Regulatory Recon: Kite Looks to File CAR-T Application FDA Approves J&J's Stelara for Crohn's (27 September 2016)

Posted 27 September 2016 | By Michael Mezher 

Regulatory Recon: Kite Looks to File CAR-T Application FDA Approves J&J's Stelara for Crohn's (27 September 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter

In Focus: US

  • Mylan faces scrutiny over EpiPen profit data shown to Congress (Reuters) (WSJ)
  • Kite's groundbreaking CAR-T hits key study goal, heads to the FDA (Endpoints) (Fierce) (Press) (Xconomy) (Reuters)
  • A Drug Cartel at the FDA (WSJ)
  • BioCentury Digs Into FDA's Approval of Exondys 51 (BioCentury)
  • From CARTs To Checkpoints, Here's What's Coming In Immuno-Oncology (Forbes)
  • Senate Votes to Extend Pediatric Voucher Program and Expand Eligibility (FDA Law Blog) (Focus)
  • FDA Extends Wait for Biosimilar Interchangeability Guidance (Bloomberg) (Focus)
  • Bristol-Myers to test Opdivo with Nektar drug for several cancers (Reuters) (Fierce) (Press)
  • FDA approves J&J's autoimmune drug Stelara for Crohn's disease (Reuters) (Press) (MedPage) (PharmaTimes)
  • Big Pharma's Big Debate Win (Pink Sheet-$)
  • Biogen closes in on bringing muscular atrophy preventing drug to market (Pharmafile) (BioCentury)
  • GDUFA II: FDA Looks to Speed Up Generic Drug Approval Process (Focus)
  • Biomarkers Used as Outcomes: FDA Wants to Hear More on Examples (Focus)
  • St. Jude seeks shareholder approval for Abbott merger (MassDevice)
  • Amgen's Krypolis fails newly diagnosed multiple myeloma study (Reuters) (Fierce)  (The Street)
  • Medication Assisted Treatment for Opioid Use Disorders Reporting Requirements (HHS)
  • Sanofi gets $43 million U.S. funding to spur Zika vaccine development (Reuters)
  • FDA issues clinical hold on CEL-SCI's head and neck cancer study with Multikine (PharmaLetter-$) (Press)
  • Pain Therapeutics tanks as FDA issues another CRL for Remoxy ER (PharmaLetter-$) (The Street) (BioCentury)

In Focus: International

  • Twenty Years of Global Surveillance of Antituberculosis-Drug Resistance (NEJM)
  • Samsung Bioepis Seeks Regulatory Approval For An Adalimumab Biosimilar In EU And South Korea (Big Molecule Watch)
  • Child TB deaths set to fall as Kenya launches new drugs (Reuters)
  • EMA and FDA Set Up New Working Group on Rare Diseases (Focus)
  • Review of International Regulation of Social Media Promotions at the 2016 RAPS Conference (National Law Review)
  • China Fast Tracks Merck's Cancer Drug For Approval, But There's A Catch (Forbes)
  • CDSCO Advances Draft Medical Device Rules, Outlines Fees (Focus)
  • New measures aim to make Australia more attractive for R&D and trials (PharmaLetter-$)
  • Interview: German Merck Set For Big "Leap" In India (SCRIP-$)
  • New agreement on drug pricing to allow state funding of new medicines in Ireland (PharmaLetter-$)
  • Sun Pharma founder Dilip Shanghvi heads this year's list of Asian pharma billionaires (Fierce)
  • 500+ Sun Pharma Reps on Strike in India (PharmaceuticalManufacturing)
  • NICE clears Gilead's pan-genotypic hep C drug Epclusa (PharmaTimes)

US: Pharmaceuticals & Biotechnology

  • Adaptimmune, MD Anderson do I/O deal in T-cell receptors (Fierce)
  • Pfizer Remains Whole, but the Option to Split Could Return (NYTimes)
  • Novartis hopes speedy new diagnostic gadget can help boost Xolair scripts (Fierce)
  • Cancer patients may be overly optimistic about early drug trial participation (Reuters)
  • PhRMA Rips Feds For 'Regulation By Litigation' On Kickbacks (Law360-$)
  • Bio Report on Intellectual Property in India (BIO)
  • Data sharing through an NIH central database repository: a cross-sectional survey of BioLINCC users (BMJ)
  • Interview – Geneuro tries a different take on multiple sclerosis (EP Vantage)
  • Dismal Arithmetic of Hepatitis C Treatment? (Healthcare Economist)
  • BD to invest $100 million in Nebraska to expand insulin syringe manufacturing (Manufacturing Chemist Pharma)
  • 4 recommendations for ICER (PhRMA)
  • Packaging and serialization tech companies enter into global agreement (Outsourcing Pharma)
  • Clovis short sellers undaunted as stock price surges (Reuters)
  • Effectiveness of Fluticasone Furoate–Vilanterol for COPD in Clinical Practice (NEJM)
  • Parexel to acquire functional service provider ExecuPharm (Outsourcing Pharma)

