Regulatory Focus™ > News Articles > Regulatory Recon: Chicago to License Pharma Sales Reps to Curb Opioid Overprescribing; WHO Secures F

Regulatory Recon: Chicago to License Pharma Sales Reps to Curb Opioid Overprescribing WHO Secures Funds for Malaria Vaccine Pilot (18 November 2016)

Posted 18 November 2016 | By Michael Mezher 

Regulatory Recon: Chicago to License Pharma Sales Reps to Curb Opioid Overprescribing WHO Secures Funds for Malaria Vaccine Pilot (18 November 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

In Focus: US

  • BIO Chair: Trump Should Re-Appoint Califf to Head FDA (Focus)(
  • NIH Director Looks at Presidential Transition (Scientific American)
  • Americans want Trump to focus on healthcare first (Reuters)
  • Following Injuries and Deaths, FDA Amends Regulations on CGMP and Labeling of Medical Gases (Focus)
  • Survey: Doctors Want FDA To Reverse Course on Biosimilar Naming (IHP-$)
  • Chicago will license pharma sales reps to fight opioid overprescribing (STAT) (Law360-$)
  • Is the peer review system sustainable? (STAT)
  • He's a Trump in-law who has bet big on Obamacare. What now? (STAT)
  • GlobeImmune draws the curtain as Gilead kills drug deal, CEO role abandoned (Fierce)
  • FDA joins pact for cybersecurity in medical devices (MassDevice)
  • Obama Advisers Say CRISPR is a Bioterror Threat (MIT Technology Review)
  • FDA research to help speed development of Zika virus vaccines and therapeutics (FDA) (PharmTech)
  • Drug Affordability Review By National Academies Kicks Off With Lower Profile Than Expected (Pink Sheet-$)
  • Eli Lilly's Alzheimer's Drug Study Results Are Coming -- Here's What Investors Need to Know (The Street)
  • GSK/J&J release how their drug measures up against Humira (Pharmafile)
  • Clovis sued over statements about lung cancer drug roci (Fierce) (Press)
  • GOP aims to start Obamacare repeal in January (Politico)
  • Therapeutic Proteins International Renames Company to Adello Biologics, LLC; Relocates HQ to NJ (Press)
  • Is Social Media And "Employee Advocacy" Possible Within Regulated Industries? (Forbes)

In Focus: International

  • European Regulatory Roundup: Ireland to Offer Regulatory Advice via New Innovation Office (Focus)
  • Amgen's Parsabiv's Gets EU Approval While It Languishes At The FDA (SCRIP-$)
  • UK politicians demand Brexit guarantee for EU scientists (Nature)
  • Two-thirds of pharmaceutical manufacturing is outsourced, ISR Reports (Outsourcing Pharma)
  • Comparison OF EMA and FDA Guidance on Data Management and Data Integrity (FDAZilla)
  • ICH Looks to Revamp GCP Guidelines, Adds New Members (Focus)
  • NICE thumbs up for BMS leukaemia treatment (Pharmafile)
  • WHO says funds secured for Africa pilots of world's first malaria vaccine (Reuters) (WHO)
  • Amidst insecurity, WHO and partners have reached an estimated 1.1 million South Sudanese children with oral polio vaccines (WHO)
  • WHO and the World Bank engage in new funding framework agreements (WHO)
  • Cancer vaccines market set to triple by 2022, new report indicates (PharmaLetter-$)
  • Market watch: Antibacterial innovation in European SMEs (Nature)
  • EU Medical Devices Regulation Series on Key Issues (InsideMedicalDevices)
  • NICE welcomes five new Non-Executive Directors to its board (NICE)
  • MedDRA Management Board, Osaka, Japan, November 2016 (ICH)

