Regulatory Recon: FDA May Launch New Inspection Protocols in 2017 NHS Scotland Backs Five New Drugs (11 October 2016)

Posted 11 October 2016 | By Michael Mezher 

Regulatory Recon: FDA May Launch New Inspection Protocols in 2017 NHS Scotland Backs Five New Drugs (11 October 2016)

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

In Focus: US

  • FDA's Rollout of New Inspection Protocols May Begin Next Year (Pink Sheet-$)
  • Innovation–Innovation Tradeoffs in Drug Pricing (Annals of Internal Medicine)
  • In Trump's America, towns in poor health don't think he will save them (STAT)
  • Investors flee as firm scraps RNA-interference drug candidate (Nature)
  • One Mom Is So Mad About Vertex's Pricey CF Drugs She's Taking On The CEO (Forbes)
  • This federal drug discount program is actually boosting cancer care costs (STAT)
  • St. Jude warns of heart-device battery issue linked to two deaths (Reuters) (FDA)
  • FDA Completes 20 Meetings on Patient Involvement in Drug Development (PharmTech)
  • Women aren't equal in biopharma. Here's what 4 female leaders would do to fix that (Fierce)
  • Some blood pressure drugs tied to risk of mood disorder hospital stays (Reuters)
  • Hedge Fund Lawsuit Alleges Theranos 'Knowingly And Repeatedly Lied ' (Forbes) (WSJ) (Reuters)
  • Astellas takes to court over patent infringement of Myrbetriq in USA (PharmaLetter-$)
  • Breast cancer chemo costs vary despite similar effectiveness (Reuters)
  • Bristol-Myers shares tumble 10% on failed clinical trial (Financial Times) (Bloomberg)
  • Copay assistance is the problem, not the solution to high drug prices, policy experts say (MNT) (Annals of Internal Medicine)
  • Is genetic testing the new paradigm in treating addiction? (MedCityNews)

In Focus: International

  • Australian biotech sector crafts response to R&D Tax Incentive Review (PharmaLetter-$)
  • Companies respond to EMA's efforts to release clinical trial data (Outsourcing Pharma)
  • GSK attempts to remake itself in China with local ties (Endpoints)
  • Five medicines approved for use by NHS Scotland (PharmaTimes)
  • Outcome of the EMA survey on centralised postauthorisation procedures 2015 (EMA)
  • Medivir reorganizes to focuses exclusively on oncology (PharmaLetter-$)
  • NZ to fund use of GlaxoSmithKline's HIV drugs Kivexa and Tivicay (PharmaLetter-$)
  • French Campaign To Boost Generics Gets Thumbs Up From European Industry Body (Pink Sheet-$)
  • Asia Regulatory Roundup: India Looks to Meet WHO Standards for GMPs (Focus)
  • EMA Board Signs Off On New Medicines Web Portal (Focus)
  • WHO Seeks API Manufacturers For Prequalification Program (Focus)
  • French Regulators Raise Serious Concerns With Indian API Manufacturer (Focus)
  • UAE's pharmaceutical market projected to grow from $3 billion to $5.7 billion by 2020 (Pharmafile)
  • China Resources Pharma seeks up to $2 billion in Hong Kong IPO – IFR (Reuters)
  • NICE backs Celgene's Otezla for psoriatic arthritis (PharmaTImes)

US: Pharmaceuticals & Biotechnology

  • Antibiotic history of a hospital bed may increase a patient's risk of infection (Reuters)
  • What Was Old is New Again (Lachman Consultants)
  • Single-Cell Analysis Provides Tool for Choosing More Effective Cancer Drugs (GEN)
  • Why ICER policy changes likely won't satisfy patients or drug companies (BioCentury)
  • How Maryland's biotech cluster compares to other regions around the country (Washington Business Journal)
  • BMS' Opdivo continues to impress at ESMO (PharmaTimes)
  • AbbVie re-ramps Humira TV spending to run away with September's No. 1 spot (Fierce)
  • Why guselkumab's use may be limited despite beating Humira in psoriasis Phase III (BioCentury)
  • Cancer in Retreat on One Front: Fewer Children Are Dying (NYTimes)
  • Alnylam Says Trial of Patisiran Can Continue Following Revusiran Halt (WSJ)
  • Novartis sponsors Queen Latifah's mom-inspired heart failure awareness push (Fierce)
  • Sanofi-Verily diabetes partnership is just the latest in the Internet of Medical Things trend (Fierce)

