Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves Abuse-Resistant Competitor to Zohydro (21 November 2014)

Regulatory Recon: FDA Approves Abuse-Resistant Competitor to Zohydro (21 November 2014)

Posted 21 November 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Approves Abuse-Resistant Competitor to Zohydro (21 November 2014)

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

In Focus: US

In Focus: International

  • EMA Recommends Making Emergency Contraceptive ellaOne Available OTC in Europe (EMA)
  • EMA Clears Testosterone Drugs of Elevated Heart Risks (EMA)
  • Two new medicines recommended for the treatment of chronic hepatitis C (EMA) (Reuters)
  • France Negotiates a Steep Discount for Sovaldi From Gilead (Pharmalot)
  • Only 14% of NMEs launched between 2008-12 are available in India (Twitter)
  • ICH Reforming in Ways that Could Strengthen Harmonization Process (Gold Sheet-$)

US: Pharmaceuticals and Biotechnology

  • FDA Approves Purdue's Hard-to-Abuse Hydrocodone Pill Hysingla (Fierce) (AP) (Fierce) (SCRIP-$) (BioCentury) (Press) (Reuters) (WaPo) (NYTimes) (FDA)
  • FDA Explains Hysingla Approval (FDA) (Pink Sheet-$)
  • Hamburg Signs Regulatory Agreement With Chinese Officials (SFDA)
  • Group: Pfizer Colluded With FDA to Hide Animal Feed Risk (Press)
  • FDA, Industry Metrics Initiatives Confront Challenge of Tracking Quality Culture (Gold Sheet-$)
  • Questions Linger as Industry Rushes to Meet Jan. 1 Traceability Deadline (Gold Sheet-$)
  • GPhA Says Slow FDA Approvals Contribute to Generic Drug Price Hikes (IHP-$)
  • GDUFA Fee Waivers Floated During Generic Drug Pricing Senate Hearing (IHP-$)
  • New FDA MAPP on Developing Indication-Specific Guidances (FDA)
  • Primer On FDA’s "Breakthrough Therapy" Program (In Vivo-$) (In Vivo-$) (In Vivo-$) (In Vivo-$)
  • FDA Posts Advisory Committee Materials for Discussion About How to Streamline Clinical Trial Development for Antibacterial Products (Tarius)
  • Anti-Infective Drugs Advisory Committee; Notice of Meeting (FDA) (Tarius)
  • 2014: The Social Media Guidance Year (DTC Perspectives)
  • Letter in Support of FDA Enforcement of Compounding Law (Pew)
  • Future bleak for Novartis' myeloma drug (Pharmafile)
  • Allergan Hit With $6.5M Verdict In Off-Label Botox Suit (Law 360-$)
  • Judge Scolds Kirkland & Ellis Attys In Ranbaxy-FDA Row (Law 360-$)

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

  • Basilea reports that U.S. FDA sets date of Advisory Committee meeting on isavuconazole NDA for the treatment of invasive aspergillosis and mucormycosis (Press)
  • ChemoCentryx's CCX168, an Orally Administered Complement C5a Receptor Inhibitor, Granted Orphan-Drug Designation in Atypical Hemolytic Uremic Syndrome Treatment by the FDA (Press)
  • HIV drugs show promise in treating common eye disease (Reuters)

US: Pharmaceuticals and Biotechnology: General

  • Generic Drug Medicaid Rebate Bill Aims To Counter Large Price Increases (Pink Sheet-$) (Senate-PDF)
  • Why are some generic drugs skyrocketing in price? (AEI)
  • GPhA Issues Statement on Generic Drug Costs (BioPharm International)
  • Ohio House Votes to Shield Execution Drugmaker (AP)
  • Medicare, Medicaid, And Pharmaceuticals: The Price Of Innovation (Health Affairs)

