Regulatory Recon: Roche Surges on Positive Lung Cancer, Hemophilia A Results Bayer Signs Development Deal with Japan's PeptiDream (20 November 2017)

Posted 20 November 2017 | By Michael Mezher 

Regulatory Recon: Roche Surges on Positive Lung Cancer, Hemophilia A Results Bayer Signs Development Deal with Japan's PeptiDream (20 November 2017)

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

In Focus: US

  • Roche gets $12B stock boost from positive cancer, hemophilia results (Reuters) (Endpoints) (Forbes) (Xconomy) (Press)  (Press)
  • Purdue Approaches States in Bid to Settle Opioid Claims (Bloomberg)
  • White House: True cost of opioid epidemic tops $500 billion (CNBC) (Report)
  • Acorda Therapeutics scraps Parkinson's drug after deaths (Reuters) (Endpoints) (Fierce)
  • The top 10 hit parade of biopharma licensing deals for 2014-2017 (Endpoints)
  • Gene Therapy Could Help People Overcome Meth Addiction (MIT Technology Review)
  • Rare genes yield new hope for managing pain without opioids (CNBC)
  • Will Cutting the Health Mandate Pay for Tax Cuts? Not Necessarily (NYTimes)
  • Girl taking medical marijuana for seizures suing Jeff Sessions and DEA (CBS)
  • FDA Raids Florida Stores That Consumers Use To Buy Drugs From Canada (KHN)
  • Corporate lawsuit over drug savings pulls in another party (Axios)
  • A plan to develop a Zika vaccine runs into controversy, as questions swirl about price and conflicts of interest (STAT)

In Focus: International

  • EU narrows choice for new EMA HQ to 2 cities: Milan and Amsterdam (Endpoints)
  • How to watch the Brexit battle for EU agencies like a pro (Politico)
  • Europe's drug industry waits for white smoke in Brussels (Reuters) (CNBC)
  • Brexit and the City (of London) (Reuters)
  • Bayer AG taps PeptiDream in billion-dollar deal (Endpoints) (Fierce) (Press)
  • Japan to step up price cuts for off-patent drugs (Nikkei)
  • New global commitment to end tuberculosis (WHO)
  • New ARV drugs, early diagnosis key to beating AIDS epidemic: UNAIDS (Reuters)
  • MHRA Launches Adverse Event Reporting Campaign (MHRA)
  • Samsung Bioepis' Ontruzant becomes first Herceptin biosimilar approved in Europe (Pharmafile) (Biosimilar News)
  • Novartis's Tasigna scores EU approval in paediatric patients (Pharmafile)
  • Bayer's Stivarga wins NICE approval for GIST (PharmaTimes)
  • Eris Life to acquire Strides' India business for Rs 500 crore (Economic Times)
  • How Madagascar Took Control Of Its Plague Outbreak (NPR)

Pharmaceuticals & Biotechnology

  • FDA Prolongs Review Of Lipocine's Tlando (BioCentury)
  • A cheap generic for hay fever shows a glimmer of promise in multiple sclerosis. But will pharma fund more trials? (STAT)
  • Don't cast aside an effective antidepressant just because it's old (STAT)
  • IPEC rolls out guide to reflect changing pharma excipient landscape (InPharma)
  • Amgen launches Enbrel Mini single-dose cartridges with reusable auto-injector (Drug Delivery)
  • US FDA's Patient Affairs Office Is An Office … In Spirit (Pink Sheet-$)
  • Measuring Regulatory Outcomes (BioCentury)
  • Ed Kaye on Sarepta's Duchenne Quest, Rising to CEO & His New Startup (Xconomy)
  • Neuropathic Pain Company Quartet Ending Operations (BioCentury)
  • Biotech vet Julian Adams takes top job at Gamida Cell (Fierce)
  • Radiologists want patients to get test results faster (Reuters)
  • FDA asks that Baxter saline plants in Puerto Rico get power restored ahead of others (Fierce)
  • 'Glowing' NEJM editorial highlights off-label potential for AstraZeneca's Imfinzi (Fierce)
  • An undervalued indication for Regeneron's Eylea could help it weather Novartis threat: Analyst (Fierce)
  • Women in Science: Shilpa Shah-Mehta (Novartis)
  • Small viruses could accelerate cell and gene therapy research (Novartis)
  • Diphenoxylate Hydrochloride and Atropine Sulfate Tablets by Greenstone: Recall - Possible Sub Potent and Super Potent Tablets (FDA)
  • Determination That TRINTELLIX (Vortioxetine Hydrobromide) Oral Tablet, EQ 15 Milligram Base, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • FDA Grants Alnylam Breakthrough Therapy Designation (BTD) for Patisiran for the Treatment of Hereditary ATTR (hATTR) Amyloidosis with Polyneuropathy (Press)
  • Roche's Hemlibra significantly reduced bleeds in phase III study in haemophilia A (Press)
  • FDA Grants Breakthrough Therapy Designation and Orphan Drug Designation to PellePharm for Topical Patidegib in Gorlin Syndrome (Press)
  • KemPharm Taking Ritalin Prodrug Into Phase III For ADHD (Pink Sheet-$)
  • Biohaven Receives Agreement From FDA on Initial Pediatric Study Plan for Rimegepant, a Second Generation Oral CGRP-Receptor Antagonist for the Acute Treatment of Migraine (Press)
  • Promentis Pharmaceuticals Commences Phase 1 Study for SXC-2023 Targeting Neuropsychiatric Disorders (Press)
  • Chugai's Bispecific Antibody Emicizumab Meets Primary Endpoint in Phase lll Study (Press)
  • resTORbio Advances to Part 2 of a Phase 2b Clinical Study of RTB101 Immunotherapy Following Unanimous Recommendation of Independent Data Monitoring Committee Overseeing the Study (Press)
  • New England Journal of Medicine Publishes Results of Phase III FLAURA Trial in the 1st-Line Treatment of EGFR-mutated Non-small Cell Lung Cancer (Press)

