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EMEA in Medical News

ConvaTec Names Paul Moraviec President, Continence and Critical Care Business Unit and ConvaTec EMEA Region

SKILLMAN, N.J., March 23 /PRNewswire/ -- ConvaTec, a world-leading developer and marketer of innovative medical technologies for community and hospital care, announced today that Paul Moraviec has joined the company as President of its Continence and Critical Care Business Unit and ConvaTec EMEA, ...

BELLUS Health Reports Results for Third Quarter of Fiscal 2008 and on EMEA Update

LAVAL, QC, Nov. 10 /PRNewswire-FirstCall/ - BELLUS Health Inc. (NASDAQ: BLUS; TSX: BLU) reports results for the third quarter ended September 30, 2008. For the three-month period ended September 30, 2008, the net loss amounted to $11,095,000 ($0.22 per share), compared to $13,889,000 ($0.29 pe...

1st EMEA application filed for product using innovative intradermal microinjection system BD Soluvia

Franklin Lakes, NJ, USA (February 13, 2008) -- Sanofi Pasteur, the vaccines division of sanofi-aventis Group, has submitted the first application in Europe to deliver a vaccine using BD Soluvia, the innovative microinjection system developed by BD (Becton, Dickinson and Company). The submission ...

Microsoft and HIMSS Launch Health Users Group Across EMEA

Collaborative forum designed to connect healthcare communities throughout region. COPENHAGEN, Denmark, Nov. 5 /PRNewswire-FirstCall/ -- From the World of Health IT Conference and Exhibition in Copenhagen, Microsoft Corp. and the Healthcare Information and Manageme...

Abbott's Kaletra(R) and Aluvia(R) (lopinavir/ritonavir) New Lower-Strength Tablet for Pediatric Use Receives Positive Opinion from EMEA

Lopinavir/ritonavir tablet is the first and only co-formulated protease inhibitor tablet approved for use in children with HIV ABBOTT PARK, Ill., Jan. 28 /PRNewswire/ -- Abbott (NYSE: ABT ) announced today that the European Committee for Medicinal Products for Human Use (CHMP), the sc...

ATIR Classified as "Cell Based" Medicinal Product by the EMEA

A Classification for Innovative New Treatments AMSTERDAM, December 14 /PRNewswire/ -- Kiadis Pharma announced today that its lead product ATIR has received approval for regulatory classification as a "cell based" medicinal product by the Innovation Task Force (ITF), a division of ...

Microsoft and HIMSS Expanding Healthcare User Group Across EMEA

Collaborative forum designed to connect healthcare communities throughout region. VIENNA, Austria, Oct. 23 /PRNewswire-FirstCall/ -- During the World of Health IT Conference and Exhibition today in Vienna, Microsoft Corp. and the Healthcare Information and Managem...

Data Conversion Laboratory Supports Newest SPL Requirements For Life Sciences Industry

...nteraction with the group enable us to provide rapid turnaround in support of our clients' labeling conversions with guaranteed conformance to FDA and emea standards." About Data Conversion Laboratory, Inc. Founded in 1981, DCL converts and organizes content to create electronic docu...

BioMarin Announces Second Quarter 2009 Financial Results

...oval milestones earned in July 2008 of $1.5 million for the Japanese approval of Kuvan and in December 2008 of $30.0 million for the emea approval of Kuvan. (4) Represents gross margin associated with the initial Aldurazyme product transfer to Genzyme of $2.3 million assoc...

Tyco International Reports Third Quarter Earnings from Continuing Operations Before Special Items of $0.58 Per Share and GAAP Earnings of $0.51 Per Share

... of 5%. Service revenue declined 2% organically. Installation revenue declined 7% organically, driven by continued softness in the North America and emea regions. Backlog of $1.2 billion increased 1% (a 2% decline excluding currency) on a quarter sequential basis. Operating income was $67 millio...
EMEA in Medical Technology

DOR BioPharma Receives EMEA Agreement on the Design of its Confirmatory Phase 3 Clinical Trial of orBec(R) in GI GVHD

PRINCETON, N.J., June 9 /PRNewswire-FirstCall/ -- DOR BioPharma, Inc. (DOR or the Company) (OTC Bulletin Board: DORB), a late-stage biopharmaceutical company, announced today that it has received Protocol Assistance feedback from the European Medicines Agency (EMEA) on the design of its confirmato...

