Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves CAR-T Therapy from Gilead’s Kite (19 October 2017)

Regulatory Recon: FDA Approves CAR-T Therapy from Gilead’s Kite (19 October 2017)

Posted 19 October 2017 | By Zachary Brennan 

Regulatory Recon: FDA Approves CAR-T Therapy from Gilead’s Kite (19 October 2017)

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

In Focus: US

  • FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma (FDA) (Stat) (Forbes) (Endpoints) (WSJ-$) (NY Times-$) (Reuters)
  • FDA Panel Urges Approval of Semaglutide for Type 2 Diabetes (MedPage Today) (Reuters)
  • ‘Drug Dealers in Lab Coats’ (New York Times-$)
  • Cybersecurity Concerns and Medical Devices: Lessons From a Pacemaker Advisory (JAMA)
  • Is FDA Set for Another Banner Year of Approvals? (EyeonFDA)
  • Quest Diagnostics to Acquire Cleveland HeartLab and Form Strategic Collaboration with Cleveland Clinic (Press)
  • Big Tech vs Big Pharma: the battle over US patent protection (Financial Times-$)
  • Proposed Delay to Research Rule Still Up in the Air (Bloomberg)

In Focus: International

  • Roche's Top Drug Stumbles in Europe as Biosimilars Take Hold (Bloomberg)
  • China biotech's 'coming out party' masks long road ahead (Reuters)
  • J&J to acquire German surgery software maker Surgical Process Institute (Mass Device)
  • Governments commit to reduce suffering and deaths from noncommunicable diseases (WHO)
  • AdvaMed petitions to block trade benefits to India in light of price caps (Mass Device) (Focus)
  • Pfizer pulls batches of antibiotic in Australia over anaphylaxis risk (InPharma)
  • Pharma’s ‘No-Show’ At Regulatory Meetings In India: Who Loses? (SCRIP-$)
  • New IMDRF Work Item: Personalized medical devices (IMDRF)
  • European Medicines Agency hosted meeting of EU Data Protection Officers (EMA)
  • Report of the PMDA-ATC Pharmaceuticals Seminar 2017 in Hanoi, Vietnam (PMDA)
  • TGA presentation: TGA Pharmacovigilance Inspection Program information sessions (TGA)
  • Developing treatments for blindness in children: the role of the Paediatric Medicines Regulation (EFPIA)
  • How Yemen’s Cholera Outbreak Became the Fastest Growing in Modern History (Frontline)

Pharmaceuticals & Biotechnology

  • Conversation between Bill Gates and NIH Director Francis Collins (ASHG)
  • Drug Development Costs Revisited (In the Pipeline)
  • Genentech’s complaint against Amgen regarding Mvasi (Big Molecule Watch)
  • District Court Dismisses FTC Lawsuit Regarding Marketers of Prevagen; FTC Failed to Carry Burden (FDA Law Blog)
  • Generic-Drug Maker Faces Sanctions As Adderall Trial Closes (Law360-$)
  • Updated FDA Manual Offers Inside Look at Inspection Protocols (Focus)
  • FDA Analyst Counters Critiques of Orphan Drug Act (Focus)
  • Merck KGaA's gene therapy facility passes FDA and EMA inspections (PharmaLetter-$)
  • AstraZeneca EVP: Brexit is hindering our hiring (Fierce)
  • Anthem-CVS deal raises questions for Aetna (Fierce)
  • New Global Head of Ophthalmology Research at Novartis sees the eye as a frontier of biomedical research (Novartis)

Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Once-a-month shot for opioid addiction works as well as daily medication, study finds (Stat)
  • AZ and MSD win FDA priority review for Lynparza in breast cancer (PMLive)
  • UniQure, chasing Spark-level FIX activity, tweaks hemophilia B gene therapy ahead of 2018 pivotal trial (Fierce) (Press)
  • Desperate Quest For Herpes Cure Launched ‘Rogue’ Trial (Kaiser Health News)
  • Padding its lung cancer lead, Merck's Keytruda helped PD-L1 patients live 30 months longer (Fierce) (PMLive)
  • Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation (NEJM)
  • Tofacitinib for Psoriatic Arthritis in Patients with an Inadequate Response to TNF Inhibitors (NEJM)
  • Corbus’ anabasum beats placebo in inflammatory phase 2 (Fierce)
  • German Scientists Resign from Elsevier Journals’ Editorial Boards (The Scientist)
  • Behold the power of magical thinking: How a tiny lung cancer study sent Spectrum’s stock soaring (Stat-$)

Medical Devices

  • Insulet, Dexcom partner to lure ex-Animas users (Mass Device)
  • Bracco Imaging acquires SurgVision (Mass Device)
  • UK design firm touts new device as “the Nespresso of auto-injectors” (Drug Delivery)
  • Medgadget Joins the Verily Baseline Project Study, Part 1: The First Visit (MedGadget)
  • Endurant II/Endurant IIs Stent Graft System - P100021/S063 (FDA)

US: Assorted & Government

  • Form 483 for Atlas Pharmaceuticals (FDA)
  • FDA Deserves Special Consideration at Budget-Time (Alliance for a Stronger FDA)
  • CMC Reviews of Type III DMFs for Packaging Materials (FDA MAPP)
  • FDA Search For CDER Deputy Emphasizes 'Executive Direction' (Pink Sheet-$)
  • URGENT – Voluntary Market Withdrawal – October 13, 2017: octagam [Immune Globulin Intravenous (human)] 10% Liquid Preparation] (FDA)

Upcoming Meetings & Events

General Health & Other Interesting Articles

  • NIH emails reveal divisions over renewal of gun research program (Science)
  • Removing a major CRISPR licensing roadblock in agriculture (Broad Institute)
  • State Attorneys General Ask Court For Injunction Reversing CSR Payment Halt (Health Affairs)
  • Bill and Melinda Gates on the fight against global inequality (Financial Times-$)

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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