US: Pharmaceuticals & Biotechnology

  • Eteplirsen therapy for Duchenne muscular dystrophy: skipping to the front of the line (Nature)
  • Cannabinoid receptor structure revealed (Nature)
  • Reviving optimism for regenerative medicine (STAT)
  • A New Way to Make GSK3 Inhibitors (In the Pipeline)
  • Precision Medicine Initiative Gathering Community Feedback for 1M-Subject Recruitment (GenomeWeb)
  • Pharma 'will not meet serialization deadline in US' (Securing Industry)
  • FDA Finalizes Report on the Regulation of Combination Drug Medicated Feeds (FDA)
  • Biopharma continues to thrive in CA (BioPharmaDive)
  • Adaptive Trials, Platform Trials, Master Protocols and Beyond: Pathways to Transformation—or Not? (Faster Cures)
  • Patients in the Driver's Seat: Precision Medicine and Direct to Patient R&D (Faster Cures)
  • Recent Developments Around Pharmaceutical Drug Spending In Massachusetts (National Law Review)
  • Therapeutic substitution could save Americans US$73 billion (GaBI)
  • Transparency and quality characteristics for biosimilars (GaBI)
  • Merck Foundation Announces $10 Million Initiative to Improve Access to High-Quality Diabetes Care in Vulnerable and Underserved U.S. Communities (Press)

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

  • FDA fast-track status for Eisai Alzheimer's candidate E2609 (PharmaLetter-$) (Press)
  • Novartis' acute myeloid leukaemia drug granted FDA priority review (EPR)
  • OSE Immunotherapeutics announces the online publication of positive Phase 1 clinical results with FR104 in the Journal of Immunology (Press)
  • Long-Term Analysis of All 695 Patients Enrolled in Novocure's Phase 3 Pivotal Trial in Newly Diagnosed Glioblastoma Confirms Successful Interim Analysis Results and Demonstrates Superior Two- and Four-Year Survival Rates (Press)
  • Tenax Therapeutics Announces Completion of Enrollment for Phase 3 LEVO-CTS Trial in Cardiac Surgery (Press)
  • VetDC Files Final TANOVEA™ FDA Submission for Use in Canine Lymphoma (Press)

US: Medical Devices

  • InVivo Therapeutics adds patient to Inspire spinal scaffold trial (MassDevice)
  • Medicare issues leadless pacer coverage proposal (MassDevice)
  • New Data Show Medtronic Heli-FX EndoAnchor System Enhances Outcomes and Durability in Complex Aortic Disease (Press)
  • Olympus Vying to Bring Back Laparoscopic Power Morcellation Thanks to PneumoLiner Safety Device (MedGadget)
  • MITA Announces New Director Of Pet Industry Policy (MITA)

US: Assorted & Government

  • Pfizer Sues Texas Agency For Releasing Drug Rebate Info (Law360-$)
  • "Patients simply can't afford to wait – time is running out." (E&C)
  • CMS Says it Will Not Send a Witness to Senate Hearing on Mylan EpiPen Settlement (CMS)
  • Mikulski Disappointed by GOP Decision to Abandon the Appropriations Process & Put the Government on Autopilot (Senate)
  • Fraud Charges Are Welcome in Valeant, Philidor Kickback Scheme (Public Citizen)
  • Guest Post – Tis Better to Try and Fail, Then to Have Never Tried At All: Internal Corporate Policies Do Not Create a Heightened Legal Duty (Drug and Device Law)

Upcoming Meetings & Events

Europe

  • EFPIA Health Collaboration 2016 Summary Report (EFPIA)
  • Genedrive Human Genotyping Test Gets CE-IVD Marking (GenomeWeb)
  • Public consultation on assessment criteria for combination packages policy (MEB)
  • Report Warns of Alcohol-Related Cancer Deaths in England (WSJ)
  • Xenocor wins CE Mark for low cost Xenoscope laparoscope (MassDevice)

India

  • Sun Pharma Halol site being inspected by US FDA: Sources (Economic Times)
  • Alembic Pharma gets USFDA nod for hypertension tablets (Economic Times)

Asia

  • South Korea confirms highly pathogenic bird flu outbreaks, ramps up quarantine (Reuters)
  • Chugai strengthens investment in Singapore (BioSpectrum)
  • HeartFlow wins Japanese approval for FFRct tech (MassDevice)

Australia

  • Consultation: Accelerated assessment of medical devices - Priority Review pathway – Implementation (TGA)
  • Consultation: Designation of Australian conformity assessment bodies for medical devices – Implementation (TGA)

Zika

  • Is Zika still a public health emergency? (STAT)

Other International

  • The Ebola outbreak may have been bigger than believed, with 'invisible' infection (Washington Post)

General Health & Other Interesting Articles

  • Laser used to control mouse's brain — and speed up milkshake consumption (Nature)
  • CDC estimates preventable deaths from 5 leading causes (CDC)
  • Terminally ill British girl wins right to freeze her body: BBC (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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