Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Industry Weighs in on FDA’s Biosimilars Guidance (15 August 2014)

Regulatory Reconnaissance: Industry Weighs in on FDA’s Biosimilars Guidance (15 August 2014)

Posted 15 August 2014 | By Alexander Gaffney, RAC

Regulatory Reconnaissance: Industry Weighs in on FDA’s Biosimilars Guidance (15 August 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Your editor is taking a mini-vacation through Monday, 18 August 2014. Regulatory Reconnaissance will likely not be published on the 18th as a result.

In Focus: US

In Focus: International

US: Pharmaceuticals and Biotechnology

  • PhRMA, BIO, Industry Take Aim at Biosimilars Guidance ( DrugWonks) ( Law 360-$) ( Pink Sheet-$) ( BioCentury) ( All Comments)
  • Why FDA’s Approval of Merck’s Belsomra Was Highly Unusual ( New Yorker) ( Public Citizen) ( Pink Sheet-$) ( EP Vantage-$)
  • FDA approves Avastin to treat patients with aggressive and late-stage cervical cancer ( FDA) ( Press) ( SCRIP-$) ( PharmaPhorum) ( Pharma Times)
  • FDA’s JumpStart Program Wins Coveted Government Award ( FDA)
  • FDA Guides Biologics Makers On Safety Evaluations ( Law 360-$)
  • FDA committee backs Boehringer's Spiriva Respimat ( BioCentury) ( Press) ( MedPage Today) ( Pink Sheet-$) ( SCRIP-$)
  • Re-Designed MedGuides Would Significantly Improve Patient Comprehension  ( PubMed)
  • Wockhardt Initiates Recall of 840 Bottles of Antidepressant Bupropion After Impurities Found ( FDA)
  • Sun Pharma unit recalls mutiple lots of capsules from US ( India Times) ( FDA) ( FDA)
  • Generic Drug Company Already Seeking Approval for Generic Zohydro ( Press)
  • Big Data Can Yield Big Insights On Promotional Practices ( Law 360-$)
  • API sales down 81% as Ranbaxy feels fallout from US import alerts ( In-Pharma)
  • Impax Hit With Investor Class Action After FDA Criticism ( Law 360-$)
  • Amgen Recalls Aranesp Prefilled Syringes in Several Countries Outside of the U.S. Due to the Presence of Visible Particulates ( Press)
  • Baxter Voluntarily Initiates U.S. Recall of Two Lots of Peritoneal Dialysis Solution Due to Presence of Particulate Matter ( FDA)
  • Family Seeks Compassionate Use Access to Retrophin Drug ( Bismarck Tribune)

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

  • Priority Review for Pfizer's meningitis B vaccine ( Press) ( BioCentury)
  • FDA grants fast track status for Agios's AG-221 to treat AML ( Press)
  • FDA seeks more data on Acura's abuse-resistant pain drug  ( Reuters) ( Press)
  • Coherus reports PK data for Humira biosimilar ( BioCentury) ( Biosimilar News)
  • Achillion Achieves 100 Percent Sustained Virologic Response Rate (SVR4) From an Eight Week Phase 2 Trial Evaluating a Ribavirin-Free Regimen of ACH-3102 and Sofosbuvir for Genotype 1 HCV ( Press)
  • FDA Accepts CorMedix, Inc. Pivotal Phase 3 Study Protocol ( Press)
  • Safety and Effectiveness of Bevacizumab-Containing Treatment for Non-Small-Cell Lung Cancer: Final Results of the ARIES Observational Cohort Stud ( PubMed)
  • Experimental chikungunya vaccine shows promise in human trial ( Reuters) ( MNT) ( Bloomberg) ( NIH)

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • Attacker could use default defibrillator password to launch denial of service ( Network World)
  • A Supremely Weird Case About Seimens, North Korea and Alleged Bribery ( Scout)
  • Yes, medical device security is lousy - so what? ( Network World)
  • Distributor Sues Biz Partner Over FDA Alert, IP Row ( Law 360-$)
  • Fuzzing: A Solution Chosen by the FDA to Investigate Detection of Software Vulnerabilities ( AAMI-$)
  • Controlling for Cybersecurity Risks of Medical Device Software ( AAMI-$)
  • Enhancement Medical recalls all product over manufacturing concern ( Mass Device) ( FDA)
  • Class I Recall for Cardiovascular Systems’ Diamondback 360 Atherectomy System ( FDA)

US: Assorted And Government

  • The FDA wants to use Minecraft to keep people from smoking ( The Verge)

Ebola Outbreak

  • Beware Of Fraudulent Ebola Supplements ( Forbes) ( The Hill) ( FDA) ( Reuters)
  • Liberia Gets ZMapp, Ponders Who Should Get It ( AP)
  • How a Canadian Prairie city made an Ebola vaccine ( Reuters)



  • Japan Recommends Long-Acting G-CSF Filgrastim ( PharmAsia-$)


  • What's in a name? China seeks to make device names more generic ( Clinica-$)
  • GSK Investigators Agree to Jail Time ( FT-$)
  • Roche taps drug stockpile to aid China earthquake relief efforts ( In-Pharma)

Other International

  • Pharmacopeial Modernization and Harmonization Efforts Spurred by Global Supply Chain Regulatory Needs; China’s Pharmacopeia Among Asian Participants ( IPQ)
  • UNODC Failing to Tackle Substandard Medicines ( S4S)

Clinical Trials

  • EFPIA: A 3D View of Responsible Clinical Data Sharing ( EFPIA) ( SCRIP-$)

General Regulatory And Interesting Articles

  • How A Dissolvable 'Tampon' Could One Day Help Women Stop HIV ( NPR)
  • Broader organ sharing won't harm liver transplant recipients ( Press)

Regulatory Reconnaissance #380 – 15 August 2014

RegulatoryReconnaissance is our daily intelligence briefing for the regulatory affairsspace, bringing you the top regulatory news stories from around the globe. Eachweekday morning, we aim to bring you the latest highlights of new approvals,meetings, legal and political developments, regulations and guidance, and thelatest trends with the potential to impact regulatory affairs professionals andthe industry in which they work.

Did we miss a story?Send us a tweet at @RAPSorg and we'll check it out for inclusion in ournext edition of Regulatory Reconnaissance. Want this in your inbox eachmorning? Sign up for RF Today, our morning intelligence newsletter here.

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