Regulatory Focus™ > News Articles > Regulatory Recon: BMS' Opdivo Fails in Phase III for NSCLC; FDA Panel Backs Egalet's Abuse Deterrent

Regulatory Recon: BMS' Opdivo Fails in Phase III for NSCLC FDA Panel Backs Egalet's Abuse Deterrent Opioid (5 August 2016)

Posted 05 August 2016 | By Michael Mezher 

Regulatory Recon: BMS' Opdivo Fails in Phase III for NSCLC FDA Panel Backs Egalet's Abuse Deterrent Opioid (5 August 2016)

Welcome to Regulatory Reconnaissance, your adaily 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

  • Bristol-Myers Plunges on Cancer Immunotherapy Lung Cancer Study Failure (The Street) (Bloomberg) (In the Pipeline) (Press)
  • Biogen not pursuing a sale: source (Reuters)
  • SEC charges cardiologist with insider trading on drug trials (Reuters) (SEC)
  • NIH Plans to Lift Funding Ban on Human-Animal Hybrids (MIT Technology Review) (NYTimes) (Harvard Bill of Health)
  • How to Give Fake Hands Real Feeling (MIT Technology Review)
  • Theranos and the Limits of Salesmanship (In the Pipeline)
  • The Internet of Very Expensive Things (Bloomberg)
  • Obama, Senate Democrats urge Zika funding vote as reserves run low (Reuters)
  • US panel backs approval of Egalet's abuse-resistant painkiller (Reuters) (BioCentury)
  • Teva's Cephalon Reaches $125m Settlement With 48 States Due to Generic Delays (Focus) (Reuters)
  • FDA Approves First Generic Version of Roche's Blockbuster Flu Treatment (Focus)
  • US NIH permanently halts drug production at site criticised by US FDA (In-PharmaTechnologist)
  • NIH Director Urges Caution in Gene Editing (Medpage)
  • Pediatric Clinical Trials Are Often Abandoned, Unpublished (Forbes) (NPR)
  • FDA's Flexibility in Subpart H Approvals: Analysis Shows Wide Variances Between the Quantum and Quality of Evidence for Approval (FDA Law Blog)

In Focus: International

  • Why The World Needs An Essential Diagnostics List (Forbes)
  • NICE supports Novartis' Cosentyx for ankylosing spondylitis (PharmaTimes)
  • Brexit Rejig: UK Taps Three Leaders to Helm Office for Life Sciences (Focus)
  • Tata Trusts, Gilead sign MoU on viral hepatitis in India (Economic Times)
  • Bangladesh Pharma co makes foray into the US market (BioSpectrum)
  • EU Greenlights Sanofi-Boehringer Business Exchange (WSJ-$) (PharmaLetter-$)
  • GSK Prices Gene Therapy Strimvelis at €600,000 (BioCentury)
  • European Regulatory Roundup: EMA to Revise Trial Guidance on Hemophilia, Crohn's, Ulcerative Colitis, Diabetes and Bipolar Disorder (Focus)

US: Pharmaceuticals & Biotechnology

  • 5 Features To Look For In An EIR (FDAZilla)
  • Upcoming events – Schizophrenia and tinnitus data from Intra-celluar and Auris (EP Vantage)
  • Boosting Confidence in Biosimilars (USP)
  • The bladder cancer drug market (Nature)
  • Mayo researchers identify breast microbiome/bacterial differences between healthy and cancerous tissue (MNT)
  • 'OpenTrialsFDA' Could Allow Research On Product Approval Packages (Pink Sheet-$)
  • Explosive Growth in Post-Approval Research Drives Increased Cost and Complexity (BioClinicaBlogs)
  • Juno enters MM deal with MSKCC, Eureka (BioCentury)
  • Teva CRL Response For Huntington's Drug Targeted For September (Pink Sheet-$)
  • AstraZeneca's MedImmune Gets Creative In Diabetes With PCSK9/GLP-1 Fusion Product (SCRIP-$)
  • Arthritis Drug May Have Benefits Against Alzheimer's (NYTimes)
  • Exelixis' first Cabometyx sales beat expectations (BioCentury)
  • GE strikes 2nd collaboration with firm developing a colon-imaging capsule for prep-free colonoscopy (MedCityNews)

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

  • Merck Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for MK-1293, an Investigational Follow-On Biologic Insulin Glargine (Press)
  • Amarin slips after adding second interim efficacy trial to PhIII CV trial (Fierce)
  • Momenta's necuparanib fails pancreatic cancer trial (BioCentury)
  • ReNeuron Presses On With Stroke Therapy Development On Phase I Long-Term Benefits (SCRIP-$)

US: Medical Devices

  • Dräger Recalls VentStar Oxylog 3000 Pediatric Patient Breathing Circuit Due to Potential Valve Leakage(FDA)
  • NeMaura meets with FDA, plans for regulatory submission (MassDevice)
  • TransEnterix sees light on Q2 release, shares tick up (MassDevice)
  • EndoChoice wins FDA 510(k) for Lumos imaging software (MassDevice)

US: Assorted & Governmentw

  • In Minnesota PMA Preemption Requires Plaintiffs to be Specific, Very Specific (Drug and Device Law)
  • Kratom seized in California by US Marshals Service (FDA)

Upcoming Meetings & Events

Europe

  • EU orphan designations for Bellicum's BPX-501 T-cell therapy and activator agent rimiducid (PharmaLetter-$)
  • Siemens lifts profit forecast, adapts to low-growth world (MassDevice)
  • Appeal court paves way for launch of Sandoz' Reletrans (PharmaTimes)
  • Masimo wins CE Mark for O3 pediatric indication (MassDevice)

Asia

  • CFDA Accepts NDA For Anticancer Agent Halaven® (Press)

India

  • Directorate General of Foreign Trade unveils norms for human bio samples trade (Economic Times)

Canada

  • Notice: Transition to the Revised Version of ISO 13485 and its impact on the Compliance to the Quality Management System Requirements of the Canadian Medical Devices Regulations (Health Canada)

Zika

  • New York attorney general says fake Zika protection claims swiftly dropped (Reuters)
  • Blood Banks Step Up Efforts Against Zika Contamination (WSJ-$)

General Health & Other Interesting Articles

  • Patient set to undergo the world's first human head transplant says 'Dr Frankenstein' will reveal details of the operation next month (Daily Mail)
  • Melanoma less common but more deadly for black patients (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 news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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