Regulatory Recon: Judge Upholds Massive Award in Actos Lawsuit (29 August 2014)

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In Focus: US

• Takeda, Lilly Lose Bid to Overturn $9 Billion Actos Award (Bloomberg) (Reuters)
• FDA Updates its Internal Policies on Communicating Drug Approval Information (FDA)
• FDA Mulls EFPIA Proposal on Enhanced Inspections (Gold Sheet-$)
• Elelyso Gains Pediatric Gaucher Disease Indication (MPR) (Press) (SCRIP-$)
• FDA Urges Pharmaceutical Industry to Dig Deeper in CMO Audits (Gold Sheet-$)
• FDA Faulted for 510(k) Processing that Ignores Data (MDDI)
• The Valley vs. the FDA: Getting Along With the Agency Tech Loves to Hate (Recode)

In Focus: International

• EU to trial IMDRF's device RPS initiative (Clinica-$)
• Masimo takes new infant monitors to Europe, Japan (Mass Device) (Press)
• In race for bigger margins, drug makers willing to lose the India 'advantage' (India Times)
• IMDRF Posts Presentations for Upcoming September Meeting (IMDRF)
• U.K. Docs Overwhelmingly Favor Clinical Trial Data Transparency (Pharmalot) (Pharmafile)

US: Pharmaceuticals and Biotechnology

• Takeda, Lilly Lose Bid to Overturn $9 Billion Actos Award (Bloomberg) (Reuters)
• FDA Updates its Internal Policies on Communicating Drug Approval Information (FDA)
• FDA Mulls EFPIA Proposal on Enhanced Inspections (Gold Sheet-$)
• Elelyso Gains Pediatric Gaucher Disease Indication (MPR) (Press) (SCRIP-$)
• FDA Urges Pharmaceutical Industry to Dig Deeper in CMO Audits (Gold Sheet-$)
• Friends of Cancer Research's Breakthrough Designation Tracker (FOCR)
• DOJ Legal Brief in PhRMA Off-Label Case (SCRIBD) (H/T Jeff Overly)
• Your September Biotech Back-to-School PDUFA Calendar (The Street)
• The biosimilars are coming: Tackling uncertainty and interchangeability (BioPharma Dive)
• Wockhardt Recalls More Troprol XL Generics due to Failed Dissolution Testing (FDA)
• Recall for Ben Venue Labs due to Crimp Defects in Cytarbine Packaging (FDA)
• American Cancer Society Pans Rescheduling of Hydrocodone (ACS)
• CMOs and the Track-and-Trace Race: Are You Engaged Yet? (PharmTech)

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

• Actos (Pioglitazone), Bladder Cancer Risk: No Link in 10-Year Study (MPR) (Press)
• Mylan's ANDA for Three Times Per Week Generic Copaxone 40 mg/mL Accepted for Filing by FDA (Fierce)

US: Pharmaceuticals and Biotechnology: General

• One Drug. Two Prices. A Reporter Struggles to Find Out the Cost of His Son’s Prescription (ProPublica)
• What cost-effectiveness thresholds do US health economists cite most often? (CEA)
• Forced switch? Drug cos. develop maneuvers to hinder generic competition (CBS)
• GSK: GM yeast breakthrough won't kill off poppy-based opium (In-Pharma)

US: Medical Devices

• FDA Faulted for 510(k) Processing that Ignores Data (MDDI)
• The Valley vs. the FDA: Getting Along With the Agency Tech Loves to Hate (Recode)
• FDA warns Vention Medical on Costa Rica plant (Mass Device)
• Medtronic wins U.S. clearance for pediatric spine implant (Mass Device)
• U.S. startups get OK for smartphone-based heart tracking (Reuters)
• Bayer’s Grants4Apps: An accelerator run by a pharma company (MobiHealthNews)
• FDA Awards $207,000 Contract to Company for Market Share Intelligence on Devices (FDA)
• Nonin Medical Announces FDA Clearance of Nonin Model 3231 USB Pulse Oximeter (Press)
• CorMatrix lands FDA win, touts 1st human implant of CanGaroo surgical pouch (Mass Device) (Press)
• CardiacAssist gets FDA OK for medical device (BizJournal)
• Smiths Recalls Pediatric Endotracheal Intrubation Kit (FDA)

US: Dietary Supplements

• Is FDA doing enough to stem tide of tainted products? Probably not (NI-USA)

US: Assorted And Government

• FDA Enforcement Report Posted (FDA)
• Members of Congress Want FDA to Drop Agency’s Push for FSMA User Fees (Food Safety News)
• Industry group to launch database of food additives amid growing concerns (WaPo) (FDA Law Blog)

Upcoming Meetings

• RAPS' FDA Scientific Advisory Committee Meeting Tracker

Ebola Outbreak

• GSK Planning to Make 10,000 Doses of Experimental Ebola Vaccine (NPR)
• Gene studies of Ebola in Sierra Leone show virus is mutating fast (Reuters)
• Baxter donates IVs to aid groups fighting Ebola in Africa (In-Pharma)
• BioCryst Receives Additional NIAID Funding to Conduct a Non-Human Primate Study of BCX4430 in Ebola Virus Disease (Press)
• Drug shows promise against Sudan strain of Ebola in mice (Press)

Europe

• EU to trial IMDRF's device RPS initiative (Clinica-$)
• Masimo takes new infant monitors to Europe, Japan (Mass Device) (Press)
• Acusphere Withdraws its European Marketing Authorization Application for Imagify (Press)

India

• In race for bigger margins, drug makers willing to lose the India 'advantage' (India Times)

China

• China Food and Drug Administration approves SciClone and BTG's DC Bead (PBR)

Australia

• TGA Issues Warning on Wright Medical's Claw and Claw II Bone Surgery Plates (TGA)

Other International

• IMDRF Posts Presentations for Upcoming September Meeting (IMDRF)
• Thai FDA releases draft eCTD specification and validation criteria (Exalon)
• The future of biosimilar use and regulation in Latin America (GaBi)

Clinical Trials

• U.K. Docs Overwhelmingly Favor Clinical Trial Data Transparency (Pharmalot) (Pharmafile)
• Standardising trial measurements could stop ‘wasteful’ research (Outsourcing Pharma)
• Janssen: why transparency is essential to the health of our industry (Pharmafile)
• Surgery Studies Rarely Use Females (The Scientist)

General Regulatory And Interesting Articles

• An End to Drug Errors? (Press)

Regulatory Reconnaissance #389 – 29 August 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.

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

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.