Regulatory Recon: GSK Eyes Pfizer, Merck Consumer Units Sanofi Sues Mylan Over Insulin Pen (25 October 2017)

Posted 25 October 2017 | By Michael Mezher 

Regulatory Recon: GSK Eyes Pfizer, Merck Consumer Units Sanofi Sues Mylan Over Insulin Pen (25 October 2017)

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

In Focus: US

  • Sanofi files patent infringement suit against Mylan over insulin pen (MassDevice) (Pharmafile)
  • Incyte grabs a new PD-1 checkpoint drug in $900M deal with MacroGenics (Endpoints)
  • AstraZeneca 'all in' on severe asthma launch for late-to-the-party benralizumab (Fierce)
  • Trump readies opioid plan, but some worry it won't be enough (AP)
  • PTC Therapeutics Stock Halted (Street Insider)
  • A Bipartisan Drug Cartel? (WSJ)
  • Op-Ed: The opioid crackdown is making life untenable for chronic pain patients like me (LA Times)
  • Tracking the Cost of Gene Therapy (MIT Technology Review)
  • The Medicines Co. brings out the ax, looking to jettison 100s of jobs in restructuring (Endpoint)
  • Gilead says drug profits must stay high to pay for 'innovation,' but 100% of its profits went to shareholders (LA Times)
  • California just passed a law to rein in drug prices. Here's why it's unlikely to make much difference (STAT)
  • From the C-Suite: Biopharma execs open up on what tests them as leaders (STAT)
  • Baxter expects $70 million hit to fourth-quarter sales from Hurricane Maria (Reuters) (Press)
  • Lawyers Scare Patients Out Of Taking Medication, Legal Reform Group Says (Forbes)
  • Biogen Shares Hit After Poor US Sales for Muscular Atrophy Treatment (The Street) (Fierce)
  • How much? In a 'bold' move, Celgene raises prices (STAT) (Fierce)
  • 510(k) Exemption – What's Actually Exempt, Part II (FDA Law Blog)

Sponsored Content: Georgetown's Master of Professional Studies in Project Management

In Focus: International

  • GSK draws up shopping list for Pfizer and Merck consumer unit (Financial Times) (Reuters)
  • New HIV treatments boost GSK sales after expensive start (Financial Times)
  • Bill Gates: Polio will be eradicated this year, the endgame is near (CNBC)
  • Brexit Hits Life Science Investment Decisions As UK Risks Exclusion From Key EU Projects (Pink Sheet-$)
  • Vantage Point – European approvals face delay from agency move (EP Vantage)
  • What's driving the rapid growth of the top 20 biopharma companies in the world? (Endpoints)
  • Plague kills 124 in Madagascar, cities most affected: report (Reuters)
  • China approves Ebola vaccine co-developed by Cansino Biologics and the military (BioWorld) (Fierce)
  • Chugai applies for additional indication for breast cancer drug in Japan (PharmaLetter-$)
  • China Sets Norms For Foreign Trial Data Submissions (Pink Sheet-$)
  • Consultation Deadline Approaches For New Industry Fees In Ireland (Pink Sheet-$)
  • MSF appeals to Korea, Japan to withdraw proposals hindering access to generic drugs & vaccines from RCEP negotiations (PharmaBiz)

