Regulatory Recon: PhRMA, AHIP Weigh in on Drug Pricing, NIH Appoints Director of Precision Medicine Initiative (11 April 2016)

Posted 11 April 2016 | By Michael Mezher 

Regulatory Recon: PhRMA, AHIP Weigh in on Drug Pricing, NIH Appoints Director of Precision Medicine Initiative (11 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

  • 'Systemic' antibiotics crisis troubles big investors (Financial Times) (Reuters)
  • FDA Moves to Withdraw Approval of Swine Drug (WSJ) (Reuters) (FDA)
  • How Do We Deal With Rising Drug Costs? (WSJ)
  • FDA Expands Metformin Label (CardioBrief) (Focus) (FDA)
  • Part B Payment for Medicare Drugs (Drug Abacus) (Washington Post)
  • Pfizer's next takeover target will be American (CBS)
  • Durect examination: FDA wants under way phase III to add new active control (BioWorld) (Reuters)
  • The Female Viagra, Undone by a Drug Maker's Dysfunction (NYTimes)
  • Selection of Eric Dishman as Director of the Precision Medicine Initiative Cohort Program (NIH)
  • Former Shkreli-led drug developer pledges responsible pricing (Reuters)
  • Roche says FDA fast tracks atezolizumab in specific type of lung cancer (Reuters) (Press)
  • Another Year, Another Report on National Medical Device Evaluation System but Still Few Details (FDA Law Blog) (Focus)
  • Sales of Short-Term Health Policies Surge (WSJ)
  • Outside Experts Hired By Theranos See Promise But Still Seek Proof (Forbes)
  • Senate Committee Moves to Hold Valeant CEO in Contempt, Company Asks CEO to Cooperate (STAT) (Reuters)

In Focus: International

  • EMA Begins Pharmacovigilance Training Courses (Focus) (EMA)
  • Funding by crisis is no cure for global health threats (GHTC)
  • WHO Calls for Drugmakers to Submit HIV, HCV and HBV to Prequalification Scheme (WHO)
  • FDA Continues Crackdown on Noncompliant Chinese Pharmaceutical Manufacturers (Focus)
  • Chinese Researchers Experiment with Making HIV-Proof Embryos (MIT Technology Review) (Nature)
  • EDQM Sets Deadlines For eCTD-Only Applications (SCRIP-$)

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US: Pharmaceuticals & Biotechnology

  • Orphan Drug Act's role as an incentive to develop rare disease treatments (MedCityNews)
  • ICER Questions Cost Effectiveness Of Empliciti, Kyprolis, Ninlaro (Pink Sheet-$)
  • Expiration Date Extension for North American Coral Snake Antivenin (Micrurus fulvius) (Equine Origin) Lot 4030024 Through April 30, 2017 (FDA)
  • Safety issues at compounding pharmacy underscore oversight problems (STAT)
  • Amgen Goes Public With Kyprolis Value Data To Supplement ICER Review (Pink Sheet-$)
  • Restoring FDA's Confidence In Labeling (Pink Sheet-$)
  • Biogen explores sale of hemophilia assets: sources (Reuters)
  • Slow Medicine: ELITE Doesn't Change Our Minds on HRT (Medpage Today)
  • FDA's Patient Engagement Advisory Committee milestone reflects push for patient input on drug development (MedCityNews)
  • Open Trial Databases Not Widely Popular – Yet – Duke Researcher Finds (Pink Sheet-$)
  • Why It's Time To Put Big Pharma Conspiracy Theories To Rest (Forbes)
  • Novel Dual-Sided Pill Shows Promise as a Slow-Release Drug Strategy (medGadget)
  • How Best To Address The Increase In Liver Cancer Deaths (Forbes)
  • Breaking Down FDA's Breakthrough Program – Infographic (Pink Sheet-$)
  • PCSK9 Sponsors, Payers In The Ring At ACC (Pink Sheet-$)
  • Januvia Gains Another Boost With FDA Warnings for Onglyza, Nesina (Pink Sheet-$)
  • The Case For Restricting Use Of Entresto (Pink Sheet-$)