Medical Devices

  • FDA approves first telehealth option to program cochlear implants remotely (FDA)
  • CDRH'S Approach To Tumor Profiling Next Generation Sequencing Tests (FDA)
  • Notification of the Intent To Use an Accredited Person Under the Accredited Persons Inspection Program (FDA)
  • Three shady — and all too common — things that digital health startups do to make money (CNBC)
  • Medtronic Announces FDA Approval and U.S. Launch of Next Generation Pacemakers (Press)
  • This Device Is The First Marketed To Treat Opioid Withdrawal, But Evidence It Works Is Lacking (Forbes)
  • Grifols Wins FDA Approval for AAT Deficiency Test (GenomeWeb)
  • FDA approves Kaleo's allergy auto-injector designed for infants (MassDevice) (Press)
  • After FDA nod, Flexion launches osteoarthritis injection (MassDevice)
  • Voluntis gets FDA clearance to add last two basal insulins to app (MobiHealthNews)
  • Is There Hope for an Endologix Comeback? (MDDI)
  • Medical Device Design Is Critical to Bringing Healthcare into the Home (MDDI)
  • Implandata Ophthalmic touts 1st-in-human use of next-gen Eyemate IOP sensor (MassDevice)
  • iVeena finishes pilot trial of sustained-release implant (Drug Delivery)
  • Medical Device Reading List (November 19, 2017) (BiotechDueDiligence)

US: Assorted & Government

  • The Front Lines of the Opioid Crisis: Perspectives from States, Communities, and Providers (Senate HELP)
  • Nomination of Alex Azar to serve as Secretary of Health and Human Services (Senate HELP)
  • Rep. DeLauro Introduces Bill to Limit DTC Drug Advertising (Congress)
  • Sen. Durbin Introduces Bill to Require Price of Drugs be Disclosed in Advertising (Congress)
  • Amgen Inc. v. Sanofi (Fed. Cir. 2017) (Patent Docs)
  • BMS and Nationwide Class Actions (Drug & Device Law)
  • The Illusion of Choice in Health Care Consumerism (Harvard Bill of Health)

Upcoming Meetings & Events

  • FDA Advisory Committee Calendar
  • 4th special session of the WHO Executive Board (WHO)
  • EMA Training session for patients and consumers interested in European Medicines Agency activities – 21 November 2017
  • EMA Human Scientific Committees' Working Party with Patients' and Consumers' Organisations (PCWP) meeting with all eligible organisations – 22 November 2017


  • Guideline on the evaluation of anticancer medicinal products in man (EMA)
  • Overview of comments received on 'Draft Guideline on Manufacture of the finished dosage form' (EMA)
  • EMA Publishes Q&A on Periodic Safety Update Reports, Previews Possible GVP Update (FDA News-$)
  • Swissmedic Vigilance-News Edition 19 (Swissmedic)
  • Russia's Natsimbio to invest $100 million in establishment of vaccines production in Ufa (PharmaLetter-$)
  • Orexo nabs regulatory win for fast-dissolving opioid dependence therapy (Drug Delivery)


  • Bird Flu Is Spreading in Asia, Experts (Quietly) Warn (NYTimes)


  • Maha govt, Centre to join hands for developing APIs, device parks at MIHAN, Nagpur (PharmaBiz)
  • India can become second largest market for robotic surgery: Vattikuti Foundation (Economic Times)
  • Health ministry introduces daily drug regimen for treatment of tuberculosis (PharmaBiz)
  • UK healthcare cos discuss collaborations with Indian healthcare institutions to further cancer care (PharmaBiz)
  • IPC releases Eighth Edition of Indian Pharmacopoeia (PharmaBiz)
  • Maha FDA to start surprise inspections of Sch M units to check compliance (PharmaBiz)


  • TGA business plan 2017-2018 (TGA)
  • New Product Information Form (TGA)
  • Preparing education materials and advertising for pain relief products (TGA)
  • What can pharmacy assistants say to customers about specific pain relief products? (TGA)
  • TGA Presentation: The ACSS Consortium and the Generic Medicines Work-Sharing Trial, 16 November 2017 (TGA)

General Health & Other Interesting Articles

  • Brain pathway makes head and face pain very draining (Reuters)
  • Doctors debate whether baby died from marijuana overdose (NBC)

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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