European Medicines Agency

Type: Organization
Name: European Medicines Agency
First reported 2 hours ago - Updated 2 hours ago - 1 reports

EU Commission Shifts Responsibility for Pharmaceuticals, Medical Devices, Biotechnology and Cosmetics

On September 10, 2014, European Commission President-elect Juncker issued a  press release unveiling his new EU executive team and announcing a reshuffling of certain responsibilities. In the new Commission, oversight of pharmaceutical products, medical ... [Published Sidley Austin LLP - 2 hours ago]
First reported 9 hours ago - Updated 9 hours ago - 1 reports

EMA: app to be developed to report adverse drug reactions

The European Medicines Agency is taking forward plans to develop an app that will enable adverse drug reactions to be reported by healthcare professionals to regulators in the European Union. The three year project called WEB-RADR will consider the potential ... [Published Matthew Arnold & Baldwin LLP - 9 hours ago]
First reported 12 hours ago - Updated 12 hours ago - 1 reports

Still feeling the Vioxx pain

Source: Wm. Baker / GhostWorx Images / AlamyTen years since the sudden withdrawal of the blockbuster anti-inflammatory drug Vioxx from the market and the industry is still reelingOn 30 September 2004, Vioxx (rofecoxib), a non-steroidal anti-inflammatory ... [Published Pharmaceutical Journal - 12 hours ago]
First reported 17 hours ago - Updated 17 hours ago - 1 reports

AstraZeneca receives FDA approval for opioid-induced constipation medication

AstraZeneca has received FDA approval for MOVANTIK tablets C-II as the once-daily oral peripherally-acting mu-opioid receptor antagonist, or PAMORA, medication for the treatment of opioid-induced constipation, or OIC,, in adult patients with chronic, ... [Published Individual.com - 17 hours ago]
First reported 18 hours ago - Updated 18 hours ago - 1 reports

EuropaBio calls for EMA action on labeling of biosimilars

EuropaBio has published a statement giving the perspective of the health care biotechnology industry on the labeling of biosimilars.Members of the EuropaBio Healthcare Council call on the European Medicines Agency to define specific guidance on the labelling ... [Published Pharma Letter - 18 hours ago]
First reported 20 hours ago - Updated 20 hours ago - 1 reports

Regulator assesses diclofenac risks to vultures

The European Medicines Agency (EMA) may consider a ban on veterinary medicines containing diclofenac because the anti-inflammatory product could pose a risk to the vulture population. ... [Published Pharmacy Magazine - 20 hours ago]
First reported 21 hours ago - Updated 21 hours ago - 1 reports

Vivus And Auxilium Pharma Say FDA Approves SNDA For Stendra - Quick Facts

Vivus Inc. (VVUS: Quote) and Auxilium Pharmaceuticals, Inc. (AUXL: Quote) announced that the U.S. Food and Drug Administration or FDA has approved a supplemental new drug application or sNDA for Stendra (avanafil).The companies said that STENDRA is now ... [Published RTTNews.com - 21 hours ago]
First reported 23 hours ago - Updated 23 hours ago - 1 reports

Adaptive Licensing - A Holistic Approach to Drug Development and Regulation

SummaryAdaptive Licensing (AL) is a flexible approach to drug development and regulation, with two live pilot schemes accepted by the European Medicines Agency (EMA). The system acknowledges that levels of uncertainty will always surround innovative treatments. ... [Published Individual.com - 23 hours ago]
First reported 23 hours ago - Updated 23 hours ago - 1 reports

UK doctors to Juncker: Medicines are not a commodity

The editors of the British Medical Journal and French journal, Prescribe have written to Jean-Claude Juncker demanding that he "put public health first" and reverse his decision to take medicines and medical devices, together with the European Medicines ... [Published New Europe - 23 hours ago]
First reported Sep 17 2014 - Updated Sep 17 2014 - 1 reports

Moving EMA to DG Enterprise will increase risk of adverse events says NGO

Shifting EMA oversight to DG Enterprise and Industry will put patients at greater risk of adverse events according to NGO Health Action International, which suspects EFPIA “had a hand” in planned European Commission reshuffle.Last week, EC president-elect ... [Published In-Pharmatechnologist - Sep 17 2014]
First reported Sep 17 2014 - Updated Sep 17 2014 - 1 reports

European Pharma: Paying the Price of Pharmacovigilance

Pharmacovigilance controls are becoming firmly embedded in the European Union’s post-authorization regulatory system, with the European Medicines Agency (EMA) acting as the pivot for an EU-wide network of agencies monitoring medicines throughout their ... [Published Pharmaceutical Executive - Sep 17 2014]
First reported Sep 15 2014 - Updated Sep 15 2014 - 3 reports

EC rejig will see DG Enterprise and Industry take responsibility for EMA

The EU commission plans to strip DG Sanco of responsibility for the running the European Medicines Agency (EMA) and hand it to the directorate in charge of enterprise and industry.Under a planned reshuffle announced by Commission president elect Jean-Claude ... [Published In-Pharmatechnologist - Sep 15 2014]

