Regulatory Recon: Generic Viagra Gets a Probable FDA Approval Date (14 April 2015)

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

In Focus: US

• Mylan settles Viagra patent litigation with Pfizer, Will Launch in December 2017 ( Reuters)
• Critical Path Institute Secures Regulatory Support for Skeletal Muscle Safety Biomarkers ( Press) ( BioCentury)
• FDA staff backs Medicines Co's once-rejected blood clot preventer cangrelor ( Fierce) ( Tarius) ( SCRIP-$) ( Reuters) ( BioCentury) ( Pink Sheet-$)
• Should The FDA Require CV Outcome Studies For Diabetes Drugs Before Approval? ( Forbes)
• 2nd Circ. Wary Of Anti-Competitive Intent In Namenda Plan ( Law 360-$) ( SCRIP-$) ( Pink Sheet-$)
• U.S. prescription drug spending rose 13 percent in 2014 ( Reuters) ( Forbes) ( Bloomberg)
• Former Execs Charged With Securities Fraud at Device Maker Bought by J&J ( Pharmalot)
• FDA medical app regulation and the art of intended use ( MobiHealthNews)
• 510(k) In Patent Litigation: Applicants Should Be Cautious ( Law 360-$)

In Focus: International

• UK market access issues put on hold during election ( PMLive)
• Parliament approves changes to regulations governing controlled drugs ( PharmJournal)
• European group criticizes proposed WHO, FDA biosimilar naming schemes ( BioPharmaReporter)
• Highlights from EMA’s CVMP, PRAC Meeting ( CVMP) ( PRAC)
• India to amend rules governing authenticity of drug data submissions ( PharmaBiz)
• International convergence: Australia’s TGA proposes to adopt 10 EMA guidelines ( In-Pharma)
• IMDRF to invite medtech/IVD firms to test common e-submission format ( SCRIP RA-$)

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US: Pharmaceuticalsand Biotechnology

• Mylan settles Viagra patent litigation with Pfizer, Will Launch in December 2017 ( Reuters)
• Critical Path Institute Secures Regulatory Support for Skeletal Muscle Safety Biomarkers ( Press) ( BioCentury)
• FDA staff backs Medicines Co's once-rejected blood clot preventer cangrelor ( Fierce) ( Tarius) ( SCRIP-$) ( Reuters) ( BioCentury) ( Pink Sheet-$)
• Should The FDA Require CV Outcome Studies For Diabetes Drugs Before Approval? ( Forbes)
• 2nd Circ. Wary Of Anti-Competitive Intent In Namenda Plan ( Law 360-$) ( SCRIP-$) ( Pink Sheet-$)
• North Dakota Passes Right to Try Bill, Sent to Governor for Signature ( AP)
• ‘Right-to-Try’ Bills Introduced in N.Y. ( Thompson’s)
• FDA Social Media Guidelines in 2015: Engaging with Your Audience on Their Terms ( PCM)
• FDA Addressing the Shortage of Large Volume Intravenous Solutions for Animals ( FDA)
• FDA Involvement in Off-Label Use: Debate between Richard Epstein and Ryan Abbott ( SSRN)

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

• Roche aims for 11 late-stage trials in cancer immunotherapy drug this year ( Reuters)
• FDA lifts partial clinical hold on Arrowhead drug ( SCRIP-$) ( Fierce) ( Press)
• ARCA biopharma Receives FDA Fast Track Designation for Gencaro™ Atrial Fibrillation Development in a Genetically Targeted Heart Failure Population ( Press)
• Pharmalink Announces Positive Result in Phase 2b Trial of Nefecon ( Press)

US: Pharmaceuticalsand Biotechnology: General

• U.S. prescription drug spending rose 13 percent in 2014 ( Reuters) ( Forbes) ( Bloomberg)
• Specialty, Generic Drug Costs Drive Medicaid Costs Up ( AP) ( Fierce)
• Big Bills A Hidden Side Effect Of Cancer Treatment ( NPR)

US: Medical Devices

• Former Execs Charged With Securities Fraud at Device Maker Bought by J&J ( Pharmalot)
• FDA medical app regulation and the art of intended use ( MobiHealthNews)
• 510(k) In Patent Litigation: Applicants Should Be Cautious ( Law 360-$)
• FTC increasingly active in OCR, FDA’s traditional purviews ( MobiHealthNews)
• FTC Approves Final Order Barring Misleading Claims about App’s Ability to Diagnose or Assess the Risk of Melanoma ( FTC)
• FDA posts Briefing Materials for Flow Diverter Technology Meeting ( FDA)
• Biomerieux unit Biofire submits de novo classification request to FDA ( Reuters) ( Press)
• Baltimore device company aims to bring first wearable artificial lung to market ( Fierce)

US: DietarySupplements

• Study finds troubling link between use of muscle-building supplements and cancer ( Washington Post)
• FDA warns consumers not to use muscle growth product ( FDA)
• FDA Hiring CFSAN Policy Director ( Indeed)
• GNC CEO: Fight with AG Schneiderman ‘Would Have Been, at Best, Counterproductive’ ( Press)

US: Assorted AndGovernment

• This week’s regulatory and legislative news ( PWC)
• The Significance of Warning Letters ( FDA Attorney)

Upcoming Meetings andEvents

• RAPS' FDA Advisory Committee Meeting Tracker
• Atlanta, 15/22/29 April 2015 –  Preparing for the US Regulatory Affairs Certification (RAC) Exam (Four-Part Series)
• 18 April 2015 –  Midwest Region Regulatory Career Day
• Florida, 6 May 2015 –  Canadian Medical Devices Regulations
• Philadelphia, 7 May 2015 –  Global UDI Compliance - Challenges and Opportunities of Device Identification

Europe

• UK market access issues put on hold during election ( PMLive)
• Parliament approves changes to regulations governing controlled drugs ( PharmJournal)
• European group criticizes proposed WHO, FDA biosimilar naming schemes ( BioPharmaReporter)
• Highlights from EMA’s CVMP, PRAC Meeting ( CVMP) ( PRAC)
• Seven new drugs OK'd for NHS Scotland ( PharmaTimes) ( SCRIP-$)
• Bayer’s Stivarga accepted for use by NHS Scotland ( PharmaLetter-$)
• Public consultation on the position paper on how to decide on the appropriate study design for primary research arising from HTA ( EUnetHTA)

India

• India to amend rules governing authenticity of drug data submissions ( PharmaBiz)

Japan

• Japan Vaccine files for Japanese approval of intradermal seasonal flu vaccine ( PharmaLetter-$)

Australia

• International convergence: Australia’s TGA proposes to adopt 10 EMA guidelines ( In-Pharma)
• Receiving prescription medicine streamlined submission evaluation reports by email ( TGA)

Other International

• IMDRF to invite medtech/IVD firms to test common e-submission format ( SCRIP RA-$)
• Counterfeit drugs ex-U.S. see four Asian nations atop the list ( Fierce)

Clinical Trials

• AZ partners with PatientsLikeMe for PRO data ( BioCentury)
• How FDA, industry and patient community can increase number and quality of PROs ( BioCentury)

General RegulatoryAnd Interesting Articles

• HPV Shots for Boys Could Save Millions in 'Oral Cancer' Costs ( NBC)
• Marijuana compound shows promise in treating seizures from severe epilepsy ( WashingtonPost)
• Oh, great: Brain's sarcasm center found ( CBS)

RegulatoryReconnaissance #535 – 14 April 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 anemail at [email protected].

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