European Medicines Agency

Type: Organization

Name: European Medicines Agency

First reported 18 mins ago - Updated 18 mins ago - 1 reports

Weight-loss powder can cause stroke: MoH

Dubai: The Ministry of Health (MoH) has warned the public against the use of a green coffee product used to lose weight.The product was found to increase the incidence of cardiovascular diseases such as heart attacks and strokes in those who suffer from ... [Published The Gulf Today - 18 mins ago]

Entities: Weight Loss, Al Amiri, UAE Ministry of Health

First reported May 17 2013 - Updated 13 hours ago - 2 reports

Health Canada Finds Diane-35 Benefits Better Than Potential Side-Effects

Health Canada has carried out a review on Diane-35, acne drug after France announced its decision to withdraw the medication as four women lost their lives due to the drug in the past 25 years.After carrying out the review, it has been revealed the drug's ... [Published French Tribune - 13 hours ago]

Entities: Health Canada, Drugs, Contraceptive Pill, Coagulation

First reported May 17 2013 - Updated May 17 2013 - 1 reports

MHRA statement on Dianette

The MHRA have responded to the recommendations of the European Medicines Agency’s (EMA) pharmacovigilance risk assessment committee (PRAC) on Diane 35 – known as Dianette. The EMA . (external link) Dr Sarah Branch, the MHRA’s Deputy Director for Vigilance ... [Published MHRA - May 17 2013]

Entities: European Medicines Agency, Risk Assessment, Risk Management, Health Care, Patient

First reported May 17 2013 - Updated May 17 2013 - 4 reports

News and press releases: European Medicines Agency reiterates PRAC recommendation for Diane 35 and generics

Following the conclusion of the Pharmacovigilance Risk Assessment Committee (PRAC) that the benefits of Diane 35 and its generics outweigh the risks in a specific patient group, the French National Agency for the Safety of Medicine and Health Products ... [Published Patient safety, news and press releases: human ... - May 17 2013]

Entities: European Medicines Agency, Risk Assessment (Health), France

First reported May 17 2013 - Updated May 17 2013 - 2 reports

Actelion Pharmaceuticals Ltd

Additional macitentan (Opsumit) data in pulmonary arterial hypertension presented at ATS Thomson Reuters ONE

- Actelion (ATLN.VX) today announced that further data for its investigational drug macitentan (Opsumit®) will be presented at the American Thoracic Society (ATS) International Congress, Philadelphia, USA.An oral presentation providing additional data ... [Published Yahoo! Finance - May 17 2013]

Entities: Pulmonary Arterial Hypertension, Macitentan, Actelion Pharmaceuticals Ltd, Opsumit

First reported May 17 2013 - Updated May 17 2013 - 1 reports

European Union

European Medicines Agency recommends first vaccine for foot-and-mouth disease for authorisation at EU level

Vaccine allows for the most effective strain combination to be selected in case of an outbreak of FMDThe European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) has recommended the marketing authorisation for Aftovaxpur ... [Published European Medicines Agency - May 17 2013]

Entities: Vaccine, European Medicines Agency, Foot-And-Mouth Disease, European Union, Bluetongue Disease

First reported May 17 2013 - Updated May 17 2013 - 2 reports

Bayer AG

EU watchdog backs Bayer acne drug for certain patients

LONDON (Reuters) - Bayer's acne pill Diane 35 and its generic versions are safe to use in certain women when other options have failed, the European Medicines Agency said on Friday.Following a formal safety review, conducted at the request of French authorities, ... [Published Reuters India - May 17 2013]

Entities: Bayer AG, Drugs, Patient, European Union

First reported May 17 2013 - Updated May 17 2013 - 1 reports

[This Week in Medicine] May 18–24, 2013

According to results of the US Centers for Disease Control's analysis of mortality data from the National Vital Statistics System, the age-adjusted suicide rate per 100$ 000 population aged 35—64 years in the USA increased by 28·4%, from 13·7 in 1999, ... [Published Lancet - May 17 2013]

Entities: European Medicines Agency, CERVICAL CANCER, Leprosy, The Lancet

First reported May 17 2013 - Updated May 17 2013 - 1 reports

Draft EMA Guideline Sets Biosimilar Groundwork, Clinical Study Comparisons

The European Medicines Agency (EMA) on May 2 published draft guidelines aimed at facilitating global development of biosimilars and avoiding unnecessary repeats of clinical trials. According to the guideline, the EMA would be open to comparing a biosimilar ... [Published FDA News - May 17 2013]

Entities: European Medicines Agency, clinical study, In Vivo, Clinical trials

First reported May 17 2013 - Updated May 17 2013 - 1 reports

EMA Adopts International Guideline on Evaluating Carcinogenic Risk

The European Medicines Agency (EMA) has joined the FDA in adopting draft international guidelines on identifying and mitigating impurities in drugs that use genotoxic or carcinogenic starting materials. ... [Published FDA News - May 17 2013]

Entities: European Medicines Agency, Carcinogenic, Impurity, FDA Food & Drug Administration, guidelines

First reported May 17 2013 - Updated May 17 2013 - 1 reports

Should Regulation of Combination Products Become More Centralized in Europe?

