Regulatory Focus™ > News Articles > Regulatory Reconnaissance (11 July 2013)

Regulatory Reconnaissance (11 July 2013)

Posted 11 July 2013 | By Alexander Gaffney, RAC 

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

Editor's note: Previously, all links were coded to automatically open a new page. We're stopping this practice as it was breaking a certain percentage of the links. We apologize for the inconvenience.

In Focus: US

  • Lotronex REMS' Verification Process Should be Electronic, FDA Panel says (Pink Sheet) (BioCentury)
  • Ibrutinib, Obinutuzumab are Early Tests of How Fast Breakthrough Reviews Will be (Pink Sheet) (SCRIP)
  • Risperdal plaintiff's Lawyer Demands Sealed J&J Documentss from FDA (Fierce) (PI)
  • FDA Accepts Eliquis sNDA for Review for Prophylaxis of DVT Following Surgery (BMS/Pfizer)
  • PhRMA's Castellani: Are Clinical Trial Data Shared Sufficiently Today? Yes (BMJ)
  • Myriad Sues Rivals in Early Test of Supreme Court Ruling's Reach (Law 360) (Fierce) (Fierce) (NYTimes)
  • CryoLife Gains PMA Nod for Angina Treatment Tool (Fierce) (CryoLife)
  • FDA Cancels Orthopaedic and Rehabilitation Devices AdComm Meeting for SpinalMotion's Kineflex/C Cervical Artificial Disc (FDA)

In Focus: International

  • EMA Accused of Witholding Information on Withdrawal, Return of Clotting Drug Trasylol (PMLive)
  • EMA Lifts Conditional Status for GSK's Votrient (Pazopanib) and Grants Full Approval (SCRIP) (MNT)
  • China Security Ministry says GSK Executives Confess To Economic Crimes (Reuters) (Guardian) (Pharma Times) (Bloomberg) (Pharmalot)
  • Indian Government to Further Modify Rule on Timeline, Compensation for Injury During Clinical Trials (PharmaBiz)
  • Health Canada Appoints New Acting Director of Medical Devices Bureau (MEDEC)
  • UK Ban on Wockhardt Plant Extends to all of EU (Fierce)
  • EU Urged to Act on Region's "Dreadful" Medicines Access (Pharma Times)
  • Revlimid Faces NICE Rejection for Use in Rare Blood Cancer (PMLive) (Pharmafile) (BioCentury) (Pharma Times)

