Regulatory Focus™ > News Articles > Regulatory Recon: Gilead to Buy Kite for CAR-T Pipeline in $12B Deal (28 August 2017)

Regulatory Recon: Gilead to Buy Kite for CAR-T Pipeline in $12B Deal (28 August 2017)

Posted 28 August 2017 | By Michael Mezher 

Regulatory Recon: Gilead to Buy Kite for CAR-T Pipeline in $12B Deal (28 August 2017)

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

In Focus: US

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In Focus: International

  • ​AstraZeneca to make multimillion-pound investment in UK site (The Guardian) (Financial Times)
  • Brazil May Face a New Threat, This Time From Biting Midges (NYTimes)
  • Danger of getting hooked on public cash transfusions (Financial Times)
  • EMA Increased GCP Inspections in 2016 (FDA News-$)
  • Colombian Crack Down On Compulsory Licensing Under Attack (Pink Sheet-$)
  • Why Sanofi's dengue fever vaccine fell short of expectations (MM&M)
  • Aveo takes a big step forward as comeback plan delivers EU OK for tivozanib (Endpoints)

Pharmaceuticals & Biotechnology

  • Spark Therapeutics' Vision Loss Gene Therapy Gets FDA Panel Review (Pink Sheet-$) (FDA)
  • ESC 2017 – Biotronik builds an impressive Castle (EP Vantage)
  • With Opioid Crisis, a Surge in Hepatitis C (Pew)
  • A Serious Reaction After Vaccination Rarely Occurs Again With Later Immunization (Forbes)
  • Trial And Trial: Bracing For Commercialization Of Cell & Gene Therapies (SCRIP-$)
  • CSL snags a preclinical stem cell therapy in $416M Calimmune buyout, plans to spin out HIV effort (Endpoints)
  • Ecstasy could be 'breakthrough' therapy for soldiers, others suffering from PTSD (Washington Post)
  • Viking leads a $46M raise for a struggling aTyr Pharma (Endpoints)
  • Regenxbio to buy battered Dimension for gene therapies (Fierce)
  • CHO platforms unsustainable for biopharma's future, says Dyadic (BioPharmaReporter)
  • Minecraft-based Pfizer app uses gamification to help kids with hemophilia (MobiHealthNews)
  • Bone, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting (FDA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • FDA Grants Priority Review for Genentech's Gazyva in Previously Untreated Follicular Lymphoma (Press)
  • Kedrion Biopharma and Kamada Receive FDA Approval of KEDRAB™ for Post-Exposure Prophylaxis Against Rabies Infection (Press)
  • FASLODEX® (fulvestrant) Receives US FDA Approval as Monotherapy for Expanded Use in HR+, HER2- Advanced Breast Cancer (Press)
  • Pradaxa® (dabigatran etexilate) dual therapy showed lower rates of major bleeding versus triple therapy with warfarin in atrial fibrillation patients undergoing stent placement (Press)
  • Bristol-Myers Squibb and Pfizer Present Observational Real-World Data Analysis on the Effectiveness and Safety of Eliquis® (apixaban) Compared to Warfarin in Select High-Risk Patients with Non-Valvular Atrial Fibrillation (Press)
  • Bristol-Myers Squibb and Pfizer Present Investigational Eliquis® (apixaban) Data for Patients with Non-Valvular Atrial Fibrillation (NVAF) Undergoing Cardioversion (Press)
  • New, One-Year Data from ORION-1 Phase II Study of Inclisiran Extends Excellent Long-Term Efficacy and Safety Profile, Affirming Dose for Phase III Trials (Press)
  • Biogen Reports New Data from Phase 1b Study of Investigational Alzheimer's Disease Treatment Aducanumab (Press)
  • Second Sight Receives Conditional FDA Approval to Begin First Orion Human Clinical Study (Press)
  • La Jolla Pharmaceutical Company Announces U.S. FDA Acceptance of New Drug Application for LJPC-501 (Press)

Medical Devices

  • FDA Reports on FY2016 Pediatric Device Approvals (Focus)
  • Medtronic readies pivotal trial in renal denervation (MassDevice) (Press)
  • C. R. Bard Receives FDA Premarket Approval of the LUTONIX® 035 Drug Coated Balloon as the First and Only DCB for the Treatment of Patients with Dysfunctional AV Fistulae (Press)
  • Tandem Diabetes wins FDA nod for insulin pump with Dexcom's CGM (Drug Delivery)
  • Abbott wins FDA nod for HeartMate 3 pump (MassDevice)

US: Assorted & Government

  • Trump's Threats on Health Law Hide an Upside: Gains Made by Some Insurers (NYTimes)
  • Foreign Discovery Mostly Denied In Zofran Birth Defect MDL (Law360-$)
  • Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. (D. Mass. 2017) (Patent Docs)

Upcoming Meetings & Events

Europe

  • EU Gives First Approval for Ultra-High-Field MRI Scanner, The Siemens Magnetom Terra (MedGadget)
  • Lonza expands Swiss drug product site, adds 50 jobs (BioPharmaReporter)

India

  • Meeting on draft pharma policy called in New Delhi on Aug 30 with stakeholder (PharmaBiz)
  • Maha FDA cancels 58 mfg licenses, suspends 145 licenses for non-compliance (PharmaBiz)
  • Maha FDA to have an NPPA cell to detect ceiling price violation soon (PharmaBiz)
  • Maha FDA detects 393 NSQ drugs based on annual sampling survey in state (PharmaBiz)
  • DCGI asks cos to submit stability data of non-patent & proprietary drugs with application for mfg license (PharmaBiz)
  • Drug store management in hospitals should be done by pharmacists to counter growing medication errors incidents: expert (PharmaBiz)

Australia

  • Designation notices (TGA)

General Health & Other Interesting Articles

  • 'Nanotransfection' Turns Animal Skin into Blood Vessels and Brain Cells (MDDI)
  • Science Is Showing How Gut Bacteria Affect The Brain, But Don't Bother Taking Probiotics Yet (Forbes)

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.


Categories: Recon, Regulatory News

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