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

  • Hansa Medical: First patient treated with IdeS in Phase II study in acquired Thrombotic Thrombocytopenic Purpura (TTP) (Press)
  • Gamida Cell Receives FDA Breakthrough Therapy Designation For NiCord® (Press)
  • FDA Grants Priority Review to Genentech's Lucentis® (Ranibizumab Injection) Supplemental Biologics License Application for Myopic Choroidal Neovascularization (Press) (Reuters)
  • Neurocrine Announces INGREZZA™ (valbenazine) New Drug Application for the Treatment of Tardive Dyskinesia has been Accepted for Priority Review by U.S. FDA (Press)
  • FDA Accepts Supplemental New Drug Application (sNDA) for AVYCAZ® (ceftazidime and avibactam) (Press)

US: Medical Devices

  • Clinical Diagnostics: Moving Beyond Diagnostics to Prognostics and Then Predictive (MDDI)
  • Considerations for Sterilization and Biocompatibility of 3-D Printed Orthopedic Devices (MDDI)
  • Does a Higher Degree Help a Medtech Career? (MDDI)
  • Spineology Interbody Devices Now FDA Approved with Allograft Bone (Press)

US: Assorted & Government

  • Law Firm Cannot Challenge FDA Denial of Risperdal Petition, Court Rules (FDANews-$)
  • Medicare Monday: Open enrollment starts this weekend (PhRMA)
  • Court Rejects Prosecution of Pharmacists Due to Lack of Fair Notice in FDC Act (FDA Law Blog)

Upcoming Meetings & Events


  • EU options for improving access to medicines (PharmaLetter-$)
  • PRIME Eligibility Requests – 2017 Deadlines (EMA)
  • UK's Kymab signs bispecific antibodies deal with China's EpimAb (PharmaTimes)
  • Nordic Nanovector and LegoChem Biosciences enter into collaboration (Pharmafile)
  • EMA Looks to Procure eBook Platform (EMA)
  • Scotland speeds ahead to deliver breakthrough immunotherapy to lung cancer patients (EPR)
  • Sanofi announced the appointment of Alan Main as Executive Vice President Consumer Healthcare effective October 1. (Pharmafile)
  • After one late-stage flop, Auris Medical re-jigs new PhIII for Keyzilen (Fierce)
  • New UK & Ireland general manager for Teva (Pharmafile)


  • Daiichi Sankyo Phase 1 HER2-targeting antibody drug safe and effective to treat breast cancer (EPR)


  • R&D spend by 25 Indian pharma cos jumps by 24% in 2015-16, Sun remains top (Pharmabiz)
  • Gujarat FDCA reports 479 DPCO violation cases to NPPA this year (PharmaBiz)


  • Consultation: paracetamol and ibuprofen: advisory statements for medicines (TGA)
  • Non-steroidal anti-inflammatory drugs (NSAIDs) review (TGA)
  • Safety review: Nonsteroidal anti-inflammatory drugs (NSAIDs) and spontaneous abortion (TGA)
  • ACSOM meeting statement, Meeting 30, 20 November 2015 (TGA)
  • TGA presentation: RMIT, Biomedical Engineering, 16 August 2016 (TGA)


  • Zika Virus Cases Soar in Asia, WHO Says (NBC)

Other International

  • Niger Rift Valley Fever outbreak could spread across borders: health experts (Reuters)
  • Nine ways funding for the global HIV response could go further (The Guardian)
  • WHO urges global action to curtail consumption and health impacts of sugary drinks (WHO)

General Health & Other Interesting Articles

  • For the very ill, legally ending life is increasingly costly (Reuters)

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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