Regulatory Recon: Takeda Joins AbbVie, Allergan in Single Digit Price Hikes Sanofi & Regeneron Kevzara Approved in Canada After US Rejection (1 February 2017)

Posted 01 February 2017 | By Michael Mezher 

Regulatory Recon: Takeda Joins AbbVie, Allergan in Single Digit Price Hikes Sanofi & Regeneron Kevzara Approved in Canada After US Rejection (1 February 2017)

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

In Focus: US

  • Trump wants to blow up the FDA. The drug industry? Not so much (STAT)
  • Trump to Pharma CEOs: 75% to 80% of FDA Regulations Will be Eliminated (Focus)
  • Japan's Takeda committed to single-digit U.S. drug price rises (Reuters)
  • The $2.5-billion mistake: A gullible Trump bought into Big Pharma's inflated claim about drug R&D costs (LA Times)
  • Medtronic looks to sell $5B medical supplies biz (MassDevice)
  • FDA Warns Five Medical Device, Three Pharma Companies (Focus)
  • Some Noteworthy Changes to the 2017 Orange Book Preface & Patent and Exclusivity Information Addendum (FDA Law Blog)
  • If Trump wants to lower drug prices, he's going about it all wrong (Vox)
  • Seven Important Policy Agenda Items For BioPharma (LifeSciVC)
  • Mylan's Shares Rise Despite FTC Investigation (The Street)
  • Pfizer: Trump tonic (Financial Times)
  • Pharma stocks rally on Trump pledge to speed drug approvals (Financial Times)
  • Roche underlines 'value' of drugmakers to the US (Financial Times)
  • Competition stalls Roche margin growth; drugmaker commits to diabetes unit (Reuters) (Roche)
  • Catabasis routed after DMD trial failure (Fierce) (Press)
  • A Biohacker's Plan to Upgrade Dalmatians Ends Up in the Doghouse (MIT Technology Review)
  • Three Individuals Arrested and Charged in South Dakota Fraudulent Medical Device Scheme (DoJ)

In Focus: International

  • EDQM and EMA to clarify how Ph. Eur applies to biosimilars at event next week (BioPharmaReporter)
  • African Heads of State commit to universal access to immunization (Pharmafile)
  • Italian Medicines Agency Cites Brazilian Drugmaker for GMP Violations (Focus)
  • EU options for improving access to medicines (ENVI)
  • Emergo 2017 Medical Device Industry Outlook: 5 Key Takeaways (Emergo)
  • EU clears Merck's Keytruda for un-treated lung cancer (PharmaTimes) (Press)
  • Sanofi & Regeneron's arthritis drug scores first approval following FDA rejection (Pharmafile) (PMLive)
  • Sanofi names chief of standalone vaccines unit (PharmaTimes)
  • Indian Pharma not too worried over Trump talk (Economic Times)

US: Pharmaceuticals & Biotechnology

  • Regulation Cutting Impact on FDA and AdComms (Eye On FDA)
  • Baxter Reports 2016 Fourth-Quarter and Full-Year Results (Press)
  • Black, Hispanic parents may be less likely to enroll kids in medical trials (Reuters)
  • Nothing Is Undruggable: Novartis' Bradner On CAR-T, CRISPR & DNA Libraries (SCRIP-$)
  • Allergan closes $3B Acelity LifeCell buy (MassDevice)
  • Expiration Date Extension for North American Coral Snake Antivenin (Micrurus fulvius) (Equine Origin) Lot L67530 through January 31, 2018 (FDA)
  • Galena Sacks CEO Amidst Escalating Criminal Probe (The Street)
  • FDA's Streamlined Requirements For Combination Products (Law360-$)
  • 'Trumpcare' could be a boon for pharma DTC advertising: consultant (Fierce)
  • Questions swirl around Pfizer's I-O efforts, dealmaking future amid Q4 EPS miss (Fierce)
  • Guidelines Recommend It, But Evidence That Prescription Drug For Morning Sickness Works Is Lacking (Forbes)
  • Novartis Considers Alcon Spin-Off (Forbes)
  • Moving From Big Pharma To Biotech -- A Conversation With Achillion's Joel Barrish (Forbes)
  • Dimension falls on liver toxicity concerns (BioCentury)
  • Seres Argues Different Diagnostic Needed In Recurrent C. Difficile Trials (Pink Sheet-$) (Fierce)

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

  • Audentes Therapeutics Announces FDA Clearance of Investigational New Drug Application for AT342 to Treat Crigler-Najjar Syndrome (Press)
  • Tenax Therapeutics Announces Top-Line Results From Phase 3 LEVO-CTS Trial in Cardiac Surgery (Press)
  • Sanofi's xyzal® allergy 24hr approved for over-the-counter use in the United States (Press)

US: Medical Devices

  • Who's J&J's stepchild? Its consumer diabetes device business (MedCityNews)
  • Helping Our Population Age Better—with Manufacturing (MDDI)
  • Medtronic wins FDA clearance for CardioInsight 3D mapping tech (MassDevice)
  • Abbott wins FDA nod for MRI-safe Assurity pacemaker (MassDevice) (Press)
  • LivaNova touts high survival, freedom from reoperation in Perceval study (MassDevice)
  • MediWound touts Phase II study (MassDevice)
  • FDA Grants New Clearance for Brain Surgery Technology (Press)

US: Assorted & Government

  • Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC (Fed. Cir. 2017) (Patent Docs)
  • Want to Talk to the President? Advertise Here (The Atlantic)
  • Hip Case Breaks the Right Way in New York (Drug & Device Law)              
  • CMS Has Taken Steps, but Further Efforts Are Needed to Control Improper Payments (GAO)
  • Canadian scientists were followed, threatened and censored. They warn that Trump could do the same. (Washington Post)

Upcoming Meetings & Events


  • Siemens Healthineers boosts Q1 profits despite flat sales (MassDevice)
  • Novartis unit Lek to expand Slovenian antibiotics plant (InPharmaTechnologist)
  • Agilent's Keytruda CDx Granted Expanded CE Mark (GenomeWeb)



  • Government to frame new rules on medical devices to draw investments (Economic Times)
  • IDMA, UK-based NSF to jointly launch course on quality management for QA professionals in India (PharmaBiz)
  • Pharmacist and non-pharmacist traders differ on draft proposal for amendment of D&C Rules (PharmaBiz)
  • Indian healthcare providers pin hopes on classification of the sector under 'zero percent' GST (PharmaBiz)
  • Tata Memorial Hospital to begin 10-yr long pan India study of aspirin in preventing cancer relapses (PharmaBiz)


  • Suggestions in some media that the TGA does not adequately test sunscreens is incorrect (TGA)
  • Australian ovarian and lung cancer drug subsidies come into force (PharmaLetter-$)


  • Consultation on the Health Canada Draft Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions (Health Canada)

General Health & Other Interesting Articles

  • Reached Via a Mind-Reading Device, Deeply Paralyzed Patients Say They Want to Live (MIT Technology Review)

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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