Regulatory Recon: FDA Approves Novo Nordisk's Diabetes Drug Ozempic; Australian Competition Watchdog Sues GSK, Novartis Over Pain Relief Marketing (6 December 2017)

Posted 06 December 2017 By Michael Mezher

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

In Focus: US

  • Cities, counties and schools sidestep FDA foreign drug crackdown, saving millions (Washington Post)
  • FDA approves Novo Nordisk diabetes drug Ozempic (Reuters) (Endpoints) (Press)
  • Jury orders Bayer, J&J to pay $28 million in Xarelto lawsuit (Reuters)
  • FDA's program to speed up drug approval shaved nearly a year off the process (Los Angeles Times) (FDA News-$) (Pink Sheet-$)
  • Amgen, Carmot ink backloaded $240M Parkinson's pact (Fierce)
  • Operating Systems For Living Medicines (LifeSciVC)
  • Amazon cancels pharma license application in Maine, raising more questions about its health-care plans (CNBC)
  • FDA urges maker to recall Limbrel after liver and lung injury reports (STAT)
  • Celgene, Bluebird signal quick start to CAR-T trial in multiple myeloma (STAT)
  • FDA Lifts Partial Clinical Holds on Two Opdivo Combination Studies in MM (Press)
  • Avanir lays off dozens of sales rep amid probe into its key drug (STAT)
  • UnitedHealth Buys Large Doctors Group as Lines Blur in Health Care (NYTimes) (Forbes)
  • Consistently lower cancer survival rates for black patients in US (Reuters)
  • FDA Grants Genentech's Avastin Full Approval for Most Aggressive Form of Brain Cancer (Press)
  • Troubled Depomed sells off Nucynta, axes 40% of workforce to pare down costs (Fierce) (Press)
  • As J&J holds off US biosims, Remicade's European market share falls to 50% (Fierce)
  • Revance's rival to Allergan's Botox aces phase 3 (Fierce) (STAT) (Press)
  • Allegern shares sag on promising results for potential Botox rival (Financial Times)
  • GOP pushing for spending patch this week, but don't expect health care to hitch a ride (Politico)
  • Shire in deal to develop a new way to administer hemophilia drug (Reuters)

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In Focus: International

  • GSK, other drugmakers bet on post-Brexit UK science (Reuters) (Financial Times) (Endpoints)
  • Australian watchdog takes GlaxoSmithKline, Novartis units to court (Reuters)
  • Nestlé to buy vitamin maker Atrium Innovations for $2.3bn (Financial Times) (Reuters)
  • Sanofi continues to seek clinical trial waiver in India for controversial dengue vaccine (Economic Times)
  • Walgreens To Invest $416 Million In Chinese Pharmacy Chain (Forbes)
  • EMA should remain in London post-Brexit to soften transition, UK lawmakers hear (PharmaLetter-$)
  • Roche links with UK gov on digital pathology services (PharmaTimes)
  • NHS use of Roche's Roactemra turned down for giant cell arteritis (PharmaTimes)
  • Novartis nets first acute myeloid leukaemia approval in Canada, but NICE says no (Pharmafile) (PharmaTimes)
  • Turkish Decree Places New Caps On Drug Price Increases (Pink Sheet-$)
  • French Orphan Play Advicenne Raises €27m Ipo (BioCentury)
  • Projects In Sub-Saharan Africa Propelling Drug Approval Procedures (SCRIP-$)
  • US FDA team to visit Gujarat FDCA for networking as part of global harmonization efforts (PharmaBiz)
  • New China FDA Guidance on Medical Device Registration Grouping (Emergo)
  • Paraguay Congress legalizes planting of medical marijuana (Reuters)

