Regulatory Focus™ > News Articles > Regulatory Recon: Caution, Hope and Excitement in Alzheimer's Fight (23 July 2015)

Regulatory Recon: Caution, Hope and Excitement in Alzheimer's Fight (23 July 2015)

Posted 23 July 2015 | By Michael Mezher 

Regulatory Recon: Caution, Hope and Excitement in Alzheimer's Fight (23 July 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

In Focus: US

In Focus: International

  • Establishing a Global Vaccine-Development Fund (NEJM)
  • Concept paper on the need for a single note for guidance on the chemistry of active substances (EMA)
  • EU and Swiss regulators sign confidentiality arrangement (EMA)
  • Successful Link with Germany’s securPharm Makes EMVS a Reality (EFPIA)
  • India's National IPR policy: what's cooking? (SCRIP-$)
  • IPC to CDSCO: Caution on 3 Lifesaving Drugs in Market After ADRs (PharmaBiz)
  • Emerging Markets Regulatory Tracker: China Device Classifications (PharmAsiaNews-$)
  • CFDA reports 18% increase in medical device adverse events in China (FierceMedicalDevices)
  • China state-owned drug firms move to direct consumer sales, prescriptions next? (FiercePharmaAsia)

US: Pharmaceuticals and Biotechnology

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

  • Cara Therapeutics scores another positive PhII for lead opioid (FierceBiotech)
  • Altona Dx MERS Test Lands FDA Emergency Use Authorization (GenomeWeb)
  • AstraZeneca's once-lauded drug flunks a Phase III eye cancer trial (FierceBiotech)
  • Researchers are about to launch the largest AIDS treatment trial ever (BioPharmaDive)

US: Pharmaceuticals and Biotechnology: General

  • FDA Science Forum 2015: Views of FDA (FDA Voice)
  • Pharma Company Investors Call for Clinical Trials Transparency (AllTrials)
  • Intent to Review a Study Data Reviewer's Guide Template (FDA)
  • cGMPs for Drug Manufacturers: Five Key Points from FDA’s Seminar (Registrar Corp)
  • Flexibility replacing capacity in plant design, say engineering firms (BioPharma-Reporter)

US: Medical Devices

US: Assorted and Government

  • Politicians Want to Fix Combination Product Regs (MDDI)
  • No Prescription Medical Product Strict Liability in Pennsylvania (Drug and Device Law)

Upcoming Meetings and Events

Europe

  • New Draft Version of EU eCTD Module 1 v3.0 Released for Public Consultation (Exalon)
  • Concept paper on the need for a single note for guidance on the chemistry of active substances (EMA)
  • EU and Swiss regulators sign confidentiality arrangement (EMA)
  • Successful Link with Germany’s securPharm Makes EMVS a Reality (EFPIA)
  • NICE says yes to BI's Vargatef (SCRIP-$)
  • NICE says why eye to Ozdurex and Eylea for DME (SCRIP-$)
  • Diabetes drug could protect against Parkinson’s disease (OnMedica)
  • EMA Validates Two Parallel Type II Variations to Extend Opdivo Indication (Press)
  • Boston Scientific wins FDA nod, CE Mark for Safari2 guidewire (MassDevice) (Press)
  • Bionic hand uses nitinol ‘smart’ wires to mimic muscle fibers (MassDevice)

India

  • India's National IPR policy: what's cooking? (SCRIP-$)
  • IPC to CDSCO: Caution on 3 Lifesaving Drugs in Market After ADRs (PharmaBiz)
  • DCGI needs to examine branded drugs in circulation: Dr BR Jagashetty (PharmaBiz)

China

  • Emerging Markets Regulatory Tracker: China Device Classifications (PharmAsiaNews-$)
  • CFDA reports 18% increase in medical device adverse events in China (FierceMedicalDevices)
  • China state-owned drug firms move to direct consumer sales, prescriptions next? (FiercePharmaAsia)

Canada

Australia

  • Prescription Medicine Evaluation Plan Estimator (TGA)
  • Medtronic neurostimulators used for deep brain stimulation therapy, Hazard Alert (TGA)
  • Get on TGA's Prescription Medicine NCE Registrations Email List (TGA)

Other International

  • Establishing a Global Vaccine-Development Fund (NEJM)
  • Testing for malaria reduces overprescription by more than 70 percent (MNT)

General Regulatory and Interesting Articles

  • Medical Marijuana Users Believe Drug's Effectiveness Is Greater Than Other Treatments (Forbes)
  • Leprosy From An Armadillo? That's An Unlikely Peccadillo (NPR)
  • Medical Journals Are Practicing Economics Without A License (DrugWonks)

Regulatory Reconnaissance #602– 23 July 2015

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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