Search Results for regulatory

Showing 1 – 25  of 1908

Regulatory Recon: NICE Backs Opdivo for NSCLC After Price Cut; Alnylam RNAi Drug Succeeds in Phase III (20 September 2017) By Michael Mezher - Published 20 September 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Asia Regulatory Roundup: India to Reassess Cardiac Stent Price Ceiling (19 September 2017) By Nick Paul Taylor - Published 19 September 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CFDA, TGA, Drugs, Medical Devices

Tags: Asia Regulatory Roundup

Regulatory Recon: Bayer Halts Non-US Sales of Essure; FDA Approves GSK's Triple Drug COPD Inhaler (19 September 2017) By Michael Mezher - Published 19 September 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: Teva Sells Off Remaining Women's Health Assets for $1.38B; Fosun to Buy 74 Percent Stake in Gland Pharma (18 September 2017) By Michael Mezher - Published 18 September 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: Phase III Cancer Vaccine Trial Fails; EMA’s CHMP Recommends 13 Medicines for Approval (15 September 2017) By Zachary Brennan - Published 15 September 2017

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

Categories: News, Asia, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: AZ Sells Remaining Anesthetic Rights to Aspen for $766M; FDA Panel Unanimously Backs GSK Shingles Vaccine (14 September 2017) By Michael Mezher - Published 14 September 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: Amicus Abandons Wound Treatment After Phase III Miss; Mylan Says Allergan Misusing Tribal Sovereignty (13 September 2017) By Michael Mezher - Published 13 September 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: Alexion Cutting 600 Jobs in Boston HQ Move; Teva Sells Paragard Contraceptive Business for $1.1B (12 September 2017) By Michael Mezher - Published 12 September 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Asia Regulatory Roundup: TGA Takes Tougher Line on Incomplete GMP Clearance Applications (12 September 2017) By Nick Paul Taylor - Published 12 September 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, TGA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Asia Regulatory Roundup

Regulatory Recon: Teva Hires Lundbeck's Schultz as CEO; Updates from ESMO (11 September 2017) By Michael Mezher - Published 11 September 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: Sanofi, Regeneron Get Breakthrough Status for PD-1 Skin Cancer Candidate; New Mexico Sues 8 Opioid Makers and Distributors (8 September 2017) By Michael Mezher - Published 08 September 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

European Regulatory Roundup: EU Committee Slams Plan to Cut EMA Staffing Ahead of Brexit (7 September 2017) By Nick Paul Taylor - Published 07 September 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Drugs, Medical Devices

Tags: European Regulatory Roundup, Brexit, EMA staff cuts

Regulatory Recon: Eli Lilly to Lay Off 3,500 in Global R&D Cuts; FDA Puts Holds on BMS, Celgene Cancer Trials (7 September 2017) By Michael Mezher - Published 07 September 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Health Technology Assessment, Reimbursement, Scientific Research, Risk Management, Generic Drug Legislation and a Preview of September By Gloria Hall - Published 06 September 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in September.

Categories: Features, FDA, Health Canada, Biologics and biotechnology, Generic drugs, Medical Devices, Regulatory strategy, Reimbursement

Tags: Regulatory Focus, Feature Articles, Editorial

Regulatory Recon: Merck Buys German Immuno-Oncology Specialist Rigontec; NICE Again Rejects Takeda's Ninlaro for Multiple Myeloma (6 September 2017) By Michael Mezher - Published 06 September 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: FDA Halts Cellectis' Off-the-Shelf CAR-T Trial After Patient Death; Novartis Names New CEO (5 September 2017) By Michael Mezher - Published 05 September 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Asia Regulatory Roundup: Drugmakers Push Back on Data Requirements in Australia’s Provisional Approval Pathway (5 September 2017) By Nick Paul Taylor - Published 05 September 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CFDA, PMDA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Asia Regulatory Roundup, Pfizer, inspections

Regulatory Recon: Dr. Reddy's US Suboxone Patent Win Sends Indivior's Share Price Tumbling; St. Kitts Launches Probe of Controversial Offshore Herpes Vaccine Study (1 September 2017) By Michael Mezher - Published 01 September 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: Spanish Regulator Ramps Up Hiring Ahead of Brexit; FDA Delays Decision on Biocon, Mylan Herceptin Biosimilar (31 August 2017) By Michael Mezher - Published 31 August 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: FDA Approves Medicines Co's UTI Antibiotic; Nonprofit Gets PRV for First FDA Approved Chagas Treatment (30 August 2017) By Michael Mezher - Published 30 August 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Asia Regulatory Roundup: Roche Cancer Drug First to Win TGA Priority Review Status (29 August 2017) By Nick Paul Taylor - Published 29 August 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, Biologics and biotechnology, Drugs, Government affairs

Tags: Asia Regulatory Roundup, Roche, DCGI

Regulatory Recon: FDA Refuses Acorda's Application for Parkinson's Drug; AZ Offloads Early Stage Drug to Takeda in $400m Co-Development Deal (29 August 2017) By Michael Mezher - Published 29 August 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: Gilead to Buy Kite for CAR-T Pipeline in $12B Deal (28 August 2017) By Michael Mezher - Published 28 August 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: Samsung, Biogen Humira Biosimilar Approved in Europe; FDA Approves Adamas Parkinson's Dyskinesia Drug (25 August 2017) By Michael Mezher - Published 25 August 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

European Regulatory Roundup: UK Calls for Brexit to Have Little Impact on Regulation (24 August 2017) By Nick Paul Taylor - Published 24 August 2017

The United Kingdom government has released a paper setting out its position on issues that will affect the availability of goods after Brexit. UK politicians want many regulatory factors relevant to drugmakers to remain the same immediately after Brexit, but to achieve this goal they will need persuade European negotiators to revise their position.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Clinical, Drugs

Tags: European Regulatory Roundup, EU Regulatory Roundup, Regulatory Roundup