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

  • Array plays catch-up in Braf-Mek derby (EP Vantage)
  • Amgen And UCB Announce FDA Acceptance Of Biologics License Application For Romosozumab (Press) (BioCentury)
  • Aerpio Therapeutics Initiates Phase 1a Study of AKB-4924, a First in Class Once-Daily, Orally Administered HIF-1 Stabilizer, in Development to Treat Inflammatory Bowel Disease (IBD) (Press)
  • Sage Reports Additional Positive Data on Secondary Endpoints from Phase 2 Clinical Trial of SAGE-547 in Severe Postpartum Depression at the Marcé Society for Perinatal Mental Health Biennial Scientific Meeting (Press)
  • Clinical Data Support Mechanism of Action and Patient Selection Biomarker for Imprime PGG, Biothera Pharmaceutical's Phase 2 Cancer Immunotherapy (Press)
  • X4 Pharmaceuticals Announces Initiation of Phase 1b Study of X4P-001 in Patients with Resectable Stage III and Stage IV Melanoma (Press)
  • Abeona enrols first Phase 2 patient following successful Phase 1 Epidermolysis trial (EPR)
  • Intepirdine Gets Fast Track Status for Lewy Body Dementia (MRP)

US: Medical Devices

  • Hill-Rom picks up Tridien Medical, inks $1.5B term loan, reportedly deals WatchChild (MassDevice)
  • FDA Engages Lab, Dx Players by Proposing NGS Regulatory Standards Come From Community (GenomeWeb)
  • Allergan wins FDA nod for Natrelle Inspira breast implants (MassDevice)
  • PerkinElmer looks to spin out diagnostics biz (MassDevice)
  • Accuray touts 5-year CyberKnife data in prostate cancer trial (MassDevice)
  • Medtronic's StealthStation® Cranial Software Receives FDA Clearance as an Aid for Deep Brain Stimulation Lead Placement (Press)
  • BrainScope wins FDA nod for Ahead 300 TBI scanner (MassDevice)
  • FDA OKs Regentis Biomaterials trial for GelrinC knee cartilage treatment (MassDevice)
  • FDA clears Medtronic's StealthStation DBS lead placement software (MassDevice)
  • Regentis Receives IDE Approval for Pivotal GelrinC Clinical Trial (Press)
  • Roche receives 510(k) clearance from FDA for Treponema pallidum assay to aid clinicians in the diagnosis of syphilis infection (Press)
  • Gore wins Medicare add-on status for Excluder stent graft (MassDevice)

US: Assorted & Government

  • Consumer Fraud Allegations For A Prescription Medical Device Do Not Pass The Test (Drug and Device Law)
  • Hearing: Bioresearch Labs and Inactivation of Dangerous Pathogens (E&C) (GAO Report)
  • Klobuchar: Drug Pricing Ripe For Presidential Debate Because A Top Issue For Constituents (InsideHealthPolicy)
  • CAP proposes plan to set drug prices (BioCentury)
  • Klobuchar: Administration Could Allow Rx Imports Without Congress (InsideHealthPolicy)
  • Fitzpatrick Presses For E&C Hearings On FDA's Ability To Monitor Devices (InsideHealthPolicy)
  • Use Of Hep C Rx Down 40 Percent Among Medicaid Beneficiaries In 2015 (InsideHealthPolicy)
  • Use of the Term "Healthy" in the Labeling of Human Food Products: Guidance for Industry (FDA)
  • Clinton, Trump Share Big-Pharma Attack Goals, Andrew Left Says (The Street)
  • Amgen Sues Actavis, Indian Cos. Over Sensipar Generics (Law360-$)
  • You Don't Need A Data Breach To Face Regulatory Scrutiny (Law360-$)

Upcoming Meetings & Events


  • Worldwide Clinical Trials opens new facility in Poland (Outsourcing Pharma)
  • Freshers warned to be smart and avoid Modafinil (MHRA)
  • NovaBone Products Secures Approval of CE Mark for Collagen Devices (Press)


    • Rs 2,288 cr savings for consumers after NLEM 2015: Government (Economic Times)


    • LFIT Anatomic CoCr V40 femoral heads (used in hip replacements) (TGA)
    • Recall: Metagenics NasoClear (TGA)
    • Breast implants: Update on TGA monitoring of anaplastic large cell lymphoma (TGA)


    • CDC adds St. Kitts and Nevis to interim travel guidance related to Zika virus (CDC)
    • Thailand investigates four cases of suspected Zika-linked microcephaly (Reuters)

    General Health & Other Interesting Articles

    • NIH study links morning sickness to lower risk of pregnancy loss (NIH)

    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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