Pharmaceuticals & Biotechnology

  • Bayer's big ideas for star Loxo assets (EP Vantage)
  • Gilman's Next CEO Trick: Taming CAR-T Cells With Obsidian (Xconomy) (Endpoints)
  • Adding Letters to the DNA Alphabet (NIH)
  • Could CRISPR Help to Knock Out Superbugs? (WSJ)
  • The 'smart pill' for schizophrenia and bipolar disorder raises tricky ethical questions (STAT)
  • Pregnant women who need medications face a risky guessing game. A federal task force is now trying to help (STAT)
  • Goldfinch poaches AstraZeneca research executive Tony Johnson for CEO (Fierce)
  • Biotech hedge fund titan Sam Isaly harassed, demeaned women for years, former employees say (STAT)
  • 27 Top Breast Cancer Oncologists, Picked By Big Data (Forbes)
  • 27 Top Cardiologists, Picked By Big Data (Forbes)
  • How effective is the flu vaccine this year? (CBS)
  • Ritter Pharmaceuticals Changing the Game With Lactose Intolerance Treatment (The Street)
  • 15 For '18: Key Clinical Data to Watch For Next Year (Part 1) (Part 2)
  • Neuralstem Rebounds On Additional Mdd Data (BioCentury)
  • FDA Releases Guidelines for Physicians Using Investigational Drugs in Emergency Situations (Policy & Medicine)
  • Rx Savings Solutions raises $18.4M to further goal of helping people save money on prescriptions (MedCityNews)
  • US Biological inks antibody labelling deal with Sygnis subsidiary (BioPharmaReporter)
  • GW prepping for mid-2018 CBD epilepsy candidate approval in US (InPharma)
  • AbbVie's Spin-Out Culture Helped Set Post-Humira Strategy, Execs Say (SCRIP-$)
  • Grünenthal changes partner for US opioid drug marketing (PharmaLetter-$)
  • US FDA Weighs Whether Interstitial Cystitis Should Be Studied Separately From Bladder Pain (Pink Sheet-$)
  • FDA Issues Final Guidance Documents on HCT/Ps, Announces a Three Year Period of Enforcement Discretion for Certain HCT/Ps for Autologous Use (Part I of "The FDA's Comprehensive Regenerative Medicine Policy Framework") (FDA Law Blog)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Clovis Announces Priority Review Designation for Rucaparib Supplemental New Drug Application (Press)
  • Sanofi And IBM Watson Health Real-World Analysis Showed That Individuals Not Achieving Control On Basal Insulin Within 12 Months Were Unlikely To Achieve Control During The Remainder Of The Two Year Study (Press)
  • Updated Data from Phase 3 Trial of IBRANCE® (palbociclib) Plus Letrozole in ER+, HER2- Metastatic Breast Cancer Confirm Improvement in Progression-Free Survival (Press)
  • Novaliq's NovaTears®+Omega-3 Approved in Europe for the Enhanced Treatment of Evaporative Dry Eye Disease (Press)
  • ICBII Announces the Filing of Orphan Drug Designation Application for the Use of α-Synuclein-SMART Molecule in the Treatment of Multiple System Atrophy (Press)

Medical Devices

  • Letter to File or New 510(k)?: CDRH Finalizes Two Key Guidances (Inside Medical Devices)
  • Final US FDA Guidance for Additive and 3D Printed Medical Device Manufacturers (Emergo)
  • Communication, Breaking Down Walls, and a Huge Step Forward for People with Type 1 Diabetes (FDA Voice)
  • Lilly Initiates Clinical Trial to Evaluate the Functionality and Safety of its Automated Insulin Delivery System (Press)
  • Biomaterials: Is there a better way for FDA to regulate them? (Medical Design & Outsourcing)
  • Abbott maintains Nanostim halt on docking button issue (MassDevice)
  • LivaNova puts $225m on the table for ImThera Medical (MassDevice)
  • Lilly launches trial for automated insulin delivery system (Drug Delivery)
  • Third Respiratory Assay Now FDA Cleared on Hologic's New Panther Fusion® System (Press)
  • Lia Diagnostics Announces FDA Clearance Of The First And Only Flushable, Biodegradable Pregnancy Test (Press)
  • Sunovion Receives FDA Approval for Lonhala™ Magnair™ Inhalation Solution to Treat COPD (Press)
  • Viveve touts sub-analysis results from Viveve system vaginal laxity trial (MassDevice)

US: Assorted & Government

  • The CHIP Program Is Beloved. Why Is Its Funding in Danger? (NYTimes)
  • The CVS-Aetna Merger Is A Mortal Threat To US Hospitals (Forbes)
  • Top federal health agency failed to fix billing problem for years — and may have cost taxpayers up to $102 million (CNBC)
  • Medicare And Medicaid: CMS Needs to Fully Align Its Antifraud Efforts with the Fraud Risk Framework (GAO)
  • Taking Sides On Mohawk IPR: Generic And High Tech Industries Vs. Law Profs (Pink Sheet-$)
  • Still No "Newly Acquired Information," Eliquis Claims Still Preempted (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • More cancer specialists to be employed by the NHS (UK DoH)

Asia

India

  • Even after launch of online portal, Bengal traders still forced to visit FDA office for license renewal (PharmaBiz)

Australia

  • ACSS - Generic Medicine Work Sharing Trial (TGA)
  • Presentations: Codeine up-scheduling workshops, Melbourne, 28 November 2017 (TGA)

Other International

  • Second Sight launches Argus retinal prosthesis in Iran (MassDevice)

General Health & Other Interesting Articles

  • Liver transplant distribution changed after years of debate (Washington Post)

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 news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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