Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Breakthrough Pathway Leads to Speedy Approval for Novartis (30 April 2014

Regulatory Reconnaissance: Breakthrough Pathway Leads to Speedy Approval for Novartis (30 April 2014)

Posted 30 April 2014 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

In Focus: International

  • New EMA Scientific Guideline on Process Validation for Biologics (EMA)
  • China: After GSK Debacle, Drug Gifting Rules To Be Standardized And Regulated (PharmAsia-$)
  • Analysis of Medical Device Regulatory Changes in China (Emergo)
  • South African Regulators Publish Draft Medical Device and IVD Regulation (Emergo)
  • World Medical Association Considering Policies on Biobanks and Clinical Trial Databases (WMA)
  • Following the biologic path: Biosimilar regulations in Canada, the US and Europe all have a degree of uncertainty (PMLive)

US: Pharmaceuticals/Biotechnology

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

  • Amicus Therapeutics rare disease drug effective in trial (Reuters) (BioCentury) (Fierce)
  • Purdue Pharma L.P. Submits NDA for Once-Daily Hydrocodone Bitartrate Extended-Release Tablets Formulated to Incorporate Abuse-Deterrent Properties (Press)
  • GlaxoSmithKline Gains Priority Review Designation for Promacta/Revolade for Severe Aplastic Anemia (Press)
  • Bristol-Myers heads to FDA with nivolumab, but not fast enough (Fierce)
  • Shire says new dry-eye drug fails to meet trial goal (Reuters)
  • Teva Reports Positive Results from Pivotal Phase III Study to Evaluate Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Moderate to Severe Chronic Low Back Pain (Press)
  • FDA, Armetheon Agree on SPA for Oral Anticoagulant (DD&D)
  • FDA Accepts for Review Otsuka Pharmaceutical and Lundbeck's Supplemental New Drug Application to Expand Abilify Maintena (aripiprazole) Labeling (Press)

US: Pharmaceuticals and Biotechnology: General

  • Botched Execution of Oklahoma Inmate Puts Focus on Drug Regulation and Transparency (NYTimes) (AP) (Vox)
  • In Defense Of "Me-Too" Drugs: Is Primary Care Losing Out To Rare Disease R&D? (In Vivo-$)
  • Sticker Shock in Drug Pricing: Are We Missing the Bigger Picture? (Context Matters)
  • Pharma pumps up lobbying spend (MM&M)
  • Mass. doctors are getting fewer gifts from drug and device companies (BioFlash)

US: Medical Devices

  • FDA Shells Out $500K for MDIC Patients' Perspective Study (MDDI)
  • Johnson & Johnson Suspends Sale of Power Morcellators Used in Fibroid Surgery (WSJ-$) (Reuters)
  • FDA again warns AMS and Endo Health on pelvic mesh, implants for men (Mass Device)
  • FDA flags Teleflex for repeat violations at Illinois plant (Mass Device) (FDA)
  • Intuitive Surgical touts new data on robot-assisted lung surgery (Mass Device)
  • Recall for HeartWare LVAD Device Due to Faulty Connector (FDA) (FDA)
  • CryoLife Receives FDA 510(k) Clearance for PerClot Topical Hemostatic Powder in the U.S. (PR Newswire)
  • Carestream's Newest Image Acquisition/Mini-PACS Software Receives FDA 510(k) Clearance for Viewing on iPad Mobile Devices (Press)

US: Dietary Supplements

  • Why Dangerous Supplements Linger on Store Shelves (NYTimes)
  • What DSHEA is Missing: Carrots! (NPI)
  • One third of Americans mixing supplements with meds: study (Reuters)

US: Assorted And Government

  • Quality Management: How Much Are Vendors To Blame? (Life Science Leader)
  • SCOTUS Justices Question Why FDA, Trademark Law Can't Work Together (IHP-$)

Europe

  • EC approves Biomarin rare genetic disorder drug (PMLive)
  • New EMA Scientific Guideline on Process Validation for Biologics (EMA)
  • Otsuka Wins European Marketing Authorization for Deltyba (delamanid) (Press)
  • EC approves Teva's DuoResp Spiromax (BioCentury)
  • EU's Unified Patent Court nears the home straight (SCRIP-$)
  • Changes at EU standards board as healthcare services and device apps demand attention (Clinica-$)
  • Draft European Union individual case safety report (ICSR) implementation guide (EMA)
  • An Introduction To Pharmaceutical Parallel Trade In Europe (Life Science Leader)

India

Japan & China

  • China: After GSK Debacle, Drug Gifting Rules To Be Standardized And Regulated (PharmAsia-$)
  • Medical Device Regulatory Changes in China: Emergo Group Analysis (Emergo)

Other International

  • World Medical Association Considering Policies on Biobanks and Clinical Trial Databases (WMA)
  • South African Regulators Publish Draft Medical Device and IVD Regulation (Emergo)

General Regulatory And Interesting Articles

  • Following the biologic path: Biosimilar regulations in Canada, the US and Europe all have a degree of uncertainty (PMLive)
  • A Long Look at Fecal Microbiota Transplants (FMT) (Mosaic)
  • Drug resistance found worldwide, new drugs needed (AP)
  • Swiss gold delivers hope as carrier for cancer drugs (In-Pharma)
  • J&J Eases Access for Tuberculosis Drug in Poor Nations (Bloomberg)

Regulatory Reconnaissance #308 - 30 April 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.

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

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.


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