Regulatory Recon: FDA Approves Merck's New Sleep Drug Belsomra (14 August 2014)

Posted 14 August 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA Approves Merck's New Sleep Drug Belsomra (14 August 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register by 29 August 2014 to receive the lowest rate.

In Focus: US

In Focus: International

  • India's flawed drug inspection (S4S)
  • A Whistleblower Goes Public Against China's FDA (Foreign Policy)
  • Canadian drugmaker Tekmira says not ready to make experimental Ebola drug available in Africa (AP) (WSJ-$) (Bloomberg)
  • Updates, patches, add-ons, plugins & the Blue Guide (Medical Devices Legal)

US: Pharmaceuticals and Biotechnology

  • FDA approves Merck's Belsomra (suvorexant) (BioCentury) (Fierce) (FDA) (BioPharma Dive) (Pharma Times) (SCRIP-$) (Reuters) (Press) (Bloomberg)
  • Without User Fees, OTC Monograph Changes Have Low Priority At FDA (Tan Sheet-$)
  • New Generic Drug Review Policies Raise Eyebrows Of Former FDA Officials (IHP-$)
  • FDA reviewers highlight mixed safety for Spiriva Respimat (BioCentury)
  • How Rare is the MC-to-PC Basis for Demonstrating that Two Drugs Are Not the Same Orphan Drug? Another Precedent Surfaces (FDA Law Blog)
  • Biosimilar firms must be ready for US 'patent dance,' says IP lawyer (Biopharma Reporter)
  • Tauzin: Path Needed For Cures That Spans Financing To Reimbursement (IHP-$)
  • Mini-Sentinel Study Can’t Determine If Risk Of Diabetes Varies Between Antipsychotics (Pink Sheet-$)
  • B. Braun Receives FDA Approval for Nutrilipid 20% (Press)
  • Podcast: Review of the Week's top Pharma Stories (Pink Sheet-Soundcloud)

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

US: Pharmaceuticals and Biotechnology: General

  • Second Turkish Man Pleads Guilty to Smuggling Fake Cancer Drugs (WSJ-$)
  • CDC backs routine use of Prevnar 13 in adults over 65 (BioCentury) (Press) (Reuters)
  • Merck Statement regarding Role of PNEUMOVAX 23 (Pneumococcal Vaccine Polyvalent) in Updated ACIP Recommendations for Pneumococcal Vaccination in Adults (Press)

US: Medical Devices

  • CDRH Urges Firms To Close Loop On CAPAs, Create Filters To Weed Out Poor Quality Data (Silver Sheet-$)
  • Bionic pancreas tested in diabetic kids at a summer camp (CBS)
  • Pew Charitable Trusts: Poor EHR interoperability 'hinders' accurate med device assessments (Fierce)
  • TMJ Health LLC Announces New FDA Cleared Treatment for TMJD, Temporomandibular Joint Disorders (Press)

Ebola Outbreak

  • Canadian drugmaker Tekmira says not ready to make experimental Ebola drug available in Africa (AP) (WSJ-$) (Bloomberg)
  • Canadian Company NewLink says Ebola vaccine trial could start in weeks (Reuters) (The Hill) (BioCentury)
  • Consignment of experimental Ebola drug arrives in Liberia (Reuters)
  • $4.1M in NIAID funding should carry BioCryst’s hemorrhagic fever drug into human studies (MedCity News) (Reuters)
  • Shenzhen company develops kit to test for Ebola virus, report says (SCMP)


  • Updates, patches, add-ons, plugins & the Blue Guide (Medical Devices Legal)
  • Zoely not recommended over established combined oral contraceptives (PJO)
  • New EU Clinical Trials Regulation (PCM)


  • India's flawed drug inspection (S4S)
  • Expert panel on FDC to assess safety and efficacy of several FDCs on August 22 (PharmaBiz)


Other International

  • Medicines New Zealand Issues New Social Media Rules For Drug Firms (PharmAsia-$)

Clinical Trials

  • Most discontinued trials remain unpublished (AllTrials)
  • So That’s How Much A CV Outcomes Study Costs: $40 Mil. Per Year (RPM Report)
  • How not to compare observational studies to a randomized trial (TIE)

General Regulatory And Interesting Articles

  • The Cost of Poor Quality Medicine and Foods (USP)
  • Electron Theft, Not Drug Effects, May Be How Anesthesia Knocks People Out  (SciAm)
  • Efficacy of High-Dose versus Standard-Dose Influenza Vaccine in Older Adults (NEJM)
  • Schoolchildren Who Add Hand Sanitizer To Washing Still Get Sick (NPR)

Regulatory Reconnaissance #379 – 14 August 2014

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 @AlecGaffney or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles