Regulatory Focus™ > News Articles > Regulatory Recon: 'Cures' Act Set for Wednesday Vote; J&J Looks to Acquire Actelion (28 November 201

Regulatory Recon: 'Cures' Act Set for Wednesday Vote J&J Looks to Acquire Actelion (28 November 2016)

Posted 28 November 2016 | By Michael Mezher 

Regulatory Recon: 'Cures' Act Set for Wednesday Vote J&J Looks to Acquire Actelion (28 November 2016)

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

In Focus: US

  • Regulatory Explainer: 21st Century Cures Redux and What it Will Mean for FDA (Focus)
  • 'Cures' Act Set for Wednesday Vote (E&C) (Harvard Bill of Health) (STAT) (Politico)
  • Legislation That Would Shape FDA And NIH Triggers Lobbying Frenzy (NPR)
  • The G.O.P. and Health Care Chaos (NYTimes)
  • Edwards Lifesciences to acquire Valtech Cardio in $690m deal (MassDevice)
  • Drugmakers Find Competition Doesn't Keep a Lid on Prices (WSJ)
  • Patients Increasingly Influence The Direction Of Medical Research (NPR)
  • FDA Revises Quality Metrics Guidance, Says Program Will Be Voluntary Until 2018 (Focus)
  • Johnson & Johnson Approaches Actelion About Potential Deal (WSJ) (Pharmafile) (NYTimes) (Financial Times)
  • Why J&J shouldn't buy Actelion (EP Vantage)

In Focus: International

  • Celltrion sets sights on 2017 for EU and US rituximab biosimilar success (BioPharmaReporter)
  • Janssen drops price of Imbruvica to secure NICE nod (PharmaTimes) (Reuters)
  • EU filing for GSK's shingles jab (PharmaTimes)
  • Clinical data for two more medicines now available online (EMA)
  • Japan joins international collaboration on GMP inspections (EMA) (PharmaLetter-$)
  • Janssen brings psoriasis therapy guselkumab to the EMA (PharmaTimes)
  • Opdivo first PD-1 inhibitor given European approval for haematological cancer (Pharmafile)
  • Insider interview: Roche discusses efficacy of CDF and NICE (Pharmafile)
  • Sanofi to launch 20+ new drugs in Japan by 2020 (PharmaLetter-$)
  • AbbVie's Humira Tops NHS Drug Spend List (SCRIP-$)
  • EMA's PRIME to Speed Sage's Plans For Postpartum Depression (Pink Sheet-$)
  • Takeda gains marketing authorisation for multiple myeloma pill (Pharmafile) (PharmaLetter-$)
  • European anti-trust regulators grant conditional approval for Abbott's $25B St. Jude Medical buy (MassDevice)
  • Aurobindo arm to acquire select products in France from Teva  (Economic Times)
  • Teva Pharm to market medical cannabis inhaler in Israel (Reuters)
  • French cancer specialist Innate Pharma can remain independent, for now: CEO (Reuters)
  • Pfizer scraps €400m Dublin facility expansion (Pharmafile)
  • IQWiG finds considerable added benefit for Keytruda in lung cancer (PharmaLetter-$)
  • IQWiG early assessment lukewarm on Servier's Lonsurf (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • Shingles vaccination not at goal levels for U.S. seniors (Reuters)
  • Genome-wide association studies of drug response and toxicity: an opportunity for genome medicine (Nature)
  • The case for prioritising Alzheimer's research (Financial Times)
  • Mixed late-stage data for Santen eye drug, but still plots FDA submission (Fierce)
  • Cannabinoid Market Snapshot: GW's Epilepsy Success Bodes Well (SCRIP-$)
  • States in the Mix: GAO Releases Report to Congressional Committees on Drug Compounding (FDA Law Blog)
  • Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications (FDA)
  • US FDA says Srikem plan will not fix data integrity issues at Taloja plant (InPharmaTechnologist)
  • FDA And The Transition: Reading The LDT Leaves (Pink Sheet-$)
  • Final FDA Quality Agreements Guidance Retains Focus On Commercial Manufacturing (Pink Sheet-$) (FDA Law Blog) (InPharmaTechnologist) (Focus)
  • Both small and large CMOs to benefit from pharma capacity and agility demands (InPharmaTechnologist)
  • 'No clinically meaningful impact' of switching from Enbrel to Sandoz biosimilar, study says (PharmaLetter-$)
  • Pharma most counterfeited category online, says report (Securing Industry)
  • Harvoni Approval Led To Narrowing Of Epclusa's Breakthrough Status (Pink Sheet-$)
  • Gilead's Epclusa: FDA Sought To Push Efficacy Bar Higher In Hepatitis C (Pink Sheet-$)
  • Bioequivalence Recommendations for Cyclobenzaprine Hydrochloride; Revised Draft Guidance for Industry; Availability (FDA)

