European Medicines Agency

Type: Organization
Name: European Medicines Agency
First reported 7 hours ago - Updated 7 hours ago - 1 reports

Bristol-Myers' Oral HCV Treatment Daklinza Gets EU Clearance

Good news flowed in at Bristol-Myers Squibb Company ( BMY ) from Europe with the European Commission (:EC) approving the biopharmaceutical company’s Daklinza as a combination therapy for treating adults infected with genotypes 1, 2, 3 and 4 of chronic ... [Published Yahoo! Finance - 7 hours ago]
First reported 13 hours ago - Updated 12 hours ago - 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 - 12 hours ago]
First reported Aug 27 2014 - Updated 13 hours ago - 1 reports

Takeda Announces Completion of the Post-Marketing Commitment to Submit Data to the FDA, the EMA and the PMDA for Pioglitazone Containing Medicines Including ACTOS

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 ... [Published Nycomed News RSS feed - Aug 27 2014]
First reported 14 hours ago - Updated 14 hours ago - 1 reports

CLINUVEL PHARMACEUTICALS : Chairman's Update

Dear Shareholders and friends of Clinuvel,Clinuvel is approaching its first landmark regulatory decision in October and the directors of Clinuvel keenly await European Medicines Agency's (EMA) decision on SCENESSE® (afamelanotide 16mg), our first ethical ... [Published 4 Traders - 14 hours ago]
First reported 15 hours ago - Updated 15 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 European Pharmaceutical Manufacturer - 15 hours ago]
First reported Aug 27 2014 - Updated 18 hours ago - 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]
First reported 21 hours ago - Updated 21 hours ago - 1 reports

Actavis announces positive results from Phase III bacterial infection studies

Actavis plc, a specialty pharmaceutical company, has announced positive results from RECLAIM-1 and -2, two pivotal Phase III studies evaluating the potential for the investigational antibiotic, ceftazidime-avibactam as a treatment for adult hospitalized ... [Published Individual.com - 21 hours ago]
First reported Aug 28 2014 - Updated Aug 28 2014 - 1 reports

Canadian Health Policy Institute Reports Faster Drug Approvals Don't Increase Safety Risks

According to new research published by the Canadian Health Policy Institute (CHPI), although regulatory approvals for new drugs in Europe are faster compared to Canada, the rate of discontinuations of new drugs for safety reasons is the same in both jurisdictions. ... [Published Individual.com - Aug 28 2014]
First reported Aug 27 2014 - Updated Aug 27 2014 - 1 reports

EMA accepts Cubist antibiotic for review

A new antibiotic to treat infections took a step closer to approval in Europe after regulators accepted the drug for review.Ceftolozane/tazobactam is developed by antibiotic specialist Cubist Pharmaceuticals and is now under assessment for use in the ... [Published PMLive - Aug 27 2014]
First reported Aug 26 2014 - Updated Aug 26 2014 - 1 reports

News and press releases: European Medicines Agency publishes booklet on European regulatory system for medicines

The European Medicines Agency (EMA) today published an illustrated leaflet explaining how the European regulatory system for medicines operates. ... [Published Patient safety, news and press releases: human ... - Aug 26 2014]
First reported Aug 25 2014 - Updated Aug 26 2014 - 3 reports

Cubist Pharmaceuticals' Antibiotic Accepted for EU Review

The European Medicines Agency (EMA) accepted Cubist Pharmaceuticals, Inc .’s ( CBST - Analyst Report ) Marketing Authorization Application (MAA) for its investigational antibiotic, ceftolozane/tazobactam. Cubist Pharma is looking to get the candidate ... [Published Zacks.com - Aug 25 2014]
First reported Aug 22 2014 - Updated Aug 23 2014 - 8 reports

Allergan Receives Written Requests from Pershing Square; Cubist Announces EMA Acceptance of Ceftolozane/Tazobactam Marketing

Below is a look at some of the headlines for companies that made news in the healthcare sector on August 22, 2014.Allergan, Inc. (NYSE: AGN) confirmed that Pershing Square Capital Management, L.P. (“Pershing Square”) has delivered written requests from ... [Published BioMedReports - Aug 23 2014]

Quotes

"Our Phase IIIPhase III trial of Cx601 is on track to deliver results earlier than anticipated" TiGenix CEO Eduardo Bravo said in a statement...
...for future partnering discussions and global regulatory submissions," said Mark Leuchtenberger, President and Chief Executive Officer of Acusphere. "The withdrawal of the MAA in Europe does not affect the status of Imagify's Special Protocol Assessment with the FDA and we remain committed to completing its clinical development."
"We rate LILLY (ELI) & CO (LLY) a BUY. This is driven by a few notable strengths, which we believe should have a greater impact than any weaknesses, and should give investors a better performance opportunity than most stocks we cover. The company's strengths can be seen in multiple areas, such as its largely solid financial position with reasonable debt levels by most measures, reasonable valuation levels, increase in stockstock price during the past year and expanding profit margins. We feel these strengths outweigh the fact that the company has had sub par growth in net income."
...Dr. Jennifer Cohn, medical director of the MSF Access Campaign, said: "We must ensure that people living with hepatitis C in low- and middle-income countries can actually access this important drug, so that it can have the greatest impact on hepatitis C globally in helping to cure people." MSF highlights daclatasvir's demonstrated action in genotype 3, which, it says, has proven difficult to treat with other drugs in this class, and is...