AMT Receives EMEA Orphan Drug Designation for Acute Intermittent Porphyria

AMSTERDAM, May 28 /PRNewswire-FirstCall/ -- Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, announced today that the European Medicines Agency has granted Orphan Drug Designation to AMT's gene therapy product AMT-021 for the treatment of acute int...

Anthera Completes Special Protocol Assessment With FDA and Receives EMEA Scientific Advice on Development Path Toward Varespladib Approval

SAN MATEO, Calif., Sept. 24 /PRNewswire/ -- Anthera Pharmaceuticals announced today they have reached agreement with the U.S. Food and Drug Administration (FDA) on a Phase 3 protocol for varespladib (A-002) in acute coronary syndrome (ACS) under the FDA's Special Protocol Assessment procedure....

Clinical Proof of Concept for TGF-beta 2-Inhibitor AP 12009 in Phase Iib EMEA provides Guidance on Phase III Design and Approval Requirements

CHICAGO and REGENSBURG, Germany, June 2 /PRNewswire/ -- "A two-year survival rate of more than 80 percent in recurrent or refractory anaplastic astrocytoma suggests a breakthrough in this devastating disease by targeted therapy," commented Prof. Ulrich Bogdahn, Neuro-Oncologist and Coordinatin...

Lexicon's Drug Candidate LX1032 for Carcinoid Syndrome Receives Orphan Drug Designation From EMEA

THE WOODLANDS, Texas, July 21 /PRNewswire-FirstCall/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX ), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, announced today that it has received orphan d...

Vectibix(R) in Combination With Chemotherapy Significantly Improved Progression-Free Survival in First-Line Metastatic Colorectal Cancer

...th Vectibix. Vectibix has not shown a treatment benefit for patients whose tumors had KRAS mutations in codon 12 or 13. In December 2007, the emea granted a conditional marketing authorization for Vectibix as monotherapy for the treatment of patients with EGFR-expressing mCRC with wild-type KRAS...

Jazz Pharmaceuticals and UCB Announce Second Phase III Study of Sodium Oxybate in Patients With Fibromyalgia Meets Primary Endpoints

... standard of care for the FDA-approved indications. UCB markets XYREM (R) (sodium oxybate oral solution) in Europe , where it is approved by the emea for the treatment of narcolepsy with cataplexy in adult patients under a license from Jazz Pharmaceuticals. Most commonly reported adverse drug reacti...

Amicus Therapeutics Commences Phase 3 Trial Evaluating Amigal(TM) for the Treatment of Fabry Disease

...inical study will be required for Amigal registration in Europe. The emea has recommended a registration trial evaluating the safety and efficacy of ...descriptive statistics. Amicus and Shire HGT are reviewing the final emea feedback and will provide an update regarding plans for registration in Eur...

New Safety Regulations Drive Greater Need for Resources and Expertise at Every Stage of Clinical Development

...d a considerable impact on the industry as companies implement drug safety regulations throughout the clinical development process. The FDA and emea have recently introduced more rigorous safety regulations, with a particular emphasis on post-marketing surveillance, to ensure that medications are m...

The Lancet Publishes Direct Comparison Study Between Liraglutide and Exenatide

...val in Japan on July 14, 2008. On April 23, 2009, Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) under the emea adopted a positive opinion, recommending marketing authorization of liraglutide for treatment of type 2 diabetes in Europe. In the U.S., a regul...
EMEA in Biological News

Prefilled WFI Syringe Provides a High-Quality Solution for Drug Reconstitution

...900 employees worldwide, Vetter holds about 140 patents and has longstanding experience in handling client products and processes approved by the FDA, emea and other authorities. FluroTec® is a registered trademark of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.&n...

Entrust Expands Relationship with Slovenia, Implements Second-generation ePassport Solution

...ized the importance of leveraging a proven EAC ePassport solution that is both scalable and reliable," said Neill Duff, Snr. VP and General Manager of emea for Entrust. "As a proponent of e-government capabilities, Slovenia continues to partner with Entrust to help prevent criminal organizations from acce...

Physician-scientist urges improved drug regulation to ensure heart safety of non-heart drugs

...ue of the European Heart Journal. This paper summarizes the conclusions of a group of co-authors -- including cardiologists, biostatisticians, FDA and emea (European Medicines Agency Home) regulators and representatives from the NIH and the pharmaceutical industry -- who had met previously at a Cardiovasc...

IdentiPHI Opens Paris Office to Boost European Sales and Support

... Growth of identity security market in emea spurs IdentiPHI's company expansion AUSTIN, Texas, Nov. 28 /PRNewswire/ -- IdentiPHI, Inc., an innovative leader in en...

