Regulatory Recon: NICE Backs Opdivo for NSCLC After Price Cut; Alnylam RNAi Drug Succeeds in Phase III (20 September 2017)

Posted 20 September 2017 By Michael Mezher

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

In Focus: US

  • Alnylam achieves breakthrough RNAi success as PhIII patisiran study hits all goals, shares soar (Endpoints) (STAT) (Reuters) (Financial Times) (In The Pipeline) (Press)
  • Pfizer Sues J&J Over Contracts Blocking Remicade Biosimilars (Focus)
  • The Biotech Devil's Dictionary: Your guide to the inanities of industry jargon (STAT)
  • Dozens of states probe role of drug makers and distributors in the opioid crisis (STAT) (NPR)
  • Sanofi's Elias Zerhouni says his R&D group is ready to stand alone — but big M&A and partnerships still loom large (Endpoints)
  • Real World Evidence: FDA Commits to Advancing its Use (Focus)
  • ODAC Split On Sutent For Adjuvant RCC (BioCentury) (Press)
  • 'Shocking' disregard for safety in US meningitis case –prosecutor (Reuters)
  • Trump endorses latest Republican bill to dismantle Obamacare (Reuters)
  • Obamacare Repeal Bill Offers Both Enormous Flexibility and Uncertainty (NYTimes)
  • AMA Says Latest Trumpcare Bill Violates 'Do No Harm' Pledge (Forbes)
  • FDA Weighs in on Off-Label Use and Preemption (Drug & Device Law)
  • US FDA's Benefit/Risk Framework Gets High Marks But Could Be Improved (Pink Sheet-$)

Sponsored Content: IVDR/MDR Challenges Top Roadshow Agenda

  • BSI's 6th Annual, full-day medical device Roadshow will guide participants to new EU Medical Device/In-Vitro Device Regulation compliance. The program examines key issues facing Med Dev Manufacturers under the new MDR/IVDR starting with an overview, then analyzing legacy products and transitional provisions. Implementation issues including conformity assessments, essential/clinical requirements, SPR, labeling and QMS impacts of these standards will be detailed.
  • Check here for specific dates, locations and the program agenda.

In Focus: International

  • UK backs Opdivo for lung cancer after Bristol-Myers cuts price (Reuters) (PharmaTimes) (BBC) (NICE)
  • Novartis's Rydapt wins EU approval for AML, other diseases (Reuters) (PharmaTimes)
  • Shire, Shionogi's ADHD drug for adults clears late-stage trial in Japan (Reuters) (PharmaTimes)
  • MSD's Keytruda wins new bladder cancer indication in Europe (PMLive)
  • Troubled Teva turns to risk-sharing team at Nuvelution to gamble on a new PhIII study (Endpoints)
  • UK's MHRA Unveils Human Factors Guidance for Medical Devices (Focus)
  • Samsung Bioepis will use CMOs to make Ontruzant if it is approved (BioPharmaReporter)
  • India may soon give OTC drugs definition (Economic Times)
  • Deal-Making Firm On Fosun's Agenda As Overseas Revenues Spurt (SCRIP-$)
  • BIA & MHRA publish report 'Innovation in life sciences in a changing and dynamic environment' (MHRA) (Report)
  • The world is running out of antibiotics, WHO report confirms (WHO) (Report)
  • Compelling Priorities for Global Health (WHO)
  • China has a new medical device classification catalog: what you need to know (Medical Design & Outsourcing)
  • Asia Regulatory Roundup: India to Reassess Cardiac Stent Price Ceiling (Focus)

Pharmaceuticals & Biotechnology

  • From big biopharma to biotech CEO, John Houston's R&D journey highlights a fast-changing world (Endpoints)
  • Biomarker Qualification: FDA Explains Process and Opportunities for Engagement (Focus)
  • In Pursuit of Tardive Dyskinesia: The Breakthrough Designation and Approval of Valbenazine (FDA)
  • Pediatric Trial Design and Modeling: Moving into the Next Decade (FDA Workshop Recordings)
  • ESMO 2017 review — have we reached 'peak I-O'? (PharmaLetter)
  • A call for help from the antibiotics makers (EP Vantage)
  • Lightstone crew adds a $250M Fund II with plans to back biotech startups (Endpoints)
  • A Stress Link to Lupus (NYTimes)
  • Tech maven Travis May takes the helm of Roivant's data mining startup (Endpoints)
  • Cancer Research, Parker Institutes To Test I-O Combos For Pancreatic Cancer (BioCentury)
  • FDA Withdraws 27 ANDAs That Are No Longer Marketed (FDA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Cervical screening with primary HPV testing or cytology in a population of women in which those aged 33 years or younger had previously been offered HPV vaccination: Results of the Compass pilot randomised trial (PLOS)
  • Amylyx Pharmaceuticals Receives FDA Orphan Drug Designation for AMX0035 for the Treatment of Amyotrophic Lateral Sclerosis (Press)
  • MiMedx files IND for Ph2 AmnioFix osteoarthritis trial (Drug Delivery)
  • GSK and Innoviva Report Positive Headline Results from IMPACT Study Showing Single Inhaler Triple Therapy Trelegy Ellipta Reduced COPD Exacerbations (Press)
  • Poxel Announces PXL770 Advances into a Phase 1b Multiple Ascending Dose Trial (Press)
  • Sancilio Pharmaceuticals Company, Inc. (SPCI) Receives Rare Pediatric Disease Designation From the US Food and Drug Administration for Altemia a Treatment of Sickle Cell Disease (SCD) in Children (Press)
  • Cycle Pharmaceuticals Receives FDA Approval and Launches Ketorolac Tromethamine Injection 30mg/mL in the U.S. (Press)