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All (1179) | News (844) | Reports (0) | Blogs (287) | Audio/Video (0) | Fact Sheets (1) | Press Releases (25)
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Ex-Shire exec starts at Cortendo, Innate gets o... [Published FierceBiotech - 4 hours ago]
Bristol-Myers' Oral HCV Treatment Daklinza Gets... [Published Yahoo! Finance - 7 hours ago]
Innovative Australian Companies On Canaccord An... [Published Seeking Alpha - 9 hours ago]
Acusphere pulls European bid for Imagify contrast [Published AuntMinnieEurope - 11 hours ago]
Amicus Therapeutics (FOLD) Stock Rises on High ... [Published TheStreet.com - 12 hours ago]
Amicus Therapeutics (FOLD) Stock Rises on High ... [Published The Street Latest - 13 hours ago]
Acusphere Withdraws its European Marketing Auth... [Published Nasdaq - 13 hours ago]
Acusphere Withdraws its European Marketing Auth... [Published Business Wire Health News - 13 hours ago]
CLINUVEL PHARMACEUTICALS : Chairman's Update [Published 4 Traders - 14 hours ago]
Drug for rare blood disorder gets EU orphan status [Published Industry Sourcing - 14 hours ago]
Lilly's Returning Cash to Shareholders With Gen... [Published Daily Freeman - 15 hours ago]
Lilly's Returning Cash to Shareholders With Gen... [Published The Street Latest - 15 hours ago]
ISPE releases first look at its plan to prevent... [Published European Pharmaceutical Manufacturer - 15 hours ago]
More DAAs, More Controversy [Published Applied Clinical Trials - 16 hours ago]
Takeda launches first gut-selective treatment f... [Published Pharma Letter - 19 hours ago]
Actavis announces positive results from Phase I... [Published Individual.com - 21 hours ago]
FDAnews Announces — FDA Device Advisory Panel R... [Published PRWeb - 22 hours ago]
Canadian Health Policy Institute Reports Faster... [Published Individual.com - Aug 28 2014]
FDA Approves Cerdelga for Type 1 Gaucher Disease [Published FDA News - Aug 28 2014]
Actavis Announces Positive Topline Results From... [Published 4 Traders - Aug 28 2014]
Takeda Announces Completion of the Post-Marketi... [Published Nycomed News RSS feed - Aug 27 2014]
Lilly, Boehringer Get Tentative FDA Approval fo... [Published FDA News - Aug 27 2014]
Daclatasvir (Daklinza) for Chronic Hepatitis C ... [Published General Medicine eJournal - Aug 27 2014]
Piramal Enterprises to stop early-stage research [Published Business Standard India - Aug 27 2014]
Amgen Gets FDA Priority Review For Heart Drug -... [Published RTTNews.com - Aug 27 2014]
Type 2 diabetes drug Empagliflozin launched in US [Published Diabetes.co.uk - Aug 27 2014]
BMS' Daklinza Approved in Europe for Chronic He... [Published Genetic Engineering News - Aug 27 2014]
Why Amgen (AMGN) Stock Hit a One-Year High Today [Published TheStreet.com - Aug 27 2014]
Why Amgen (AMGN) Stock Hit a One-Year High Today [Published The Street Latest - Aug 27 2014]
Eli Lilly and Boehringer receive tentative appr... [Published Individual.com - Aug 27 2014]
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Blogs

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Acusphere Withdraws its European Marketing Auth... [Published Business Wire Health News - 13 hours ago]
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 ...
Addressing the regulatory and scientific challe... [Published Multiple Sclerosis Journal current issue - Aug 26 2014]
Improving and facilitating the process of making new drugs available to patients with multiple sclerosis (MS) requires cooperation among the regulators and other stakeholders. This cooperation will also positively contribute towards developing guidelines ...
News and press releases: European Medicines Age... [Published Patient safety, news and press releases: human ... - Aug 26 2014]
The European Medicines Agency (EMA) today published an illustrated leaflet explaining how the European regulatory system for medicines operates. ...
EMA accepts to review Cubist's MAA for ceftoloz... [Published PBR - News - Aug 25 2014]
The European Medicines Agency (EMA) has accepted review of US-based Cubist Pharmaceuticals' marketing authorization application (MAA) for its investigational antibiotic ceftolozane/tazobactam to treat complicated urinary tract Infections and complicated ...
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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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