US: Medical Devices

  • Boston Scientific Slammed With $18.5M Verdict In Mesh Trial (Law 360-$) (Fierce) (Bloomberg) (Mass Device) (Reuters)
  • Majority of Android and iOS apps have been hacked, including FDA-cleared health apps (iMedicalApps)
  • Boston Scientific's Synergy Stent performs well in pivotal clinical trial (Fierce)
  • FDA needs to develop a better road map to help manufacturers make connected medical devices safer, more secure (MedCityNews)
  • Second Sight CEO Greenberg: Next-gen 'bionic eye' could treat nearly all forms of blindness (Mass Device)
  • 3Shape Implant Studio receives FDA 510(k) market clearance (Dentistry iQ)
  • Kubtec Announces FDA Approval of the Highest Resolution Low Dose Portable Digital Radiography System for NICU (Press)
  • AZE Technology, Inc. Announces FDA Approval of Phoenix (Volume Registration Viewer) (Press)
  • 510(k) for CAPRI Corpectomy Cage System (Press)
  • Class I Recall for Baxter's INTRAVIA Empty Containers with PVC Ports – Particles Found in Patient Solution (FDA)

US: Assorted And Government

  • FDA Advisory Committee Hears FDA Reports and Votes to Establish Two New Subcommittees (Tarius)
  • FDA campus reopened after brief lockdown (The Hill) (WTOP) (WUSA9)
  • Number of Indians turning whistle-blowers in US on the rise (India Times)
  • $6B Record Haul For DOJ As FCA Reaches New Heights (Law 360-$)

Upcoming Meetings

Ebola Outbreak

  • EMA: New pathways and Ebola vaccines can help expedite approvals (In-Pharma)
  • Pharma giant Merck, smaller U.S. firm in talks on Canadian Ebola vaccine production (Canada.com)
  • U.S. seeking ways to speed blood samples from remote areas for Ebola tests in Liberia (WaPo)

Europe

  • EMA Recommends Making Emergency Contraceptive ellaOne Available OTC in Europe (EMA)
  • EMA Clears Testosterone Drugs of Elevated Heart Risks (EMA)
  • Two new medicines recommended for the treatment of chronic hepatitis C (EMA) (Reuters)
  • Novartis gets CHMP backing for psoriasis drug Cosentyx (Pharma Times) (Fierce)
  • Cerdelga recommended for approval in type 1 Gaucher disease (EMA) (Press)
  • Boehringer's Nintedanib receives positive CHMP opinion in European Union for the treatment of IPF (Press) (Fierce)
  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 November 2014 (EMA)
  • European Medicines Agency recommends measures to reduce risk of heart problems with Corlentor/Procoralan (ivabradine) (EMA)
  • CMDh agrees to strengthen warnings on the use of valproate medicines in women and girls (EMA)
  • Discussion paper on the clinical investigation of medicines for the treatment of Alzheimer´s disease and other dementias (EMA)
  • ALK Abello files for European approval for its dust mite allergy sublingual tablets (Pharma Letter-$)
  • France Negotiates a Steep Discount for Sovaldi From Gilead (Pharmalot)
  • UK Data Protection Regulator Surveys Use of Smart Medical Devices (Inside Medical Devices)

India

  • Only 14% of NMEs launched between 2008-12 are available in India (Twitter)
  • Inside Indian pharma's push to reform and modernize (BioPharma Dive)
  • CDSCO & IPC discuss taking regulatory action following analysis of PvPI data (CDSCO)

Canada

  • Canada set to go electronic for high-risk device applications (Clinica-$)
  • Canadians to Save $3.8-Billion Through Unprecedented Three-Year Pan-Canadian Agreement on Generic Prescription Medicines (Press)

Other International

  • ICH Reforming in Ways that Could Strengthen Harmonization Process (Gold Sheet-$)

Clinical Trials

  • Continued Complexity Of A High Profile CRO Data Integrity Case (Lachman)

General Regulatory And Interesting Articles

Regulatory Reconnaissance #446 – 21 November 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.


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