European Medicines Agency

Type: Organization
Name: European Medicines Agency
First reported 22 hours ago - Updated 49 mins ago - 6 reports

Journal takes deep dive into dabigatran’s safety data

The journal BMJ took aim at the anticoagulant dabigatran and its manufacturer in a three-pronged package published online July 23 that cataloged the drug’s tumultuous pre-approval and post-approval journeys in the U.S. and Europe. Maker Boehringer Ingelheim ... [Published Cardiovascular Business - 49 mins ago]
First reported 7 hours ago - Updated 51 mins ago - 19 reports

GSK Applying for Regulatory Approval of World’s First Malaria Vaccine

GlaxoSmithKline (GSK. L) has developed the world's first vaccine against malaria. The vaccine will be used for children in Africa. The British drugmaker announced that it is applying for the regulatory approval for the shot, called RTS, S.The drug will ... [Published French Tribune - 1 hour ago]
First reported 6 hours ago - Updated 51 mins ago - 2 reports

BRIEF-EU concludes positive benefit risk of emergency contraceptives

12:13pm BSTJuly 24 (Reuters) - European Medicines Agency: * EU medicines agency says levonorgestrel and ulipristal remain suitableemergency contraceptives for all women, regardless of bodyweight ... [Published Reuters UK - 5 hours ago]
First reported 1 hour ago - Updated 1 hour ago - 1 reports

EU Agency Endorses Suspension of Oral Methadone Products

The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), a regulatory body representing the European Union (EU), has added its endorsement to recommendations calling for suspension of marketing authorization of methadone ... [Published Diabetes Care - 1 hour ago]
First reported 4 hours ago - Updated 2 hours ago - 2 reports

Southwest Agent Removes Passenger All Because Of A Tweet

CLOUDS TO SUN THURSDAYUpdated: Thursday, July 24 2014 9:52 AM EDT 2014-07-24 13:52:31 GMTThursday, early clouds will lead to afternoon sun as highs today remain in the mid 80s.Thursday: H-85 L-72Thursday, early clouds will lead to afternoon sun as highs ... [Published MyFox Orlando - 2 hours ago]
First reported 3 hours ago - Updated 3 hours ago - 1 reports

News and press releases: European Medicines Agency launches public consultation on rules of procedures for public hearings

The European Medicines Agency has today launched a public consultation on draft rules of procedures for public hearings held by its Pharmacovigilance Risk Assessment Committee (PRAC). ... [Published Patient safety, news and press releases: human ... - 3 hours ago]
First reported 4 hours ago - Updated 4 hours ago - 1 reports

Contraceptive pill safe for all women

A review of morning-after contraceptive pills has concluded they are suitable for heavier women.The European Medicines Agency said pills containing levonorgestrel or ulipristal acetate, such as Norlevo, "can continue to be used in women of all weight ... [Published BBC - 4 hours ago]
First reported 4 hours ago - Updated 4 hours ago - 1 reports

EU finds 'morning after pills' work, regardless of a woman's weight

LONDON, July 24 (Reuters) - Emergency contraceptives, known as the "morning after pill", remain suitable for all women who need them, regardless of a woman's weight, European regulators said on Thursday.The European Medicines Agency had questioned whether ... [Published Yahoo! Finance - 4 hours ago]
First reported 5 hours ago - Updated 5 hours ago - 1 reports

European regulator: Morning-after pill OK for heavier women despite French maker's claim

, EDT. LONDON - The European Medicines Agency says a commonly used morning-after pill is suitable for use by heavier women after reviewing the evidence, sparked by a French pharmaceutical company's declaration last year that the drugs didn't work in women ... [Published CJAD 800 - 5 hours ago]
First reported 6 hours ago - Updated 6 hours ago - 4 reports

European Medicines Agency Accepts Marketing Authorization Application for Asfotase Alfa as a Treatment for Patients with Hypophosphatasia

First reported 6 hours ago - Updated 6 hours ago - 1 reports

European Medicines Agency Accepts Marketing Authorization Application for Asfotase Alfa as a Treatment for Patients with Hypophosphatasia

-- Application designated for review under accelerated assessmentprocess --CHESHIRE, Conn.--( BUSINESS WIRE )--Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that theMarketing Authorization Application (MAA) for asfotase alfa, aninvestigational, ... [Published Business Wire - 6 hours ago]
First reported Jul 23 2014 - Updated Jul 23 2014 - 1 reports

EMA policy on publication of clinical trial data – update

the European Medicines Agency (EMA) Management Board agreed a policy on publication of clinical trial data that will allow it to proactively publish clinical trial data that is submitted as part of a marketing authorisation application after grant of ... [Published Lexology - Jul 23 2014]

Quotes

"It is important to offer patients a range of therapeutic options to take into account their needs and preferences" said Zoe Diana Draelos
...that it may allow the use of RTS, S from 2015 provided that the European Medicines Agency (EMA) drugs regulators supports its license application. "An effective vaccine for use alongside other measures such as bed nets and anti-malarial medicines would represent an advance in malaria control" , affirmed GSK
"The PRAC concluded that risk minimization measures would be insufficient to mitigate the risks with oral solutions containing high molecular weight povidone" according to a release from the
"This is a key moment in GSK's 30-year journey to develop RTS,S and brings us a step closer to making available the world's first vaccine that can help protect children in Africa from malaria" Sophie Biernaux, head of GSK's malaria franchise, said in a statement

