Regulatory Recon: FDA Grants BMS Lung Cancer Drug Super-Fast Approval (5 March 2015)

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

In Focus: US

• Bristol-Myers bags a record-fast approval for its cancer blockbuster Opdivo  (Fierce) (Press) (MM&M) (Pink Sheet-$) (PharmaPhorum) (FDA) (BioCentury) (NYTimes) (WSJ-$) (Reuters) (SCRIP-$) (Bloomberg)
• FDA’s Anti-Franchising Policy: What Is It and Where Did It Come From? (FDA Law Blog)
• BIO Survey on Effective FDA-Sponsor Communication (BIO)
• FDA Advisory Committee Makes Recommendations About Strains for the 2015-2016 Flu Vaccine (Tarius) (AP)
• U.S. FDA updates safety alert for 'superbug' scopes (Reuters) (FDA)
• Second Los Angeles Hospital Reports 'Superbug' Infections (AP) (LATimes) (Reuters)
• FDA Unlikely to Get Full Budget Request (FDAnews-$) (Pink Sheet-$)

In Focus: International

• EMA Launches two new Guidelines on the use of Antibiotics in Animals (EMA) (EMA) (EMA)
• Rheumatologists want to see system in place to track efficacy and safety of biosimilar products (PharmJournal) (MNT)
• EU court rules Boston Scientific must pay pacemaker replacement surgery (Reuters)
• Behind the scenes of medicines regulation (PharmJournal)
• Major policy shift on costs and safety views as China moves to lift price controls on drugs (Fierce)
• Nurofen manufacturer Reckitt Benckiser sued over false claims on packets (Guardian)
• How to Tip Off a GCP Auditor in 25 Words or Less (Polaris Consultants)
• Ebola vaccine efficacy trial ready to launch in Guinea (WHO) (Reuters)

As the EU Gears up for Major Device Changes, What do Regulatory Pros Need to Know?

• In Europe, medical devices currently are regulated much the same way they have been since the 1990s. Now, almost 20 years and several major scandals later, EU officials are preparing a massive overhaul of the region's medical device regulatory directives in the hopes of modernizing the system—if only they could agree on what those changes should look like. ( Regulatory Focus)
• Find out what changes are likely to affect medical devices and IVDs next year in this 11 March 2015 webcast featuring expert Erik Vollebregt. ( RAPS Webcast)

US: Pharmaceuticals and Biotechnology

• Bristol-Myers bags a record-fast approval for its cancer blockbuster Opdivo  ( Fierce) ( Press) ( MM&M) ( Pink Sheet-$) ( PharmaPhorum) ( FDA) ( BioCentury) ( NYTimes) ( WSJ-$) ( Reuters) ( SCRIP-$) ( Bloomberg)
• FDA’s Anti-Franchising Policy: What Is It and Where Did It Come From? (FDA Law Blog)
• BIO Survey on Effective FDA-Sponsor Communication ( BIO)
• FDA Advisory Committee Makes Recommendations About Strains for the 2015-2016 Flu Vaccine ( Tarius) ( AP)
• REMS “Abuses” Concern FDA, But Can Scolding Help Speed Generic Entry? ( RPM Report-$)
• DOJ Targets Small Pharma: Expects Companies To Mine Their Data For Misconduct; Finds Speaker Programs, Specialty Pharmacies, R&D “Prone to Abuse” ( Policy and Medicine)
• Can the rise in drug-drug interactions be halted, or is it an inevitable side effect? ( PharmaPhorum)
• Biosimilar substitution bill advances in Tennessee ( Scout)
• Fighting mosquitoes with more mosquitoes ( CNBC)
• Second Circuit to Hear Actavis’ Appeal on Namenda Decision ( FDAnews-$)
• Celgene Hit With Suit For Blocking Generic Cancer Drugs ( Law 360-$)

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

• Novartis' NDAs For QVA149 And NVA237 Accepted For Review By FDA ( RTT)
• Vanda's eczema drug fails mid-stage study, shares fall ( Reuters)
• Bayer says won't get results from Stivarga trial in bowel cancer ( Reuters)
• Axsome Therapeutics Announces FDA Fast Track Designation for AXS-02 for the Treatment of Pain Associated With Complex Regional Pain Syndrome ( Press)

US: Pharmaceuticals and Biotechnology: General

• Akorn to prisons: Give us back our execution drugs ( CNBC) ( Reuters)