While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.Pharmaceutical Technolo ... [Published Pharmaceutical Technology - May 17 2013]

Entities: European Medicines Agency, Medical Devices, Poly Implant Prothèse SA, European Union

First reported May 16 2013 - Updated May 16 2013 - 1 reports

News and press releases: European Medicines Agency closed 20 May 2013

The European Medicines Agency will be closed from 6.30pm on Friday 17 May until 7.30am on Tuesday 21 May 2013. ... [Published Patient safety, news and press releases: human ... - May 16 2013]

Entities: European Medicines Agency

Quotes

...treatments available, many patients remain symptomatic," said Madhukar Trivedi, M D , professor of psychiatry, UT Southwestern Medical Center. "As a clinician, I’m encouraged by these data. They represent an important addition to the broader clinical profile for vortioxetine and support its potential as a new treatment for patients with MDD."

Vortioxetine clinical phase III data show significant improvement in symptoms of major depression [Published NASDAQ OMX - 6 hours ago]

"In the UK, Dianette is an effective medicine for treating the distressing conditions of severe acne and excessive undesirable hair in women. Our advice is that there is no need for a woman who is feeling well to stop taking her medicine. If any woman has concerns about her treatment she should contact her doctor."

MHRA statement on Dianette [Published MHRA - May 17 2013]

As a supplement to the ATS conference Actelion will host a symposium with Richard Channick, MD. The program entitled: "Emerging Developments and Insights in Pulmonary Arterial Hypertension: How We Think, How We Practice." will be hosted at Millennium Hall, Loews Philadelphia Hotel on Tuesday 21 May between 18:30 and 21:00

Additional macitentan (Opsumit) data in pulmonary arterial hypertension presented at ATS (Actelio ... [Published Presscontacts.com - May 17 2013]

n4 See Daniel S Hamilton and Joseph P Quinlan, "The Transatlantic Economy 2013: Annual Survey of Jobs, Trade and Investment between the United States and Europe" Center for Transatlantic Relations Johns Hopkins University

House Ways and Means Subcommittee on Trade Hearing [Published Zecco - May 17 2013]

More Content

sort by: Date \| Relevance
Weight-loss powder can cause stroke: MoH [Published The Gulf Today - 19 mins ago]
Acne Drug Diane-35, Benefits Outweighs Risks [Published ITechPost - 4 hours ago]
Vortioxetine clinical phase III data show signi... [Published NASDAQ OMX - 6 hours ago]
H. LUNDBECK A/S: Vortioxetine clinical phase II... [Published 4 Traders - 6 hours ago]
H. Lundbeck A/S: Vortioxetine clinical phase II... [Published FinanzNachrichten.de - 7 hours ago]
Health Canada Finds Diane-35 Benefits Better Th... [Published French Tribune - 13 hours ago]
Patients get ‘too strong’ cancer drug due to cost [Published Times of Malta - 17 hours ago]
MHRA statement on Dianette [Published MHRA - May 17 2013]
News and press releases: European Medicines Age... [Published Patient safety, news and press releases: human ... - May 17 2013]
Diane-35 benefits outweigh risks when used as a... [Published Brandon Sun - May 17 2013]
Diane-35's benefit as acne drug outweigh risks,... [Published CBC - May 17 2013]
News and press releases: International Clinical... [Published Patient safety, news and press releases: human ... - May 17 2013]
Additional macitentan (Opsumit) data in pulmona... [Published Saudi Fransi Capital - May 17 2013]
Additional macitentan (Opsumit) data in pulmona... [Published Presscontacts.com - May 17 2013]
Additional macitentan (Opsumit) data in pulmona... [Published Yahoo! Finance - May 17 2013]
Actelion Pharmaceuticals Ltd : Additional macit... [Published Investegate - May 17 2013]
Additional macitentan (Opsumit) data in pulmona... [Published Best Invest - May 17 2013]
ACTELION LTD : Additional macitentan (Opsumit) ... [Published 4 Traders - May 17 2013]
Actelion Pharmaceuticals Ltd: Additional macite... [Published FinanzNachrichten.de - May 17 2013]
Additional macitentan (Opsumit) data in pulmona... [Published Reuters - May 17 2013]
Additional macitentan (Opsumit) data in pulmona... [Published ACN Newswire - May 17 2013]
Additional macitentan (Opsumit) data in pulmona... [Published TD Ameritrade - May 17 2013]
Information Update: Health Canada's Review of D... [Published Live-PR.com - May 17 2013]
House Ways and Means Subcommittee on Trade Hearing [Published Zecco - May 17 2013]
Stocks in Focus (Celldex Therapeutics, BioMarin... [Published SBWire - May 17 2013]
European Medicines Agency recommends first vacc... [Published European Medicines Agency - May 17 2013]
Acne pill benefits outweigh blood clot risk: EU... [Published GlobalPost - May 17 2013]
EMA says Bayer's Diane-35 has more benefit than... [Published FiercePharma - May 17 2013]
Europe Faces Persistent Gaps in International G... [Published Applied Clinical Trials - May 17 2013]
EU watchdog backs Bayer acne drug for certain p... [Published Reuters India - May 17 2013]

sort by: Date \| Relevance
Veloxis Pharmaceuticals announces financial res... [Published PR Newswire: Financial Services - May 15 2013]
Synageva BioPharma™ Joins the International MPS... [Published Business Wire - May 15 2013]
Exelixis Announces First Quarter 2013 Financial... [Published Business Wire - May 07 2013]
Synageva BioPharma™ Reports First Quarter 2013 ... [Published Business Wire - May 07 2013]
BIO to Use ViS Analytics to Streamline Pediatri... [Published Business Wire Science: Science News - May 07 2013]