Regulatory Focus™ > News Articles > Regulatory Recon: GPhA, BIO Come Together on Biosimilars Substitution (10 December 2014)

Regulatory Recon: GPhA, BIO Come Together on Biosimilars Substitution (10 December 2014)

Posted 10 December 2014 | By Alexander Gaffney, RAC

Regulatory Recon: GPhA, BIO Come Together on Biosimilars Substitution (10 December 2014)

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

In Focus: US

  • GPhA, BIO Create ‘Compromise Legislation’ for State Biosimilar Substitution (IHP-$) (FDAnews-$) (GPhA)
  • Funding deal gives Ebola $5.4bn; FDA, NIH slight boosts (SCRIP-$) (FDA Attorney)
  • FDA ‘Real-Time’ Communications Deemphasize Phone Calls (Pink Sheet-$)
  • Broad Provider and Pharmacy Coalition Urges Congress to Fix Drug Quality and Security Act (Press)
  • Brookings roadmap outlines UDI implementation (Fierce) (FDA)
  • FDA postpones panel meeting for VertiFlex's Superion spine device (Mass Device)(FDA)
  • They Know You Buy Viagra and They Want to Sell You More (Bloomberg)
  • FDA Faces Mounting Pressure to Ban Powdered Caffeine (NPI) (FSN) (FPD) (AP)

In Focus: International

  • Germany names 16 companies with drugs suspended over Indian data (Reuters)
  • EC Establishes Blood Directive Definitions (EC)
  • India Spending Big to Strengthen Regulatory Systems (PharmaBiz)
  • Indian Industry wants govt. to fast track regulatory approvals & renewals of licenses (PharmaBiz)
  • India Wants Price Controls on Medical Devices (India Times)
  • Trade groups weigh in on China FDA's biosimilars guidance (BioCentury)

US: Pharmaceuticals and Biotechnology

  • GPhA, BIO Create ‘Compromise Legislation’ for State Biosimilar Substitution (IHP-$) (FDAnews-$) (GPhA)
  • FDA ‘Real-Time’ Communications Deemphasize Phone Calls (Pink Sheet-$)
  • Broad Provider and Pharmacy Coalition Urges Congress to Fix Drug Quality and Security Act (Press)
  • FDA Posts Advisory Committee Materials About Pediatric Written Requests For Three Investigational Cancer Drugs (Tarius)
  • From Bench to FDA to Bedside: US Regulatory Trends for New Stem Cell Therapies (PubMed)
  • BIO: Secretary Burwell’s PREP Act Declaration Will Advance Ebola Vaccine Development (Press)

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

  • ARCA biopharma Receives FDA Orphan Drug Designation for rNAPc2 as a Potential Treatment for Ebola (Press)
  • Lundbeck and Otsuka present Phase III results of brexpiprazole in major depressive disorder  (Pharma Letter-$)
  • Merck Checkpoint Inhibitor Shows Activity in Hard-to-Treat Form of Breast Cancer (The Street) (WSJ-$)
  • Special K, a Hallucinogen, Raises Hopes and Concerns as a Treatment for Depression (NYTimes)
  • Lilly psoriasis drug hits Phase-III endpoint (MM&M) (SCRIP-$)
  • Immunovaccine Gets FDA Fast Track Status For DPX-Survivac For Ovarian Cancer (RTT) (Press)
  • UAB marijuana oil study still awaiting FDA approval (Gannett)

US: Pharmaceuticals and Biotechnology: General

  • They Know You Buy Viagra and They Want to Sell You More (Bloomberg)
  • Lawyers Gearing up to Take on Pricing of Gilead's Sovaldi (Press)
  • Ohio lawmakers debate execution drugmaker bill (AP)

US: Medical Devices

  • Shuren: Implementing the Unique Device Identifier System into health care systems is critical for reaching its potential to benefit public health (FDA)
  • Brookings roadmap outlines UDI implementation (Fierce)
  • FDA postpones panel meeting for VertiFlex's Superion spine device (Mass Device)(FDA)
  • Battelle to offer cybersecurity services for medtech companies (Mass Device)
  • Renal denervation: Analysis highlights 'confounding' factors in Medtronic's Symplicity-3 trial (Mass Device)
  • Cyberdyne Wants to Offer Robot Suit HAL in the U.S. (IEEE)
  • Medtronic touts long-term data for Endurant stent graft (Mass Device)
  • Class 1 Device Recall for Covidien Ventilator (FDA)

US: Dietary Supplements

  • Natural Organics, Inc. to FDA: Don’t Add Supplements to Redbook (WholeFoodsMag)
  • FDA Faces Mounting Pressure to Ban Powdered Caffeine (NPI) (FSN) (FPD) (AP)
  • Dietary Supplements Containing Live Bacteria or Yeast in Immunocompromised Persons: Warning - Risk of Invasive Fungal Disease (FDA)

US: Assorted And Government

  • Funding deal gives Ebola $5.4bn; FDA, NIH slight boosts (SCRIP-$) (FDA Attorney)
  • Chiji Ogbuka, Regulatory Affairs Manager for Health Decisions, Among Those Killed in Plane Crash (WRAL) (ABC 11) (BizJournal)
  • Only Thirty Days Left to Renew Facility Registration (FDA Attorney)

Upcoming Meetings

Ebola Outbreak

  • Mass drug campaign needed to fight malaria in Ebola countries: expert (Reuters)

Europe

  • Germany names 16 companies with drugs suspended over Indian data (Reuters)
  • EC Establishes Blood Directive Definitions (EC)
  • Europe Edges Toward a New Understanding on HTA (PharmExec)
  • Lupin Fights EU's 'Wholly Novel' Pay-For-Delay Fine (Law 360-$)
  • HTA: The methodological guideline on “Meta-analysis of diagnostic test accuracy studies” now available (EUnetHTA)
  •  EFPIA gives president role to Novartis chief executive (Pharmafile) (PharmaTimes)

India

  • Centre launches schemes to strengthen CDSCO & states' drug regulatory systems at Rs. 1750 cr (PharmaBiz)
  • Industry wants govt. to fast track regulatory approvals & renewals of licenses (PharmaBiz)
  • National Pharmaceutical Pricing Authority asks companies to reveal MRPs of medical devices (India Times)

China

  • Trade groups weigh in on China FDA's biosimilars guidance (BioCentury)
  • China FDA Set To Greenlight First Domestic Lymphoma Drug (PharmAsia-$)

Australia

  • Pfizer payout: Parkinson’s drug caused sex, gambling, shopping addictions (Herald Sun)

Other International

  • Partnering with Russia to Develop Quality Drug Standards (USP)

Clinical Trials

  • Evolution of the Clinical Data Management Role, 1994-2014 (BioClinica)

General Regulatory And Interesting Articles

  • Five Common Issues that could Jeopardize Training Compliance (MasterControl)

Regulatory Reconnaissance #456 – 10 December 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 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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