Regulatory Recon: Bluebird Reports Promising Results From Small CAR-T StudyTop US Heart Docs Want Califf to Continue as FDA Commissioner (1 December 2016)

Posted 01 December 2016 | By Michael Mezher 

Regulatory Recon: Bluebird Reports Promising Results From Small CAR-T StudyTop US Heart Docs Want Califf to Continue as FDA Commissioner (1 December 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

In Focus: US

  • Top US heart doctors want Califf to remain FDA Commissioner (Reuters)
  • Bluebird, Celgene myeloma treatment impresses in tiny CAR-T study (Reuters) (BioCentury) (Press)
  • House Overwhelmingly Approves 21st Century 'Cures' Act (NYTimes) (Focus) (Reuters) (WSJ) (BioCentury) (Pink Sheet-$) (STAT) (Forbes)
  • The Current 21st Century Cures Legislation Is Still A Bad Deal For Patients (Health Affairs Blog)
  • Does A Trump Administration Equal Status Quo for Drug Pricing? Think Again (Forbes)
  • Getting Obamacare Replacement Through Senate Will Be a Test (WSJ)
  • Democrats See Medicare as Winning Wedge Issue (NYTimes)
  • Some drug makers are better corporate citizens than others (STAT)
  • Clinical Trials, Up and Very Much Down (In The Pipeline)
  • FDA Warns Specialty Pharma Company Over Adverse Event Reporting (Focus)
  • Juno deaths: Toxicity is therapy specific, not risk to whole CAR-T field, say experts (BioPharmaReporter)
  • Quest to find cure for Alzheimer's shows symptoms of failure (Financial Times)
  • 'Regulatory Risk': A New Factor In Risk/Benefit Equation At US FDA? (Pink Sheet-$)
  • Final FDA Rule Reworks Import Data Submissions (Focus) (FDA)
  • Deaths in Immune-Therapy Trials Haunt the Experimental Cancer Treatment (MIT Technology Review)
  • Human embryo experiment shows progress toward 'three-parent' babies (Washington Post) (Nature)
  • Hallucinogen Eases Depression in Cancer Patients, Studies Find (NYTimes)
  • Aradigm's inhaled antibiotic fails late-stage study, shares sink (Reuters) (Press)
  • Antivaccine Activists Reveal True Colors By Hitching Their Wagon To Trump (Forbes)
  • AbbVie's risankizumab bags Orphan status for paediatric Crohn's (PharmaTimes)

