Regulatory Focus™ > News Articles > Regulatory Recon: Tonix Walks Away From Fibromyalgia Drug in Phase III; NIH Looks to License Anti-CD

Regulatory Recon: Tonix Walks Away From Fibromyalgia Drug in Phase III NIH Looks to License Anti-CD19 CAR Technology to Sangamo (7 September 2016)

Posted 07 September 2016 | By Michael Mezher 

Regulatory Recon: Tonix Walks Away From Fibromyalgia Drug in Phase III NIH Looks to License Anti-CD19 CAR Technology to Sangamo (7 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

  • Promotional Materials at ASCO Land Jazz Subsidiary FDA's Third Untitled Letter of 2016 (Focus) (STAT)
  • FDA Hits Valeant's Bausch & Lomb With Form 483 (Focus)
  • Prospective Grant of Exclusive Patent License: The Development of an Anti-CD19 Chimeric Antigen Receptor (CAR) for the Treatment of Human Cancers (NIH)
  • Mylan faces two potential class action lawsuits over EpiPen pricing (STAT)
  • Why Congress Needs to Vote Again on Zika (Bloomberg) (NYTimes) (STAT)
  • Senate Democrats Block Zika Bill Over Planned Parenthood Provisions (NYTimes)
  • Treating Zika Infection: Repurposed Drugs Show Promise (NIH)
  • Percentage of Uninsured Historically Low (WSJ-$)
  • A $14,000 Price Tag For A Cholesterol Drug Can Be A Bargain (Forbes)
  • SPRINT: More Controversy And Confusion About 'Landmark' Trial (Cardiobrief)
  • Tonix to stop testing drug for fibromyalgia, shares plunge (Reuters)
  • Novartis and CAR-T: What's Going On? (In the Pipeline)
  • Startup's Artificial DNA Could Revolutionize Drug Design (MIT Technology Review)
  • Bill Gates Doubles His Bet on Wiping Out Mosquitoes with Gene Editing (MIT Technology Review)
  • Precision Medicine Initiative Cohort Coming (National Law Review)
  • What is immunotherapy? (The Guardian)

In Focus: International

  • European Commission approves new RA treatment from BMS (Pharmafile)
  • Pharmaceutical Regulators Propose Principles for Indication Extrapolation for Biosimilars (Focus)
  • Asia Regulatory Roundup: India Continues Clinical Trial Reform Agenda (Focus)
  • Germany's Merck latest to commit to UK post-Brexit (InPharmaTechnologist)
  • EMA Tackles Complexities Introduced By Literature Monitoring Service (Pink Sheet-$)
  • The future of the biopharma industry: emerging markets and biosimilars (BioPharmaReporter)
  • USFDA issues 6 observations post Indoco's Goa plant inspection (Economic Times)
  • A Médecins Sans Frontières Ethics Framework for Humanitarian Innovation (PLOS)
  • ANVISA Expands List of Items Not Considered "Health Products" (Emergo)

US: Pharmaceuticals & Biotechnology

  • Horizon and fledgling Fulcrum team up on using CRISPR for genetic diseases (Fierce) (BioCentury)
  • Medivation elation (BioCentury)
  • For EDCs, Flexibility is Key (Bioclinica)
  • Harnessing the power of real-world evidence to benefit patients through PDUFA VI (PhRMA)
  • Fixing Drug Pricing Means Paying For "Value" (Incidental Economist)
  • Thinking straight about orphan drugs, Part 3. (Incidental Economist)
  • U.S. CMO buys AstraZeneca U.K. plant, saves 210 jobs (Fierce)
  • AstraZeneca to explore link between epigenetics and respiratory diseases (PMLive)
  • Dynavax still expecting timely Heplisav-B decision (BioCentury)
  • FDA extends IDegLira review (BioCentury)
  • FDA extends review of BioMarin's Batten therapy (BioCentury)
  • David Epstein: Industry should 'remain optimistic' on cell and gene therapy after Novartis cull (Fierce)
  • Pharma's Big Opportunity: Digital Engagement With HCPs (SCRIP-$)
  • State of the biopharma industry: the double-edged sword of single-use (BioPharmaReporter)
  • The Values And Vices Of Observational Studies In Postmarketing Research (Cutting Edge Info)