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

  • FDA Grants Priority Review to Merck's Supplemental Biologics License Application (sBLA) Seeking Approval for KEYTRUDA® (pembrolizumab) for New Indication in Microsatellite Instability-High Cancer (Press)
  • GSK kicks off Phase III programme for daprodustat (PharmaTimes)
  • Medivir announces that Janssen has initiated an open-label phase IIb study of the 3DAA combination of simeprevir, odalasvir and AL-335 (JNJ-4178) (Press)
  •  Nature Cell Co., Ltd. Receives U.S. FDA Approval for Phase I and II Alzheimer's Clinical Trial (Press)
  • PhaseRx Receives Orphan Drug Designation from FDA for PRX-OTC for the Treatment of Ornithine Transcarbamylase Deficiency (Press)
  • OncoPep Announces Initiation of Phase 1b Clinical Trial of PVX-410 in Triple Negative Breast Cancer (Press)
  • Aimmune Therapeutics Completes Global Enrollment of Phase 3 PALISADE Trial of AR101 for the Treatment of Peanut Allergy (Press)

US: Medical Devices

  • DILON Diagnostics and GE Healthcare announce the FDA clearance of the Discovery NM 750b biopsy accessory (Press)

US: Assorted & Government

  • A Battle to Change Medicare Is Brewing, Whether Trump Wants It or Not (NYTimes)
  • Many in Florida Count on Obama's Health Law, Even Amid Talk of Its Demise (NYTimes)
  • Pence Expanded Health Coverage As Governor, Now Threatens To Take It Away (KHN)
  • Why Trump's Block Grants For Medicaid Face Opposition (Forbes)
  • A Reminder To Be Careful With Ex-Employees And Confidential Information (Drug and Device Law)

Upcoming Meetings & Events


  • Novo Nordisk: shot in the dark (Financial Times)
  • Medicines and Healthcare products Regulatory Agency board member expenses from April to June 2016 (MHRA)
  • Belgian probe into 'anti-competitive' pharma companies (PharmaLetter-$)
  • Russian government sets out new restrictions for foreign drugmakers in state tenders (PharmaLetter-$)


  • Baxter Divests Serum Business In Turkey Business Rejig (SCRIP-$)
  • AHWP Releases Host of Proposed Documents for Endorsement (AHWP)


  • Attractive growth opportunities for Indian Pharma through M&As: Moody's (Economic Times) (PharmaLetter-$)
  • Some drugs, banned in other countries, allowed in India: Government (Economic Times)
  • Strides Shasun to acquire Moberg Pharma's PediaCare for $5 million (Economic Times)

    Other International

    • Opening remarks at the Emergency medical teams global meeting (WHO)

    General Health & Other Interesting Articles

    • As the Aedes aegypti mosquito spreads globally, so does the risk of epidemics (Washington Post)
    • Experts call for fair vaccine pricing, not 'random acts of charity' (MNT)
    • Flossing and the Art of Scientific Investigation (NYTimes)

    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.

    Categories: Recon, Regulatory News

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