Medical Devices

  • 10 of the world's largest medical device companies  (MassDevice)
  • Medtech complaint handling: Is there something to complain about? (Medical Design & Outsourcing)
  • Stryker's Spine Division Receives FDA Clearance for 3D-Printed Tritanium® C Anterior Cervical Cage (Press)
  • FDA Approves Agilent Complementary Dx for Two Additional Indications (GenomeWeb)
  • Centinel Spine acquires Prodisc assets from J&J's DePuy Synthes (MassDevice)
  • Pentax Unveils Easier to Clean Duodenoscopes Thanks to Disposable Business End (MedGadget)
  • Mevion files for FDA clearance for S250i proton therapy system (MassDevice)
  • Boston Scientific touts increased HF risk detection in HeartLogic study (MassDevice)
  • Q&A: How to Control Development Costs for Implantables (MDDI)

US: Assorted & Government

  • FDA Diversity And Inclusion Strategic Plan  (FDA)
  • Price's private-jet travel breaks precedent (Politico)
  • Revising CMS policy on biosimilars could save $11.4 billion over 10 years, says AAM's Biosimilars Council (Biosimilar News)
  • While Premiums Soar Under Obamacare, Costs of Employer-Based Plans Are Stable (NYTimes)
  • A Review Of Willfulness Findings In Hatch-Waxman Actions (Law360-$)
  • Walgreens gets regulator's nod to buy Rite Aid stores (CNBC)
  • The opioid epidemic is so bad it's driving down life expectancy in the US (CNBC)
  • Draft Released on Nevada Pharmaceutical Representative Registration Procedure (Policy & Medicine)
  • False Claims Act Mid-Year Review: Significant Life Science Settlements, Post-Escobar Developments & Industry Round Up (Policy & Medicine)
  • As Medical Food Industry Grows, So May FDA Scrutiny (Law360-$)
  • FTC Contests Impax's Defense Of Opana ER Patent Settlement (Law360-$)
  • Mass. Opioid Substitution Law A Nice Idea, But Falls Short (Law360-$)
  • Bayer, Janssen Win Denial Of New Xarelto Trials (Law360-$)
  • AstraZeneca, Amneal Settle Generic Diabetes Drug Fight (Law360-$)

Upcoming Meetings & Events

  • FDA Advisory Committee Calendar
  • Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review; Public Workshop – 2-3 October 2017
  • Demonstrating Equivalence of Generic Complex Drug Substances and Formulations – 6 October 2017
  • Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access – 20 October 2017
  • FDA, CDC, and USDA Announce 2017 Scientific Meeting of the National Antimicrobial Resistance Monitoring System – 24-25 October 2017
  • Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting – 13 October 2017
  • European Medicines Agency (EMA) / Drug Information Association (DIA) statistics forum: The role of observational data in assessing the benefits and risks of medicines – 1 December 2017
  • The Cost of Medications: Current Realities and the Future of Pharmaceutical Pricing Regulations in the United States – 4 October 2017

Europe

  • Pentax Medical wins CE Mark for DEC duodenoscope (MassDevice)
  • Mazor Robotics wins CE Mark for Mazor X surgery platform (Robot Report)
  • New Human Immunoglobulin Reference Standards Available (EDQM)

Asia

  • FDA Warns Korean, Chinese Drugmakers (Focus)
  • Puracap's Wuhan site passes US FDA inspection prompted by ANDA (InPharmaTechnologist)

India

  • Dr. Reddy's Gets Form 483 With Three Observations for Mirfield, UK Facility (BSE Filing)
  • Glenmark gets USFDA nod for chest pain tablets (Economic Times)
  • Health ministry equips 300 healthcare professionals with skills on pharmacovigilance to strengthen PvPI (PharmaBiz)
  • Maha FDA calls for joint efforts with pharma industry to fight against counterfeit drugs (PharmaBiz)
  • DBT to conduct 'India-UK antimicrobial resistance sandpit' to address the challenge of antimicrobial resistance in India (PharmaBiz)

General Health & Other Interesting Articles

  • A $200 million gift promotes alternative therapies at a California medical school — and critics recoil (STAT)
  • Artificial Human Embryos Are Coming, and No One Knows How to Handle Them (MIT Technology Review)
  • Genetic Engineering Holds the Power to Save Humanity or Kill It (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 news@raps.org.

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

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