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

  • FDA Accepts Supplemental Biologics License Application, Assigns Priority Review and Grants Breakthrough Therapy Designation to Merck's KEYTRUDA® (pembrolizumab) for First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer (Press)
  • Retrophin's kidney drug succeeds in mid-stage study (Reuters)
  • Micro cap CoLucid spikes on positive PhIII migraine data (Fierce)
  • GSK presents positive results from phase III FULFIL study of closed triple combination therapy FF/UMEC/VI versus Symbicort® Turbohaler® in COPD at ERS International Congress (Press)
  • GlycoMimetics Initiates Dosing in Phase 1 Clinical Trial of GMI-1359 (Press)
  • Cerecor Announces Last Patient Enrolled in Phase 2 Clinical Trial with CERC-501 for Smoking Cessation (Press)
  • Exelixis Announces Outcome from First Planned Interim Analysis of the Phase 3 CELESTIAL Trial of Cabozantinib in Patients with Advanced Hepatocellular Carcinoma (Press)
  • Proclara Biosciences Announces Initiation of Phase 1b Clinical Trial of NPT088 for Alzheimer's Disease (Press)
  • Alnylam Reports Positive Interim Results from Ongoing Phase 1 Study of ALN-AS1, an Investigational RNAi Therapeutic for the Treatment of Acute Hepatic Porphyrias (Press)
  • vTv Therapeutics Completes Enrollment of Part A of Pivotal Phase 3 Trial Evaluating Azeliragon for the Treatment of Patients with Mild Alzheimer's Disease (Press)

US: Medical Devices

  • St. Jude Medical levels lawsuit against short seller (MassDevice)
  • Teleflex Closes NC Plant, Laws Off 104 (MassDevice)
  • Cook Medical Recalls Roadrunner® UniGlide® Hydrophilic Wire Guide Because of Potential Coating Contamination (FDA)
  • Reliability of at-home wrist blood pressure monitoring questioned (Reuters)
  • Mammography Facility Adverse Event and Action Report - September 6, 2016: AdvancedTech Breast Imaging Specialists, LLC (FDA)

US: Assorted and Government

  • Rehearing Sought in Colchicine 505(b)(2) Listed Drug/Patent Certification Dispute (FDA Law Blog)
  • PTAB Life Sciences Report (Patent Docs)
  • FDA's Off-Label Hearing Set for the Day after the 2016 Election (Strasburger)
  • FTC Says Allergan Must Face Lidoderm Generic Delay Suit (Law360-$)

Upcoming Meetings & Events


  • UK launch for Biogen's biosimilar infliximab (PharmaTimes)
  • Henkel and Sanofi set new milestone with negative yielding bonds (Financial Times)
  • European Commission Approves Bristol-Myers Squibb's ORENCIA® (abatacept) for the Treatment of Highly Active and Progressive Disease in Adult Patients with Rheumatoid Arthritis Not Previously Treated with Methotrexate (Press)


  • Abdi İbrahim to start $115 million manufacturing investment early to drive Turkish economy (PharmaLetter-$)
  • Medtronic opens office in Vietnam (MassDevice)
  • Biotronik hits the market in Japan with Ilivia MRI-safe ICD (MassDevice)
  • Daiichi Sankyo promotes Marielle Cohard-Radice to new global head of development (PharmaLetter-$)


  • WHO strengthens safe sex guidance when returning from Zika zones (Reuters)
  • Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability (FDA)
  • Zika virus found in tears of mice - U.S. study (Reuters)
  • China offers 'free screening' for travelers from Zika-hit countries (Reuters)
  • Zika concerns could test Singapore's efforts to boost birth rate (Reuters)
  • Malaysia confirms first case of Zika in a pregnant woman (Reuters)
  • Aimed at Zika Mosquitoes, Pesticide Kills Honeybees (NYTimes)

Other International

  • WHO declares Sri Lanka malaria-free in 'truly remarkable' achievement (Reuters)

General Health & Other Interesting Articles

  • When People Ate People, A Strange Disease Emerged (NPR)
  • Sexual function problems common for younger adults after heart attack (Reuters)
  • MRIs in early pregnancy appear safe, but contrast agent may not be (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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