Regulatory Focus™ > News Articles > Regulatory Recon: Purdue's Zohydro Competitor Gets Priority Review Status (8 July 2014)

Regulatory Recon: Purdue's Zohydro Competitor Gets Priority Review Status (8 July 2014)

Posted 08 July 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Purdue's Zohydro Competitor Gets Priority Review Status (8 July 2014)

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

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In Focus: US

  • Purdue’s Abuse-Resistant Pill Gets FDA Priority Review (Bloomberg) (Press)
  • FDA Denies Ex-Staffer’s LASIK Petition After 30 Months (MDDI)
  • FDA Confident About Postmarket Requirements For Expedited Device Approvals (IHP-$)
  • Few Think the FDA Will Reclassify Marijuana (Roll Call)
  • FDA Was Wrong About Google Functionality (RegulatoryRX)

In Focus: International

  • CDSCO issues raft of new trial regulations (In-Pharma)
  • Novartis Issues Research Guidelines After Japan Study Scandal (Bloomberg)
  • China Sees Lobbying Tug-Of-War Over Drug Registration Regulation (PharmAsia-$)
  • UK Review of Antibiotics Will Take Too Long, Critics Say (PharmaPhorum)
  • EU to slap big fine on French drugmaker Servier: sources (AFP)

US: Pharmaceuticals and Biotechnology

  • FDA Was Wrong About Google Functionality (RegulatoryRX)
  • KV Lawsuit Involving MAKENA and Compounded 17p Concludes . . . . In Sopranos Style (FDA Law Blog)
  • Clinical Data Transparency Would Counter-Balance Off-Label Promotion – NEJM (Pink Sheet-$)
  • FDA Social Media Guidance Webinar (RegulatoryRX)
  • Bausch + Lomb blames weather for recall of 880,000 tubes of eye ointment (Fierce)
  • FDA Approves NovoSeven RT for the Treatment of Glanzmann's Thrombasthenia (GT) With Refractoriness (Press)
  • FDA Approves Anacor Pharmaceuticals’ KERYDIN (Tavaborole) Topical Solution, 5% for the Treatment of Onychomycosis of the Toenails (Press)
  • Compassionate Use Questions Could Arise At FDA/Patient Meeting On IPF Treatments (Pink Sheet-$)
  • Requests for Nominations: Cellular, Tissue, and Gene Therapies Advisory Committee (FDA)
  • Pfizer Faces 3 Class Actions Over Generic Delay Scheme (Law 360-$)
  • Sanofi Sues To Block Unimark’s Generic Multaq (Law 360-$)
  • Consumer Reports advises against using spray sunscreen on kids while FDA investigates (WPTV)

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

  • Purdue’s Abuse-Resistant Pill Gets FDA Priority Review (Bloomberg) (Press)
  • Novartis, UPenn get breakthrough status for CAR-T therapy (BioCentury) (Fierce) (Press) (SCRIP-$) (Pharma Times)
  • Eagle Pharmaceuticals Receives Orphan Drug Designation for Lower Volume, Shorter Infusion Time Bendamustine Hydrochloride Product for Chronic Lymphocytic Leukemia and Indolent B-Cell Non-Hodgkin’s Lymphoma (Press)
  • Celltrion to target US next for Remicade biosim approval (SCRIP-$)
  • Sanofi's NDA for basal insulin Toujeo accepted by FDA (Pharma letter-$) (PMLive) (Press)
  • InSite Vision Plans to Submit New Drug Application to FDA for DexaSite for the Treatment of Blepharitis in Adults (Press)

US: Pharmaceuticals and Biotechnology: General

  • Report: When it comes to drug spending, DOD pays the highest price (Fierce)
  • Yet another major report on antibiotic resistance (TIE)

