Regulatory Focus™ > News Articles > Regulatory Recon: E-Cigarettes Come Under FDA Purview; Panel Calls for Mandatory Opioid Training for

Regulatory Recon: E-Cigarettes Come Under FDA Purview Panel Calls for Mandatory Opioid Training for Doctors (5 May 2016)

Posted 05 May 2016 | By Zachary Brennan 

Regulatory Recon: E-Cigarettes Come Under FDA Purview Panel Calls for Mandatory Opioid Training for Doctors (5 May 2016)

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

In Focus: US

In Focus: International

  • European priority medicines scheme attracts 18 applications in first month (PharmaLetter-$)
  • European approval for Eisai’s Halaven for advanced liposarcoma (PharmaLetter-$) (PharmaTimes) (PR)
  • European Commission's Scientific Committee Sets Out Five-Year Focus For Medical Devices (SCRIP-$)
  • Health Canada reviewing safety concerns of controversial Essure birth control implant (CTV News)
  • Japanese drugmaker Daiichi wins damages from former Ranbaxy owners (Reuters)
  • One year into the Zika outbreak: how an obscure disease became a global health emergency (WHO)
  • HIV-positive patients get organs from donors with HIV in UK transplant first (Guardian)
  • Interview – Adavium targets Brazil and beyond (EPVantage)

US: Pharmaceuticals and Biotechnology

  • Sanofi ready to raise Medivation offer, could oust board (Reuters) (FierceBiotech) (Bloomberg)
  • Biotech VC Funding Rises As Fewer Companies Get More Dollars (SCRIP-$)
  • Pfizer inks a $911M discovery pact with Greg Verdine’s WaVe Life Sciences (FierceBiotech)
  • Pfizer Cools To Tax Inversion After Nixed Allergan Deal (Law360-$)
  • FDA Should Remove Warning Label On The Smoking Cessation Drug Chantix (Forbes)
  • Reframing the Debate: Why Drug Spending Can Lower Costs (MM&M)
  • Peregrine Knew Cancer Drug Trials Were Bunk, 9th Circ. Told (Law360-$)
  • Industry Questions FDA Study on Efficacy Claims in DTC Pharma Ads (Focus)
  • AMRI Acquires Euticals for $358M (Contract Pharma)
  • Alnylam CEO is going all-in on a first drug approval (STAT)
  • More than a Matter of Appearances: Pharma’s Existential PR Problem (Xconomy)
  • Why is a company that makes a drug for blind people spending millions on TV ads? (STAT)

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

  • Regeneron secures more coverage for cholesterol drug Praluent (Reuters)
  • FDA accepts IND app for Epizyme’s mesothelioma drug (FierceBiotech)
  • Merck sales disappoint as Januvia, Remicade fall short (Reuters) (AP) (PR)
  • East Coast Biotech Roundup: Homology, Biogen, Intellia & More (Xconomy)
  • Tildrakizumab’s moment in the Sun (EPVatage)
  • Complaint Against Turing Pharmaceuticals (US District Court Southern District of NY)
  • FDA Grants Orphan Drug Designation to Allena’s Investigational Therapy for the Treatment of Pediatric Hyperoxaluria (PR)
  • Bayer eyes liver cancer indication for Stivarga (PMLive)
  • Eleven Bio shows signs of life on hopes of companion gene test (Boston Business Journal)

US: Medical Devices

  • US FDA Tackles Medical Device Biocompatibility Ahead Of New Guidance (SCRIP-$)
  • Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices (FDA Webcast)
  • Bayer Wants All Mirena IUD Cases Tossed For Lack Of Experts (Law360-$)
  • BD tops estimates with fiscal Q2 earnings, sales meet expectations (Mass Device)
  • IBM taps Bausch + Lomb to develop new cataract surgery app (FierceMedicalDevices) (PR)
  • Siemens healthcare rebrands as "Healthineers" (Reuters)
  • Humanyze Snags $4M to Push Wearable “Fitbit For Your Career” (Xconomy)
  • DICOM WG-06 FINALIZES 20 CHANGE PROPOSAL TO STANDARDS (MITA)

US: Assorted and Government

  • Hepatitis C Kills More Americans than Any Other Infectious Disease (CDC) (NY Times)
  • CDER’s Continuity of Operations Program (FDA)
  • FDA Requested Recall Letter to Alabama’s Medaus (FDA)
  • GAO Appoints Three New Members to Health IT Policy Committee (GAO)
  • A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods-Part II (Federal Register)
  • Capitol Hill Fight Against Medicare Rule Change Gathers Steam (OncLive)
  • CMS mulling modifications to proposed Part B model (BioCentury) (SCRIP-$)

Upcoming Meetings and Events              

Europe

  • Draft information in the package leaflet for aspartame in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (EMA)
  • Draft information in the package leaflet for fructose and sorbitol in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (EMA)

India

  • Minutes of the meeting with participants from ACRO India for BA/BE (CDSCO)
  • Pharma industry needs to use patent information to reduce R&D costs: Bindu Sharma (PharmaBiz)

Zika

  • A creative way to fight Zika: infect mosquitoes so that they can't spread the disease (Vox)
  • Panama confirms four microcephaly cases tied to Zika (Reuters)

General Health and Other Interesting Articles

  • Health Insurers Struggle to Offset New Costs (WSJ-$)
  • How club drug ketamine fights depression (Nature News)
  • Computer gleans chemical insight from lab notebook failures (Nature News)
  • Cancer is a gangster (STAT’s Podcast)
  • Will Prince finally get us talking about the prescription pill epidemic in America? (QZ)
  • Reckitt Benckiser CEO apologizes over South Korean sterilizer scandal (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? 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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