Regulatory Recon: Sanofi, Regeneron Get Breakthrough Status for PD-1 Skin Cancer Candidate; New Mexico Sues 8 Opioid Makers and Distributors (8 September 2017)

Posted 08 September 2017 By Michael Mezher

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

In Focus: US

  • FDA Vows Modernization to Keep Up With Biotech Advances (Bloomberg)
  • The top 5 trends reshaping biopharma starts with an R&D earthquake (Endpoints-$)
  • Sanofi, Regeneron earn 'breakthrough' status for a fast-track drug out to prove PD-1 dominance (Endpoints) (Fierce) (Press)
  • FDA Wants to Know What Regulations and Paperwork Requirements Need to Go (Focus)
  • FDA Warns Pfizer Subsidiary Over Faulty EpiPen Components (Focus)
  • AbbVie's positive eczema study drags down Regeneron's shares (Reuters)
  • New Mexico sues opioid drug manufacturers, distributors (Reuters)
  • Governors Rally Around Health Law Fixes as White House Pushes Repeal (NYTimes) (KHN)
  • Meningitis B Vaccine's High Price Tag Poses A Health Care Conundrum (KHN)
  • (FDA Voice)
  • It's not just one suspect herpes vaccine trial: Most experimental drugs are tested offshore — raising concerns about data (STAT)

In Focus: International

  • Roche blood test could help 'personalize' cancer immunotherapy (Reuters 1, 2) (PharmaTimes) (Press)
  • Merck's data on Keytruda/chemo combo for lung cancer takes early spotlight at ESMO (Endpoints) (Reuters)
  • Boehringer, Gubra strike backloaded €250M obesity deal (Fierce)
  • European Regulatory Roundup: EU Committee Slams Plan to Cut EMA Staffing Ahead of Brexit (Focus)
  • GSK bets on pioneering cancer therapy with Adaptimmune deal (Reuters) (Fierce)
  • German regulator issues six major observations to Dr Reddy's Duvvada facility (Economic Times)
  • French Govt Has The Chance To Act Now To Boost Pharma Prospects, Says Industry Body (Pink Sheet-$)
  • ICH Advances Q&A on Drug and Biologic Starting Materials (Focus)

Pharmaceuticals & Biotechnology

  • FDARA Enacted; HP&M Issues Detailed Summary and Analysis (FDA Law Blog) (Report)
  • FDA Researchers Explore Fundamental Chemical Reaction that Could Threaten the Quality of Therapeutic Protein Products (FDA)
  • Replimune adds a $55M round and some expert help as it pursues next-gen oncolytics R&D (Endpoints)
  • Buyers of cancer assets fan the licensing deal market (EP Vantage)
  • He edited a human embryo, with startling results. Now he's toiling to understand just what happened (STAT)
  • Four-year-old Californian boy fights fatal disease with new treatment (Reuters)
  • Bristol-Myers Squibb Completes Previously Announced Acquisition of IFM Therapeutics (Press)
  • Piramal Pharma Solutions names John Fowler as COO (Economic Times)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Two Pivotal Opdivo (nivolumab) Trials Show Three-Year Survival Benefit in Patients with Previously Treated Advanced Non-Small Cell Lung Cancer (Press)
  • Verona COPD drug beats Boehringer blockbuster in phase 2 (Fierce)
  • Puma Biotechnology Presents 5-Year Analysis of Phase III ExteNET Trial in Extended Adjuvant HER2-Positive Breast Cancer at ESMO 2017 Congress (Press)
  • IHC 2017: Lilly's Galcanezumab Demonstrates Positive Long-Term Safety Results for up to 12 Months in Patients with Migraine (Press)
  • ERYTECH Announces Positive Full Results from Phase 2b Study of Eryaspase in Combination with Chemotherapy for Treatment of Metastatic Pancreatic Cancer in Second-Line (Press)
  • Clovis Oncology Presents Comprehensive Dataset from Successful Phase 3 ARIEL3 Maintenance Treatment Trial of Rucaparib in Advanced Ovarian Cancer at ESMO 2017 (Press)
  • Ignyta Announces Presentation of New Phase 1B Clinical Data on RXDX-105 in RET Fusion-Positive NSCLC at ESMO 2017 Congress (Press)
  • Oral tetrahydrouridine and decitabine for non-cytotoxic epigenetic gene regulation in sickle cell disease: A randomized phase 1 study (PLOS)
  • Antibe Therapeutics Announces Enrollment of First Subjects in Phase 2B GI Safety Study for Lead Drug, ATB-346 (Press)
  • New Data Presented at ESMO 2017 Shows That Abiraterone Acetate Plus Prednisone Provides Benefits in Patient Reported Outcomes in Both Metastatic Hormone-Sensitive and Castration-Resistant Prostate Cancer (Press)

Medical Devices

  • FDA Issues Final Guidance on Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (National Law Review)
  • New FDA De Novo User Fees: Effects for cutting-edge medical device manufacturers (Emergo)
  • Bayer offloads Multi Vendor Service radiology service and repair biz (MassDevice)
  • ClaroNav wins FDA 510(k) for NaviENT surgical navigation system (MassDevice)
  • NuVasive acquires Vertera Spine (MassDevice)
  • FDA details possible regulatory paths for Strata Sciences Optimal Dosing Tech (MassDevice)

US: Assorted & Government

  • Statement from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health claim advising that early introduction of peanuts to certain high-risk infants may reduce risk of peanut allergy (FDA) (Press)
  • Mylan Pharm. v. AstraZeneca AB (PTAB 2017) (Patent Docs)
  • Mallinckrodt v. Praxair – Innomax Method Patent Fails Alice/Mayo Test (National Law Review)
  • Talcum Plaintiffs Can't Show Personal Jurisdiction In Show Me State (Drug & Device Law)
  • J&J's Ethicon hit with $57m verdict in pelvic mesh case (MassDevice)

Upcoming Meetings & Events

Europe

  • BeNeLuxA Website Goes Live (Pink Sheet-$)
  • Liverpool man jailed for selling dodgy ED medicines (GOV.UK)
  • Ireland consults on National Biosimilar Medicines Policy (GaBI)
  • IntegraGen Theranostic Test for Colorectal Cancer Gets CE-IVD Mark (GenomeWeb)

Asia

  • Drug regulators get trained on regulatory aspects of data integrity, impurity profiling (PharmaBiz)
  • Biocon's insulin facility in Malaysia clears inspections for European market (Economic Times)
  • Medtronic Announces Japanese Regulatory Approval for the IN.PACT(TM) Admiral(TM) Drug-Coated Balloon (Press)

India

Australia

  • Reminder: Planned process improvements for GMP Clearance (TGA)

Other International

  • Regulation of follow-on biological products in Brazil (GaBI)

    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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