In Focus: International

  • French drugs agency suspends new Carmat artificial heart implants (Reuters 1, 2)
  • AstraZeneca in broad drug deal with Bicycle worth up to $1 billion (Reuters)
  • Japan considering annual drug price reviews (BioCentury)
  • Valeant's Discussions to Sell Salix to Takeda Have Broken Down (WSJ) (The Street)
  • NICE backs GSK's novel asthma biologic after price cut (PharmaTimes) (Reuters)
  • Delhi High Court Quashes Government Ban On Fixed Dose Combination Drugs (Bloomberg) (Economic Times)
  • Brazilian ANVISA Extends Deadline Again for New INMETRO Compliance Rules (Emergo)
  • Lupin partners Eli Lilly to market diabetes drug 'Eglucent' (Economic Times)
  • Young gay men at the frontline of AIDS prevention in China (Reuters)
  • New Zealand Adopts SmPC Format For Data Sheets Despite Industry Concerns (Pink Sheet-$)
  • Swiss/Brazilian collaboration for improving bioavailability via nanotechnology (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • 10 lessons for building a game-changing biotech company (STAT)
  • Thermo Fisher buys MTI-GlobalStem upping stem cell and reagent offering (BioPharmaReporter)
  • FDA Compliant Diclegis Instagram Promo by (Good) Emily Maynard Johnson Can't Compete with (Bad) Kim Kardashian's Violative Post (Pharma Marketing Blog) (MM&M)
  • FDA/Industry Dispute On Hypogonadism Drug Efficacy Endpoints To Get Panel Review (Pink Sheet-$)
  • Big Pharma and Biotech rankings on core metrics (PharmaLetter-$)
  • Role for smaller drugmakers in flu vaccines sector (PharmaLetter-$)
  • Report: medical affairs a 'constant presence' in Ph IV studies (OutsourcingPharma)
  • A Practical Roadmap for Transitioning State Licenses for Sales of Prescription Drugs and Devices in Corporate Transactions (Business Law Today)
  • IBM and Pfizer to Accelerate Immuno-oncology Research with Watson for Drug Discovery (IBM) (Forbes)
  • Snapshots of Life: Virus Hunting with Carbon Nanotubes (NIH)
  • New Contraindications, Warnings Added to Ritonavir Labeling (MPR)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • FDA Grants Priority Review to Supplemental Biologics License Application (sBLA) for Merck's KEYTRUDA® (pembrolizumab) in Relapsed or Refractory Classical Hodgkin Lymphoma (Press)
  • LYRICA® (pregabalin) Phase 3 Trial in Pediatric Epilepsy Meets Primary Endpoint (Press)
  • Arsanis Receives FDA Fast Track Designation for ASN100 for the Prevention of Staphylococcus aureus Pneumonia (Press)
  • Biostage Receives FDA Orphan Drug Designation for Cellspan™ Esophageal Implant (Press)
  • Agilis Biotherapeutics Announces Orphan Designation Approval in Europe for the Treatment of AADC Deficiency (Press)
  • Ignyta Announces Compelling Phase 1/1b Clinical Data on RXDX-105, Its VEGFR-Sparing RET Inhibitor, at the 2016 EORTC-NCI-AACR Annual Meeting (Press)
  • Global First IND for Subcutaneous Injectable anti-PD-L1 Domain Antibody Receives FDA Approval (Press)
  • Pharnext to Present Phase 2 Data From PXT864 at the 9th Clinical Trials on Alzheimer's Disease (CTAD) Conference in San Diego, United States (Press)
  • ACADIA Pharmaceuticals Initiates Phase II Trial of Pimavanserin for Adjunctive Treatment in Patients With Major Depressive Disorder (Press)

US: Medical Devices

  • What Medtech Is Saying About HHS, CMS Picks (MDDI)
  • Siemens US CEO Spiegel to step down, Marks & Davis step up (MassDevice)
  • FDA approves Cardiac Dimensions trial for Carillon mitral repair device (MassDevice)
  • Becton Dickinson to shutter Creedmoor, N.C. plant, lay off 120 (MassDevice)
  • Medtronic Recalls Neurovascular Products due to Potential Separation and Detachment of Polytetrafluoroethylene (PTFE) Coating (FDA)

US: Assorted & Government

  • Abortion-Rights Groups Challenge Restrictions In Three States (NPR) (Reuters)
  • A Trump Pick, and Why Indiana's Strict Medicaid Rules Could Spread (NYTimes)
  • Perfect Surgical Techniques, Inc. v. Olympus America, Inc. (Fed. Cir. 2016) (Patent Docs)
  • Buckle Up: The Jury Is Out in the Pinnacle Hip Implant MDL's Third Bellwether Trial (Drug and Device Law)
  • Intuitive Surgical, J&J's Ethicon bury the hatchet over sales rep's non-compete (MassDevice)
  • SEC Discloses Correspondence Over Valeant's Accounting Practices (The Street)

Upcoming Meetings & Events


  • ExactVu Micro-Ultrasound System for Prostate Imaging and Biopsy Guidance Cleared in Europe (MedGadget)
  • Abbott wins CE Mark for i-Stat handheld blood tester (MassDevice)


  • Sun Pharma in race for UK buyout in hospital-initiated & emergency care segment (Economic Times)
  • Bombay Court Won't Send Contract Row To Arbitration (Law360-$)


Other International

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

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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