Regulatory Recon: Novartis' Heart Failure Drug Gets Green Light From FDA (8 July 2015)

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

In Focus: US

• Novartis' Heart Failure Drug Entresto Gets FDA Approval (FDA) (WSJ-$) (Reuters) (FierceBiotech) (NYTimes) (Press)
• New Rule Requires Drugmakers to Give FDA Notice Prior Ahead of Shortages (Federal Register) (FDANews)
• Off-Label Promotion Seems On Track: Judge Supportive Of Amarin, Skeptical Of FDA (Pink Sheet-$) (Law360-$)
• 'Female Viagra' a political tightrope for FDA, advisors warn (LA Times)
• Would 21st Century Cures Act Make Drug Approvals Too Fast? (Wonkblog)
• The Powers of Pediatric Exclusivity (FDA Law Blog)
• US court’s decision highlights risk of using a CMO prior to filing a patent application (Outsourcing-Pharma)
• FDA Posts Materials Ahead of Lilly Cancer Drug Review, Highlighting Clot Risk (SAC-Tracker) (FDA) (SCRIP-$)

In Focus: International

• China to impose surprise inspection on drug and medical device companies (Xinhua) (PharmaLetter-$)
• EU Regulators Also Looking Into Indian CRO After WHO Outs Data Issues (Reuters)
• Serious adverse events rare in healthy volunteers participating in Phase I trials (European Pharmaceutical Review)
• Consistency of Vaccine Production Using Non-Animal Test Methods (EDQM) (Study)

US: Pharmaceuticals and Biotechnology

• Novartis' Entresto Gets FDA Approval (FDA) (WSJ-$) (Reuters) (FierceBiotech) (NYTimes) (Press)
• New Rule Requires Drugmakers to Give FDA Notice Prior Ahead of Shortages (Federal Register) (FDANews)
• 'Female Viagra' a political tightrope for FDA, advisors warn (LA Times)
• J&J opens expanded access to daratumumab (BioCentury)

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

• Summit Therapeutics Gets Fast Track Designation for New Antibiotic (Press)
• Catabasis Duchenne Muscular Dystrophy Drug Given Fast Track Designation (PharmaBiz) (Press)
• Esperion's PCSK9 spoiler clears another FDA roadblock as it heads to Phase III (FierceBiotech) (Press)
• Boehringer Touts Giotrif over Tarceva After Phase III Trial (Press) (Lancet Oncology)

US: Pharmaceuticals and Biotechnology: General

• Off-Label Promotion Seems On Track: Judge Supportive Of Amarin, Skeptical Of FDA (Pink Sheet-$) (Law360-$)
• ALS Association Drafting Drug Development Guidance; Learning From DMD Advocacy (RPM Report)
• The Powers of Pediatric Exclusivity (FDA Law Blog)

US: Medical Devices

• Public Citizen pushes FDA to recall Sanofi’s Seprafilm (MassDevice)

US: Assorted and Government

• Would 21st Century Cures Act Make Drug Approvals Too Fast? (Wonkblog)
• California Court Tosses Out Sunscreen Cases (Drug and Device Law)

Upcoming Meetings and Events

• RAPS' FDA Advisory Committee Meeting Tracker

Europe

• EU Regulators Also Looking Into Indian CRO After WHO Outs Data Issues (Reuters)
• Serious adverse events rare in healthy volunteers participating in Phase I trials (European Pharmaceutical Review)
• Consistency of Vaccine Production Using Non-Animal Test Methods (EDQM) (Study)
• Genticel cleared to proceed with ProCervix Trial (PharmaLetter-$)
• Vanda Pharmaceuticals' Hetlioz approved in Europe for sleep disorder (PharmaLetter-$) (Press)

China

• China to impose surprise inspection on drug and medical device companies (Xinhua) (PharmaLetter-$)
• AstraZeneca and Ironwood See Positive Phase III Results for China Linaclotide Trial (Press)

Other International

• One step at a time towards HTA and reimbursement goals in South Africa (Clinica-$)

Ebola Outbreak

• Report: WHO Not Well-Equipped For Epidemics Like Ebola (Report) (WHO Statement) (SCRIP-$) (NYTimes) (MedPageToday)

Regulatory Reconnaissance #591 – 8 July 2015

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 @Michael_Mezher or send him an email at [email protected].

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