

  • The Legacy Of Justice Scalia On IP Law (Law360-$)
  • Are Antibacterial Soaps Safe? (WSJ)
  • Left-Leaning Economists Question Cost of Bernie Sanders's Plans (NYTimes)
  • Pfizer, Inc. v. Lee (Fed. Cir. 2016) (Patent Docs)
  • An Oldie, But a Goodie: Revisiting a Not-Quite-Yet Vestigial Remnant of a Pre-MMA Era (FDA Law Blog)
  • Cancer patients snagged in health law's tangled paperwork (Modern Healthcare)
  • Evidence-Based Medicine Loses a Round in Federal Court (MedpageToday)
  • How to Improve Nutrition Labeling on Food (WSJ)

Upcoming Meetings & Events

  • RAPS' FDA Advisory Committee Meeting Tracker
  • EMA Human Scientific Committees' Working Parties with Patients' and Consumers' Organisations and Healthcare Professionals' Organisations joint meeting – 8, 9 March 2016
  • EMA Workshop on immunogenicity assessment of biotechnology-derived therapeutic proteins - 9 March 2016
  • FDA Workshop: Building the National Evaluation System for Medical Devices: Using Real-World Evidence To Improve Device Safety and Effectiveness - 24 March 2016
  • FDA Workshop: Evaluation of the Safety of Drugs and Biological Products Used During Lactation – 27 April 2016
  • FDA Workshop: Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practices – 9-10 March 2016
  • FDA Workshop: Proposed Pilot Project(s) Under the Drug Supply Chain Security Act – 5-6 April 2016


  • WHO Director-General launches the European Medical Corps (WHO)             
  • Countdown to pharma disclosure in Europe – but cultural divides remain (PharmaPhorum)
  • CAD treatment gets EU Orphan Drug Designation (PharmaLetter-$)
  • Lilly Loses UK High Court Alimta Battle (SCRIP-$)
  • Shield Raises Reduced IPO As Anemia Drug Nears Approval (SCRIP-$)
  • What would BREXIT mean for pharma? (Pharmafile)
  • e-Therapeutics' ETS610 misses targets, shares tank (PharmaLetter-$)
  • EMA benefit/risk revision of fusafungine-containing medicines (PharmaLetter-$)
  • Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man (EMA)
  • Qualification opinion on ingestible sensor system for medication adherence as biomarker for measuring patient adherence to medication in clinical trials (EMA)


  • Biocon receives first generic approval in EU (In-PharmaTechnologist)
  • DBT keen on creation of Bangalore Boston biotech corridor, sees need for industry to stimulate entrepreneurship (PharmaBiz)
  • Kerala govt neglects state's pharma sector with no allocation of funds or incentives (PharmaBiz)
  • Pharmexcil & US FDA to expand collaboration on data sharing initiatives to boost exports to US (PharmaBiz)
  • Rising non communicable diseases drive genomics test market in India: Samarth Jain (PharmaBiz)
  • Task Force asks govt to provide infrastructure & regulatory support to boost domestic production of drugs for NCDs (PharmaBiz)



  • Strong half-year results from Australia's CSL (PharmaLetter-$)


  • Consultation on the Draft Guidance Document: Master Files (MFs) - Procedures and Administrative Requirements (Health Canada)

Zika Virus

  • Genes, bugs and radiation: WHO backs new weapons in Zika fight (Reuters)
  • Zika research continues depite lack of animal models; Epidemiological studies underway (In-PharmaTechnologist)
  • Zika Virus in Colombia Presents Complicated Choice About Abortion (NYTimes)
  • American Samoa Says It Has 205 Suspected Cases Of Zika (NPR)
  • Microcephaly in the US (ICT)
  • Threat of Cytomegalovirus Far Outweighs Zika Risk, Expert Says (ICT)

Other International

  • Biotech blooming in Peshawar as second batch of bio-entrepreneurs graduate (BioSpectrum)

General Health & Other Interesting Articles

  • When my brother got TB, doctors said there was no hope. How could that be? (Washington Post)
  • A New Tool in the Toolbox: New Method Traces Free-Floating DNA Back to Its Source (NIH)
  • Electronic health records can help catch undiagnosed cases of Type 2 diabetes (MNT)
  • Family caregivers may be sacrificing their own health to help loved ones (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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