Sequella receives US and EU orphan drug status for SQ109 for the treatment of TB

...ty than the current standard of care. We are pleased that the FDA and the emea awarded Sequella orphan drug and orphan medicinal product status for the us...provisions of EU legislation relating to medicinal products. In 2001, the emea established the Committee for Orphan Medicinal Products (COMP), and charged...

OneWorld Health drug receives 'Orphan' designation from U.S. and European regulatory agencies

...sors of drugs for rare diseases or conditions. The emea regulations are similar, and have the added advant... the drug approval process with the FDA and/or the emea next year. "We are pleased with the swift, positive responses by the FDA and emea agencies," said Victoria Hale, Ph.D., CEO and Foun...
EMEA in Biological Technology

Abbott's HUMIRA(R) Receives Positive Opinion From EMEA for Treatment of Moderate to Severe Plaque Psoriasis

ABBOTT PARK, Ill., Nov. 16 /PRNewswire-FirstCall/ -- The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), granted Abbott (NYSE: ABT ) a positive opinion recommending approval of HUMIRA(R) (adalimumab) for the treatment of...

European EMEA Acceptance of Marketing Authorization Application Filing for SNT-MC17 in Friedreich's Ataxia by Santhera

LIESTAL, Switzerland and OSAKA, Japan, August 16 /PRNewswire-FirstCall/ -- Santhera Pharmaceuticals (SWX: SANN, "Santhera"), a Swiss specialty pharmaceutical company with a focus on neuromuscular diseases, and Takeda Pharmaceutical Company Limited (TSE:4502, "Takeda"), jointly announced today ...

Arpida's iclaprim MAA Accepted for Review by EMEA

REINACH, Switzerland, August 21 /PRNewswire-FirstCall/ -- Arpida Ltd. (SWX: ARPN) today announced that the European Medicines Agency (EMEA) has accepted for review its Marketing Authorisation Application (MAA) for intravenous iclaprim. Arpida is seeking approval of intravenous iclaprim in the ...

InterMune Reports Second Quarter 2009 Financial Results and Business Highlights

... progressing very well; we had a successful pre-submission meeting with the emea in July and we expect to submit the MAA for pirfenidone in the first quarte...--- ------- Submission of pirfenidone MAA to emea Q1 2010 -------------------------------------...

Mylan Reports Adjusted Diluted EPS of $0.32 for the Quarter Ended June 30, 2009

... quarter of 2009. Total revenues from emea were $367.8 million in the current quarter, compar... a decrease of 5.6%. On a constant currency basis, emea revenues increased by nearly 10% over the prior ye... in the market at that time. Also contributing to emea revenues were sales from the Central and Eastern E...

Sanofi-aventis Announces Second Quarter 2009 Results

...althcare authorities around the world, such as the emea and the FDA, and by patient associations and scien...for Medicinal Products for Human Use (CHMP) of the emea issued a positive opinion on Roche's Avastin((R)) ...When applications for generics are filed under the emea centralized procedure, the scientific opinion issu...

NewBridge Pharmaceuticals Announces Licensing of Pylera(R) for Middle East, Africa, Turkey & Caspian Region

... prevalence such as cancer, diabetes, obesity, cardiovascular diseases and other metabolic disorders. NewBridge in-licenses and commercializes FDA and emea approved therapeutics, medical devices and diagnostics. Headquartered in UAE with Business Development in the US, NewBridge was founded in 2007 by Bur...

Schering-Plough Reports Financial Results for 2009 Second Quarter

...erck, has initiated arbitration proceedings relating to Schering-Plough's rights to REMICADE and SIMPONI. (Announced May 27) Announced that the emea had accepted for review the Marketing Authorization Application for SYCREST (asenapine) sublingual tablets for the treatment of schizophrenia and mani...

Virtify, Inc. Delivers Industry's First Enterprise Content Compliance Software Suite for Life Sciences Companies

...l Disclosure System for global compliance automation and management Upcoming Standards Support: Virtx PIM - Labeling supporting EU emea Product Information Management standards Virtx RPS - Product supporting HL7 (Health Level 7) Regulated Product Submission standards ...

InterMune Reports First Quarter 2009 Financial Results and Business Highlights

... results at ATS May 19 -- Submission of pirfenidone NDA to FDA Summer -- Submission of pirfenidone MAA to emea Year-End ITMN-191 Milestones and Key Events Expected Date -- Phase 2b initiation by...
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