Regulatory Focus™ > News Articles > Regulatory Recon: Eli Lilly Lung Cancer Drug Scrapes Through AdComm on Modest Benefit (10 July 2015)

Regulatory Recon: Eli Lilly Lung Cancer Drug Scrapes Through AdComm on Modest Benefit (10 July 2015)

Posted 10 July 2015 | By Michael Mezher 

Regulatory Recon: Eli Lilly Lung Cancer Drug Scrapes Through AdComm on Modest Benefit (10 July 2015)

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

In Focus: US

In Focus: International

  • Fresenius and Calea UK Fined £550,000 After Death Related to Defective Insulin Syringes (GOV.UK) (FiercePharma)
  • Pharma Badly Prepared for Incoming EU Data Regulation Changes (PharmaLetter-$)
  • TTIP: MEPs Back Investor-Friendly Legal System Proposal Despite Opposition (In-Pharma Technologist)
  • Imbruvica Authorized for Waldenstrom's Macroglobulinemia in EU (Press)  
  • Japan Approves Extended Indication of Cryolife’s Bioglue (Biospectrum)
  • Indian MoH Launches Initiative to Monitor Medical Device Safety (PharmaBiz)
  • Regulators Tighten Scrutiny of India Clinical Research Firms (Business Standard)
  • NICE Recommends Vedolizumab for Severe Crohn’s Disease (EuropeanPharmaceuticalReview)

US: Pharmaceuticals and Biotechnology

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

  • Seattle Genetics Begins 1st Non-Cancer Study for Adcetris (SCRIP-$)
  • Thrasos to Seek Breakthrough Status for Kidney Injury Drug, CEO Says (BioSpace)
  • Tocagen Glioma Treatment Gets Fast Track (Biocentury)
  • Janssen Completes Rolling BLA Submission for Daratumumab (Seeking Alpha) (Press)
  • Blue Earth Gets Orphan Status for Glioma Diagnostic From FDA and EMA (PharmaBiz)

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • FDA to Focus on “Complementary” Diagnostics in Addition to Companion Diagnostics (InsideMedicalDevices)
  • Judge Lifts System 1 Consent Decree Against Steris ( MassDevice)
  • Jury Finds Against Boston Scientific in $200m Spat With Stent Pioneer Jang (MassDevice)
  • What Does FDA's Mobile Medical Apps Pyramid Mean for Companies? (Geeks Talk Clinical)
  • FDA Opens Class 1 Recall on Medtronic Pediatric Tracheostomy Tube (FDA)
  • Graphene Coating Could Improve Chemotherapy Effectiveness (MNT)
  • Seven Mistakes That can Delay Your FDA 510(k) Clearance (MedDeviceOnline)

US: Assorted and Government

  • Harvard Professor Concerned 'Cures' Act Reliance on Biomarkers and Surrogates Could Lead to Ineffective Drugs (NPR) (NEJM)
  • Opioid Labeling: Congress Wants Box Warning On Immediate-Release Products (Pink Sheet-$)

Upcoming Meetings and Events

Europe

India

  • Regulators tighten scrutiny of India clinical research firms (Business Standard)
  • Indian MoH Launches Initiative to Monitor Medical Device Safety (PharmaBiz)
  • Flawed Procurement Crux of India's ARV Supply Woes? (SCRIP-$)
  • US FDA Inspectors Visit Sharon Bio-Medicine in Maharashtra (Economic Times)
  • Aurobindo Pharma gets USFDA Nod for Heart Rate-Regulating Drug Flecainide Acetate (Economic Times)

China

  • China Looks At Innovation, Quality Policies as Chronic Diseases Rise (PharmAsiaNews-$)

Australia

  • TGA Recalls Line of Children's Ibuprofen Over Risk of Plastic Shards in Bottle (TGA)

Japan

  • Japan Approves Extended Indication of CryoLife’s BioGlue (BioSpectrum)

Ebola Outbreak

  • Ebola Resurgence in Liberia Could be Tied to a Survivor (Reuters) (NYTimes)

Other International

  • WHO Lays out Plans for Financing New Global Health Goal (WHO)

General Regulatory and Interesting Articles

  • Genetic Differences May Help Explain Inconsistent Effectiveness of Anti-HIV Drug (ICT)

Categories: Recon, Regulatory News

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