Regulatory Recon: Canada Supreme Court Hands Patent Victory to Pharma GSK Signs $43m AI Drug Discovery Deal (3 July 2017)

Posted 03 July 2017 | By Michael Mezher 

Regulatory Recon: Canada Supreme Court Hands Patent Victory to Pharma GSK Signs $43m AI Drug Discovery Deal (3 July 2017)

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

In Focus: US

  • Shortage of Simple Drugs Thwart Treatments (WSJ)
  • Fears over a medical gold rush in cancer drug race (Financial Times)
  • Merck moves up sales rankings in vaccine industry projection (Fierce)
  • The $100 billion per year back pain industry is mostly a hoax (Quartz)
  • Is There A Better Place To Decide What's Right For Patients? (Forbes)
  • FDA Delays Enforcement of Product Identifier Requirements (Focus) (FDALawBlog)
  • Fears Over Device Surveillance Amid Talk of Deregulation (Focus)
  • McConnell Has About $200B In 'Candy' To Make Deals On Obamacare Repeal (KHN)
  • $45 Billion to Fight Opioid Abuse? That's Much Too Little, Experts Say (NYTimes)
  • Oklahoma sues opioid drugmakers; New Hampshire presses epidemic probe (Reuters)
  • For Millions, Life Without Medicaid Services Is No Option (NYTimes)
  • Scientists are dusting off a long-forgotten weapon to cope with modern bacteria (Washington Post)
  • Shire Planning Redeployment, R&D Head Leaving (BioCentury)

In Focus: International

  • Big pharma turns to AI to speed drug discovery, GSK signs deal (Reuters) (PharmaTimes)
  • Canada's top court hands patent win to pharmaceutical companies (Reuters)
  • Congo declares Ebola outbreak over after four deaths (Reuters)
  • Dr Tedros takes office as WHO Director-General (WHO)
  • Can financial innovation help prevent catastrophes? (Financial Times)
  • Google DeepMind patient data deal with UK health service illegal, watchdog says (CNBC)
  • Commission seeks 'measurable goals' in new antimicrobial resistance plan (EurActiv) (EC)
  • China Genomics Giant Drops Plans for Gene-Edited Pets (MIT Technology Review)
  • Aurobindo Pharma looks to push deeper into EU, US over next 3-4 years (Economic Times)
  • Bayer shares slide as pharma and chemicals group warns on profits (Financial Times)
  • EMA Says Yes To First Sickle Cell Drug For PRIME (Pink Sheet-$)
  • Lilly's Olumiant, spurned by FDA, gets nod from NICE (Fierce)
  • NICE recommends AstraZeneca lung treatment (Pharmafile)
  • Big success and even bigger failure for Daiichi Sankyo's experimental therapy (Pharmafile) (BioCentury)
  • The General Election and medicines manufacturing (ABPI)
  • More On The ECJ Vaccine Liability Decision (Harvard Bill of Health)
  • Global Ministerial Conference on Ending Tuberculosis in the Sustainable Development Era
  • (GHTC)
  • From bench to bedside in two years: a new drug for bowel cancer patients starts clinical trials across the UK (MRC)