Pharmaceuticals & Biotechnology

  • To IPO or Not To IPO (LifeSciVC)
  • Panel: No Age Limit to Opioid Abuse (Medpage)
  • Can changes to prescription labels and other public standards help tame the opioid crisis? (USP)
  • Abbvie's Jak flashes a warning for the whole class (EP Vantage)
  • Ablynx IPO raises $200M for its nanobody platform effort (Endpoints)
  • Why Precision Research May Lead To Blockbuster, Not Customized, Medicines (Forbes)
  • As Drugs Fail, Some Researchers Urge a Return to Alzheimer's Roots (Xconomy)
  • Allergan preps 300-representative army, branded DTC to make Esmya a 'flagship' women's health drug (Fierce)
  • RAND's 'Best Guess' On Biosimilars Is $54 Bil. In Cost Savings (Pink Sheet-$)
  • Evoke Pharma's Gimoti On Way To US FDA On 'Mixed' Data (SCRIP-$)
  • Novartis gives Arzerra a new lease of life (EP Vantage)
  • CRISPR, the Future of Life Science Research But Still Much to Learn (MIT Technology Review)
  • Type 3 diabetes more common than Type 1 and often misdiagnosed (Pharmafile)
  • Quad wins patent for alternative to magnetic beads in CAR T separation (BioPharmaReporter)
  • GenSight Biologics' CMO steps down as Barrett Katz takes over (Fierce)
  • BioInvent CEO resigns in shift toward scientific leadership (Fierce)
  • Science Exchange signs University of California life science startup hub (Fierce)
  • Y-mAbs raises $50M funding to propel cancer duo into late-stage testing (Fierce)
  • Catalent reorganizes after closing Pharmica purchase (Drug Delivery)
  • Takeda, Lundbeck and Advocate Health Care Research Study Aims to Enhance Patient-Provider Engagement in Major Depressive Disorder Treatment using Digital Technology (Press)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Prometic Receives Fast Track Designation for PBI-4050 in Development for Idiopathic Pulmonary Fibrosis (IPF) (Press)
  • Kala Pharmaceuticals Submits New Drug Application to U.S. Food and Drug Administration for INVELTYSTM (KPI-121 1%) (Press)
  • Janssen's New Darunavir-Based Single Tablet Regimen SYMTUZA® Shows Positive Outcome in Treatment of Antiretroviral-Naïve HIV Patients (Press)
  • Sobi: Alprolix® Approved in the Kingdom of Saudi Arabia for the Treatment of Haemophilia B (Press)

Medical Devices

  • Medical Device Development Tools: Helping to Speed Medical Device Evaluation and Approval (FDA Voice)
  • Robotic-assisted surgery: more expensive, but not always more effective (Reuters)
  • Will Experience Triumph Over New Robotics Innovation? (MDDI)
  • Why Healthcare Entrepreneurs Developing Devices Or Software Better Grok Sales & Marketing (Forbes)
  • Can Machine Learning Save Medicine? (MDDI)
  • Neural Analytics wins $10m DoD for point-of-care TBI diag device (MassDevice)
  • Edwards Lifesciences slides on Q3 sales, earnings misses (MassDevice)
  • NuVasive posts Q3 earnings that beat EPS but miss on sales, $100m share repurchase program (MassDevice)
  • J&J's LifeScan touts studies of OneTouch blood glucose monitoring system (Drug Delivery)
  • What's Needed to Scale Digital Health Initiatives? (MDDI)
  • Medtronic Announces First Economic Analysis Demonstrating Benefits of Professional CGM in People with Type 2 Diabetes (Press)
  • Income, sales rise for 3M Health Care's during Q3 (MassDevice)

US: Assorted & Government

  • Mr. Quixote goes to Washington? A bill would allow Medicare to negotiate drug prices (STAT)
  • Pick the wrong Medicare drug plan and the cost will shock you (CNBC)
  • Allergan invokes the victim defense to protect a brand-name drug from a generic challenge (STAT)
  • PTAB Life Sciences Report (Patent Docs)
  • Amgen, Hospira Challenge $70M Biosimilar Judgment (Law360-$)
  • Stacking The Deck Against Opioid Plaintiffs (Law360-$)
  • Ensnarement 101: Anatomy Of An Uncommon Patent Defense (Law360-$)
  • US health insurer Anthem's quarterly profit beats estimates (Reuters)
  • Centene warns on Obamacare subsidy cuts, shares dive (Reuters)
  • Walgreens 'Rebrand' Of Rite Aids Will Take Three Years, Cost $750M (Forbes)
  • Johnson & Johnson lawyers deny tampering allegations in hip case (MassDevice)
  • M.D. PA Declines to Dismiss Monitoring/Declaratory Judgment Action vs.  Blood Temperature Regulation Device (Drug & Device Law)

Upcoming Meetings & Events


  • Final Assessment Report, External Comments/Answers and Project Plan for pharma JA on Regorafenib (Stivarga) (EUnetHTA)
  • MHRA pulls Evertogen's GMP certificate after inspection (InPharmaTechnologist)


  • Myriad Genetics Submits BRACAnalysis CDx for Approval in Japan (GenomeWeb)


  • Gujarat FDCA officials get trained for compliance through collaborations with MNCs (PharmaBiz)


  • Submissions received: Alignment with European medical device regulatory framework (TGA)

General Health & Other Interesting Articles

  • The Symptoms of Protracted Dying (NYTimes)
  • Paul Allen Just Made His Biggest Step Yet To Map The Human Brain (Forbes)
  • My Amyloid Is "Elevated," So What's My Risk Of Getting Alzheimer's Disease? (Forbes)
  • Ducks' Patrick Eaves Has Suspected Guillain-Barré Syndrome - What You Need To Know (Forbes)

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