Regulatory Reconnaissance (15 November 2013)
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In Focus: US
- FDA: Amgen and Sanofi PCSK9 Drugs Can Reach U.S. Without Long Studies (Bloomberg) (Reuters) (Bloomberg)
- Neurostimulator for Epilepsy Wins FDA Nod (MedPage Today) (Press) (FDA) (Gray Sheet-$) (Fierce) (Mass Device)
- Is FDA Reviewing A Biosimilar Marketing Application? (Pink Sheet-$)
- Vanda Wins U.S. Panel Backing for Sleep Drug for Blind (Bloomberg) (Reuters) (Pharma Letter-$) (SCRIP-$) (Press) (Pink Sheet-$) (BioCentury) (PMLive) (Pharma Times)
- A Questionable Cancer Cure: FDA Steps Up Scrutiny Of Stanislaw Burzynski (USA Today)
- Biologics exclusivity unresolved in trade deal (BioCentury)
In Focus: International
- EMA provides guidance on development of medicines to prevent stroke in patients with atrial fibrillation (EMA) (EMA)
- EU approval for Bayer's prostate cancer drug Xofigo (Pharma Letter-$) (Press)
- No More Mr NICE Guy? Big Pharma Takes On UK Drug Watchdog (PharmExec) (Telegraph)
- Court Orders German Firm to Pay Victims of Defective Breast Implants (NYTimes)
- India DCGI To Conduct Routine Inspections Of China API Suppliers (PharmAsia-$)
US: Pharmaceuticals/Biotechnology
- FDA: Amgen and Sanofi PCSK9 Drugs Can Reach U.S. Without Long Studies (Bloomberg) (Reuters) (Bloomberg)
- Is FDA Reviewing A Biosimilar Marketing Application? (Pink Sheet-$)
- Vanda Wins U.S. Panel Backing for Sleep Drug for Blind (Bloomberg) (Reuters) (Pharma Letter-$) (SCRIP-$) (Press) (Pink Sheet-$) (BioCentury) (PMLive) (Pharma Times)
- A Questionable Cancer Cure: FDA Steps Up Scrutiny Of Stanislaw Burzynski (USA Today)
- Outcry Follows Leak Of Secret Trade Negotiations (Forbes) (Pharmalot)
- Biologics exclusivity unresolved in trade deal (BioCentury)
- Senate inches toward passing drug bill (The Hill)
- Sanofi MS Drug's Mixed Verdict at FDA Panel Puzzles Analysts (Bloomberg)
- Court: biosimilar sponsors can't preemptively sue (BioCentury) (FDA Lawyers Blog)
- The Breakthrough Designation Program: Four Factors for Long Term Success (Eye for Pharma)
- Smoking Cessation Labels Cleared Without Duration-Of-Use Limit (Tan Sheet-$)
- Lawmakers affirm FDA authority over biosimilar naming (BioCentury) (IHP-$)
- AstraZeneca, Generic Drugmakers Face Nexium Class Action (Bloomberg)
- In Defense of Sarepta's Chris Garabedian (Xconomy)
- Supreme Court nixes Teva's last-ditch bid to block Copaxone generics (Fierce)
- GW Pharma receives FDA orphan drug designation for cannaboid-based agent (Pharma Letter-$)
- Pennsylvania advancing state biosimilar bill (BioCentury)
- Nasty Odor as a Drug Side Effect (In the Pipeline)
US: Pharmaceuticals and Biotechnology: General
- ONC initiative looks to curb prescription drug abuse (Fierce)
- PCORI Building Non-Traditional Research Capacity With "Pipeline To Proposal" Awards (Pink Sheet-$)
US: Medical Devices
- Neurostimulator for Epilepsy Wins FDA Nod (MedPage Today) (Press) (FDA) (Gray Sheet-$) (Fierce) (Mass Device)
US: Assorted And Government
- Enforcement Report - Week of November 13, 2013 (FDA)
Upcoming Meetings And Events
- 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
- EMA provides guidance on development of medicines to prevent stroke in patients with atrial fibrillation (EMA) (EMA)
- EU approval for Bayer's prostate cancer drug Xofigo (Pharma Letter-$) (Press)
- No More Mr NICE Guy? Big Pharma Takes On UK Drug Watchdog (PharmExec) (Telegraph)
- Carmat aims for EU approval of artificial heart by early 2015 (Reuters)
- Court Orders German Firm to Pay Victims of Defective Breast Implants (NYTimes)
- G-BA may assess pre-AMNOG cancer drugs (BioCentury)
Asia
- India DCGI To Conduct Routine Inspections Of China API Suppliers (PharmAsia-$)
- China: Anhui Implements Drug Safety Credibility Grading System (PharmAsia-$)
Other International
- WHO: New malaria vaccines roadmap targets next generation products by 2030 (WHO)
General Regulatory And Interesting Articles
- Insight: Profit bonanza eludes companies chasing obesity business (Reuters)
- New IV bag designed for relief workers can turn any water into a sterile saline solution (MedCity News)
- New device helps patients remember their meds (USA Today)
Regulatory Reconnaissance #203 - 15 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].