Regulatory Recon: Drug Pricing Sets Tone for Iowa Caucus, UK Scientists Given Go Ahead to Modify Human Embryos (1 February 2016)

Posted 01 February 2016 | By Michael Mezher 

Regulatory Recon: Drug Pricing Sets Tone for Iowa Caucus, UK Scientists Given Go Ahead to Modify Human Embryos (1 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

  • Theranos Is Running Out of Time (Bloomberg) (STAT)
  • FDA warns IPCA Labs on manufacturing lapses at 3 plants (Reuters) (In-Pharma Technologist)
  • Payers see price leverage with entry of Merck hepatitis C drug (Reuters)
  • Clinton's Price-Gouging Complaint Sidesteps Generic Drug Problem (Bloomberg) (Reuters)
  • How drug prices and single-payer define the Democratic battle for Iowa (STAT)
  • How Would Government Negotiation Of Medicare Part D Drug Prices Work? (Health Affairs Blog)

In Focus: International

  • More than 2,100 pregnant Colombian women infected with Zika virus (Reuters)
  • Britain gives scientist go-ahead to genetically modify human embryos (Reuters) (WSJ-$) (The Guardian) (BBC)
  • The contribution of mutual recognition to international regulatory co-operation (OECD)
  • Indian Panel Flaws Biosimilar Humira Package Insert (SCRIP-$)
  • Turkish Industry, Govt Agree Price Hikes For Cheapest Drugs (PharmAsiaNews-$)

US: Pharmaceuticals and Biotechnology

  • Will Liability, Advertising Lawsuits Plague Biosimilars Market? (SCRIP-$)
  • Compassion, Drug Prices, and Money (In The Pipeline)
  • FY 2015 Drug GMP Warning Letters Hit Compounders and Foreign Sites (Gold Sheet-$)
  • USP Seeks Input as It Works to Update 1,700 Monographs by 2020 (Gold Sheet-$)
  • FDA Reaching Out To Payers, Health Technology Bodies On Cancer Endpoints (Pink Sheet-$)
  • Feeling Is Believing: Evaluative Conditioning and the Ethics of Pharmaceutical Advertising (Study)
  • Keeping Track: Telework Kept FDA On Track During Blizzard (Pink Sheet-$)
  • Blizzard Doesn't Stop PDUFA Talks (Pink Sheet-$)
  • Parkinson's Advisory Committee: Nuplazid Review Will Test Targeted Endpoint (Pink Sheet-$)
  • The FDA's Priority List For 2016 (Law360-$)
  • Pharmaceutical Brand Spending Focus Shifts To Commercialization During Registration And Launch (Cutting Edge Info)
  • The Challenges of Clinical Trial Enrollment (Lilly)
  • Improving CMC Review for Breakthrough Therapies (PharmTech)
  • Adverse outcome pathways: Path to improved chemical tests without animals (MNT)
  • PEG codes used as anti-counterfeit marker in pharma (Securing Industry)
  • First US biosimilar gradually eroding Amgen's market share, Sandoz (BioPharma-Reporter)
  • All indications? Newer biosimilars may prompt US FDA extrapolation rethink says expert (BioPharma-Reporter)
  • Mixed Rotavirus Vaccine Series Safe and Immunogenic (Medscape)
  • FDA panel to discuss Acadia's Nuplazid for PDP (BioCentury)
  • Biosimilars Forum Launches "Partnership for Biosimilars Education and Access" (Biosimilars Forum)

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

  • Medtronic to Present Data on Micra Transcatheter Pacing System at Upcoming FDA Advisory Committee Meeting (Press)
  • Combo Tx Fast Tracked for Fibromyalgia (MPR)
  • Allergan's depression drug bags a 'breakthrough' tag on the way to Phase III (FierceBiotech)
  • FDA Grants Fast Track Designation to RYANODEX for Treatment of Exertional Heat Stroke; Fast Track Designation Highlights Serious, Unmet Medical Need that Exists for Patients with EHS (Press)
  • Matinas BioPharma Receives FDA Clearance to Initiate Phase 1 Clinical Study of MAT2501 for the Treatment of Non-Tuberculous Mycobacterium Infections (Press)
  • ARIAD Announces FDA Clearance to Begin Clinical Development of AP32788 (Press)
  • Alnylam Completes Enrollment in APOLLO Phase 3 Study with Patisiran, an Investigational RNAi Therapeutic for Patients with Transthyretin (TTR)-Mediated Amyloidosis (Press)
  • Synergy Pharmaceuticals Files New Drug Application for Plecanatide in Chronic Idiopathic Constipation (Press)
  • Tenax Therapeutics Provides Update of Phase 3 LEVO-CTS Trial for LCOS (Press)
  • AbbVie Initiates Enrollment In Phase 3 Clinical Program For Elagolix (BioprocessOnline)

