Regulatory Reconnaissance (22 August 2013)

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

In Focus: US

• FDA Should Boost Plavix Warning For Stent Implants: Watchdog (Pharmalot) (Pharma Letter) (Law 360) (Pink Sheet)
• FDA's rule on antibiotic trials haunts Basilea shares (Fierce) (SCRIP)
• Takeda's Experimental Bowel Drug Effective, Studies Find (Bloomberg)
• FDA Approves New Testing System Capable of Identifying 193 Differents Disease-Causing Yeasts and Bacteria (FDA) (BioCentury)
• Legal: Personal injury lawyers prepare to fight over medical device cybersecurity (Mass Device)
• Bard Settles 2nd Vaginal Mesh Bellwether On Trial's 1st Day (Law 360) (Mass Device)
• Anonymous FDA Official: "70% Of Supplements Companies Violate Agency Rules" (Food Ct)
• FSMA and Third-Party Audits: What is a "Serious Risk to the Public Health?" (FDA Law Blog)

In Focus: International

• UK transposes Falsified Medicines Directive (Securing Industry) (In-Pharma Technologist)
• China industry body quizzes medical device makers over pricing, possible corruption (Reuters) (Fierce) (PharmAsia)
• Indian Parliamentary Panel Recommends CDSCO be Brought Under Control of Department of Pharmaceuticals (PharmaBiz)
• India's Drug Advisory Body Calls For Larger Study To Approve Pfizer's Xeljanz (PharmAsia)
• Trial co-op persuades pharmas to stop sabotaging head-to-head drug studies (Fierce)
• Open access to research is reaching tipping point, says EU (Pharma Times)

Comments? Suggestions? Email me at [email protected].

US

Pharmaceuticals/Biotechnology

• FDA Should Boost Plavix Warning For Stent Implants: Watchdog (Pharmalot) (Pharma Letter) (Law 360) (Pink Sheet)
• FDA's rule on antibiotic trials haunts Basilea shares (Fierce) (SCRIP)
• Takeda's Experimental Bowel Drug Effective, Studies Find (Bloomberg)
• Call for US DEA to improve review process for new "controlled" treatments (Pharma Letter)
• Onyx provides drug trial data to potential bidders (Reuters)
• Mallinckrodt Pharmaceuticals' New Drug Application Accepted for Review by FDA (Mallinckrodt)
• Incyte pancreatic cancer drug improves survival in mid-stage trial (Reuters) (Fierce) (Pharma Times) (BioCentury)
• Gastroenterology Endpoints For IBD Drugs Once Again In FDA Spotlight (Pink Sheet)
• Antipsychotic Drugs Raise Diabetes Risk in Children, Study Finds (WSJ)
• Navidea Biopharmaceuticals Announces Agreement with FDA on Special Protocol Assessments for NAV5001 Phase 3 Program (Navidea)

Pharmaceuticals: General

• Malaria drug overused on Guantanamo Bay prisoners? (Aljazeera)
• The Dry Pipeline For Psychiatric Drugs Doesn't Rest On Pharma's Shoulders (Forbes)
• CVS cuts access to opioid pain-killers for suspect doctors (Reuters)
• Rules would make it harder to get painkillers (USA Today)

Medical Devices

• FDA Approves New Testing System Capable of Identifying 193 Differents Disease-Causing Yeasts and Bacteria (FDA) (BioCentury)
• Legal: Personal injury lawyers prepare to fight over medical device cybersecurity (Mass Device)
• Bard Settles 2nd Vaginal Mesh Bellwether On Trial's 1st Day (Law 360) (Mass Device)
• Medical Device Innovation Consortium (MDIC) Announces William V. Murray Appointed President & CEO (MDIC)
• Boston Scientific Receives FDA Approval For IntellaTip MiFi XP Ablation Catheter And 510(k) Clearance Of Zurpaz 8.5F Steerable Sheath (BSC) (Mass Device) (Fierce)
• Novo Nordisk receives U.S. FDA clearance for the insulin injection device NovoPen Echo (Novo Nordisk) (DSN)
• AngioDynamics BioFlo Port with Endexo Technology Helps Prevent Thrombus Accumulation, Gets FDA Nod (MedGadget)
• Argus II Retinal Prosthesis System Obtains CMS Approval (Argus)

Assorted And Government

• Anonymous FDA Official: "70% Of Supplements Companies Violate Agency Rules"; Number Likely Inflated (Food Ct)
• FSMA and Third-Party Audits: What is a "Serious Risk to the Public Health?" (FDA Law Blog)
• Enforcement Report - Week of August 21, 2013 (FDA)
• Reform Update: PCORI to award $300 million for research (Modern Healthcare)
• ObamaCare birth-control mandate on fast track to Supreme Court (The Hill)

Upcoming Meetings And Events

• 19 August 2013: FDA Basics Webinar: Biological Products, Part 2: Biosimilar Biological Products (FDA)
• 26 August 2013: WMA Declaration of Helsinki Meeting (WMA)
• 4-5 September 2013: Public Workshop on the Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Fatty Liver Disease (FDA)
• 24 September 2013: Public Meeting on Narcolepsy Patient-Focused Drug Development (FDA)
• 25-26 September 2013: FDA Small Business Regulatory Education for Industry Conference (FDA)
• Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

• UK transposes Falsified Medicines Directive (Securing Industry) (In-Pharma Technologist)
• SOBI files for Orfadin oral suspension with EMA (Pharma Letter)
• Meeting: First information day on the use of Medical Dictionary for Regulatory Activities (MedDRA) including medication errors (EMA)
• Open access to research is reaching tipping point, says EU (Pharma Times)

Asia

• China industry body quizzes medical device makers over pricing, possible corruption (Reuters) (Fierce) (PharmAsia)
• Indian Parliamentary Panel Recommends CDSCO be Brought Under Control of Department of Pharmaceuticals (PharmaBiz)
• India's Drug Advisory Body Calls For Larger Study To Approve Pfizer's Xeljanz (PharmAsia)
• Edwards Receives Reimbursement Approval for Sapien XT Valve in Japan (Edwards) (Mass Device) (Fierce)
• Indian Court Reverses Union Health Ministry's June 2013 Suspension of Deanxit Antidepressant (PharmaBiz)
• Eli Lilly Latest Pharma Company to be Dragged into Bribery Scandal (Reuters) (FT)
• Merck And Ono Japan File For Approval Of Combined DPP4 Inhibitors Januvia/Glactiv With Insulin Secretion Drug (PharmAsia)
• First Herceptin biosimilar in India may come before the end of 2013 (Biosimilar News)

Other International

• Nigeria to overhaul drugs delivery system by 2014 (PharmAfrica)

General Regulatory And Interesting Articles

• Trial co-op persuades pharmas to stop sabotaging head-to-head drug studies (Fierce)
• Flu shot may fend off heart attacks, too (Cardiovascular Business)
• Implanted Device Controls Rheumatoid Arthritis (MIT)
• Ebola Treatment Works In Monkeys, Even After Symptoms Appear (NPR) (NBC)
• Now that biomarkers for suicide risk have been identified, could a diagnostic test be far off? (MedCity News)
• H7N9 genesis work uncovers 'new' H7N7 flu threat; vax R&D continues (SCRIP)

Regulatory Reconnaissance #137  - 22 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 [email protected].