Trend Results : European Medicines Agency
Blog Post Results (1-20 of 418)
FILTER RESULTS ►Celgene Announces U.S. FDA Grants Priority Review for ABRAXANE® sNDA in Advanced Pancreatic Cancer
Celgene Announces U.S. FDA Grants Priority Review for ABRAXANE ® sNDA in Advanced Pancreatic Cancer European Medicines Agency Accepts Regulatory Submission of Type II Variation for ABRAXANE for the Treatment of Advanced Pancreatic Cancer BOUDRY,...Show More Summary
European Medicines Agency Validates Gilead's Marketing Application for Sofosbuvir for the Treatment
European Medicines Agency Validates Gilead's Marketing Application for Sofosbuvir for the Treatment of Hepatitis C -- Once-Daily Sofosbuvir will Receive an Accelerated Assessment by EMA; Designation Granted to New Medicines of Major Public Health Interest -- FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. Show More Summary
Pharmacovigilance Risk Assessment Committee (PRAC) Present At SMi's 3rd Annual Event On Pharmacovigilance, London UK
In recent weeks, The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended restrictions in the use of strontium ranelate (Protelos/Osseor) to reduce the risk for adverse cardiac events in postmenopausal women and will move ahead with a more in-depth risk-benefit evaluation. Show More Summary
European Court Puts Release Of Drug Safety Data On Hold
Last month Techdirt wrote about the case of the giant pharma company AbbVie seeking to prevent the European Medicines Agency from releasing basic health safety data that AbbVie claims contains commercially sensitive information. Unfortunately,...Show More Summary
BLOG: Europe asks EMA for antibiotic resistance advice
The European Medicines Agency (EMA) has been requested to provide advice by the European Commission (EC) on the impact on Public (Human) Health and Animal Health from the use of antibiotics in animals. Potentially, this is very good news, as long as the conclusions have not been pre-written.
European Medicines Agency receives interim decisions of the General Court of the EU on access to clinical and non-clinical information
via ema.europa.eu Posted via email from Jack's posterous
Europe Hands Down 2 Critical Drug Decisions
In this video, health-care analyst David Williamson takes a closer look at two of the recent European Medicines Agency opinions -- one positive and one negative, even though both drugs have U.S. approval. Watch and find out what it means...Show More Summary
Pfizer's Arthritis Drug Xeljanz (tofacitinib) Receives A Negative Opinion In Europe
Pfizer's Arthritis Drug Xeljanz (tofacitinib citrate) should not be approved for the treatment of rheumatoid arthritis, CHMP (Committee for Medicinal Products for Human Use) advised the European Medicines Agency on April 25th, 2013. Pfizer can request a re-examination of the opinion with the next 15 days, EMA (European Medicines Agency) informed. Show More Summary
Fatster’s Roundup
? The UN Human Rights Chief says “Guantanamo Bay prison ‘must close’” and expressed deep disappointment “that the US was not honouring its pledge to close the camp.” ? Beginning 2014, the European Medicine Agency “will release all information about clinical studies submitted to it by organisations seeking authorisation for new treatments”. Show More Summary
Pfizer's Oncology Division Gets A Boost With European Approval For Bosulif
By Trefis: The European Medicine Agency (EMA) has conditionally approved Pfizer’s (NYSE:PFE) Bosulif as a second-line treatment in certain chronic myelogenous leukemia (a type of white blood cell cancer) adult patients [Pfizer’s BOSULIF® (bosutinib) Receives Conditional Marketing Authorization From The European Commission, Pfizer, March 29 2013]. Show More Summary
European Medicines Agency Investigates Findings On Pancreatic Risks With GLP-1-based Therapies For Type 2 Diabetes
The European Medicines Agency is investigating findings by a group of independent academic researchers that suggest an increased risk of pancreatitis (inflammation of the pancreas) and pre-cancerous cellular changes called pancreatic...Show More Summary
Aubagio EU Backing Comes With Generic Worries
By EP Vantage: Thanks to a European regulatory verdict, the golden age of oral multiple sclerosis medications might be short-lived in the region. The European Medicines Agency's vote in support of Aubagio came with a surprise judgement...Show More Summary
Adocia Announces Its Phase III Development Program For The Treatment Of Diabetic Foot Ulcer
This program has been validated by scientific advice from the European Medicines Agency Adocia (NYSE Euronext Paris: FR0011184241 - ADOC), a biotechnology company specialized in the development of 'best-in-class' medicines from already...Show More Summary
Roche Wins Expanded European Approval for Pegasys
The European Medicines Agency, or EMA, has awarded Big Pharma Roche expanded approval for its antiviral Pegasys, alongside ribavirin, in treating chronic hepatitis C virus, or HCV. The EMA's expanded approval will now allow Roche toShow More Summary
Transparency? AbbVie Sues EMA Over Trial Data
in a direct challenge to the proponents of disclosing clinical trial data, AbbVie has filed an injunction to prevent the European Medicines Agency from releasing detailed patient-level data from studies concerning its top-selling Humira rheumatoid arthritis treatment, The Financial Times writes. The filing comes after two Freedom of Information requests were made to the EM [...]
Cancer Immune Therapy AV0113 Receives Orphan Drug Designation
The European Medicines Agency recently awarded the Austrian biotech company Activartis an Orphan Drug Designation for its innovative Cancer Immune Therapy AV0113. The Orphan Drug Designation applies specifically to the use of AV0113 for the treatment of glioma, a type of brain tumour, which afflicts around one in 10.000 people in the EU. Show More Summary
GlaxoSmithKline Files for Diabetes Drug's European Approval
Pharmaceutical firm GlaxoSmithKline announced Thursday that it has filed its type-2 diabetes drug albiglutide for regulatory approval with the European Medicines Agency (EMA). Glaxo submitted the drug for FDA approval in the United States...Show More Summary
Alltrials contd. - Professor Peter C Gotzsche of the Nordic Cochrane Centre writes
GlaxoSmithKline (GSK) and Roche have declared they are willing to disclose their trial data. But not like the European Medicines Agency, which from January 2014 will provide public access to the full clinical study reports for all new...Show More Summary
Dealing With Medication Errors - EMA Calls For Coordinated EU Approach
The European Medicines Agency (EMA) conducted a workshop aimed at a coordinated EU approach to tackling medication errors, which included proposals on how such errors are reported and prevented. EMA says that national patient safetyShow More Summary
European Medicines Agency Recommends Approval Of Hexyon 6-In-1 Paediatric Vaccine
Upon approval Hexyon will be the only fully liquid, ready-to-use 6-in-1 paediatric vaccine in Europe Sanofi Pasteur MSD, the joint venture between MSD and Sanofi Pasteur in Europe, announced today that their innovative 6-in-1 paediatric...Show More Summary
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