European Medicines Agency

Type: Organization
Name: European Medicines Agency
First reported 3 hours ago - Updated 3 hours ago - 1 reports

ISPE Releases First Look at its Plan to Prevent Drug Shortages

ISPE, the International Society for Pharmaceutical Engineering, has released a preview of its Drug Shortages Prevention Plan aimed at helping the pharmaceutical industry avoid drug shortages and maintain a robust and reliable supply of medications to ... [Published PharmaAsia - 3 hours ago]
First reported 6 hours ago - Updated 6 hours ago - 1 reports

[Correspondence] Drug–drug interactions with tyrosine-kinase inhibitors

In their Review, Roelof van Leeuwen and colleagues1 recommend various dose adjustments during concomitant use of tyrosine-kinase inhibitors and drugs that inhibit or induce cytochrome P450 3A4 (CYP3A4).1 Most information is taken from the US Food and ... [Published Lancet Oncology - 6 hours ago]
First reported 20 hours ago - Updated 12 hours ago - 3 reports

Takeda to submit data for pioglitazone containing medicines including ACTOS

Takeda Pharmaceutical Company Limited announced the completion of the post-marketing commitment and submissions of data from a 10-year epidemiology study to regulatory authorities including the United States (U.S.) Food and Drug Administration (FDA), ... [Published Hospital Pharmacy Europe - 12 hours ago]
First reported 14 hours ago - Updated 14 hours ago - 1 reports

News and press releases: European Medicines Agency welcomes new Head of Communication Department and new Head of Human Resources

The European Medicines Agency (EMA) is pleased to announce two new appointments to its management team. ... [Published Patient safety, news and press releases: human ... - 14 hours ago]
First reported 20 hours ago - Updated 17 hours ago - 3 reports

BIOCRATES Life Sciences AG Announces Launch of First-ever Standardized Metabolomics-based Bile Acids...

/PRNewswire/ --Austrian BIOCRATES Life Sciences AG, internationally renowned developer and viagra purchase marketer of innovative targeted metabolomics solutions, further expands its range of metabolomics-based kits with the buy cialis discount addition ... [Published BioMedReports - 19 hours ago]
Entities: Life Science, Cialis, Acids
First reported 21 hours ago - Updated 21 hours ago - 1 reports

News and press releases: Regulatory information - European Medicines Agency encourages marketing-authorisation holders to prepare for start of EU PSUR single assessment for nationally authorised medicines

The European Medicines Agency (EMA) has updated its procedural guidance to ensure that marketing-authorisation holders are prepared for the start of single assessments of periodic safety update reports (PSURs) for nationally authorised medicines. ... [Published Patient safety, news and press releases: human ... - 21 hours ago]
First reported Aug 31 2014 - Updated 22 hours ago - 2 reports

Trial Provokes Sound And Fury Over Controversial Servier and Amgen Drug

The controversial drug ivabradine just got a little more controversial. The drug, which is marketed by Servier under the brand names of Corlentor and Procoralan, is available in Europe and elsewhere and is used for the treatment of heart failure and stable ... [Published Forbes.com - Aug 31 2014]
First reported Aug 31 2014 - Updated Aug 31 2014 - 1 reports

Are the two FDA-approved weight loss drugs safe?

(foodconsumer.org) - A report in JAMA Internal Medicine suggests that physicians should exercise caution when they consider giving their obese patients one of the two weight loss drugs, lorcaserin and phentermine/topiramate, which were approved by the ... [Published Food Consumer - Aug 31 2014]
First reported Aug 30 2014 - Updated Aug 30 2014 - 1 reports

Silencio! Claiming Pressure From European Regulators, Trial Leaders Cancel Press Conference

Investigators of the much-anticipated and controversial SIGNIFY trial have told the European Society of Cardiology leadership that they will not participate in a previously scheduled press conference on Sunday at the society’s main meeting in Barcelona. ... [Published Forbes.com - Aug 30 2014]
First reported Aug 29 2014 - Updated Aug 29 2014 - 1 reports

Obligation to share clinical trial results

Pharmaceutical companies operating in the European Union must make their clinical trial data available to the public starting this week.A law adopted last week obliges drug firms to publish the data on the European Clinical Trials Database (EudraCT), ... [Published European Voice - Aug 29 2014]
First reported Aug 28 2014 - Updated Aug 28 2014 - 2 reports

Amicus Therapeutics (FOLD) Stock Rises on High Volume

08/28/14 - 12:40 PM EDTNEW YORK ( TheStreet ) --  Amicus Therapeutics  ( FOLD ) nearly touched a 52-week high of $7.40 on Thursday as the stock continued to rise on high volume.Last week, the company announced its potential Fabry disease treatment drug ... [Published TheStreet.com - Aug 28 2014]
First reported Aug 27 2014 - Updated Aug 28 2014 - 2 reports

Why Amgen (AMGN) Stock Hit a One-Year High Today

08/27/14 - 10:32 AM EDTNEW YORK ( TheStreet ) --  Amgen  ( AMGN ) hit a 52-week high of $137.99 on Wednesday after the Food and Drug Administration granted priority review for the biopharmaceutical company's New Drug Application for its prospective chronic ... [Published TheStreet.com - Aug 27 2014]

Quotes

"The completion of this long-term study is a milestone in the history of ," said Tom Harris, head, global regulatory affairs, Takeda. "The results of the study provide reassurance with regard to the use of and the risk of bladder and further support the positive benefit risk profile of the product."
The study was funded by Servier. "Fox reports personal fees and nonfinancial support from Servier during the conduct of the study; personal fees from"
The United States has approved the two weight loss medications, but "the required post-marketing safety trials are behind schedule', according to the report authored by S Woloshin and L M Schwarts from Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, New Hampshire."
"It is a non-calcium, iron-based and chewable phosphate binder, which contains mixture of polynuclear iron oxyhydroxide, sucrose and starches."