US: Medical Devices

  • FDA Hits User-Fee ERA Record (Medical Device CRO Blog)
  • To Ensure Cybersecurity Focus on These 6 Areas (MDDI)
  • Premarket Sterility Guidance for Devices is the Latest in a Flurry (Blizzard Pun Intended) of Device Guidance Activity for FDA (FDA Law Blog) (Focus)
  • Birth-control device under FDA review (CT Post)
  • Emerging trends in microbiological diagnostics: an introduction to rapid microbiological methods (EPR)

US: Assorted and Government

  • The Prompt Confirmation of a New Commissioner (Alliance for a Stronger FDA)
  • GPhA responds to Senate HELP committee's GDUFA hearing (DSN)
  • Challenge of Non-Interference (National Law Review)
  • Will Shkreli Show Up? (Roll Call)
  • Millions Eligible for Medicaid Go Without It (WSJ-$)
  • California Voters Will Have Their Say on Drug Prices (MedpageToday)
  • How healthcare systems can become digital-health leaders (McKinsey)

Upcoming Meetings and Events              


  • EMA's Policy On Proactive Publication Of Clinical Data: First Reports To Be Made Public In Mid-Sept (SCRIP-$)
  • Changing Regulatory Information Gets Easier For Pharma As Of February (SCRIP-$) (Focus)
  • European Medicines Agency Validates Gilead's Type II Variation Application for Truvada for Reducing the Risk of Sexually Acquired HIV (Press)
  • UK scientists gain licence to edit genes in human embryos (Nature)
  • Briefing for Report Stage and Third Reading of the Access to Medical Treatment Bill (ABPI)
  • NICE Guideline on Non-Hodgkin's lymphoma diagnosis and management (NICE)


  • Pharma, biotech, med-devices & cosmetic sectors find it tough to access skilled & experienced regulatory teams (PharmaBiz)
  • Dr Reddy's Laboratories gets tentative approval from USFDA for Zenavod (Economic Times) (Press)
  • Two cases of H1N1 flu detected in Jammu & Kashmir; measures put in place (Economic Times)
  • Even one year after introduction, no state council has implemented Pharmacy Practice Regulations fully (PharmaBiz)
  • Experts argue for uniform SOPs to complement expansion of SECs for effective functioning of clinical trials (PharmaBiz)
  • Task Force asks govt to provide incentives on infrastructure to boost domestic production of APIs (PharmaBiz)


  • NCRM gets Japanese patent for nanotechnology-based corneal stem cell (BioSpectrum)
  • Takeda gets NDA approval for VAXEM Hib vaccine in Japan (BioSpectrum)


  • China's Fast Track Process For Medical Devices Growing With 46 Products Admitted So Far (SCRIP-$)
  • China fines 5 companies for monopoly on drug sales (FiercePharmaAsia)
  • Understanding Regs Key As CFDA Toughens GMP Enforcement (PharmAsiaNews-$)


  • Required Advisory Statements for Medicine Labels (RASML) (TGA)


  • Canada's single payer system doesn't cover drugs? (Healthcare Economist)
  • Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances - ICH Topic Q6A (Health Canada)
  • Q3C(R5): Impurities: Guideline For Residual Solvents (Health Canada)
  • Q3D: Guideline for Elemental Impurities (Health Canada)

Zika Virus

  • The Brazilian Doctors Who Sounded the Alarm on Zika and Microcephaly (WSJ)
  • Hawaii Biotech joins race to develop Zika vaccine (Reuters)
  • This Is How to Stop the Zika Virus (MIT Technology Review)
  • Zika could be declared a global health emergency — a distinction the WHO rarely uses (Vox)
  • New York City Officials Announce Efforts to Fight Zika Virus (NYTimes)
  • Zika-Linked Brain Damage In Infants May Be 'Tip Of The Iceberg' (NPR)
  • Ecuador reports 22 Zika virus cases, suspects 67 more (Reuters)
  • Peru reports first patient carrying the Zika virus (Reuters)
  • Third Zika case confirmed in Illinois: health officials (Reuters)
  • Gov't says four Canadians infected with Zika virus after travel (Reuters)
  • Did Brazil, global health agencies fumble Zika response (Reuters)
  • 64 percent of U.S. survey respondents to cancel travel to Zika-hit regions (Reuters)
  • Zika survivor: "All of my joints felt like lead weights" (CBS)

Other International

  • Avastin Faces New Rival In Korea As Lynparza Approved (PharmAsiaNews-$)

General Health and Other Interesting Articles

  • An ethical way to choose which kids get chemo during a shortage? (Reuters) (Forbes)

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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