Regulatory Recon: Third Time's the Charm for Alkermes' Depression Drug Gilead Sees Promise for NASH Candidate, New HCV Combo (21 October 2016)

Posted 21 October 2016 | By Michael Mezher 

Regulatory Recon: Third Time's the Charm for Alkermes' Depression Drug Gilead Sees Promise for NASH Candidate, New HCV Combo (21 October 2016)

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

In Focus: US

  • Agony, Alarm and Anger for People Hurt by Theranos's Botched Blood Tests (WSJ)
  • Epigenetic drug discovery: breaking through the immune barrier (Nature)
  • California Man Dies After Apparent Failure Of Artificial Heart Compressor (KHN)
  • The Limits of Big Data (In The Pipeline)
  • Reckitt Benckiser sued by 35 US states for 'profiteering' from opioid treatment (The Guardian)
  • Alkermes depression drug succeeds in key trial; shares surge (Reuters) (The Street) (Forbes) (Press)
  • Political Appointees Shouldn't Influence Approval Decisions, Califf Says (Pink Sheet-$)
  • Accelerated Approval Should Be Less 'Wide Open,' Califf Says (Pink Sheet-$)
  • Biomarin comes up short with vosoritide (EP Vantage)
  • SetPoint leads the Crohn's medtech race by being the only entrant (EP Vantage)
  • ICER Atopic Dermatitis Review Prompted By First Biologic (SCRIP-$)
  • Drug companies funnel $108 million to defeat California drug price ballot question (Modern Healthcare)
  • BsUFA II: What's Coming For Biosimilar Sponsors From FY 2018 Through FY 2022 (Focus)
  • Biosimilar Guidance Development Timelines Criticized By Docs And Patients (Pink Sheet-$)
  • Sanders And Cummings Question $80,000 Price Hike Of Ariad Cancer Drug (Focus) (Reuters)
  • Eliquis Nipping At The Heels of NOAC Market Leader Xarelto (CardioBrief)
  • Gilead unveils promising hep C, fatty liver data; setbacks elsewhere (Reuters) (The Street) (BioCentury) (Press) (Fierce)
  • Gilead reports data for latest HCV combo (BioCentury) (Press)
  • GSK, Teva Urge High Court To Review Pay-For-Delay Accords (Law360-$)
  • Stop "Gene Spills" Before They Happen (MIT Technology Review)
  • Creative Minds: Building the RNA Toolbox (NIH)

In Focus: International

  • EMA Transparency: New Clinical Reports Go Live (Focus)
  • Roche bid for Avastin follow-on suffers blow with trial failure (Reuters)
  • Regulatory watch: Innovative drug availability in China (Nature)
  • China Resources Pharma Said to Raise $1.8 Billion From IPO (Bloomberg)
  • Roche says new drug launches will offset ageing blockbusters (Financial Times)
  • Merck's Keytruda succeeds in key bladder cancer trial (Reuters) (Press)
  • ICH Sets Three-Year Goal To Harmonize Criteria For Biowaivers (Pink Sheet-$)
  • In a change of heart, NICE recommends Opdivo for advanced renal cell cancer (PharmaLetter-$) (SCRIP-$)
  • European Regulatory Roundup: Italy Fines Aspen $5.7M For Increasing Cancer Drug Prices By 1,500% (Focus)
  • Anti-inflammatory pills tied to heart failure risk (Reuters)

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US: Pharmaceuticals & Biotechnology

  • Glucose tablets likely better for easing low blood sugar symptoms (Reuters)
  • Precision Medicine and the FDA (Cato)
  • Prosecuted For Truthful Off-Label Promotion: Part 2 (Law360-$)
  • KEI Comments on NIH Proposed Exclusive License to Kite Pharma for Cancer Treatment (KEI)
  • Bio-synonyms: describing biosimilars without saying 'copycats' or 'knock-offs' (BioPharmaReporter)
  • Off-Label Compendia Weaknesses Illustrated By Tarceva Evidence Gaps (Pink Sheet-$)
  • Fred Hutch Team Wants To Move Clean-Room Gene Therapy To Tabletop (Xconomy)
  • Cloud-Centered IT Transformation At AstraZeneca (Forbes)
  • Hats Off to Regulatory (Lilly)

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

  • Theravance COPD therapy clears pair of Phase III hurdles (BioCentury)
  • CEL-SCI Provides Update on Partial Clinical Hold on Phase 3 Clinical Trial (Press)
  • Teva Announces FDA Acceptance of Resubmitted New Drug Application for SD-809 for Treatment of Chorea Associated with Huntington Disease (Press)
  • Tobira Therapeutics Announces Late-Breaking Oral Presentation of CENTAUR Phase 2b Trial Results at the American Academy for the Study of Liver Diseases Annual Meeting (Press)
  • Omeros Announces Positive Data from OMS721 Phase 2 Trial in Patients with Stem Cell Transplant-Associated Thrombotic Microangiopathy (Press)
  • US FDA Considers Newron's Re-Submitted NDA for Xadago to be a Complete, Class 2 Response to Complete Response Letter (Press)
  • Sanifit launches Phase II calciphylaxis study (EPR)

US: Medical Devices

  • 2016 Medtech Company of the Year Finalists (MDDI)
  • What is the STED Format for Medical Device Technical Documentation? (Emergo)
  • 2016 Meeting Materials of the Technical Electronic Product Radiation Safety Standards Committee (FDA)
  • TeleFlex Medical Recalls Tracheostomy Tube Set Due to Possible Disconnection During Patient Use (FDA)
  • Radiation Therapy Devices by Multidata Systems International: Discontinue Use – Concerns about Risks to Patients (FDA 1, 2)
  • Class 1 Device Recall TwinPass Dual Access Catheter (FDA 1, 2, 3)
  • Stryker recalls Boston Scientific Guider guide cath (MassDevice)
  • Akesys, Elixir Medical tout 1st implant for Prava bioresorbable peripheral stent (MassDevice)
  • FDA adds diagnostic indication for Avinger's Pantheris atherectomy device (MassDevice)
  • Medicrea Announces 2 FDA Clearances of New Specialized Components for Pediatric Deformity on PASS® and LigaPASS® Platforms for Complex Spine in Younger Patients (Press)

US: Assorted & Government

  • Lame Duck Congress Likely to Mull Health Bills (Medpage)
  • Medtech CEO rails against DOJ at industry conference (MedCityNews)
  • Warning Causation Potpourri in New Jersey Mass Tort (Drug and Device Law)

Upcoming Meetings & Events


  • Test everyone with bowel cancer for inherited syndrome, NICE urges (OnMedica)
  • UK Government announces deep cuts to pharmacy funding (Pharmafile)
  • Almost 1 adult in 6 in the EU is considered obese (EC)


  • Malaysian facility to be commercialised in H2 FY17: Biocon (Economic Times)
  • MicuRx'S Phase III MRSA antibiotic trial to support Chinese NDA filing (EPR)


  • Eurolife to buy Baxter India's form-fill-seal infusion business (Economic Times)
  • 3 Indian Pharma cos breeding drug-resistant Bacteria: Report (Economic Times)
  • Merck merges pharma, consumer health units; aims to ramp up businesses (Economic Times)


  • Summary Safety Review - GILENYA (fingolimod) - Assessing the Risk of the Abnormal Tissue Growth (Cancer) (Health Canada)


  • AusBiotech members unite in response to R&D Tax Incentive review (PharmaLetter-$)


  • Researchers Unlock Mystery Of How Zika Spreads In Human Cells (KHN)

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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