Pharmaceuticals & Biotechnology

  • Cancer patients should check drug list with pharmacist (Reuters)
  • Will Pruning the Biomedical Field Keep it Alive? (Medpage)
  • Precision medicine 2.0 (MedCityNews)
  • Fortress Appoints New CFO (SEC)
  • Therapix Biosciences Ltd. (Therapix Biosciences Appoints New Board Member (SEC)
  • The FDA's take on Biosimilars (PharmaLetter)
  • Boehringer Ingelheim's Partnering Focus: An Interview With Ioannis Sapountzis (SCRIP-$)
  • Forging a path forward in neurological disorders (Pharmafile)
  • How to regenerate a regenerative company: Admedus CEO Paterson on the company's turnaround efforts (MassDevice)
  • Still More Bad News For Patients With Alzheimer's Disease, And Now America's Women (Forbes)
  • People Are Not Petri Dishes--A New Study Shows Why Antibiotics Fail (Forbes)
  • Patheon to spend $45m on manufacturing plants ahead of Thermo takeover (InPharmaTechnologist)
  • Advisory Committee; Medical Imaging Drugs Advisory Committee – Renewal (FDA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • FDA Approves Vectibix® (Panitumumab) For Use In Wild-Type RAS Metastatic Colorectal Cancer (Press)
  • BioMarin Submits Pegvaliase Biologics License Application (BLA) to the U.S. FDA for Treatment of Phenylketonuria (PKU) (Press)
  • Bayer starts Phase III study program with Vilaprisan in the treatment of symptomatic uterine fibroids (Press)
  • SteadyMed seeks FDA nod for Trevyent drug-device combo (MassDevice)

Medical Devices

  • CHF Solutions wins IDE for pediatric trial of Aquadex FlexFlow aquapheresis system (MassDevice)

US: Assorted & Government                  

  • Hospital Value-Based Purchasing: CMS Should Take Steps to Ensure Lower Quality Hospitals Do Not Qualify for Bonuses (GAO)
  • Medicaid Worsens Your Health? That's a Classic Misinterpretation of Research (NYTimes)
  • African-Americans who buy Medicare Advantage fare worse (Reuters)
  • Both Sides Equal Under the First Amendment (Drug & Device Law)
  • Novartis Escapes End Payors' Gleevec Antitrust Suit (Law360-$)
  • Opioid Users Join Fight Against Endo, Purdue, Teva (Law360-$)

Upcoming Meetings & Events

  • FDA Advisory Committee Calendar
  • FDA Commissioner Scott Gottlieb to Deliver Keynote at RAPS Regulatory Convergence (RAPS)
  • Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting – 26 July 2017


  • Behind the scenes of: Submissions (MHRA)
  • Maloff Protect antimalarial tablets to be available to buy from pharmacies (MHRA)
  • France confirms case of H5N8 bird flu in the north (Reuters)
  • Roche expands cobas Liat PCR System menu with launch of cobas MRSA/SA test to target healthcare-associated infections (Press)
  • Bayer invests 92 million euros in Animal Health production (Press)


  • Indian pharma sector growth to moderate in next 3 years: ICRA (Economic Times)
  • NPPA fixes ceiling prices of 814 scheduled formulations (Economic Times)
  • GST may lead to drug shortage; chemists not keeping stock: Kiran Mazumdar-Shaw, Biocon (Economic Times)
  • Immunotherapy still unaffordable treatment option for cancer patients in India: Dr Vijay Agarwal (PharmaBiz)
  • Controversial issue of classifying products as 'nutraceutical' or 'drug' referred to DGHS for further review (PharmaBiz)
  • ICMED trains manufacturers at AMTZ to fill regulatory gap in certification for medical devices (PharmaBiz)


  • Traditional Chinese medicine seeks clinical legitimacy (Financial Times)
  • Japan Ministry of Health, Labor and Welfare (MHLW) Grants Marketing Approval For Olumiant® (baricitinib) for the Treatment of Rheumatoid Arthritis (Press)


  • Consultation on Possible Changes to the Food and Drug Regulations: Generic Drug Equivalence and Related Terminology (Health Canada)
  • Frequently Asked Questions: Access to naloxone in Canada (including NARCAN™ Nasal Spray) (Health Canada)
  • Abbott wins Health Canada nod for FreeStyle Libre glucose monitor (MassDevice)


  • Regulation of live animal cells, tissue and organs (TGA)
  • Authorised prescribers (TGA)
  • Special Access Scheme (TGA)

Other International

  • Takeda selects global CSR programs for developing and emerging countries (PharmaLetter-$)
  • Yemen's cholera death toll rises to 1,500: WHO (Reuters)

General Health & Other Interesting Articles

  • With a Tick Boom, It's Not Just Lyme Disease You Have to Fear (NYTimes)

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.

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles