European Medicines Agency - European Union Examiner

In fall 2012, the European Medicines Agency (EMA) approved the modified adeno-associated virus AAV-LPL S447X as the first ever gene therapy for clinical use in the Western world. uniQure, a Dutch biotech company, had developed...

LONDON (Reuters) - Pharmaceutical companies need to boost the benefits of drug research by working with regulators and healthcare providers to overhaul the way medicines are approved and paid for, a thinktank backed by...

Companies don't publish all their results. How can we get more information into the public domain? It's always been a bit of a puzzle to me that the government has pharmaceutical companies conduct clinical trials for new drugs....

SAN FRANCISCO (MedPage Today) -- The Endocrine Society has joined its voice to the recent call for incretin drugmakers to release all patient-level data on their products, the group announced at its annual meeting.

Date: Thursday 11 July 2013 Time: 5:30 pm Venue: John Snow Lecture Theatre A, LSHTM, Keppel Street, London, WC1E 7HT, UK Type of event: Seminar Speaker(s): Mair Powell, Medicines and Healthcare Products Regulatory Agency and...

Raptor's PROCYSBI(TM) Now Commercially Available in the U.S. for Nephropathic Cystinosis PatientsNOVATO, Calif., June 19, 2013 (GLOBE NEWSWIRE) -- Raptor Pharmaceutical Corp. (Nasdaq:RPTP) today announced that PROCYSBI™...

Gothenburg, 2013-06-18 10:50 CEST (GLOBE NEWSWIRE) -- Immunicum AB (publ), a Swedish listed company developing therapeutic cancer vaccines, today received prolonged SME-status from the European Med...

The European Lawyer Reference Series: Guide to the Distribution and Marketing of Drugs 2013 provides practical information on the sale, promotion, distribution and marketing of drugs in an easy-to-read "question and answer"...

As the result of an unusual effort designed to bolster transparency in clinical trials, two independent analyses have found that a Medtronic ( MDT ) product used as a bone graft substitute in spinal fusion surgeries offers... All similar articles: 178 »

Jun 18 2013, 12:25 by: Bay Area Biotech Investor | about: ECYT Endocyte is a small-cap biopharmaceutical company valued at $457 million with 71 employees located in West Lafayette, Indiana. The company specializes in small...

The European Medicines Agencys Pharmacovigilance Risk Assessment Committee PRAC has recommended a series of measures to address safety concerns with codeinecontaining medicines when used for the management of pain in children....

Shortages of key medicines have been increasing in recent years, and a new survey from the International Society for Pharmaceutical Engineering (ISPE) says quality failures are the most common cause. "Respondents weighted...

Last week, the NIH ran a workshop to examine the safety of several widely used diabetes drugs and whether a definitive link can be established to acute pancreatitis and pancreatic cancer, which were the subject of recent...

Cytokinetics Announces Results From ATOMIC-AHF Will Be Presented At Late Breaking Clinical Trials Session At The European Society Of Cardiology Congress 2013 South San Francisco, CA June 18, 2013 - Cytokinetics Incorporated...

At its meeting held on 13 June 2013 the European Medicines Agencys EMA Management Board adopted the revised EMA Code of Conduct which aims to ensure that the Agency maintains the highest professional standards of integrity...

"She can't vacuum,The ingenuity and creativity of inventors like Hines are one of the many things that are good about America. 2012 FOXBusinessPopular () posted lower net income in the second quarter compared with a year-ago... All similar articles: 392 »

Cell Therapeutics, Inc. announced results from sub-set analyses of data from the Phase 3 EXTEND, or PIX301, clinical trial of PIXUVRI® (pixantrone). The analyses evaluated the efficacy of PIXUVRI in the subset of patients with...

The European Medicines Agency says codeine, which is converted to morphine in the body, can pose problems for kids. THE EUROPEAN UNION’S medicines advisory body has issued a public health warning, advising parents not to...

Jun 17 2013, 11:52 by: John Reisman | about: ARNA Arena Pharmaceuticals has a new drug that recently had its label approved by the DEA. That drug is called Belviq. There seems to be some confusion about the efficacy though....

Jun 17 2013, 14:14 by: Bio Jedi | about: HALO Some biotechnology firms have had one heck of a 2013 thus far: Clovis Oncology Inc. presented monster data for their cancer drug at ASCO and saw its' shares explode as much as 130%...

The European Medicines Agency has released revised guidance advising pharmaceutical manufacturers on the clinical and non-clinical issues that they should address when developing biosimilar medicines containing...

Anti-inflammatory painkiller no longer suitable for certain at risk groups. By Nicky Broyd WebMD UK Health News Medically Reviewed by Dr Rob Hicks 17th June 2013 - The European Medicines Agency has recommended that patients...

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that the effects of the painkiller diclofenac on the heart and circulation when given systemically (by means such as capsules,...

DHL Launches Cold Chain Air Distribution Service Logistics company DHL has launched a new temperature controlled air freight service to service for biologics. The new Thermonet service uses DHL’s SmartSensor RFID technology...

FREE Breaking News Alerts from StreetInsider.com! RARITAN, N.J., June 17, 2013 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen)Â today welcomes the World Health Organization (WHO) interim policy guidance on the use...

NEW YORK, June 17, 2013 /PRNewswire/ --Intercept Pharmaceuticals, Inc.(NASDAQ: ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel bile acid therapeutics to treat chronic...

Retinitis Pigmentosa (Retinitis) Pipeline Review, H1 2013 Summary Global Markets Directs, 'Retinitis Pigmentosa (Retinitis) Pipeline Review, H1 2013', provides an overview of the indications therapeutic pipeline. This report...

Cataract Pipeline Review, H1 2013 Summary Global Markets Directs, 'Cataract Pipeline Review, H1 2013', provides an overview of the indications therapeutic pipeline. This report provides information on the therapeutic... All similar articles: 163 »