Regulatory Recon: Promising Phase III Results for Novartis, Teva Migraine Drugs Sanofi Expects $120m Hit Over Dengue Vaccine Safety Issues (30 November 2017)

Posted 30 November 2017 | By Michael Mezher 

Regulatory Recon: Promising Phase III Results for Novartis, Teva Migraine Drugs Sanofi Expects $120m Hit Over Dengue Vaccine Safety Issues (30 November 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • Senate GOP clears key hurdle on taxes (Politico)
  • FDA's Pazdur Named to Bloomberg 50 (Bloomberg)
  • US troops get freeze-dried plasma for battlefield bloodshed (AP)
  • Center for Responsible Science Sues FDA Over Clinical Trial Protections (CRS) (Complaint)
  • Health Nominee Grilled on Commitment to Lower Drug Prices (NYTimes) (Reuters) (Bloomberg)
  • FDA Approves ECG Band For Apple Watch (CardioBrief) (The Verge) (Pharmafile)
  • In Search Of Novelty: 2017's New FDA Drug Approvals (Forbes)
  • Advocates For Patients With Rare Diseases Defend Tax Credits For Orphan Drugs (NPR)
  • Pharma charity under fire for letting drug makers access data (STAT) (Reuters) (Bloomberg)
  • Looking to cure Type 1 diabetes, investors front $114M to launch a pioneering human study at Semma (Endpoints) (Fierce)
  • Amgen pulls ahead in sprint towards CGRP approval with promising PhIII migraine data (Endpoints)
  • Stellar results for Novartis/Amgen, Teva anti-CGRP migraine drugs (PharmaTimes) (Pharmafile) (The Guardian) (NEJM – Fremanezumab,  Erenumab)
  • GSK, MMV submit malaria drug in the US (PharmaTimes)
  • Gilead taps X-Chem's DNA-encoded libraries for drug discovery (Fierce)
  • Ferring gains US approval for ready-to-drink colonoscopy prep product (PharmaLetter) (Press)
  • What you're giving away with those home DNA tests (NBC)
  • US to open office, award grants in opioid fight (Reuters) (CBS) (DOJ)

RAPS Book Release: Fundamentals of EU Regulatory Affairs, Eighth Edition

  • Get the new, updated ultimate reference guide which includes the latest information on the new Medical Device and In Vitro Device Regulations, developments in implementation of the Clinical Trial Regulation and a number of new topics.
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In Focus: International

  • Sanofi expects $120 million hit as dengue vaccine hits major snag (Reuters) (Pharmafile) (Endpoints)
  • Europe's top biotech expects delays from drugs watchdog's HQ move (Reuters)
  • Genmab and J&J 'love' partnership as some ponder takeover (Reuters)
  • WHO Report on Public Health, Innovation and Intellectual Property (WHO)
  • In reorganization, Joerg Moeller gathers all the pharma R&D reins at Bayer as discovery chief exits (Endpoints)
  • MorphoSys sells China rights to Darzalex rival in $120M deal (Fierce)
  • EU regulators review AZ' Tagrisso for first-line use in lung cancer (PharmaTimes)
  • New vaccine, long-acting drug trials buoy hopes in HIV fight (Reuters)
  • J&J-led coalition launches a landmark efficacy study for an HIV mosaic vaccine (Endpoints) (Fierce)
  • GSK starts big African study of injectable drug to prevent HIV (Reuters)
  • Dr Reddy's gets nod to restart exports to EU from Vizag plant (Economic Times)
  • Cipla gets WHO nod to sell TB preventing drug in HIV patients (Economic Times)
  • Novartis 'clearly' plans to hang on to GSK consumer stake: analyst (Fierce)
  • European biotechs outperform US for investment return, report claims (Pharmafile)
  • Russia's Biocad launches production in North Africa (PharmaLetter-$)
  • Russia to postpone mandatory drug labeling for two years (PharmaLetter-$)
  • EMA To Change Rules After Ombudsman Clears Director Of Failure To Disclose Patents (Pink Sheet-$)