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

  • FDA Grants Fast Track Status for Investigational Antibiotic CARBAVANCE (meropenem-vaborbactam) (Press)
  • AZ, Lilly Alzheimer's drug trial gets green light for Ph III (PharmaTimes)
  • ARIAD Announces Initiation of Randomized, First-Line Phase 3 Trial of Brigatinib in Treatment of ALK-Positive Non-Small Cell Lung Cancer (Press)
  • Inotek Pharmaceuticals Announces the Journal of Ocular Pharmacology and Therapeutics has Published its Phase 2 Data for Trabodenoson in Patients with Glaucoma and Ocular Hypertension (Press)
  • Prana Regains Compliance with NASDAQ Continued Listing Requirements Continues to Work Towards FDA Submission (Press)

US: Medical Devices

  • Question Of Risk: Medtronic's Lost Study (Star Tribune) (MassDevice)  (Medtronic)
  • US FDA Approves Abiomed's Impella For Cardiogenic Shock Ahead Of Schedule (Clinica-$)
  • Proposed FDA Powdered Glove Ban: Effect On Device Makers (Law360-$)

US: Assorted & Government

  • Innovation Bill Scorecard: Device, Diagnostic Provisions In Senate And House (Gray Sheet-$)
  • Abbott Wins Off-Label Stent Marketing Suit (Gray Sheet-$)
  • Small, Piecemeal Mergers in Health Care Fly Under Regulators' Radars (NYTimes)
  • California Insurance Marketplace Imposes New Quality, Cost Conditions On Plans (KHN)
  • A Federal Pennsylvania Decision That We Like in Small Bites (Drug and Device Law)

Upcoming Meetings & Events


  • Mixed IQWiG views on Gilead's Genvoya (PharmaLetter-$)
  • Pharma industry's investment in Finland topped $250 million last year (PharmaLetter-$)
  • CHMP issues positive opinion for Xtandi label update (EPR)
  • Russian watchdog suspects cartel agreement in domestic pharmaceutical market (PharmaLetter-$)
  • NICE poised to reject Celgene's Vidaza for some AML patients (PharmaTimes) (PharmaPhorum)
  • New administration route for Sandoz' Binocrit biosimilar approved in EU (PharmaLetter-$)


  • Cheaper drug prices the destination in China healthcare reform map (Fierce)
  • Full-speed ahead in China's online drug sales push? (Fierce)
  • New Strategies Needed As China Shakes Up Drug Classes? (Pink Sheet-$)


  • Pharmacovigilance dept to be mandatory for all cos, D&C Act to be amended (PharmaBiz)
  • Orchid Pharma gets EIR report from USFDA on inspection closure (Economic Times)
  • Adcock Ingram in pact for strategic sale of Indian operation (Economic Times)
  • Sun Pharma gets USFDA nod for eye inflammation drug (Economic Times)
  • Lupin to market Novartis' inhaler under Loftair brand name (Economic Times)
  • FDCs of cos with no data submitted to DCGI to prove safety, efficacy banned (PharmaBiz)
  • Now, drugs regulator gets a plan for vegetarian capsules (Economic Times)
  • IPC to hold meeting of industry stakeholders to sensitise on effective ADRs on April 29 (PharmaBiz)


  • Summary Safety Review - Celecoxib (CELEBREX and generics) - Assessing the Risk of Serious Heart and Stroke Side Effects at High Doses Relative to Other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (Health Canada)


  • Brazilian scientists find new Zika-linked brain disorder in adults (Reuters)
  • Zika Virus, Birth Control And Abortion (Forbes)
  • Brazilian Doctor Crafts System Hailed As 'Way Forward' For Combating Zika (NPR)

General Health & Other Interesting Articles

  • Turing Tests and the Problem of Artificial Olfaction (MIT Technology Review)
  • Paid maternity leave linked to lower infant mortality rates (Reuters)
  • Yeast Infection Led to Removal of Transplanted Uterus (NYTimes)
  • Marijuana use in pregnancy tied to health problems for babies and mothers (Reuters)
  • The Association Between Income and Life Expectancy in the United States, 2001-2014 (JAMA)
  • Amid clinic closures, young doctors seek abortion training (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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