Regulatory Recon: FDA Panel to Focus on Safety of CAR-T Therapy (10 July 2017)

Posted 10 July 2017 | By Zachary Brennan 

Regulatory Recon: FDA Panel to Focus on Safety of CAR-T Therapy (10 July 2017)

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

In Focus: US

In Focus: International

  • Roche, Shire court fight underscores high stakes in hemophilia (Reuters) (PMLive)
  • ABPI applies for Judicial Review over new procedures that restrict access to cost-effective medicines (ABPI)
  • Pharma firms and consumer groups united over EMA relocation (Euractiv)
  • Remarks delivered by WHO Director-General to G20 (WHO)
  • MedTech Europe calls for further action following AMR discussion at G20 (Press)
  • Price cut secures a place for Ipsen’s Cabomeytx on the NHS (PharmaTimes) (NICE)
  • Mylan’s EU biosimilar ambition hit by GMP issues at Biocon plant (BioPharma-Reporter)
  • Lupin sets off down Indian pharma's long road to redemption (Reuters)
  • Call for public comments on draft statement on improving availability and transparency of observational studies on influenza vaccine effectiveness (WHO)
  • Successful reclassification of Nasonex Allergy Control Nasal Spray (MHRA)
  • EMA Restricts Use of Biogen MS Drug (Focus)
  • Australia’s TGA to Take Over Regulation of Therapeutic Goods Advertising (Focus)

Pharmaceuticals & Biotechnology

  • Celgene vet Jackie Fouse grabs the reins of a Vivek Ramaswamy vant-up (Endpoints)
  • Biopharma sector turns in strong performance in second quarter (BioWorld-$)
  • The private equity firm that quietly profits on top-selling drugs (NY Times-$)
  • Crispr Patent-Holders Move Toward Easing Access to Gene-Editing Technology (WSJ-$)
  • The Gene Editors Are Only Getting Started (WSJ-$)
  • CRISPR Gene Editing Problems: Does It Really Cause Unexpected Mutations? (Forbes)
  • Shire blasts Roche over its ‘misleading’ case for trailblazing hemophilia drug emicizumab, scoring injunction (Endpoints)
  • Teva Targets Ex-Exec Who Dated, Gave Info To Apotex CEO (Law360-$)
  • Apotex, Ranbaxy End Pay-For-Delay Suit Over Narcolepsy Med (Law360-$)
  • Bristol-Myers, Pfizer Again Sued Over Eliquis Risks (Law360-$)
  • Scientists are good for more than R&D (C&EN)
  • Cellectis: Calyxt Announces Proposed Initial Public Offering of $100 Million (Press)
  • Biogen Appoints Amy Chevalier Efantis Vice President of Government Affairs (Press)
  • InVivo Therapeutics Appoints Richard Toselli, M.D. as Chief Medical Officer (Press)
  • NovaBay Pharmaceuticals Announces CFO Transition (Press)

Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Experimental gene-silencing drug from Alnylam and Sanofi shows strong results in hemophilia (Stat) (Endpoints)
  • NIH launches prospective study of Zika and HIV co-infection during pregnancy (NIH)
  • Review article supports interchangeability of infliximab and CT-P13 (Big Molecule Watch)
  • FDA Grants Priority Review for Lilly's Abemaciclib for the Treatment of Advanced Breast Cancer (Press)
  • Ignyta Receives FDA Orphan Drug Designation for Entrectinib for Treatment of NTRK Fusion-Positive Solid Tumors (Press)
  • FDA Accepts for Priority Review Bristol-Myers Squibb’s Application for Sprycel (dasatinib) in Children with Philadelphia Chromosome-Positive Chronic Phase Chronic Myeloid Leukemia (Press)
  • Exelixis and Bristol-Myers Squibb Initiate Phase 3 Trial of Opdivo in Combination with CABOMETYX (Press)
  • CRISPR Therapeutics and Neon Therapeutics Enter Research Collaboration (Press)
  • Spring Bank Announces Collaboration with Gilead for Hepatitis B (HBV) Phase 2 Study Exploring Combination Treatment of SB 9200 and Vemlidy (Press)

Medical Devices

  • India’s health ministry releases draft list of devices & in vitro diagnostics along with risk-based classifications (PharmaBiz)
  • FDA develops rapid and sensitive assay to assess antibody response to Ebola virus vaccine without using the virus (FDA)
  • Prosthetics Maker Says Shumaker Loop Error Cost It $50M (Law360-$)
  • FDA Approves 6-Month Primary Endpoint for the Tack Endovascular System in Below the Knee Disease (Press)
  • New Canadian medical device incident reporting rules proposals (Mass Device)

US: Assorted & Government

  • Improved Vaccination Rates Would Fall Victim to Senate Health Cuts (Scientific American)
  • Schumer calls on FDA to regulate ‘snortable chocolate’ (AP)
  • Trump's Pick To Head CDC Partnered With Coke, Boosting Agency's Longstanding Ties To Soda Giant (Forbes)

Upcoming Meetings & Events


  • Requirements and information relating to combination products (medicinal products with a medical device component) in the form (Swissmedic)
  • The EU-FMD compliance project: is Europe ready? (Manufacturing Chemist-$)
  • UK launch for Pfizer’s MenB jab Trumenba (PharmaTimes)
  • Owlstone Medical, CR UK test potential of breath test for cancer (PharmaTimes)

General Health & Other Interesting Articles

  • Biology’s roiling debate over publishing research early (Wired)
  • First Opioid Court in the U.S. Focuses on Keeping Users Alive (AP)
  • Crime Labs Struggle To Identify Opioids In Race To Stop Epidemic (NPR)
  • Career of the Future: Robot Psychologist (WSJ-$)
  • Yemen cholera cases pass 300,000 mark, ICRC says (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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