US: Medical Devices

  • FDA Denies Ex-Staffer’s LASIK Petition After 30 Months (MDDI)
  • FDA Confident About Postmarket Requirements For Expedited Device Approvals (IHP-$)
  • EarlySense Chair Sensor Monitors Vitals Through The Butt (MedGadget)
  • J&J Pays Oregon $4M To Settle Hip Implant Marketing Claims (Law 360-$)
  • FDA Clears NeuroMetrix Wearable Technology for Over-the-Counter Use in Treatment of Chronic Pain (Press)
  • Ulthera device clears FDA for décolleté on heels of Merz acquisition plans (Fierce)
  • FDA Classifies ConvaTec’s Voluntary Global Recall of Flexi-Seal™ CONTROL Fecal Management System (FMS) as Class I (FDA)
  • Vascular Solutions Langston V2 Dual Lumen Catheters (Models 5540 and 5550) - Inner Catheter May Separate During Use and Cause Injury (FDA)

US: Assorted And Government

  • FDA Weighs Role Overseeing the Marijuana Trade (Roll Call)
  • Few Think the FDA Will Reclassify Marijuana (Roll Call)
  • Congressman Mike Honda Urges FDA to Overturn Ban on Gay Blood Donors (NBC)
  • New York governor signs medical marijuana bill into law (Reuters) (Law 360-$)

Europe

  • ENVI Elects New Chair, Vice Chair (ENVI) (ENVI)
  • UK Review of Antibiotics Will Take Too Long, Critics Say (PharmaPhorum)
  • When can a CEP be withdrawn? (ECA)
  • How can a CEP for a starting material be used in a CEP application for an API? (ECA)
  • EU to slap big fine on French drugmaker Servier: sources (AFP)
  • Scottish Medicines Consortium Accepts Genzyme's Lemtrada for Use in RRMS (SMC)
  • SMC negative on Celgene’s Imnovid for MM (Pharma Letter-$) (SMC) (Pharma Times) (Pharmafile)
  • SMC Restricts Use of Roche's Mabthera, AZ's Forxiga, UCB's Cimzia and Allergan's Botox
  • SMC Recommends Against Use of Botox for Focal Lower Limb Spasticity (SMC)
  • SMC Recommends Fostair for COPD (SMC)
  • SMC Recommends Against Use of Priligy for PE (SMC)
  • Merck Says It Regrets Strong-Arming Italian Researcher (Forbes)
  • Pharma Hopes EU Commission Policy Report Will Lead To Real Dialogue (Pink Sheet-$)
  • Gruenenthal submits Zalviso MAA (BioCentury)

India

  • CDSCO issues raft of new trial regulations (In-Pharma)
  • Government Presses MNCs To Sell In India Drugs Tested In India (PharmAsia-$) (India Times)
  • USFDA enforcements to push up costs for Indian pharma (India Times)
  • CDSCO to set up training academy in Hyderabad with investment of Rs.50 cr (PharmaBiz)

China

  • China Sees Lobbying Tug-Of-War Over Drug Registration Regulation (PharmAsia-$)
  • China Redrafting Regulatory Process for Dietary Supplements (Nutritional Outlook)

Japan

  • Novartis Issues Research Guidelines After Japan Study Scandal (Bloomberg)
  • Nippon Kayaku announces marketing approval of infliximab biosimilar in Japan (BioSimilar News)
  • Ono receives marketing approval for Opdivo in Japan (Press)

Canada

  • Canadian drug regulators give thumbs up to Bayer’s FDA-approved thyroid cancer treatment (MedCity News)
  • BioMarin wins OK in Canada for Morquio A drug Vimizim (SCRIP-$) (Press)
  • Health Canada gives GSK 30 days to show how it will fix its vaccine plant (Fierce)

Australia

  • Australia Relaxing Limits on HIV Self-Testing Kits (AU)
  • Australia’s TGA clears the way for Gilead’s Sovaldi for hepatitis C (Pharma Letter-$)
  • Australian patients mobilise to fight Kalydeco block (PharmaPhorum)

Other International

  • Meet the 23-year-old TB survivor taking on South Africa's patent laws (Guardian)
  • IMDRF Unveils Locations of Upcoming Meetings (IMDRF)

Clinical Trials

  • CDSCO issues raft of new trial regulations (In-Pharma)
  • Government Presses MNCs To Sell In India Drugs Tested In India (PharmAsia-$) (India Times)
  • Novartis Issues Research Guidelines After Japan Study Scandal (Bloomberg)

General Regulatory And Interesting Articles

Regulatory Reconnaissance #352 – 8 July 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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