Regulatory Recon: NICE Wants Direct Line to Trials Data Seen by Regulators (10 September 2014)

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This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register here.

In Focus: US

• FDA advisory panel recommends against approval of Actavis' experimental fixed-dose combination for hypertension (First Word Pharma) (Press) (Tarius) (Pharma Times)
• US Regulators Signal Support for Novo Nordisk's Weight Loss Drug Saxenda (liraglutide)(Bloomberg) (BioCentury) (Fierce) (Tarius) (Pink Sheet-$) (SCRIP-$)
• FDA staff: NPS drug effective; no significant safety imbalance (Reuters) (Press)
• Purple will be the new orange for biosimilar makers (BioWorld) (FDA Law Blog)
• PhRMA Fires Back At Feds In FCA Off-Label Suit (Law 360-$) (Fierce) (DOJ)
• PBM Sides With Generic Industry In Biosimilar Naming Debate (IHP-$)
• Congress Takes Skeptical View of FDA Efforts to Regulate LDTs (E&C) (Burgess) (E&C) (BioCentury) (Law 360-$) (Genome Web)
• Court Vacates FDA’s Classification Decision (Again) (FDA Law Blog)

In Focus: International

• NICE 'will go straight to regulators for trial data' (PharmaPhorum) (Pharmafile)
• Insulin glargine biosimilar approved in Europe (PharmaPhorum) (Reuters) (Press) (Fierce)
• Device regulation must face overhaul (OnMedica) (BMJ)
• UK drug regulator inspects Wockhardt Chikalthana unit (Business Standard)
• The hidden cost of low prices: limited access to new drugs in India (PubMed)

US: Pharmaceuticals and Biotechnology

• FDA advisory panel recommends against approval of Actavis' experimental fixed-dose combination for hypertension (First Word Pharma) (Press) (Tarius) (Pharma Times)
• US Regulators Signal Support for Novo Nordisk's Weight Loss Drug Saxenda (liraglutide)(Bloomberg) (BioCentury) (Fierce) (Tarius) (Pink Sheet-$) (SCRIP-$)
• FDA staff: NPS drug effective; no significant safety imbalance (Reuters) (Press)
• Purple will be the new orange for biosimilar makers (BioWorld) (FDA Law Blog)
• PhRMA Fires Back At Feds In FCA Off-Label Suit (Law 360-$) (Fierce) (DOJ)
• PBM Sides With Generic Industry In Biosimilar Naming Debate; Says INNs Never Denoted Sameness (IHP-$)
• Flaws In TEA Process Delay Reviews, Monograph Changes – FDA (Tan Sheet-$)
• Primary Care Physicians' Use of FDA-Approved Prescription Drug Labels (PubMed)
• New Link Shortener for Risk Info (RegulatoryRX)
• Recent Development Highlighting The Off-Label Paradox (D&D Law)
• FDA Asks Recalcitrant Compounder to Recall Products, Again (Pharmalot) (FDA)
• Lawsuits claiming Merck lied about mumps vaccine efficacy headed to trial (Fierce) (Law 360-$)
• FDA: Don’t Leave Childhood Depression Untreated (FDA)

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

• Rolapitant NDA Submitted for Chemotherapy-Induced Nausea and Vomiting (MPR)
• NIH Allergy Institute Taps Emergent BioSolutions for Anthrax Vaccine Dry Formulation (ExecBiz)

US: Pharmaceuticals and Biotechnology: General

• Medicines in Development for HIV/AIDS (PhRMA)
• 1 in 5 young men unable to purchase emergency contraception (Press)

US: Medical Devices

• Congress Takes Skeptical View of FDA Efforts to Regulate LDTs (E&C) (Burgess) (E&C) (BioCentury) (Law 360-$) (Genome Web)
• Court Vacates FDA’s Classification Decision (Again) (FDA Law Blog)
• Male Birth Control, Without Condoms, May Be Here by 2017 (Daily Beast)
• Boston Scientific dealt $73M blow in vaginal mesh case (Fierce) (Bloomberg) (Law 360-$)
• Regulatory clearance opens the way for new single-size contraceptive diaphragm in the US (Press)
• New Prevantics Device Swab from PDI Receives FDA 510k Market Authorization (Press)
• Global Kinetics Corporation Announces FDA Clearance of the Personal KinetiGraph for Assessment of Parkinson's Disease Symptoms (Press)

US: Dietary Supplements

• Hi-Tech Executives End Up in Jail; District Court Imposes Incarceration as a Coercive Sanction in Civil Contempt Proceedings (FDA Law Blog)

US: Assorted And Government

• Small Business Administration Releases "Small Business" Definitions for Pharma, Device Manufacturers (SBA)

Upcoming Meetings

• RAPS' FDA Scientific Advisory Committee Meeting Tracker

Ebola Outbreak

• US Senate to hold joint hearing on Ebola (The Hill)

Europe

• NICE 'will go straight to regulators for trial data' (PharmaPhorum) (Pharmafile)
• Insulin glargine biosimilar approved in Europe (PharmaPhorum) (Reuters) (Press) (Fierce)
• Device regulation must face overhaul (OnMedica) (BMJ)
• EU Proposes New legislation for veterinary medicines (EMA) (EC)
• NICE's Rejection of Celgene's Abraxane Puts Spotlight On Cost Again (Pink Sheet-$)

India

• UK drug regulator inspects Wockhardt Chikalthana unit (Business Standard)
• The hidden cost of low prices: limited access to new drugs in India (PubMed)
• Indian Patients Suffer from India’s Weak Pharmaceutical Patents (NCPA)

Other International

• Drug Master Files (DMFs) in the United States, Canada, and European Union (Cato)
• Philippines to adopt ASEAN medtech registration requirements (Clinica-$)

Clinical Trials

• Clinical Trials: Little is Known about Participation by Supplemental Security Income Recipients (GAO)

General Regulatory And Interesting Articles

• Long-term use of pills for insomnia and anxiety linked to Alzheimer’s risk (WaPo) (NBC) (OnMedica)
• Autism Prevalence Unchanged in 20 Years (SBM)
• Passing of Steve Wratten, TOPRA Director of Corporate Services (TOPRA)
• Rise in Drug Use Is Found in Pilots Killed in Crashes (NYTimes)

Regulatory Reconnaissance #396 – 10 September 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].

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