Regulatory Focus™ > News Articles > Regulatory Recon: In Depth Look Inside Biotech Startup Moderna; Postmarketing Study Fails to Ease FD

Regulatory Recon: In Depth Look Inside Biotech Startup Moderna Postmarketing Study Fails to Ease FDA Concerns on Pfizer's Chantix (13 September 2016)

Posted 13 September 2016 | By Michael Mezher 

Regulatory Recon: In Depth Look Inside Biotech Startup Moderna Postmarketing Study Fails to Ease FDA Concerns on Pfizer's Chantix (13 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

  • Moderna: Ego, ambition, and turmoil: Inside one of biotech's most secretive startups (STAT)
  • On Second Thought: DC District Court Does a 180 on PREPOPIK NCE Exclusivity; Remands to FDA (FDA Law Blog) (FDANews-$)
  • FDA staff flags concerns about Pfizer's quit-smoking drug study (Reuters)
  • Biotech CEOs: Don't Let EpiPen Threaten Innovation (Forbes)
  • FDA to Revise Draft Guidance on Quality Metrics Data (Focus)
  • AstraZeneca climbs on cancer drugs pipeline hopes  (Financial Times)
  • Obama Pledges Redoubled Efforts to Make Health Law Successful (WSJ)
  • U.S. Congress to advance Zika funding bill: Sen. McConnell (Reuters 1, 2)
  • Scientists Honored for Hep C Research (WSJ)
  • Celgene Data Offer A Rorschach Test To Wall Street (Forbes) (BioCentury)
  • Most Parents Give the Wrong Dose of Liquid Medication (NYTimes) (Reuters)
  • Precision Oncology Isn't Quite There Yet (In the Pipeline)
  • Pediatricians Give Thumbs-Down to FluMist Flu Vaccine (NBC)
  • High Cost of New Hepatitis C Drugs Strains Prison Budgets, Locks Many Out of Cure (WSJ)
  • FDA Seeks Public Input on Next Steps to Help Ensure Judicious Use of Antimicrobials in Animal Agriculture (FDA)
  • Teva's pricey Parkinson's drug unnerves some patients (CBS)
  • Investigating investment in biopharmaceutical R&D (Nature)
  • The ever-expanding myokinome: discovery challenges and therapeutic implications (Nature)
  • Impact of genetically supported target selection on R&D productivity (Nature)
  • Screening out irrelevant cell-based models of disease (Nature)
  • 3-D Printing Startup Seeks Niche in Low-Cost Prosthetic Legs (WSJ)

In Focus: International

  • Canada OKs Samsung Bioepis and Merck's Enbrel biosimilar (BioPharmaReporter)
  • Reform WHO by outsourcing its key activities, urge experts (OnMedica)
  • ICH and Pharmaceutical Inspection Co-operation Scheme: No Expectations for China or India to Join (Focus)
  • Cancer overtakes heart disease as Australia's biggest killer (Reuters)
  • Antimicrobial Resistance: Is the World UNprepared? (PLOS)
  • Asia Regulatory Roundup: TGA Offers Guidance on High-Risk IVD Online Applications (Focus)
  • Takeda darts to the door as it punts back the rights to MacroGenics' med (Fierce) (Pharmafile) (BioCentury)
  • Brexit Briefing: Life sciences mobilise for voice in negotiations (Financial Times)
  • Fosun Pharma looks to digest India's Gland, eyes other markets (Economic Times)
  • Korean Health Tech Blueprint Highlights Precision, Regenerative Medicine (Pink Sheet-$)
  • Pharmaceutical companies targeted nurses at 48,000 events in four years (The Guardian)
  • Aiming for Dengvaxia boost, Sanofi pushes for campaign deals in Mexico, Asia (Fierce)
  • Dodgy kits give dodgy results (MHRA)

