Regulatory Recon: Pharma Fears Brexit Could Leave Drugs in Legal Limbo, Challenges of Mobile Health Regulation (22 March 2016)

Posted 22 March 2016 | By Michael Mezher 

Regulatory Recon: Pharma Fears Brexit Could Leave Drugs in Legal Limbo, Challenges of Mobile Health Regulation (22 March 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

  • The Medical Marijuana Mess: A Prescription for Fixing A Broken Policy (Brookings)
  • New Evidence Fitness Trackers Don't Actually Track Fitness (CardioBrief)
  • QSR/cGMP Compliance, the Failure to Document, and "A Few Good Men" (FDA Law Blog)
  • Our Healthcare System Abandons Adult Sickle Cell Patients (Washington Post)
  • Sanders Urges Treasury to Set Tax Restrictions on Inversion Deals (WSJ-$) (BioWorld)
  • How Much Should That Drug Cost? Depends What Disease it Treats (STAT)
  • Federal Circuit's Jurisdictional Decision for ANDA Cases Has Important Implications for BPCIA Litigation (Biologics Blog)

In Focus: International

  • Illicit drugs? How Brexit risks legal limbo for medicines (Reuters)
  • TGA Finds No New or Unexpected Safety Issues for Bexsero Meningococcal B Vaccine (TGA)
  • France Wants Medicine Prices to Be on Agenda at G7 Summit (Reuters)
  • How are Japan's Regenerative Meds Regs Playing Out? (PharmAsiaNews-$)
  • Malaysian Advertising Rules for Medical Devices Published (Emergo)
  • Demystifying Device Reimbursement in Japan (MDDI)
  • DCGI May Ban 619 More FDCs based on review of expert panel report (PharmaBiz)
  • Health Canada DMF Guidance (IPQ)
  • EMA Human Medicines Highlights (EMA)
  • GSK, Novartis Promotional Materials Found Compliant (MHRA)

US: Pharmaceuticals & Biotechnology

  • US heart disease rates decline (Reuters)
  • What GSK CEO Andrew Witty Doesn't Get About Drug Pricing (Forbes)
  • Kiss Your FDA District Office Goodbye: Big Changes Afoot Thanks To ORA's Inspectional Program Alignment (Gray Sheet-$)
  • Unpacking Drug Price Spikes: Generics (Health Affairs Blog)
  • Academic DMD Experts Criticize 'Errors' in FDA Ad Com Briefing Documents (Focus)
  • Pharma Companies Call on FDA to Make Clinical Outcome Assessment Pilot More Useful (Focus)
  • FDA bans clinical trial co-ordinator who faked patient samples and stole funds (Pharmafile)
  • When Health Policy Gets Personal (Health Affairs Blog)
  • Final Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH)
  • You can complain about TV drug ads. They may have saved my life (STAT)
  • Older Americans taking more medications (Reuters)
  • BioMarin Heads to FDA With Mixed Data For Rare Disease Drug (Xconomy)
  • FDA Approves Galliprant, a New Animal Drug for Osteoarthritis in Dogs (FDA)
  • When Opioids And NSAIDs Aren't The Answer For Relief Of Chronic Pain, What Is? (Forbes)
  • Gilead using iRhythm patch in late stage trial for novel hypertrophic cardiomyopathy candidate (Fierce)
  • White Paper: Signals from Noise: Making the Most of Social Media Intelligence (IMS Health)
  • Precision Medicine's Potential to Define the Genetics of Autoimmune Disease (DD&D)
  • Hospira Issues a Voluntary Recall for One Lot of Sodium Bicarbonate Injection, USP Due to the Presence of a Particulate (FDA)
  • GSK's Kathy Rouan Tells Inside Scoop On Surpassing Scandal (SCRIP-$)
  • Radiation Combined with Immune-stimulating Drugs Could Pack a Powerful Punch Against Cancer Cells (DD&D)
  • Prospective Grant of Exclusive License: Development and Commercialization of Cancer Immunotherapy (NIH)
  • NYT investigates whether industry deceived NEJM editors (AHCJ)

