Regulatory Reconnaissance: FDA Review: Aleve Safer Than Other NSAIDS, Labeling Should be Changed (29 January 2014)

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In Focus: US

• What's holding up biosimilars in the US? (Biopharma Reporter)
• Report: FDA Documents Show Decade of Unsuccessful Attempts to Control Farm Antibiotics (Wired) (Washington Post) (NYTimes) (NRDC Report) (Reuters) (Bloomberg) (NPR)
• FDA Reviewers: Aleve may be safer on heart than other anti-inflammatory drugs (CBS) (WSJ-$) (FDA)
• FDA panel backs Merck's ragweed allergy drug Ragwitek (SCRIP-$) (Press) (BioCentury) (Pharma Letter-$) (Reuters) (MedPage Today) (Pink Sheet-$) (Pharma Times) (Fierce)
• Louisiana's top court rules for J&J in appeal of Risperdal suit (Reuters) (D&D Law)
• FDA Sends Rare Warning Letter to Mammography Facility (FDA)

In Focus: International

• EU, UK evaluating FDA findings on Ranbaxy's Toansa facility (India Times)
• India Drug Regulator Vows Surprise Inspections For All Drug Makers (PharmAsia-$)
• Ranbaxy Execs Called On DCGI Carpet To Explain Drug-Making Problems (PharmAsia-$)
• China's pharma blacklist could be weakened by inconsistent enforcement (Pharma Letter-$)
• Canada approves infliximab biosimilar (BioCentury)

US: Pharmaceuticals/Biotechnology

• What's holding up biosimilars in the US? (Biopharma Reporter)
• Report: FDA Documents Show Decade of Unsuccessful Attempts to Control Farm Antibiotics (Wired) (Washington Post) (NYTimes) (NRDC Report) (Reuters) (Bloomberg) (NPR)
• FDA Reviewers: Aleve may be safer on heart than other anti-inflammatory drugs (CBS) (WSJ-$) (FDA)
• New FDA community acquired bacterial pneumonia guidance is practical, feasible (BioCentury-$)
• FDA panel backs Merck's ragweed allergy drug Ragwitek (SCRIP-$) (Press) (BioCentury) (Pharma Letter-$) (Reuters) (MedPage Today) (Pink Sheet-$) (Pharma Times) (Fierce)
• Louisiana's top court rules for J&J in appeal of Risperdal suit (Reuters) (D&D Law)
• Analysis of FDA side-effect reports flags Sanofi, Celgene meds (Fierce)
• PDA Panel Proposes Limited Set of Metrics to Measure Quality Trends (PharmTechTalk)
• US okay for Teva's high-dose Copaxone (Pharma Times) (PMLive) (Fierce) (BioCentury) (Press) (Bloomberg)
• PhRMA: Where's FDA on FDAMA Section 114? (PhRMA)
• Indiana Biosimilar Provision Moves Forward (Scout)
• Merck, Bristol-Myers Settle With Generics Co. Over HIV Drug (Law 360-$)

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

• Xtandi Shows Promise in Advanced Prostate Cancer When Used Before Chemotherapy (NYTimes) (Pharma Letter-$) (SCRIP-$) (Pharma Times) (Press) (Reuters)
• Amgen announces top-line results from Phase III trial of evolocumab (Pharma Letter-$) (BioCentury) (Fierce)
• Novartis' Hepatitis C Drug Alisporivir Returns To Clinical Testing Minus Interferon (Pink Sheet-$)

US: Medical Devices

• Health app makers face privacy and security regulation from many quarters (MobiHealthNews)
• FDA Sends Rare Warning Letter to Mammography Facility (FDA)
• Benvenue notches FDA nod for spinal-repair device (Fierce)
• Atheromed Gains FDA Approval for Phoenix Atherectomy Device (MedGadget)
• Kiva VCF Now Cleared in U.S. as New Option for Treatment of Vertebral Compression Fractures (MedGadget)
• Calif. Court Reverses Preemption Of Medtronic Injury Suit (Law 360-$)
• Judge allows Riata lawsuits to move forward (Cardiovasvcular Business)

US: Dietary Supplements

• Hydroxycut False Ad Claims Must Be Clarified, Judge Says (Law 360-$)

US: Assorted And Government

• Pharma companies differ on Sunshine Act payment definition (PMLive)
• SOTU: Research, trade & Obamacare among Obama's 'ladders of opportunity' (SCRIP-$)
• DARPA awards cooperative agreement to assess mechanisms of drugs and chemical agents (Press)

Upcoming Meetings And Events

• 28-29 January 2013: Workshop - Strategies to Address Hemolytic Complications of Immune Globulin Infusions (FDA)
• 29-30 January 2014: Science Advisory Board to the National Center for Toxicological Research Meeting (FDA)
• 19 February 2014: FDA OAGS Small Business Outreach Vendor Fair (FDA)
• Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

• EU, UK evaluating FDA findings on Ranbaxy's Toansa facility (India Times)
• OctreoPharm Sciences GmbH Receives EMA Orphan Drug Designation for OPS202 (SOMscan), a next generation antagonistic peptide for the Management of Neuroendocrine Tumors (Press)
  

India

• India Drug Regulator Vows Surprise Inspections For All Drug Makers (PharmAsia-$)
• Ranbaxy Execs Called On DCGI Carpet To Explain Drug-Making Problems (PharmAsia-$)
• Ranbaxy plant at Toansa under UK and Aussie regulators' inspection (India Times)

Japan & China

• China's pharma blacklist could be weakened by inconsistent enforcement (Pharma Letter-$)
• China FDA Warns Of Serious Adverse Reactions For Cefazolin (PharmAsia-$)

Other International

• Canada approves infliximab biosimilar (BioCentury)
• Peruvian regulator amends law for non-commercial device imports (Clinica)
• Counterfeit drug war in Liberia (IRIN)

General Regulatory And Interesting Articles

• Scientists create embryonic-type stem cells without embryos (Reuters)
• Anti-VEGF drugs making a difference in vision, longterm care (Reuters)
• U.K. researchers unveil an artificial pancreas they've been developing for 20 years (Fierce)

Regulatory Reconnaissance #245 - 29 January 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.

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Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at [email protected].