Regulatory Focus™ > News Articles > Regulatory Reconnaissance (6 August 2013)

Regulatory Reconnaissance (6 August 2013)

Posted 06 August 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • FDA panel rebuffs Otsuka's tolvaptan (BioCentury) (Pink Sheet) (Pharma Times) (Otsuka) (Med Page Today) (SCRIP)
  • FDA Review Looks Good for Riociguat (Med Page Today)
  • New Legislation Seeks to Provide 5-Year NCE Exclusivity For Certain Combination Drugs (FDA Law Blog)
  • FDA Drug REMS Standardization Efforts To Focus On Building 'Common Language' (IHP)
  • FDA Issues Approval for ACS Dobfar Info SA's Application for Zoledronic Acid (NDA #203231) (FDA)
  • Regeneron Could Seek FDA Approval for Diabetic Blindness Drug One Year Early (Forbes) (Reuters)
  • Ambry Genetics Sues Myriad Genetics for 'Violating Federal Antitrust Laws' (Ambry)

In Focus: International

  • EMA to streamline BE testing for specific generic substances (SCRIP)
  • Roche's Perjeta not value for money, says NICE draft (Pharma Times) (BioCentury) (Pharmafile) (Pharma Letter)
  • After Novartis Scandal, Japan Considers Penalties For False Data (Pharmalot)
  • India: DCGI to take action against independent ECs reviewing & approving new clinical trials (PharmaBiz)
  • India: AIDCOC objects to proposed bill to centralize drug licensing (PharmaBiz)
  • Australian TGA backs down on 'costly' product name proposal for devices (Clinica)

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

US

Pharmaceuticals/Biotechnology
  • FDA panel rebuffs Otsuka's tolvaptan (BioCentury) (Pink Sheet) (Pharma Times) (Otsuka) (Med Page Today) (SCRIP)
  • FDA Review Looks Good for Riociguat (Med Page Today)
  • New Legislation Seeks to Provide 5-Year NCE Exclusivity For Certain Combination Drugs (FDA Law Blog)
  • FDA Drug REMS Standardization Efforts To Focus On Building 'Common Language' (IHP)
  • The List So Far: FDA Breakthrough Designations (PharmExec)
  • The FDA OKs 5 blockbusters in slow start to 2013 drug approvals (Fierce)
  • FDA Liver Disease Guidance Gets Boost From Sponsor-Sponsored Meeting (Pink Sheet)
  • Isis Pharma halts ineffective rheumatoid arthritis trial  (BioSpectrum)
  • Deja Vu All Over Again: Study Links Calcium-Channel Blockers To Breast Cancer (Forbes) (CBS) (Reuters) (Bloomberg)
  • 82 lawmakers ask for end to ban on gay men donating blood (The Hill) (Harvard BOH)
  • FDA Issues Approval for ACS Dobfar Info SA's Zoledronic Acid (NDA #203231) (FDA)
  • FDA Issues Generic Approvals for Taro's Gabapentin (#077261) and Tentative Approval for Apotex's Atacand (Candesartan Cilexetil, #202079) (FDA)
  • GlaxoSmithKline receives FDA approval to ship four-strain (quadrivalent) influenza vaccine to healthcare providers (GSK) (Pharma Letter)
  • Data Dive Finds Doctors For Rent by Pharmaceutical Companies (NPR)
  • US FDA Goes After Another Indian Site with Form 483 for Strides Injectable Facility (In-Pharma)
  • FDA 483 Trend: International Inspections & FDA 483s on the Rise (FDAzilla)
  • Regeneron Could Seek FDA Approval for Diabetic Blindness Drug One Year Early (Forbes) (Reuters)
  • Medicines Co's hemostasis drug effective in late: stage study (Reuters)
  • VEGF Trap-Eye (aflibercept solution for injection) Met Primary Endpoint in Two Phase 3 Trials for the Treatment of Diabetic Macular Edema (Bayer)
  • Drug shortage complicates execution schedule for death penalty leader Texas (Fierce)
  • Sanofi initiates Phase III study for C diff vaccine (Pharma Times) (PMLive)
  • Arthritis Drug for Horses and Dogs Scheduled to Return to Market (FDA)
  • TV Ads For Statins Lead To Overdiagnosis And Overprescribing: Study (Pharmalot)
  • Bethel Nutritional Consulting, Inc. Expands Voluntary Recall to Include Bethel Advance and Quick Thin Products Found to Contain an Undeclared Drug Ingredient (FDA)
Pharmaceuticals: General
  • GSK adding 2-D barcodes to vaccine containers (Fierce)
Medical Devices
  • Ambry Genetics Sues Myriad Genetics for "Violating Federal Antitrust Laws" (Ambry)
  • Total recall: Safety alerts surge in Q2 (Clinica)
  • Alere MobileLink Receives FDA Clearance (Alere)
  • Hospira Recalls Blood Bags Due to Puncture Risk (FDA)
  • Edwards gains FDA's blessing to test next-gen Sapien valve (Fierce) (Mass Device)
  • In Myriad, Did Supreme Court Confuse Its Own Precedent? (Law 360)
Assorted And Government
  • Bodybuilding Steroids Don't Belong In Vitamin Products (Forbes)
  • Supplement company winds up mentioned in IRS complaint, criminal probe after celebrity endorsement went awry (Nutra-Ingredients)
  • GOP bill: Add a new regulation, kill two existing regulations (The Hill)
Upcoming Meetings And Events
  • 5 August 2013: Webinar: Draft GFI On Expedited Programs For Serious Conditions Drugs And Biologics (FDA)
  • 5 August 2013: Cardiovascular and Renal Drugs Advisory Committee Meeting (FDA)
  • 6 August 2013: Cardiovascular and Renal Drugs Advisory Committee Meeting (FDA)
  • 15 August 2013: Alliance for a Stronger FDA/FDA International Programs Meeting (Strengthen FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

Asia

  • After Novartis Scandal, Japan Considers Penalties For False Data (Pharmalot)
  • India: DCGI to take action against independent ECs reviewing & approving new clinical trials (PharmaBiz)
  • India upholds basic patent on Tykerb; generics versions unlikely before 2019 (SCRIP)
  • India: AIDCOC objects to proposed bill to centralize drug licensing (PharmaBiz)
  • DIPP may seek information from DCGI to manufacture generic version of Roche's anti-cancer drug (India Times)
  • Main India Herceptin patent still valid but procedural lapses hit 'divisionals' (SCRIP) (PharmAsia)

Other International

  • Australian TGA backs down on 'costly' product name proposal for devices (Clinica)
  • Australian pharma fury at 492 drug price cuts (Pharma Times)

General Regulatory And Interesting Articles

  • Public disclosure under the spotlight (PMLive)

Regulatory Reconnaissance #125  - 6 August 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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