Regulatory Focus™ > News Articles > Regulatory Recon: Ebola Vaccine Shows Promise (23 December 2016)

Regulatory Recon: Ebola Vaccine Shows Promise (23 December 2016)

Posted 23 December 2016 | By Zachary Brennan 

Regulatory Recon: Ebola Vaccine Shows Promise (23 December 2016)

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing. This will be our last Regulatory Recon until 3 January. Thanks for tuning in over the last year and we wish you happy holidays.

In Focus: US                                      

  • Now You See It, Now You Don’t: Vanishing Drug Approval Information and Other FDA Actions Making Drug Approvals Opaque (FDA Law Blog)
  • In Cancer Trials, a Lopsided Shot at Hope for Minorities (New York Times-$)
  • What Will Tom Price Do as HHS Secretary? (MedPage Today)
  • No Real Movement on High Drug Prices (MedPage Today)
  • Donald Trump’s Pick for Health Secretary Traded Medical Stocks While in House (WSJ-$)
  • Arizona Agrees to Stop Using Drug Tied to Botched Executions (New York Times-$)
  • FDA Offers New Bioequivalence Recommendations for 31 Active Ingredients, 13 Revisions (Focus)
  • CDRH Lays Out Guidance Plans for FY 2017 (Focus)
  • Medtronic supply chain snafu delays Aussie operations (Mass Device)

In Focus: International

  • European Commission: Entry into force of MDR, IVDR set for late May 2017 (Mass Device)
  • China reports first two human deaths from bird flu this winter (Reuters)
  • Ebola vaccine highly effective, WHO says (AP) (Reuters)
  • Swiss scientists to regain full access to EU research programmes (Nature News)
  • Many Brazilian women avoiding pregnancy due to Zika fears: study (Reuters)
  • Myanmar govt proposes tender for massive purchase of generic medicines (PharmaBiz)
  • BioNet Received Thai FDA Approval of the World's Only Available Recombinant Monovalent Acellular Pertussis (aP) Vaccine (PR)
  • Indian pharma hiring trends for 2017 indicate robust manpower growth across quality control & manufacture
  • Angola declares end to world's worst yellow fever epidemic in decades (Reuters)

US: Pharmaceuticals and Biotechnology

  • Courtesy of Intrexon, a cautionary tale for trusting investors (EP Vantage)
  • Expanding CRISPR toolkit may render patent fight moot (C&EN)
  • Bio Roundup: Crazy ’16, Trials of ’17, Senate on Drugs & More (Xconomy)
  • Did Big Pharma Hire Dozens Of DEA Officials To Reduce Scrutiny Of Opioid Painkillers? (Consumerist)

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

  • Pain relievers tied to hearing loss (NY Times-$)

Medical Devices

  • Takeaways From China's Antitrust Case Against Medtronic (Law360-$)
  • Varian Medical Systems puts up $276m for PerkinElmer’s medical imaging biz (Mass Device)
  • Milestone Scientific closes $3m round (Mass Device)
  • ZipLine Medical wins Chinese clearance, launches Zip surgical skin closure device (Mass Device)

US: Assorted and Government

  • FDA Warns Health Care Providers Against Relying Solely on Zika Virus Serological IgM Assay Results; Reminds them to Wait for Confirmatory Test Results Before Making Patient Management Decisions: FDA Safety Communication (FDA)
  • New Obama Innovation Hub Targets Artificial Skin For Soldiers (Law360-$)

Upcoming Meetings and Events             

General Health and Other Interesting Articles

  • Despite Pledges To Cut Back, Farms Are Still Using Antibiotics (NPR)

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.

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