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
- AdComm Finds Positive Risk/Benefit for Eli Lilly Lung Cancer Drug (Reuters) (MedPageToday) (FierceBiotech) (Pink Sheet-$) (SCRIP-$) (Press)
- FDA to Strengthen Warnings on NSAIDs (NYTimes) (WSJ-$) (MedPageToday) (FDA)
- FDASIA Turns Three (FDA Voice)
- FDA to Focus on “Complementary” Diagnostics in Addition to Companion Diagnostics (InsideMedicalDevices)
- Review of 900k Experiments Shows Stronger Bias in Non-Blind Studies (MNT) (PLOS Biology)
- Evening the Score on Off-Label Use Information (Drug and Device Law)
- Separating Fact From Fiction on 'Female Viagra' (Reporting on Health)
- The FDA's Quality Revolution (DrugWonks)
In Focus: International
- Fresenius and Calea UK Fined £550,000 After Death Related to Defective Insulin Syringes (GOV.UK) (FiercePharma)
- Pharma Badly Prepared for Incoming EU Data Regulation Changes (PharmaLetter-$)
- 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
- AdComm Finds Positive Risk/Benefit for Eli Lilly Lung Cancer Drug (Reuters) (MedPageToday) (FierceBiotech) (SCRIP-$) (Pink Sheet-$) (Press)
- FDA to Strengthen Warnings on NSAIDs (NYTimes) (WSJ-$) (MedPageToday) (FDA)
- Separating Fact From Fiction on 'Female Viagra' (Reporting on Health)
- New Technique for Precise Light-Activated Chemotherapy Drugs (Pharmpro)
US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations
- Seattle Genetics Begins 1st Non-Cancer Study for Adcetris (SCRIP-$)
- 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
- FDASIA Turns Three (FDA Voice)
- Review of 900k Experiments Shows Stronger Bias in Non-Blind Studies (MNT) (PLOS Biology)
- Evening the Score on Off-Label Use Information (Drug and Device Law)
- The FDA's Quality Revolution (DrugWonks)
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
- 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-$)
- TTIP: MEPs Back Investor-Friendly Legal System Proposal Despite Opposition (In-Pharma Technologist)
- Imbruvica Authorized for Waldenstrom's Macroglobulinemia in EU (Press)
- NICE Recommends Vedolizumab for Severe Crohn’s Disease (EuropeanPharmaceuticalReview)
- Gene Therapy Improves Lung Function in Cystic Fibrosis Patients (Pharmaceutical Journal-$) (Study)
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
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)