Regulatory Recon: FDA Warns Against Ovarian Cancer Test Takeda Launches Global Phase III for Dengue Vaccine (8 September 2016)

Posted 08 September 2016 | By Michael Mezher 

Regulatory Recon: FDA Warns Against Ovarian Cancer Test Takeda Launches Global Phase III for Dengue Vaccine (8 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

  • Celgene Shows Spending Pays (Bloomberg) (Xconomy)
  • FDA warns against widely used ovarian cancer screening test (STAT) (FDA) (BioCentury)
  • Cancer 'moonshot' panel names top 10 ways to speed progress against the disease (Washington Post) (NBC) (Blue Ribbon Report) (STAT)
  • FDA Extends UDI Compliance for Certain Class II Devices (Focus) (Emergo)
  • Woodcock on Biosimilars: Earning the Trust of Prescribers and Patients is Key (Focus)
  • FDA Warns Pan Over Data Integrity, Sanitation Issues (Focus)
  • The Primary Outcome Is Positive — Is That Good Enough? (NEJM)
  • Diabetic Medical Equipment Companies to Pay More Than $12 Million to Resolve False Claims Act Allegations (DoJ)
  • FDA to Review Merck's Keytruda as First-Line Treatment for Lung Cancer (WSJ) (BioCentury)
  • How Gilead could go back to basics (EP Vantage)
  • EpiPen's Dominance Driven By Competitors' Stumbles And Tragic Deaths (NPR)
  • Senate investigations panel to probe Mylan's EpiPen pricing (Reuters)
  • The EpiPen Debacle Coupled With Theranos And Turing: Is This Industry Broken? (Forbes)
  • Florida politicians urge use of Intrexon GM mosquitoes for Zika (Reuters)
  • US lawmakers seek compromise on Zika virus funding (Reuters)
  • 'Superbug' scourge spreads as US fails to track rising human toll (Reuters)
  • Chantix: A Lesson in Why Litigation Should Not Be Allowed to Get Ahead of Science (Drug and Device Law)
  • Allergan Eye Drop Antitrust Suit Revived By 3rd Circ. (Law360-$)
  • Gene therapy for sickle cell moves closer as scientists clear unexpected obstacle (STAT)
  • Getting Real About An Alzheimer's Cure (Forbes)
  • FDA Is Evolving On Qualifications For 'New Chemical Entity' (Law360-$)

In Focus: International

  • Takeda signals global ambitions with dengue vaccine trial (Financial Times) (OutsourcingPharma) (Press)
  • Japan's Oncolys BioPharma aims to rival Amgen's cancer-killing virus therapy (Fierce)
  • CF Trust launches trial accelerator programme (PharmaTimes)
  • Positive EMA opinions could bode well for US approvals of biosimilars (PharmaLetter-$)
  • UK Accelerated Access Proposals Due Out Soon (Pink Sheet-$)
  • WHO updates view on Zika as cause of brain abnormalities (Reuters)
  • Scientists find deadly scrub typhus bacteria in South America (Reuters)

US: Pharmaceuticals & Biotechnology

  • Pfizer appoints new chief scientific officer for neuroscience research (Pharmafile) (Press)
  • Need for a New Lyme Disease Vaccine (NEJM)
  • GW Pharma gains on M&A rumor as it preps for FDA submission (Fierce)
  • Promoting Off-Label Use: Are Times Changing at FDA? (National Law Review)
  • This is how 3-D bioprinting companies are transforming drug development (MedCityNews)
  • Study Says Concerns About Orphan Drug Spending Are Unjustified (KHN) (NPR)
  • All Roads For OTC Policy Improvements Lead To User Fees, FDA Suggests (Pink Sheet-$)
  • From Partner to Purchaser: Tesoro Buys Madison Biofuels Maker Virent (Xconomy)
  • FDA's Decline In Promotion Enforcement Highlighted By Celator Booth Letter (Pink Sheet-$)
  • Celgene takes a deeper look in Crohn's (EP Vantage)
  • Fate partners with Memorial Sloan Kettering on off-the-shelf CAR-T (Fierce)
  • Announcement of Requirements and Registration for "Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test" Challenge (NIH)
  • ICH S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies-Questions and Answers; International Council for Harmonisation; Draft Guidance for Industry; Availability (FDA)
  • United Exchange Corp Issues Voluntary Nationwide Recall of Family Care Brand Eye Wash Due to Microbial Contamination (FDA)

