Recon: Ebola Vaccine Arrives in DRC

Regulatory NewsRegulatory News
| 21 May 2018 | By Zachary Brennan 

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

In Focus: US
  • ALS patients losing time and hope as they wait for insurers to cover a pricey new drug (Stat)
  • Nabriva goes 2 for 2 in Phase III antibiotic program, scoring on a key catalyst and teeing up an FDA pitch for lefamulin (Endpoints) (Reuters) (Fierce)
  • FDA approves new drug for patients with chronic liver disease (FDA)
  • Biosimilar Approval: Better, Stronger, Faster (FDA Law Blog) (Citizen Petition)
  • Requiring Prices in Drug Ads: Would It Do Any Good? Is It Even Legal? (NYT-$)
  • BD chief George Golumbeski is the latest top exec to exit Celgene (Endpoints)
  • AstraZeneca potassium drug finally approved, threatening Vifor (Reuters)
  • More Competition for Pharma (WSJ Editorial)
  • Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA Alerts Health Care Professionals and Investigators (FDA)
  • McCaskill letters to DoD and VA on Teva (HSGAC)
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In Focus: International
  • Ebola Vaccine Arrives in Democratic Republic of Congo (WSJ-$) (Reuters)
  • WHO supports Ebola vaccination of high risk populations in the Democratic Republic of the Congo (WHO)
  • AstraZeneca rocked by shareholder revolt over executive pay (Guardian)
  • Janssen Announces European Commission Approval of Juluca (dolutegravir/rilpivirine), the First Two-Drug Regimen, Once-Daily, Single-Pill for the Treatment of HIV-1 (Press)
  • Tedros Makes His Case for a Transformed WHO (Global Health Now) (Delegate List)
  • MHRA, March 2018 ‘GXP’ Data Integrity Guidance and Definitions (Lachman Consultants)
Pharmaceuticals & Biotechnology
  • Amgen And Avalere Reports Reveal "Upside Down" Payer Biosimilar Realities (Biosimilar Development)
  • Top 20 Best Selling Drugs in 2018 (IGEA Hub) (BioSpace)
  • Galecto brings on GSK’s fibrosis lead as CMO (Fierce)
  • Cantor Fitzgerald: 18 Drug Companies With Catalysts Worth Watching (Benzinga)
  • FDA just approved the first drug to prevent migraines. Here’s the story of its discovery—and its limitations (Science Magazine)
  • FTC Admin. Judge Says Endo-Impax Opana Deal Is Lawful (Law360-$)
  • Bioasis and WuXi Biologics Announce Initial Strategic Collaboration for the Development and Manufacturing of xB3-001, the Company’s Lead Investigational Candidate to Treat Brain Cancer (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Beta receives FDA go-ahead for home trials of AI-guided bionic pancreas (Fierce)
  • Small molecule could help modulate the microbiome (C&EN)
  • Roche drug dramatically reduces bleeds in key hemophilia tests (Reuters) (Press)
  • Richard Lehman’s weekly journal review—21 May 2018 (BMJ)
  • Monoclonal Antibodies for Migraine Prevention: Progress, but Not a Panacea (JAMA)
  • TV scientists star in AstraZeneca's first ad campaign for asthma biologic Fasenra (Fierce)
  • Fixing the Clinical Trial Bottleneck by Making Patients a Priority (Xconomy)
Medical Devices
  • The Theranos deception (60 Minutes)
  • Interview – Boston Scientific’s plan to keep the rhythm going (EP Vantage)
  • Don’t Put That in My Heart Until You’re Sure It Really Works (NYT-$)
  • Updated list of PMAs approved (FDA)
  • Medtronic Recalls MindFrame Capture LP Revascularization Device Due to Wire Material That May Break or Separate During Use (FDA)
  • Medtronic Faces Cybersecurity Risk for Clinical Programmer (MDDI)
  • User Session - Digital Health Software Precertification (Pre-Cert) Pilot Program - May 10, 2018 (FDA)
US: Assorted & Government
  • House Rules Committee to Talk Right-to-Try tonight (House Rules)
  • Trump official on defensive as critics scoff at drug plan (The Hill)
  • Trump’s New Health and Human Services Secretary Is a Joyful Regulator (NYT-$)
  • HHS Seeks Public Comments on Trump Administration's Plan to Lower Drug Prices (Big Molecule Watch)
  • Medicines were tainted with pesticides in sloppy drug facility, FDA warns (Ars Technica)
  • Avalere Analysis Highlights Complexities of Transitioning Medicare Part B Drugs into Part D (Avalere)
  • FDA Is Continuing to Crack Down on Youth E-Cigarette Use (Time)
  • ACRO opposes “fatally flawed” right-to-try legislation (ACRO)
  • House Appropriators Warn US FDA: Stop Working On Electronic Labeling Rule (Pink Sheet-$)
  • Framework for Assessing pH-Dependent Drug-Drug Interactions; Establishment of a Public Docket (Federal Register)
  • Advisory Committee; Blood Products Advisory Committee; Renewal (Federal Register)
  • Proposed Collection; Comment Request; Guidance for Industry: Controlled Correspondence Related to Generic Drug Development (Federal Register)
  • Justice Department rescinds order stopping opioid sales by Louisiana distributor (Washington Post-$)
Upcoming Meetings & Events Europe
  • PRAC recommends new measures to minimise risk of rare but serious liver injury with Esmya for fibroids (EMA)
  • London hospitals to replace doctors and nurses with AI for some tasks (Guardian)
  • To B or not to B (MHRA Med Regs Blog)
  • Europe’s open-access drive escalates as university stand-offs spread (Nature)
  • Third industry stakeholder platform on research and development support (EMA)
  • EMA review of Zinbryta confirms medicine’s risks outweigh its benefits (EMA)
  • PM May challenges scientists to help transform Britain after Brexit (Reuters)
  • ABPI responds to PM speech on plans to transform outcomes for people with chronic diseases (ABPI)
  • Launch of a new partnership to improve development of new drugs for children in Europe (Press)
  • Pakistan Has Just One New Polio Case, but Isn’t Declaring Victory Yet (NYT-$)
  • China comes to Europe (BioCentury)
  • Health Care Reforms in India (JAMA)
  • Deadly Nipah virus claims victims in India (BBC)
  • Submissions received: Proposal to change the medicine GMP fees and charges (TGA)
General Health & Other Interesting Articles
  • The Opioid Crisis Is Not Just An American Epidemic (Buzzfeed)
  • Death of a biohacker (NYT-$)
  • When a great researcher isn’t a great person (C&EN)
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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