Comments? Suggestions? Email me at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • Lotronex REMS' Verification Process Should Be Electronic, FDA Panel Says (Pink Sheet) (BioCentury)
  • Ibrutinib, Obinutuzumab Are Early Tests Of How Fast Breakthrough Reviews Will Be (Pink Sheet)
  • Risperdal plaintiff's lawyer demands sealed J&J docs from FDA (Fierce) (PI)
  • FDA Accepts Eliquis® (apixaban) Supplemental New Drug Application for Review for Prophylaxis of Deep Vein Thrombosis Following Hip Or Knee Replacement Surgery (BMS/Pfizer)
  • FDA's New Breakthrough Designation Process: A Patient Perspective (PharmExec)
  • Opinion: On the Priority Breakthrough Accelerated Fast Track (In the Pipeline)
  • PhRMA's Castellani: Are clinical trial data shared sufficiently today? Yes (BMJ)
  • UCB's Kremers Urban Pharmaceuticals Inc. receives FDA approval for extended release methylphenidate hydrochloride (UCB)
  • 2013 GDUFA and You Conference Presentation Slides (FDA)
  • FDA Approves ANDAs for Roxane's Evoxac (Cevimeline Hydrochloride, #091591), Kudco Ireland's Ritalin (Methylphenidate Hydrochloride, #091695) (FDA)
  • FDA Releases Final Labeling for Abuse-Resistant Oxycontin (FDA)
  • Pharmacy Compound Infringes Horse Drug Patents, Suit Says (Law 360)
  • Rockwell Medical's iron deficiency drug succeeds in trial (Reuters)
  • Ipsen announces positive results from phase III CLARINET study of Somatuline® Autogel® 120mg in gastrointestinal and pancreatic neuroendocrine tumors ("GEP-NETs") (Ispen)
  • Phase III Study (MM-020/IFM 07-01) of Oral REVLIMID® (Lenalidomide) in Newly-Diagnosed Multiple Myeloma Meets Primary Endpoint (Celgene)
Pharmaceuticals: General
  • Report Suggests Malaria Drug May Have Played Role In U.S. Soldier's Deadly Rampage (Forbes)
Medical Devices
  • Myriad Sues Rivals in Early Test of Supreme Court Ruling's Reach (Law 360) (Fierce) (Fierce) (NYTimes)
  • CryoLife gains PMA nod for angina treatment tool (Fierce) (CryoLife)
  • FDA Cancels Orthopaedic and Rehabilitation Devices AdComm Meeting for SpinalMotion's Kineflex/C Cervical Artificial Disc (FDA)
  • Class 1 Recall of Verathon's GlideScope Video Laryngoscope and Reusable Blades for Risk of Breakage (FDA)
  • Bard Avaulta mesh case ends in mistrial (Mass Device)
  • Patient claims Bard concealed vaginal mesh problems (Fierce)
  • IOM to Research Human Biological Effects of Low-Level Ionizing Radiation (IOM)
  • Alzheimer's disease: FDA expands deep-brain stimulation trial (Mass Device)
Assorted And Government
  • Are You Ready For The Sunshine Act? You Better Be... Bennett Explains (Pharmalot)
  • FDA's Weekly Enforcement Report (FDA)
  • Regulatory czar starts work at White House (The Hill)
  • NVCA Releases New Venture Capital Numbers for Q2 2013 (NVCA)
  • Government Launches "Pay for Success" Model for Funding New Projects. Could Pharma Beneit? (White House)
  • Congress urged to cut SEC 'red tape'  (SCRIP) (BioCentury)
  • SEC votes to lift general solicitation ban (BioCentury)
  • Regulatory: Investigating potential bribery means looking beyond the FCPA (Inside Counsel)
Upcoming Meetings And Events
  • 10 July 2013: Meeting of the Drug Safety and Risk Management Advisory Committee Meeting Announcement (FDA)
  • 12 July 2013: Public Meeting: Implementation of Drug Supply Chain Provisions of Title VII of FDASIA (FDA)
  • 16 July 2013: Hearing: Reforming the Drug Compounding Regulatory Framework (House)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EMA Accused of Witholding Information on Withdrawal, Return of Clotting Drug Trasylol (PMLive)
  • EMA Lifts Conditional Status For GSK's Votrient (Pazopanib) And Grants Full Approval (SCRIP) (MNT)
  • U.K. ban on Wockhardt plant extends to all of EU (Fierce)
  • EU urged to act on region's "dreadful" medicines access (Pharma Times)
  • Revlimid faces NICE rejection for use in rare blood cancer (PMLive) (Pharmafile) (BioCentury) (Pharma Times)
  • SMC yes for Humira, but Afinitor and Zaptrap ousted (Pharma Times)
  • Stentys' self-apposing cardiac stent gains expanded CE mark indications (Fierce)
  • Pharma chooses Microsoft in drug counterfeit fight (Pharmafile)
  • EU, pharma industry pledge $4.4B for R&D projects (Fierce)
  • Pharmacists asked by MHRA to ensure safe OTC diclofenac supply (PJO)
  • Claims made by Society of Homeopaths breach UK advertising code (PJO)

Asia

  • China security ministry says GSK executives confess to economic crimes (Reuters) (Guardian) (Pharma Times) (Bloomberg) (Pharmalot)
  • Indian Government to Further Modify Rule on Timeline, Compensation for Injury During Clinical Trials (PharmaBiz)
  •  Abbott Announces Approval of Next-Generation XIENCE Xpedition Drug Eluting Stent System in Japan (Abbott)
  • Japan Plans Two-Year Approval Time For iPS-Based Products (PharmAsia)
  • China flexing its anti-monopoly law muscle: Revenge or self-defense? (Straits Times)
  • New China price probe a policy portent? (SCRIP)
  • Baxter Japan Files Additional Application For Feiba To Prevent Bleeding (PharmAsia)

Other International

  • Health Canada Appoints New Acting Director of Medical Devices Bureau (MEDEC)
  • Aussie Federal Court Rules Oxycontin A Patentable Pharma Substance (PharmAsia)

General Regulatory And Interesting Articles

  • Plant Design Critical in Sterile Manufacturing, Expert Says (In-Pharma Technologist)
  • Researchers Developing Safer Acetaminophen (DD&D)
  • Former Bristol-Myers Squibb Chemist Convicted of Fatally Poisoning Husband (PharmPro)

Regulatory Reconnaissance #105  - 11 July 2013

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.


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