Pharmaceuticals & Biotechnology

  • Incoming Novartis CEO On $475,000 Cancer Therapy: 'No Question That The List Price Raises Eyebrows' (Forbes)
  • Indication 'Carve In' Allowed Under Generic Labeling 'Carve-Out' Authority, US FDA Says (Pink Sheet-$)
  • CRISPR's not the only gene-editing game in town. Remember TALENs and zinc fingers? (STAT)
  • After all the love and money, analysts speculate that J&J may swoop in with a buyout offer for Genmab (Endpoints)
  • 'Value' is medicine's favorite buzzword. But whose definition are we using? (STAT)
  • One big Novartis takeaway from Entresto's slow start? Heart failure doesn't work like oncology (Fierce)
  • Merck drafts game plan for lung cancer with awareness campaign expansion (Fierce)
  • Creative Minds: Taking Aim at Adverse Drug Reactions (NIH)
  • IDSA warns: Tax reform will hit infectious disease R&D (Fierce)
  • NIH's All of Us Research Program partners with the National Library of Medicine to reach communities through local libraries (NIH)
  • What's driving change in drug discovery and development? (Pharmafile)
  • Anti-aging startup ResTORbio gets $40M to fuel Phase IIb study (Endpoints) (Fierce)
  • Novartis says Cosentyx effective for nail, palmoplantar psoriasis (PharmaTimes)
  • Put Yourself In The CEO's Shoes: Audience Makes Drug Pricing And Investment Decisions At EHFG (Pink Sheet-$)
  • FDA Form 483 for Dignity Health (FDA)
  • Barr Laboratories, Inc. et al.; Withdrawal of Approval of 68 Abbreviated New Drug Applications (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Carrick Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial of its Oral CDK7 Inhibitor: CT7001 (Press)
  • Aimovig™ (erenumab) Phase 3 STRIVE Data Published In The New England Journal Of Medicine Demonstrate Significant, Sustained Efficacy In Migraine Prevention (Press)
  • Revance Plans Phase 3 Program for RT002 Injectable to Treat Cervical Dystonia (Press)
  • Pharnext: Successful Intermediate Analyses for PLEO-CMT Phase III Clinical Trial in Charcot-Marie-Tooth Disease Type 1A (Press)
  • Bristol-Myers Squibb to Present New Data Across a Broad Range of Blood Cancers at the 59th Annual Meeting & Exposition of the American Society of Hematology (Press)
  • Astellas to Present New Data Exploring Gilteritinib in Newly Diagnosed Acute Myeloid Leukemia (AML) Patients at the 2017 American Society of Hematology Annual Meeting (ASH) (Press)

Medical Devices

  • How Collective Medical Technologies Conquered Emergency Rooms On A Bootstrap (Forbes)
  • Is Digital Health Making an Impact on Healthcare? (MDDI)
  • The Surgeon Who Wants to Connect You to the Internet with a Brain Implant (MIT Technology Review)
  • These 10 medtech companies care a lot about research (MDDI)
  • Combination Therapies: Incentives Needed To Encourage Labeling Across Products (Pink Sheet-$)
  • Biocorp inks safety syringe deal with pharma player (Drug Delivery)
  • Dexcom inks continuous glucose monitoring deal with UnitedHealth (MassDevice)

US: Assorted & Government

  • Sign-up pace much slower in week 4 of 2018 Obamacare enrollment (Reuters)
  • Survey Shows Americans Want Healthcare Reform, But Are Also Cynical And Afraid Of Change (Forbes)
  • Reps Meadows, Renacci Introduce Bill to Combat Opioid Crisis (Meadows)
  • Unavoidably Unsafe PMA Medical Devices (Drug & Device Law)
  • Pharmakon Compliance Director Pleads Guilty to Conspiracy Charges (FDA Law Blog)
  • J&J Moves To Duck Pfizer Suit Over Remicade Biosimilar (Law360-$)
  • Pfizer Settles With Purchasers for $94 Million Over Celebrex Pay-For-Delay Deal (FDANews-$)
  • Teamsters Files Suit Against Drug Cos. For Opioid Push (Law360-$)
  • Pharma Marketers Can't Escape Tricare Kickback Suit (Law360-$)
  • Reckitt, Generics Makers Settle Mucinex Antitrust Case (Law360-$)
  • Researcher allegedly used thousands in NIH grant money for trips with a ballet dancer and bar tabs (STAT)
  • VA Health Care: Improved Oversight Needed for Reviewing and Reporting Providers for Quality and Safety Concerns (GAO)

Upcoming Meetings & Events


  • Joint European and UK life sciences associations statement to EU27 and UK Government calls for Brexit progress (ABPI)
  • NICE asks Merck to submit Cancer Drugs Fund proposal for immunotherapy drug (Pharmaceutical Journal)
  • UK Department of Health appoints new team of non-executive directors (GOV.UK)
  • New research shows desperate dieters in danger - the secret world of online slimming pills (MHRA)
  • Cerebrotech wins expanded CE Mark for brain bioimpedance monitor (MassDevice)


  • Astellas Submits a New Drug Application for Gonax® 12-Week Extended-Release Formulation for Treatment of Prostate Cancer in Japan (pdf 249KB) (Press)
  • Korean Firm Draws FDA Warning for GMP Violations, Mislabeling (FDANews-$)
  • Japan's Aging Problem Will Limit Industry Growth (SCRIP-$)


  • In India, copycat competition closes in on Avastin (PharmaLetter-$)
  • Government needs proactive approach to boost pharma sector: Industry (Economic Times)
  • India Sets Out Modalities Of Perpetual Licensing Initiative (Pink Sheet-$)
  • DoP asks NPPA to re-fix ceiling prices of snake venom antiserum – soluble/liquid polyvalent injection (PharmaBiz)
  • Piramal acquires Digeplex from Shreya Lifesciences (Economic Times)

Other International

  • Combination HIV prevention reduces new infections by 42 percent in Ugandan district (NIH)
  • Vaccine alliance backs typhoid shots for poor with $85 million (Reuters)
  • Insecticide resistance spreads in Africa, threatens malaria progress (Reuters)

General Health & Other Interesting Articles

  • Semi-Synthetic Life Form Now Fully Armed and Operational (MIT Technology Review)
  • The flu season gets off to an early start — and may shift into high gear around the holidays (STAT)
  • Epidurals with fentanyl not linked to lower odds of breastfeeding (Reuters)
  • Forecast predicts over half of U.S. children will be obese by age 35 (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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