Regulatory Recon: EMA Fights to Reinstate Former Leader Guido Rasi (18 June 2015)
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
- FDA Plans To Seize Nebraska's Illegal Execution Drug Shipment When It Arrives In The US (BuzzFeed)
- Merck to pay $5.9 million for misleading marketing of pink eye drug (Reuters)
- FDA Central Review Likely For Novel Surrogate Endpoints (Pink Sheet-$)
- FDA's Bob Califf on Combo Products, Open Data and More (SoundCloud)
- FDA OKs new Sapien 3 valve from Edwards (MassDevice) (Press) (FDA)
- Senators Overseeing Seniors Committee Investigate Dietary Supplements (NPI) (NI-USA) (CBS)
In Focus: International
- European Medicines Agency fights the removal of its pick for executive director (Politico)
- Investigation Finds Conflicts of Interest in France's Reimbursement of Sovaldi (Mediapart)
- NICE opens consultation on Gilead's leukaemia drug (PMLive)
- Regulators play catch up with ever more complex manufacturing processes (In-Pharma)
- India's Struggle to Regulate Online Drug Sales (Fierce) (Financial Express)
- Global Biosimilar Firms Face China Regulatory Challenges (PharmAsia-$)
US: Pharmaceuticals and Biotechnology
- FDA Plans To Seize Nebraska's Illegal Execution Drug Shipment When It Arrives In The US (BuzzFeed)
- Merck to pay $5.9 million for misleading marketing of pink eye drug (Reuters)
- FDA Central Review Likely For Novel Surrogate Endpoints (Pink Sheet-$)
- Patient-Focused Drug Development: Moving Up The Development Timeline (RPM Report-$)
- PCSK9 Cholesterol Drugs And FDA's Missing Mandatory Study Authority (RPM Report-$)
- Genentech's Actemra Receives Breakthrough For Systemic Sclerosis; Potential Future Beneficiary of OPEN ACT? (RPM Report-$)
- Quality Expert Urges FDA to Require Pharmacovigilance Audits (FDAnews-$)
US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations
- Synergy soars on Phase III constipation data (BioCentury)
- BioMarin's dwarfism drug improves growth in a mid-stage study (Reuters) (PMLive) (NYTimes)
- New class of drugs being tested for migraine prevention shows promise (WaPo) (NBC)
- Lilly's investigational medicine for prevention of migraine met primary endpoint in a Phase 2b study (Press)
- Aimmune Therapeutics Receives FDA Breakthrough Therapy Designation for AR101 (Press)
US: Pharmaceuticals and Biotechnology: General
- The quickening pace of medical progress and its discontents (AEI)
- Drug pricing drives debates at BIO convention (MM&M)
US: Medical Devices
- FDA's Bob Califf on Combo Products, Open Data and More (SoundCloud)
- FDA OKs new Sapien 3 valve from Edwards (MassDevice) (Press) (FDA)
- FDA Hiring for New Director for its Office of Device Evaluation (Indeed)
- HeartWare, hit with its fifth Class 1 recall of 2015, will replace defective blood pump controllers (Fierce)
- BTL Vanquish by BTL Industries Receives FDA Clearance for Non-Surgical Circumferential Reduction of the Abdomen (Press)
US: Dietary Supplements
- Senators Overseeing Seniors Committee Investigate Dietary Supplements (NPI) (NI-USA) (CBS)
- Twenty Years of the Dietary Supplement Health and Education Act—How Should Dietary Supplements Be Regulated? (Nutrition) (NI-USA)
US: Assorted And Government
- FDA Enforcement Update From CDRH, CDER, and CBER: Advertising and Promotion (Policy and Medicine)
Upcoming Meetings and Events
Ebola Outbreak
- Study of Ebola survivors opens in Liberia (NIH)
Europe
- European Medicines Agency fights the removal of its pick for executive director (Politico)
- Investigation Finds Conflicts of Interest in France's Reimbursement of Sovaldi (Mediapart)
- NICE opens consultation on Gilead's leukaemia drug (PMLive)
- Regulators play catch up with ever more complex manufacturing processes (In-Pharma)
- UK leads the way with £15.8 million seizure in global operation targeting counterfeit and unlicensed medicines and devices (MHRA)
- BIA responds to UK antibiotics resistance proposals (PharmaTimes)
India
- CDSCO reducing regulatory approval time through 'just-in-time' service (PharmaBiz)
- India's Struggle to Regulate Online Drug Sales (Fierce) (Financial Express)
China
- Global Biosimilar Firms Face China Regulatory Challenges (PharmAsia-$)
- China FDA publishes online false ad sanctions on 8 local drug and device firms (Fierce)
Clinical Trials
- Mobile data collection's role in precision medicine and the clinical trial of the future (MobiHealthNews)
General Regulatory And Interesting Articles
- New drug compound may beat malaria with single $1 dose (Reuters)
Regulatory Reconnaissance #578 – 18 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].
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.