More Content

All (1165) | News (828) | Reports (0) | Blogs (290) | Audio/Video (0) | Fact Sheets (1) | Press Releases (25)
sort by: Date | Relevance
ISPE Releases First Look at its Plan to Prevent... [Published PharmaAsia - 3 hours ago]
[Correspondence] Drug–drug interactions with ty... [Published Lancet Oncology - 6 hours ago]
Takeda to submit data for pioglitazone containi... [Published Hospital Pharmacy Europe - 12 hours ago]
News and press releases: European Medicines Age... [Published Patient safety, news and press releases: human ... - 14 hours ago]
Takeda announces long term pioglitazone study r... [Published Pharma Field - 16 hours ago]
BIOCRATES Life Sciences AG Announces Launch of ... [Published BioMedReports - 19 hours ago]
Takeda completes post-marketing commitment to s... [Published PBR - News - 20 hours ago]
BIOCRATES Life Sciences AG Announces Launch of ... [Published Individual.com - 20 hours ago]
BIOCRATES Life Sciences AG Announces Launch of ... [Published SearchBug - 20 hours ago]
News and press releases: Regulatory information... [Published Patient safety, news and press releases: human ... - 21 hours ago]
Trial Provokes Sound And Fury Over Controversia... [Published Forbes.com - Aug 31 2014]
SIGNIFY: No Ivabradine Clinical Outcomes Gain i... [Published Diabetes Care - Aug 31 2014]
Study raises concerns over Servier, Amgen heart... [Published Reuters - Aug 31 2014]
Are the two FDA-approved weight loss drugs safe? [Published Food Consumer - Aug 31 2014]
Diet and health controversies [Published Times of Malta - Aug 31 2014]
Neprilysin Inhibition — A Novel Therapy for Hea... [Published New England Journal of Medicine - Aug 31 2014]
Silencio! Claiming Pressure From European Regul... [Published Forbes.com - Aug 30 2014]
Rxisky business [Published ShowMe - Aug 30 2014]
Empagliflozin (Jardiance) SGLT-2 Inhibitor Now ... [Published Diabetes in Control - Aug 30 2014]
MSF urges BMS to make daclatasvir accessible in... [Published PharmaBiz - Aug 30 2014]
GSK's Witty Pays Price for China Scandal [Published Genetic Engineering News - Aug 29 2014]
Obligation to share clinical trial results [Published European Voice - Aug 29 2014]
Vifor Pharma’s Velphoro gets EU marketing autho... [Published Pharmaceutical Technology - Aug 29 2014]
Could This Drug Help to Alleviate Your Depression? [Published Vice UK - Aug 29 2014]
New ESC registries launched on cardiac oncology... [Published EurekAlert! - Aug 29 2014]
Drug control cooperation between Serbian, Russi... [Published Tanjug - Aug 29 2014]
Plethora Solutions Holdings PLC INTERIM RESULTS [Published ADVFN UK - Aug 29 2014]
Janssen: why transparency is essential to the h... [Published Pharmafocus - Aug 29 2014]
Acusphere to withdraw its European marketing au... [Published Individual.com - Aug 29 2014]
India's Piramal will divert resources from earl... [Published Pharma Letter - Aug 29 2014]
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Blogs

sort by: Date | Relevance
News and press releases: European Medicines Age... [Published Patient safety, news and press releases: human ... - 14 hours ago]
The European Medicines Agency (EMA) is pleased to announce two new appointments to its management team. ...
Takeda completes post-marketing commitment to s... [Published PBR - News - 20 hours ago]
Takeda Pharmaceutical (Takeda) has completed the post-marketing commitment and submissions of data from a 10-year epidemiology study to regulatory authorities including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and ...
News and press releases: Regulatory information... [Published Patient safety, news and press releases: human ... - 21 hours ago]
The European Medicines Agency (EMA) has updated its procedural guidance to ensure that marketing-authorisation holders are prepared for the start of single assessments of periodic safety update reports (PSURs) for nationally authorised medicines. ...
Acusphere Withdraws its European Marketing Auth... [Published Business Wire Health News - Aug 28 2014]
LEXINGTON, Mass.--(BUSINESS WIRE)--Acusphere announced the strategic decision to voluntarily withdraw its Marketing Authorization Application (MAA) submitted to the European Medicines Agency’s CHMP for Imagify. ...
Takeda Announces Completion of the Post-Marketi... [Published Nycomed News RSS feed - Aug 27 2014]
No overall statistically significant increased risk of bladder cancer in patients ever exposed to pioglitazone in a completed 10-year epidemiological study Osaka, Japan, August 28, 2014 – Takeda Pharmaceutical Company Limited (“Takeda”) today announced ...
1 2 3 4 5 6 7 8 9 10 ...

Press Releases

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European Medicines Agency accepts Basilea's isa... [Published GlobeNewswire: Acquisitions News - Aug 21 2014]
Active Biotech AB Interim report January-June 2014 [Published GlobeNewswire: Acquisitions News - Aug 07 2014]
Draft Revision of EudraVigilance access policy ... [Published EMA Ongoing public consultations - Aug 04 2014]
Raptor Receives Orphan Drug Designation for Cys... [Published GlobeNewswire: Acquisitions News - Aug 04 2014]
Answer to the second, third and fourth requests... [Published EMA Ongoing public consultations - Aug 01 2014]
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