Regulatory Recon: Allergan to Buy Tobira in $1.7b Deal GSK Names Emma Walmsley as New CEO (20 September 2016)

Posted 20 September 2016 | By Michael Mezher 

Regulatory Recon: Allergan to Buy Tobira in $1.7b Deal GSK Names Emma Walmsley as New CEO (20 September 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

  • Drugmakers pledge to clean up antibiotic factories, curb overuse (Reuters)
  • Allergan to Buy Tobira Therapeutics in $1.7 Billion Deal (WSJ)
  • Is Zika deal finally here? (Politico)
  • Re-Balancing Immunity via Regulatory T Cell Potentiation: Introducing Delinia (LifeSciVC)
  • Sanofi Files Suit Against Merck, Claiming Patent Infringements (WSJ)
  • No change in hospital antibiotic use overall in recent years (Reuters)
  • When drug firms give doctors free lunches, costlier prescriptions may result (Washington Post)
  • U.S. trade authorities to probe some imported sleep disorder systems (Reuters)
  • Of Mice and Men: Study Pinpoints Genes Essential for Life (NIH Director's Blog)
  • Hackers Offer a DIY Alternative to the $600 EpiPen (IEEE Spectrum)
  • Draft Guidance: Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices (FDA)
  • FDA launches competition to spur innovative technologies to help reduce opioid overdose deaths (FDA)
  • FDA Electronic Registration for Human Drugs, Animal Drugs, and BLAs (FDA Law Blog)
  • Amgen pushes for access to biosimilar information (BioCentury)
  • EPA, FDA, and USDA Release Updates to Coordinated Framework on Biotechnology (National Law Review)
  • USFDA slaps ban on API supplied by India's Laxachem (Economic Times)
  • AAFP Delegates Debate Single-Payer System, Soaring Drug Prices (MedPage 1, 2)

In Focus: International

  • GSK taps consumer goods veteran Emma Walmsley as new chief (Financial Times 1, 2, 3, 4) (Reuters)
  • EMA Official: Data Sharing and Collaboration Can Fill Scientific Gaps in Alzheimer's (Focus)
  • Vical's CMV vaccine misses in kidney transplant study (BioCentury) (Press)
  • Big pharma targets drug-resistant superbugs (Financial Times)
  • Common Blood-Pressure Drug May Work on Malaria, Too (NYTimes)
  • Alnylam to brave Brexit and set up European HQ in UK (Financial Times)
  • Zydus Cadila partners Takeda for chikungunya vaccine (Economic Times)
  • Bayer raises sales targets for top-selling drugs after Monsanto deal (Reuters)
  • Swedes Explain Why They Should Have the EMA 'Gem' After Brexit (Pink Sheet-$)
  • Chinese pharma is about to hit the global market, says a leader of the charge (PharmaLetter-$)
  • How Sanofi Invigorated Its Heritage Brands In India (SCRIP-$)
  • Pricey New HCV, Cancer Drugs Push Up Japan's Health Care Costs (Pink Sheet-$)
  • NICE does not recommend obinutuzumab to treat follicular lymphoma (EPR)

US: Pharmaceuticals & Biotechnology

  • Regeneron, in Pain Drug Race With Pfizer & Lilly, Gets $250M From Teva (Xconomy) (Fierce)
  • Report: More than 60 percent used digital health tools in clinical trials but accuracy concerns linger (MedCityNews)
  • Novartis to test digital coaching as adherence aid for clinical trials (MobiHealthNews)
  • Pharmaceutical Price Controls Might Be Closer Than You Think (Xconomy)

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

  • AmpliPhi Biosciences Provides Update on Phase 1 Trial in Chronic Rhinosinusitis Patients (Press)
  • Windtree Therapeutics Announces FDA Fast Track Designation for AEROSURF (Press)
  • TherapeuticsMD Announces FDA Acceptance of New Drug Application (NDA) and Prescription Drug User Fee Act (PDUFA) Date for Yuvvexy™ (TX-004HR) (Press)
  • Teva HD candidate pridopidine heading for Phase III (BioCentury)
  • Citius initiates Phase 3 Trial to salvage infected central venous catheters (Press)

US: Medical Devices

  • Guidance: Reporting of Computational Modeling Studies in Medical Device Submissions (FDA)
  • Biggest body scanning study provides 'window into the brain' (Financial Times)
  • Wearable device helps reduce low blood sugar episodes (Reuters)
  • Medical society backs drug-eluting sinus implants (MassDevice)
  • Microchip mimics human cells for drug trials (MassDevice)
  • New Data Presented in VIVA Late Breaking Clinical Trials Demonstrate Durability, Safety and Efficacy for the Medtronic In.Pact Admiral DCB (Press)
  • Medtronic touts CRT study showing heightened medication adherence (MassDevice)
  • QT Vascular Announces FDA Has Granted Approval To Initiate The Pivotal Trial Of Its Novel Drug-Coated Balloon (Press)
  • FDA Approves 6-Month Primary End Point for the Lutonix® Below-the-Knee Drug Coated Balloon (Press)
  • FDA Clears Way for ClearRead CT Software (Press)
  • FDA approves Nuvasive's Reline system for Magec spine implants (MassDevice)

US: Assorted & Government

  • Judge OKs $486M Celebrex, Bextra Securities MDL Deal (Law360-$)
  • Wisconsin Preemption Ruling Makes Our Cheese Curdle (Drug and Device Law)

Upcoming Meetings & Events


  • UK pharma body welcomes action from drugs companies on Antimicrobial Resistance (ABPI)
  • NHS England vows to tackle conflicts of interest (OnMedica)
  • Armed with PhI data, Serono spinout plots path forward for Parkinson's drug (Fierce)
  • ViewRay wins CE mark for MRIdian Linac scanner (MassDevice)
  • European Medicines Agency Validates Bristol-Myers Squibb's Type II Variation Application for Opdivo (nivolumab) in Advanced Form of Bladder Cancer (Press)
  • China's Venus Medtech launches CE Mark trial for pulmonary valve replacement (MassDevice)
  • Edwards Lifesciences wins expanded CE Mark for Sapien 3 replacement heart valve (MassDevice)
  • List of centrally authorised products requiring a notification of a change for update of annexes (EMA)


  • Sharon Bio-Medicine gets USFDA nod for API plant in Taloja (Economic Times)


  • Recall: Rehab Assist C-Series ceiling hoists (TGA)


  • Florida declares neighborhood Zika-free, but CDC remains cautious (Reuters)
  • CDC updates guidance for Wynwood (FL) neighborhood with active Zika transmission (CDC)
  • Planes from Zika areas no longer need to use insecticide (UK DOH)

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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