US: Medical Devices

• U.S. FDA updates safety alert for 'superbug' scopes ( Reuters) ( FDA)
• Second Los Angeles Hospital Reports 'Superbug' Infections ( AP) ( LATimes) ( Reuters)
• FDA Approves Feasibility Trial Of Disappearing Tissue Tricuspid Valve ( Gray Sheet-$) ( Mass Device)
• ECRI Institute advises culturing of duodenoscopes to help reduce risk of deadly infections ( MNT)
• joimax Receives 510(k) Clearance for Percusys Pedicle Screw-Rod System ( Press)

US: Dietary Supplements

• FDA reveals reasons for not meeting FSMA mandate ( FQN) ( Registrar Corp)
• Budget Subcommittee Zeroes in on FDA’s Request for More FSMA Funding ( FSN)
• Cannabis Supplements’ Cancer Claims Spark FDA Warnings, Policy Point ( Pink Sheet-$)

US: Assorted And Government

• FDA Unlikely to Get Full Budget Request ( FDAnews-$) ( Pink Sheet-$)
• Grassley, Feinstein Announce Drug Caucus Hearing on Controlled Substances Quota Process ( Senate)
• Results Wire: US FDA Science Board Hears Subcommittee Updates and Reviews Science Activities – MAR 4, 2015 (SBFDA) ( Tarius)
• Varmus Stepping Down as Director of NIH’s National Cancer Institute ( NIH)
• NIH-led effort launches Big Data portal for Alzheimer’s drug discovery ( NIH)
• Pallone, Upton Introduce Bipartisan Legislation to Ban Use of Microbeads in Cosmetics ( House)

Upcoming Meetings

• RAPS' FDA Advisory Committee Meeting Tracker

Ebola Outbreak

• Ebola vaccine efficacy trial ready to launch in Guinea ( WHO) ( Reuters)
• J&J, Merck to advance Ebola vaccines in Africa, but their fate rests in WHO's hands ( Fierce)

Europe

• EMA Launches two new Guidelines on the use of Antibiotics in Animals ( EMA) ( EMA) ( EMA)
• Rheumatologists want to see system in place to track efficacy and safety of biosimilar products ( PharmJournal) ( MNT)
• EU court rules Boston Scientific must pay pacemaker replacement surgery ( Reuters)
• Behind the scenes of medicines regulation ( PharmJournal)
• European Commission Grants "2+1 Immunization Schedule" for Sanofi Pasteur MSD's Hexyon 6-in-1 Paediatric Vaccine ( Press)
• European CHMP issues positive opinion for a label update of Lundbeck's Brintellix (vortioxetine) to reflect its effect on certain aspects of cognitive function in patients with depression ( Press)

India

• Oviya MedSafe calls for streamlining Indian PSUR submission & review process ( PharmaBiz)
• Indian panel recommends waiving late-stage trials for some drugs ( Reuters)

Japan

• AdvaMed calls for more appropriate medical device reimburesment in Japan ( Fierce)

China

• Major policy shift on costs and safety views as China moves to lift price controls on drugs ( Fierce)

Australia

• Nurofen manufacturer Reckitt Benckiser sued over false claims on packets ( Guardian)

Other International

• Philipines FDA Warns About Regulatory Imposters ( GMA)

Clinical Trials

• How to Tip Off a GCP Auditor in 25 Words or Less ( Polaris Consultants)
• The US Food and Drug Administration's efforts to support ophthalmology clinical trials ( PubMed)
• A University’s Clinical Trial Oversight Practices are Skewered ( Pharmalot)

General Regulatory And Interesting Articles

• Pharmaceutical marketing swag we actually want: Cards against humanity, biotech edition ( Fierce)
• Cybersecurity in Medical Devices: 3 Key Strategies to Inspire Consumer Confidence ( MedicalDeviceSummit)
• Using Root Cause Analysis for Powerful Defect Prevention ( MedicalDeviceSummit)
• Could Oxygen Make Cancer Therapy Work Better? ( NBC)

Regulatory Reconnaissance #507 – 5 March 2015

RegulatoryReconnaissance is our daily intelligence briefing for the regulatory affairsspace, bringing you the top regulatory news stories from around the globe. Eachweekday morning, we aim to bring you the latest highlights of new approvals,meetings, legal and political developments, regulations and guidance, and thelatest trends with the potential to impact regulatory affairs professionals andthe industry in which they work.

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

A story's inclusion inRegulatory Reconnaissance does not imply endorsement by Regulatory Focus orRAPS.