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

  • Positive Data For Amgen/UCB's Romosozumab In Men With Osteoporosis (SCRIP-$)
  • Takeda presents long-term Entyvio data in CD and UC (Pharmafile)
  • Positive Top-Line Results From Phase 3 Study Evaluating Romosozumab In Men With Osteoporosis (Press)
  • RetroSense Therapeutics Doses First Patient in Phase I/II Clinical Trial for Lead Compound RST-001 (Press)
  • Librede Receives Phase I SBIR to Develop Yeast-Based Cannabinoid Production and Drug Discovery Platform (Press)
  • Neuropore Announces Successful Completion of Phase I with its Lead Compound NPT200-11 (Press)
  • Moberg Pharma Announces Plans to Develop BUPI Through Phase III (SCRIP-$)
  • CSL Behring using Albumedix tech to extend the half-life of new haemophilia drug (In-PharmaTechnologist)
  • Anacor Pharmaceuticals Announces FDA Acceptance of NDA for Crisaborole Topical Ointment, 2% for the Treatment of Mild-to-Moderate Atopic Dermatitis (Press)

US: Medical Devices

  • New standards set to improve safety of medical device connections in clinical settings (ISO)
  • FDA Seeks Ban on Powdered Medical Gloves (Focus)(NYTimes)
  • Abiomed, FDA come to terms on Impella PMA requirements (MassDevice)
  • 5 Takeaways from FDA's Draft Guidance on Postmarket Management of Cybersecurity Risks in Medical Devices (MDDI)
  • Repro-Med updates on FDA warning letter over Freedom Infusion sets (MassDevice)
  • 23andMe to Share DNA Data with Researchers Using Apple iPhone (MIT Technology Review) (mobihealthnews)
  • Going long in genomics (BioCentury)
  • Graphene Wristband Senses Your Blood Sugar—and Treats It (IEEE Spectrum)
  • Medinol launches trial for NIRxcell stent (MassDevice)

US: Assorted & Government

  • Supreme Court Declines to Hear Challenge to Colorado's Marijuana Laws (NYTimes)
  • Patients Target Bayer Over Essure Safety Amid FDA Scrutiny (Law360-$)
  • Daiichi Urges High Court To Allow Patent Term Extension (Law360-$)
  • Trouble in Texas II (Drug and Device Law)
  • FDA "Intercenter Institutes" Legislation Headed For Senate Mark-Up (RPM Report-$)
  • Zubik v. Burwell, Part 4: The Compelling Interest in Contraceptive Coverage (Harvard Bill of Health)

Upcoming Meetings & Events


  • New Active Substance Guide (IPQ)
  • PRIME-ing the system (BioCentury)
  • European Medicines Agency IT systems unavailable from 16 April to 17 April 2016 (EMA)
  • EMA to review safety of direct-acting antivirals after reports of hepatitis B reactivation (Pharmaceutical Journal-$)
  • Guideline on the scientific application and the practical arrangements necessary to implement Commission Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 (EMA)
  • IQWiG: Roche's Melanoma Combo Offers 'Minor' Benefit In Germany (SCRIP-$)
  • Europe's EN ISO 13485:2016 Out Now – But Another Review Expected In Three Years (Clinica-$)
  • Leo Pharma gets EU scientific approval for its psoriasis drug Enstilar (Pharmafile)


  • New CFDA guidelines could stem MNCs' pricing power (BioCentury)
  • Med tech consultant discusses China FDA, tries to clear up Chinese clinical trial confusion (Fierce)
  • Apira Science's iGrow Becomes First Hair Growth Device Cleared by China Food and Drug Administration (CFDA) (Press)
  • Eisai Withdraws New Drug Application For Mecobalamin Ultra-High Dose Preparation As Treatment For Amyotrophic Lateral Sclerosis (Press)


  • Zydus Overhauling Vaccine Site Amid WHO Notice (SCRIP-$)
  • Pfizer India Obtains Injunction Against Platinum Pharma For Trade Name Infringement (24 Insight)
  • Confusion over banned drugs due to absence of complete, detailed list of brands which are banned (PharmaBiz)
  • State FDA seizes drug stocks in violation of Drugs & Magic Remedies Act (PharmaBiz)
  • Health ministry to take stock of blood component separation facilities in country (PharmaBiz)
  • EOS imaging Receives China Food and Drug Administration (CFDA) Approval for the EOS System (Press)


  • MHRA contributing to the global fight against Zika (MHRA)
  • Bangladesh confirms first case of Zika virus(Reuters)
  • South Korea confirms first case of Zika virus (Reuters)
  • In Uganda's Zika Forest, global health scare seems a world away (Reuters)

Other International

  • Guinea monitoring 816 Ebola contacts following flare-up (Reuters)
  • West Africa vulnerable to new major Ebola outbreak as vigilance fades (Reuters)
  • WHO calls on countries and partners to "Unite to End Tuberculosis" (WHO)

General Health & Other Interesting Articles

  • Uterus Transplants: Challenges and Potential (Harvard Bill of Health)
  • Doctors often disagree on when to call abnormal breast cells cancer (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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