US: Pharmaceuticals & Biotechnology

  • Merck aiming to help biopharmas make CHO cells resistant to MVM (BioPharmaReporter)
  • Raptor faces up to its new reality (EP Vantage)
  • Bristol-Myers Squibb's Response to ICER's Call for Improvements to its Value Assessment Framework (Press)
  • Study: Cancer Drug Websites More Likely to Offer Data on Benefits Than Risks (Focus)
  • Are Superenhancers Even Real? (In the Pipeline)
  • Chinese biotech Vcanbio opens first U.S. subsidiaries in Natick (Boston Biz Journal)
  • Guest Post: JACC Retracts AF Ablation Trial (CardioBrief)
  • FDA issues final guidance on COPD biomarker (BioCentury) (FDA)
  • A Reprieve For Women: Embracing Inclusive Scientific Research (Health Affairs Blog)
  • Vaccinate Your Children (Says a Federal Judge) (Harvard Bill of Health)
  • Biosimilars Face Repercussions of Drug Pricing Debate (PharmTech)
  • AbbVie's Humira, Pfizer's Lyrica dominate a year of TV ad spend with almost $500M total (Fierce)
  • RN1, a novel galectin-3 inhibitor, inhibits pancreatic cancer cell growth in vitro and in vivo via blocking galectin-3 associated signaling pathways (Nature)

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

  • Aptinyx Receives FDA Fast Track Designation for Development of NYX-2925 as Treatment for Neuropathic Pain Associated with Diabetic Peripheral Neuropathy (Press)
  • Tesaro begins niraparib submission (BioCentury)
  • Geron hangs on, just, after weak PhII blood cancer data (Fierce) (BioCentury)
  • Flex Pharma Initiates Phase 2 Efficacy Study in Amyotrophic Lateral Sclerosis (Press)
  • Ligand Initiates Phase 2 Trial with LGD-6972 in Type 2 Diabetes (Press)
  • FDA Approves the Cleveland Cord Blood Center's CLEVECORD™ for Stem Cell Transplants (Press)

US: Medical Devices

  • Abbott touts 38% hypoglycemia reduction in FreeStyle Libre study (MassDevice)
  • Ethicon wins FDA nod for Enseal X1 tissue sealer (MassDevice)
  • AstraZeneca, Bespak ink deal for metered-dose inhaler (MassDevice)
  • Novocure touts long-term analysis of Optune drug-device combo (MassDevice)
  • Biotronik touts dual drug-coated balloon-stent therapy for lower-limb disease (MassDevice)
  • Chemists develop 3D bone-scanning technique (MassDevice)
  • FDA OKs expanded trial for Precision Biopsy's ClariCore prostate biopsy device (MassDevice)
  • Coapt looks to bring prosthetic electrodes into the 21st century (MassDevice)
  • Nordisk issues voluntary recall of GlucaGen HypoKits (MassDevice)
  • Survey: The Fractured State of Enterprise Sales Enablement and Training (MassDevice)
  • Obalon Announces FDA Approval of Obalon Balloon System (Press)
  • EBR Systems Receives FDA Approval to Begin U.S. Pivotal Study of Wireless Cardiac Pacing System for Heart Failure (Press)

US: Assorted & Government

  • Quest Diagnostics Wins Appeal On La. Income Tax Refund (Law360-$)
  • Ohio court reinstates drug pricing initiative (BioCentury)
  • What The DEA's Plan To Schedule 1 Kratom Will Mean For Millions (Forbes) (NPR)
  • PATIENT PROTECTION AND AFFORDABLE CARE ACT: Most Enrollees Reported Satisfaction with Their Health Plans, Although Some Concerns Exist (GAO)
  • New Jersey – At the Intersection of the Scientific Method and the Rule of Law (Drug & Device Law)

Upcoming Meetings & Events


  • GSK submits sirukumab MAA (BioCentury)
  • Janssen Submits Marketing Authorisation Application for Darunavir-Based Single Tablet Regimen for Treatment of HIV-1 to European Medicines Agency (Press)
  • Marketing authorisations granted in August 2016 (MHRA)
  • Parallel import licenses granted in August 2016 (MHRA)


  • Changing an OTC medicine: using the Changes Tables (TGA)


  • About 200 Zika cases recorded in Thailand: ministry (Reuters)
  • No new Zika cases in Singapore on Tuesday - government agency website (Reuters)

Other International

  • WHO says Angola, Congo yellow fever outbreak under control (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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