Regulatory Reconnaissance (14 November 2013)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: [email protected].

In Focus: US

• U.S. health regulators approve J&J, Pharmacyclics lymphoma drug, second "Breakthrough" Therapy (Reuters) (WSJ-$) (Xconomy) (Press) (MedPage Today) (Pharma Letter-$) (SCRIP-$) (FDA) (FDA) (BioCentury) (The Street) (PMLive) (Fierce) (MM&M) (Pink Sheet-$) (NYTimes) (Pharma Times)
• Text of Proposed Trans-Pacific Partnership (TPP) Trade Agreement Leaked (WikiLeaks)
• 2013 FDA Approval Rates Suggest Record Year for Post-Launch Success (EP Vantage) (MM&M) (Fierce)
• FDA panel supports approval of Sanofi MS drug Lemtrada (MedPage Today) (SCRIP-$) (BioCentury) (Fierce) (Pink Sheet-$) (Pharma Times)
• 1st Biosimilars Act Ruling May Limit Patent Challenges (Law 360-$)
• FDA slaps 'deadly' tag on Atossa's cancer Dx recall (Fierce) (FDA)

In Focus: International

• EU API shortages avoided so far… thanks to stockpiling (In-Pharma)
• EU Updates Scientific Guideline on Pharmacokinetics (EMA)
• India further amends clinical trial regulations, looks to reduce timelines (Outsourcing Pharma) (PharmaBiz)
• Establishing a common regulatory framework for Australia and New Zealand (Pharma Letter-$) (TGA)

US: Pharmaceuticals/Biotechnology

• U.S. health regulators approve J&J, Pharmacyclics lymphoma drug, second "Breakthrough" Therapy (Reuters) (WSJ-$) (Xconomy) (Press) (MedPage Today) (Pharma Letter-$) (SCRIP-$) (FDA) (FDA) (BioCentury) (The Street) (PMLive) (Fierce) (MM&M) (Pink Sheet-$) (NYTimes) (Pharma Times)
• 2013 FDA Approval Rates Suggest Record Year for Post-Launch Success (EP Vantage) (MM&M) (Fierce)
• FDA panel supports approval of Sanofi MS drug Lemtrada (MedPage Today) (SCRIP-$) (BioCentury) (Fierce) (Pink Sheet-$) (Pharma Times)
• 1st Biosimilars Act Ruling May Limit Patent Challenges (Law 360-$)
• What does clinically meaningful mean? US lawyer predicts biosimilar battles (BioPharma)
• Another quarter, another 483 for Hospira, this time in Kansas (Outsourcing Pharma)
• FDA Advisory Committee to Review Vanda Pharmaceuticals' Hetlioz NDA Today (Press)
• GSK Terminates Study After Preclinical Data Assumed to be Fraudulent (ClinicalTrials) (Nature)
• GPhA's Fall Technical Conference Delivers Messages of GDUFA, Quality, and More (FDA Lawyers) (2)
• Citizen Petition: Allow ANDA Approval of Glaucoma Drug Based on Reference to Diamox (FDA)
• Experimental bird flu vaccines show promise in early trials (Reuters)
• Pay-For-Delay Remains Top Priority For Ramirez's FTC (Law 360-$)
• Suits Target Endo, Actavis Over Lidoderm Pay-For-Delay (Law 360-$)
• Mast Ischemia Drug Gets Orphan Drug Designation (DD&D)

US: Pharmaceuticals and Biotechnology: General

• U.S. heart guidelines threaten hot new cholesterol drugs (Reuters) (Forbes)

US: Medical Devices

• FDA slaps 'deadly' tag on Atossa's cancer Dx recall (Fierce) (FDA)
• Promotion and Advertising of Medical Devices: What You Can or Can't Do (MedicalDeviceSummit)

US: Assorted And Government

• Text of Proposed Trans-Pacific Partnership (TPP) Trade Agreement Leaked (WikiLeaks)
• Dems reject 'fast-track' trade deal power for Obama (The Hill)

Upcoming Meetings And Events

• 14 November 2013: Peripheral and Central Nervous System Drugs Advisory Committee Meeting (FDA)
• 19 November 2013: Endocrinologic and Metabolic Drugs Advisory Committee Meeting (FDA)
• 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
• 9 December 2013: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (FDA)
• 11 December 2013: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
• Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

• EU API shortages avoided so far… thanks to stockpiling (In-Pharma)
• EU Updates Scientific Guideline on Pharmacokinetics (EMA)
• UK warns against another USPLabs pre-workout supplement (Nutra-Ingredients)
• ReliantHeart expands CE Mark for HeartAssist5 ventricular assist device (Mass Device)

Asia

• India further amends clinical trial regulations, looks to reduce timelines (Outsourcing Pharma) (PharmaBiz)
• Roche's Kadcyla Delayed In Japan And Simeprevir Gets First Market Nod In New Chuikyo Price Listings (PharmAsia-$)
• India-Style Patent Laws Targeted In Trans-Pacific Trade Negotiations (Pink Sheet-$)

Other International

• Establishing a common regulatory framework for Australia and New Zealand (Pharma Letter-$) (TGA)

General Regulatory And Interesting Articles

• Car Mechanic Dreams Up a Tool to Ease Births (NYTimes)
• "Like I said, it's complicated" drug-food interactions discussed at AAPS (In-Pharma)
• World's biggest cancer database launched (Pharma Times)
• Northeastern researchers have discovered a new treatment to cure MRSA infection (Press)

Regulatory Reconnaissance #202 - 14 November 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.

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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].