Quotes

"We are delighted with the approval of Trulicity. Lilly now has treatment options in several classes of diabetes medications: orals, GLPs and insulin. Trulicity will help grow the GLP-1 receptor agonist class as a new choice for adults with type 2 diabetes" Lilly Diabetes President Enrique Conterno said in a statement
...now has treatment options in several classes of diabetes medications: orals, GLPs and insulin," said Enrique Conterno, president, Lilly Diabetes. "Trulicity will help grow the GLP-1 receptor agonist class as a new choice for adults with type 2 diabetes."
Physicians in the U K are applauding NICE's approval of Tafinlar. "Its approval underlines the importance of a new generation of cancer drugs targeted at specific molecular features of [tumors]--drugs which after years of painstaking development are now making their way to patients" said Paul Workman, interim chief executive of London's Institute of Cancer Research, in an interview with the BBC
...effect of opioid therapy," said Dr Briggs Morrison, Executive vice president, Global Medicines Development & Chief Medical Officer, AstraZeneca. "We are pleased to provide physicians and their patients with a once-daily oral treatment supported by a robust clinical programme." The FDA approval of MOVANTIK was based on data from the KODIAC clinical programme, which is comprised of four studies: KODIAC-4, -5, -7 and -8...

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All (1064) | News (722) | Reports (0) | Blogs (296) | Audio/Video (0) | Fact Sheets (1) | Press Releases (25)
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EU Commission Shifts Responsibility for Pharmac... [Published Sidley Austin LLP - 2 hours ago]
Lilly Says FDA Approves Type 2 Diabetes Drug Tr... [Published RTTNews.com - 4 hours ago]
EMA: app to be developed to report adverse drug... [Published Matthew Arnold & Baldwin LLP - 9 hours ago]
FDA Approves Trulicity(TM) (dulaglutide), Lilly... [Published Scottrade - 10 hours ago]
Still feeling the Vioxx pain [Published Pharmaceutical Journal - 12 hours ago]
NICE says 'yes' to GSK's melanoma pill, but onl... [Published FiercePharma - 14 hours ago]
AstraZeneca receives FDA approval for opioid-in... [Published Individual.com - 17 hours ago]
EuropaBio calls for EMA action on labeling of b... [Published Pharma Letter - 18 hours ago]
Regulator assesses diclofenac risks to vultures [Published Pharmacy Magazine - 20 hours ago]
Vivus And Auxilium Pharma Say FDA Approves SNDA... [Published RTTNews.com - 21 hours ago]
Adaptive Licensing - A Holistic Approach to Dru... [Published Individual.com - 23 hours ago]
UK doctors to Juncker: Medicines are not a comm... [Published New Europe - 23 hours ago]
Xtandi Nabs New Prostate Cancer Indication [Published FDA News - Sep 18 2014]
ZS Pharma to Present at the 21st Annual BioCent... [Published BusinessWeek - Sep 17 2014]
Cancer cell treatment first to be classed 'prom... [Published Out-Law.com - Sep 17 2014]
Moving EMA to DG Enterprise will increase risk ... [Published In-Pharmatechnologist - Sep 17 2014]
PTC Therapeutics Expands Global Presence in Sup... [Published Nasdaq - Sep 17 2014]
PTC Therapeutics : Expands Global Presence in S... [Published 4 Traders - Sep 17 2014]
Denovo Biopharma acquires Lilly’s enzastaurin f... [Published Pharma Letter - Sep 17 2014]
FDA approves AstraZeneca’s Movantik for opioid-... [Published Pharma Letter - Sep 17 2014]
European Pharma: Paying the Price of Pharmacovi... [Published Pharmaceutical Executive - Sep 17 2014]
Merck announces data from pivotal Phase 3 fract... [Published Medical News Today - Sep 17 2014]
Sequent Scientific inks licensing agreement wit... [Published Indian-Commodity - Sep 17 2014]
CTI BioPharma And Servier Announce Exclusive Li... [Published Scottrade - Sep 17 2014]
New Halaven (Eribulin) and Lenvatinib Data to b... [Published FinanzNachrichten.de - Sep 17 2014]
Eli Lilly & BI Win EU Marketing Authorization f... [Published FDA News - Sep 16 2014]
Newron Pharmaceuticals Reports Half-Year Result... [Published BioSpace - Sep 16 2014]
BMS and Merck Race to Melanoma Treatment Market [Published Pharmaceutical Executive - Sep 16 2014]
FDA Approves MOVANTIK™ (naloxegol) Tablets For ... [Published KSFY - Sep 16 2014]
DHL Launches Cold Chain Air Distribution Service [Published Outsourcing Pharma - Sep 16 2014]
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Blogs

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News and press releases: Policy on veterinary m... [Published Patient safety, news and press releases: human ... - Sep 16 2014]
European Medicines Agency focuses support on medicines that are most needed and launches public consultation ...
News and press releases: Is diclofenac a threat... [Published Patient safety, news and press releases: human ... - Sep 12 2014]
European Medicines Agency starts assessing risks of the use of veterinary medicines containing diclofenac to vultures and other necrophagous birds and launches public consultation ...
News and press releases: Meeting highlights fro... [Published Patient safety, news and press releases: human ... - Sep 12 2014]
The European Medicines Agency updates on key outcomes of the meeting ...
News and press releases: Regulatory information... [Published Patient safety, news and press releases: human ... - Sep 11 2014]
European Medicines Agency still welcomes new applications ...
Research and Markets: Adaptive Licensing 2014 R... [Published Business Wire Health News - Sep 11 2014]
DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/9bvft9/adaptive) has announced the addition of the "Adaptive Licensing - A Holistic Approach to Drug Development and Regulation" report to their offering. Adaptive ...
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Press Releases

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European Medicines Agency accepts TiGenix Paedi... [Published GlobeNewswire: Advertising News - Sep 08 2014]
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]
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