Regulatory Recon: FDA AdComm Recommends Amgen’s Cholesterol Drug (11 June 2015)
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
- Former FDA Commissioner Comes out Against 21st Century Cures Act ( NYTimes)
- FDA AdComm Votes in Favor of Amgen’s PCSK9 Drug Repathain Narrow Population ( SCRIP-$) ( Tarius) ( Forbes) ( BioCentury) ( Fierce) ( Reuters) ( WSJ-$) ( MedPage Today) ( NYTimes) ( Pink Sheet-$)
- New FDA Guidance: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products ( FDA)
- FDA Guidance: Assessment of Male-Mediated Developmental Risk for Pharmaceuticals ( FDA)
- New FDA Compliance Guide for its Pregnancy Labeling Guidance ( FDA)
- Florida Signs Right to Try Bill Into Law ( Press)
- Dept. of Homeland Security Issues Warning About Hospira Devices ( DHS) ( DHS)
- What's Next for the FDA-CMS Parallel Review Pilot? ( MDDI)
- Insulet gets FDA warning letter over some insulin pumps ( Reuters)
- NEJM Op-Ed: FDA Could do More to Promote Trial Results Reporting ( NEJM)
In Focus: International
- Updates to product information templates for all medicines for human use ( EMA)
- New market surveillance manual for EU member states on the way ( Clinica-$)
- Call for adaptive licensing to smash UK cancer drugs bottle-neck ( PharmaTimes)
- NICE not yet convinced by Lundbeck's Brintellix ( SCRIP-$)
- Debate over naming of biosimilars intensifies ahead of WHO meeting ( PharmJournal)
- South Africa’s department of health to fast-track sourcing of APIs ( PharmAfrica)
US: Pharmaceuticals and Biotechnology
- Former FDA Commissioner Comes out Against 21st Century Cures Act ( NYTimes)
- FDA AdComm Votes in Favor of Amgen’s PCSK9 Drug Repathain Narrow Population ( SCRIP-$) ( Tarius) ( Forbes) ( BioCentury) ( Fierce) ( Reuters) ( WSJ-$) ( MedPage Today) ( NYTimes) ( Pink Sheet-$)
- New FDA Guidance: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products ( FDA)
- FDA Guidance: Assessment of Male-Mediated Developmental Risk for Pharmaceuticals ( FDA)
- New FDA Compliance Guide for its Pregnancy Labeling Guidance ( FDA)
- Florida Signs Right to Try Bill Into Law ( Press)
- FDA Posts Advisory Committee Materials for Review of Drugs on the Not Allowed List and Bulk Substances for the Allowed List for Pharmacy Compounding ( Tarius)
US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations
- InSite Vision Announces Completion of the New Drug Application Submission to the U.S. FDA for BromSite ( Press)
- Positive Data for Ph3 Trial of Lilly’s Ixekizumab ( Press)
- Agios Pharmaceuticals Announces FDA Orphan Drug Designation Granted to AG-120 for Treatment of IDH1-Mutant Positive Acute Myelogenous Leukemia ( Press)
US: Pharmaceuticals and Biotechnology: General
- Murder charges for woman who took pills to terminate pregnancy ( AP)
- Surprising Approach for STDs Allows Prescription Drugs for Sexual Partners ( SciAm)
US: Medical Devices
- Dept. of Homeland Security Issues Warning About Hospira Devices ( DHS) ( DHS)
- What's Next for the FDA-CMS Parallel Review Pilot? ( MDDI)
- Insulet gets FDA warning letter over some insulin pumps ( Reuters)
- Bard, Medtronic get additional CMS reimbursement for their drug-coated balloons ( Fierce)
- Medical Informatics wins FDA nod for Sickbay system ( MassDevice)
US: Dietary Supplements
- Supplement Claims For Autism Treatment Could Ring A Bell At FTC ( Tan Sheet-$)
US: Assorted and Government
- NEJM Op-Ed: FDA Could do More to Promote Trial Results Reporting ( NEJM)
- FDA Enforcement Report ( FDA)
- Hatch to introduce bill aimed at costly regs ( The Hill)
Upcoming Meetings and Events
Europe
- Updates to product information templates for all medicines for human use ( EMA)
- New market surveillance manual for EU member states on the way ( Clinica-$)
- Call for adaptive licensing to smash UK cancer drugs bottle-neck ( PharmaTimes)
- NICE not yet convinced by Lundbeck's Brintellix ( SCRIP-$)
- Scottish nod for psoriasis drug contradicts NICE and IQWiG decisions ( SCRIP-$) ( Pharmafile)
India
- Industry welcomes Centre's move to set up National Medical Device Authority' under draft NMDP-2015 ( PharmaBiz)
China
- China graft probes a tough tonic as pharma margins bounce ( Reuters)
Australia
- New Website Aims To Improve Australian Trial Competitiveness ( PharmAsia-$)
Other International
- Debate over naming of biosimilars intensifies ahead of WHO meeting ( PharmJournal)
- South Africa’s department of health to fast-track sourcing of APIs ( PharmAfrica)
- Exporting to Brazil? ANVISA is tough and hands-on ( Outsourcing Pharma)
- Malaysia consults on declaring conformity with medtech regulations, refurbishing used devices ( SCRIP RA-$)
General Regulatory And Interesting Articles
- A man who can’t stand the sight of blood has saved 2 million babies by donating ( MedCityNews)
- Beyond games, Oculus virtual reality headset finds medical uses ( Reuters)
Regulatory Reconnaissance #574 – 11 June 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 @AlecGaffney or send him an email at [email protected].