More Content

All (1174) | News (876) | Reports (0) | Blogs (252) | Audio/Video (0) | Fact Sheets (1) | Press Releases (24)
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Journal takes deep dive into dabigatran’s safet... [Published Cardiovascular Business - 49 mins ago]
Perspective on Pradaxa [Published Cardiovascular Business - 49 mins ago]
Phase III Investigational Trial of Azelaic Acid... [Published Bio-Medicine - 1 hour ago]
GSK Applying for Regulatory Approval of World’s... [Published French Tribune - 1 hour ago]
GSK seeks regulatory approval for world's first... [Published Sharewatch Global Market - 1 hour ago]
GSK files malaria vaccine with EMA for use in A... [Published Pharma Times - 1 hour ago]
GSK seeks regulator approval for malaria vaccine [Published Local Tech Wire - 1 hour ago]
EU Agency Endorses Suspension of Oral Methadone... [Published Diabetes Care - 1 hour ago]
Southwest Agent Removes Passenger All Because O... [Published MyFox Orlando - 2 hours ago]
World’s First Malaria Vaccine Submitted for EMA... [Published The Utah People's Post - 2 hours ago]
GSK submits world's first malaria vaccine for E... [Published FierceVaccines - 3 hours ago]
GSK asks European regulators & WHO to approve w... [Published MedCity News - 3 hours ago]
News and press releases: European Medicines Age... [Published Patient safety, news and press releases: human ... - 3 hours ago]
NJ pays $150K to man injured by off-duty trooper [Published MyFoxPhilly.com - 4 hours ago]
Biogen Idec’s Plegridy approved in Europe for r... [Published Pharma Letter - 4 hours ago]
BMJ alleges Boehringer Ingelheim withheld Prada... [Published Pharma Letter - 4 hours ago]
Contraceptive pill safe for all women [Published BBC - 4 hours ago]
EU finds 'morning after pills' work, regardless... [Published Yahoo! Finance - 4 hours ago]
GSK seeks approval for world's first malaria va... [Published DailyMe.Com - 4 hours ago]
Glaxo Seeks European Approval for World’s First... [Published Washington Post - 4 hours ago]
Phase III Investigational Trial of Azelaic Acid... [Published CEOWorld Magazine - 4 hours ago]
Phase III Investigational Trial of Azelaic Acid... [Published Wall Street Select - 4 hours ago]
Levonorgestrel and ulipristal remain suitable e... [Published FiercePharma - 4 hours ago]
GSK announces EU regulatory submission for mala... [Published BioPortfolio - 5 hours ago]
Malaria vaccine a step closer [Published Yahoo! UK and Ireland - 5 hours ago]
European regulator: Morning-after pill OK for h... [Published CJAD 800 - 5 hours ago]
MALARIA VACCINE A STEP CLOSER [Published Mail Online UK - 5 hours ago]
BRIEF-EU concludes positive benefit risk of eme... [Published Reuters UK - 5 hours ago]
GSK asks European regulator to OK malaria shot [Published Crawford Financial Planning - 5 hours ago]
GSK seeks approval for world's first malaria va... [Published Business Daily Africa - 5 hours ago]
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Blogs

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News and press releases: European Medicines Age... [Published Patient safety, news and press releases: human ... - 3 hours ago]
The European Medicines Agency has today launched a public consultation on draft rules of procedures for public hearings held by its Pharmacovigilance Risk Assessment Committee (PRAC). ...
News and press releases: Levonorgestrel and uli... [Published Patient safety, news and press releases: human ... - 6 hours ago]
The European Medicines Agency has concluded its review of emergency contraceptives containing levonorgestrel or ulipristal acetate to assess whether increased bodyweight affects the effectiveness of these medicines in preventing unintended pregnancy following ...
European Medicines Agency Accepts Marketing Aut... [Published EON Science - 6 hours ago]
CHESHIRE, Conn.--(EON: Enhanced Online News)--Alexion announced that the marketing authorization application for asfotase alfa has been validated and granted accelerated assessment by the European Medicines Agency. ...
European Medicines Agency Accepts Marketing Aut... [Published Business Wire Science: Science News - 6 hours ago]
CHESHIRE, Conn.--(BUSINESS WIRE)--Alexion announced that the marketing authorization application for asfotase alfa has been validated and granted accelerated assessment by the European Medicines Agency. ...
European Medicines Agency Accepts Marketing Aut... [Published Business Wire Health News - 6 hours ago]
CHESHIRE, Conn.--(BUSINESS WIRE)--Alexion announced that the marketing authorization application for asfotase alfa has been validated and granted accelerated assessment by the European Medicines Agency. ...
1 2 3 4 5 6 7 8 9 10 ...

Press Releases

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Basilea submits isavuconazole European Marketin... [Published GlobeNewswire: Acquisitions News - Jul 17 2014]
Sunesis Pharmaceuticals Announces European Medi... [Published GlobeNewswire: Acquisitions News - Jul 09 2014]
European Medicines Agency renews Marketing Auth... [Published GlobeNewswire: Acquisitions News - Jul 01 2014]
Hyperion Therapeutics Announces EMA Acceptance ... [Published GlobeNewswire: Advertising News - Jun 25 2014]
European Medicines Agency Validates Marketing A... [Published Financial Services - Jun 17 2014]
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