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

  • Juno posts positive lymphoma response data from a small CAR-T trial (Fierce)
  • Retrophin kidney drug exceeds expectations in trial, shares jump (Reuters)
  • Ovid Therapeutics Receives Orphan Drug Designation from the U.S. FDA for OV101 for the Treatment of Patients with Angelman Syndrome (Press)
  • La Jolla Pharmaceutical Company Reports Positive Results from Phase 1 Study of LJPC-401 (Press)
  • Sensorion Announces Positive Results From SENS-218 Phase 1 Clinical Trial Undertaken in the UK (Press)
  • GTx Achieves Stage 1 Milestone in Phase 2 Clinical Trial of Enobosarm in ER+/AR+ Breast Cancer (Press)bluebird bio Opens Phase 3 Study of LentiGlobin™ Drug Product in Patients with Transfusion-Dependent Beta-Thalassemia (Press)
  • New analysis showed dose adjustment of Giotrif® (afatinib) improved tolerability without an apparent impact on efficacy in patients with EGFR mutation-positive non-small cell lung cancer (Press)

US: Medical Devices

  • St. Jude Medical Sues Short Seller Over Device Allegations (WSJ)
  • PMA Monthly approvals from 8/1/2016 to 8/31/2016 (FDA)
  • New Guidances on the No New 510(k) Rationale (MDDI)
  • Cepheid Gets FDA Approval for Trichomonas Test in Men (GenomeWeb)
  • Rotation Medical touts regenerative rotator cuff repair data (MassDevice)
  • Apple Issues More Explicit Guidelines for Mobile Medical and Health App Developers (Emergo)

US: Assorted & Government

  • MDL Judges: Information-Forcing or Settlement Forcing? (Drug and Device Law)
  • The EpiPen Controversy Signals Intensifying Scrutiny of Drug Classification Under Medicaid Rebate Program (National Law Review)
  • Patients Seek Revival Of Diabetes Drug Claims In 9th Circ. (Law360-$)
  • Vaginal Mesh MDL Judge Sick And Tired Of Bogus Suits (Law360-$)
  • FDA Tries New Approach to Removing Marketed Dietary Ingredients; Prepares About-Face on Dietary Ingredient Status of Vinpocetine (FDA Law Blog)
  • Hartig Drug Co. v. Senju Pharmaceutical Co. (3rd Cir. 2016) (Patent Docs)

Upcoming Meetings & Events


  • EUnetHTA-EFPIA Technical meeting (EUnetHTA)
  • Experts call on regulators to revisit nalmefene decision (OnMedica)
  • Bluewind Medical wins CE Mark for Vivendi mini-neurostim pain implant (MassDevice)
  • OrthoSera wins CE Mark for hypACT regenerative osteoarthritis device (MassDevice)


  • Ono announces progress with Opdivo and Kyprolis in Japan (PharmaLetter-$)


  • Mandatory marketing code for drugmakers in India to have strong penal provisions (PharmaLetter-$)
  • Pharma companies air concerns over plans to cap prices (Economic Times)


  • TGA presentation: University of New South Wales, Faculty of Medicine, 19 August 2016 (TGA)
  • TGA statutory advisory committee and specialist advisor vacancies (TGA)
  • Recall - GlucaGen HypoKit (TGA)
  • Recall – potential for bacterial contamination - Comfort impregnated cloth topical skin products (TGA)


  • Zika Fears Expected to Lift Condom Demand (WSJ-$)
  • Why The Low Zika Numbers In Haiti Might Be Wrong (NPR)

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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