Regulatory Recon: J&J Pays $417M for Baby Powder Link to Cancer (22 August 2017)

Posted 22 August 2017 By Zachary Brennan

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

In Focus: US

  • $417 Million Awarded in Suit Tying Johnson’s Baby Powder to Cancer (NY Times-$) (Reuters) (AP) (USA Today)
  • States impatient for opioid declaration (Politico)
  • HHS Proposes Longer Delays to Implementation of the 340B Final Rule (FDA Law Blog) (Axios)
  • Medtronic beats profit estimates led by strong heart device sales (Reuters) (CNBC) (Mass Device) (Medtronic)
  • J&J Wades Into Death Penalty Debate For First Time (Wall Street Journal-$)
  • Vantage Point – Why generic competition might not stem price moderation calls (EP Vantage)
  • Path forward on healthcare 'somewhat murky,' Senate leader says (SNL) (The Hill)
  • Advancing the Development of Pediatric Therapeutics: Application of “Big Data” to Pediatric Safety Studies; FDA Public Workshop (Federal Register)
  • Regulatory Explainer: FDA User Fee Reauthorizations From 2018 to 2022 (Focus) (E&C)
  • FDA Weighs Limited Risk Info in DTC Ads (Focus)
  • Working to Improve Information on Medication Use during Pregnancy (FDA Voice blog)

In Focus: International

  • EU Commission starts in-depth probe of Bayer, Monsanto deal (Reuters) (Bayer)
  • India grants Pfizer patent on pneumonia vaccine in blow to aid group (Reuters)
  • New vision and strengthened partnership for WHO and China (WHO)
  • Notice - Publication of the Health Canada Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions (Health Canada)
  • Alembic JV operations hit by fire at Algerian facility (InPharma)
  • Indian Pharmaceutical Alliance demands streamlining of approval of new drugs, biosimilars & revamping of CDSCO (PharmaBiz)
  • New flu vaccine approved for UK use (PharmaTimes)
  • Continuity in the availability of goods for the EU and the UK (MHRA Position Paper) (ABPI)
  • MHRA seizes more than 100 unreliable HIV home-testing kits (MHRA)
  • CFDA's Vice Minister Wu Zhen meets the Chief Executive of the British MHRA, Dr. Ian Hudson (CFDA)
  • Report of the PMDA-ATC GMP Inspection Seminar 2017 (PMDA)

Pharmaceuticals & Biotechnology

  • Building up its I/O ops, CRISPR Therapeutics allies with Marcela Maus at Mass General (Endpoints)
  • Temasek investing $150m in Coherus (BioCentury-$)
  • EvaluatePharma World Preview 2017, Outlook to 2022 (Evaluate)
  • The return of the medtech megadeal (EP Vantage)
  • Their genes put them at high risk of Alzheimer’s. So they’re experimenting — on themselves (Stat)
  • What the J&J CEO told employees about the Trump manufacturing council (Stat-$)
  • Impax Loses Fees Bid In Opioid Pay-For-Delay Row With FTC (Law360-$)
  • Martin Shkreli Was ‘His Own Worst Enemy,’ Juror Says (NY Times-$)
  • The legal and regulatory challenges of getting a biosimilar product to market (PharmaLetter-$)
  • Lilly to Use Topas Platform in Immunology Collaboration (GEN)
  • High Potency Active Pharmaceutical Ingredients (APIs) Market to Reach $34.8 Billion by 2025 (Press)

Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Novartis launches MS smartphone trial (PharmaTimes)
  • Janssen collaborates with Australian institute on Alzheimer’s disease research (PharmaLetter-$)
  • Ethris hooks big pharma partner in five-year mRNA discovery deal (BioWorld-$)
  • Research unveils new drug targets for more effective treatment of liver disease (Pharmafile)
  • Context: the grey matter of cancer (Nature Reviews Clinical Oncology)
  • MRC Consortium works with industry to launch trial into anti-inflammatory drug for depression (MRC)

Medical Devices

  • FDA Adds UL 2900 for Medical Device Cybersecurity to List of Recognized Standards (Emergo)
  • Diagnostic Errors and Diagnostic Calibration (JAMA)
  • Medical Devices; Exception From General Requirements for Informed Consent (Federal Register)
  • Pediatric medical device competition extending its deadline (MassDevice)
  • Samsung launches Relúmĭno to help the visually impared see (MobiHealthNews)
  • IBM, JDRF partnership using machine learning methods to tackle Type 1 diabetes (MobiHealthNews)
  • Malin Announces U.S. FDA Approval for New Hourglass Peripheral Embolisation Plug (Press)
  • Smart Medical Devices Market to Reach $24.4 Billion by 2025 (Press)
  • Infections associated with heater-cooler devices (TGA)

US: Assorted & Government

  • We’re not prepared for the next public health emergency (The Hill)
  • FDA Oversight of Tobacco Manufacturing Establishments (HHS OIG)
  • Philip Morris International CEO cheers U.S. FDA tobacco proposal (Reuters)
  • FDA warns consumers about health risks of herbal coffee products from Malaysia containing undeclared active pharmaceutical ingredients and milk (FDA)
  • Oncology Drugs for Companion Animals; Guidance for Industry; Availability (Federal Register)
  • HHS ordered to explain Medicare outlier payment formula (Modern Healthcare)
  • Comment Request; Additional Criteria and Procedures for Classifying Over-the-Counter
  • Drugs as Generally Recognized as Safe and Effective and Not Misbranded (Federal Register)

Upcoming Meetings & Events

Europe

  • UK condemned over 'shocking' export of deadly weedkiller to poorer countries (Guardian)
  • Better veterinary medicines for healthier animals and people (EMA)

General Health & Other Interesting Articles

  • Using Genetics to Uncover Human History (Patent Docs)
  • How To Tell If Watching The Eclipse Damaged Your Eyes (NPR)
  • Hospitals Are Clogged With Patients Struggling With Opioids (NY Times-$)
  • Dying At Home In An Opioid Crisis: Hospices Grapple With Stolen Meds (Kaiser Health News)
  • Coca-Cola, PespiCo and others agree to cap sugar in drinks in Singapore (Reuters)

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.

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