Navigation Links
Wyeth Submits European Marketing Authorization Application for its 13-Valent Vaccine for the Prevention of Pneumococcal Disease in Infants and Young Children
Date:12/3/2008

COLLEGEVILLE, Pa., Dec. 3 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMEA) for approval to market its investigational 13-valent pneumococcal conjugate vaccine (PCV13) for infants and young children. Wyeth is seeking an indication for the prevention of pneumococcal disease (PD) caused by the 13 serotypes included in the investigational vaccine in infants and children from two months to five years of age. The review of the MAA will be coordinated by the EMEA for all 27 countries in the European Union, as well as Norway, Iceland and Liechtenstein.

PCV13 includes the 13 most prevalent pneumococcal serotypes associated with serious PD. Seven of these (4, 6B, 9V, 14, 18C, 19F and 23F) are included in Prevenar* (Pneumococcal saccharide conjugated vaccine, adsorbed) - - the current global standard in PD prevention in infants and young children. The six additional serotypes (1, 3, 5, 6A, 7F and 19A) are associated with the greatest burden of remaining invasive disease. Both Prevenar (also known as PCV7) and PCV13 use CRM197 -- an immunological carrier protein with a 20-year history of use in pediatric vaccines.

"Today's submission is an important milestone for Wyeth and underscores the company's commitment to help protect current and future generations from serious pneumococcal disease," says Emilio Emini, Ph.D., Executive Vice President, Vaccine Research and Development, Wyeth Pharmaceuticals. "Since its introduction, Prevenar has had a substantial impact on public health, dramatically reducing the rate of invasive pneumococcal disease where it is routinely used. Our investigational 13-valent pneumococcal conjugate vaccine is designed to broaden protection, with the pot
'/>"/>

SOURCE Wyeth Pharmaceuticals
Copyright©2008 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4 5

Related medicine technology :

1. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
2. Wyeths Torisel and Roche/Genentechs Avastin Will Challenge Pfizers Sutent to Become the Clinical Gold Standard for Treatment of Metastatic Renal Cell Carcinoma
3. Wyeth Presents Phase 3 Fracture Data for Bazedoxifene, an Investigational Therapy for Osteoporosis
4. Wyeth Presents New Phase 3 Data and Updates Regulatory Timing for NDA Filing of Bazedoxifene/Conjugated Estrogens
5. FDA Accepts Wyeths Supplemental New Drug Application for Tygacil for the Treatment of Patients with Community-Acquired Pneumonia
6. Wyeths TORISEL Receives European Commission Approval for the Treatment of Advanced Kidney Cancer
7. Arthritis Foundation Announces Amgen and Wyeth to Be Presenting Sponsor of the 2008 Arthritis Walk (R)
8. Wyeth and Progenics Announce Preliminary Clinical Trial Results for RELISTOR Oral and Intravenous Formulations
9. Wyeth Receives Approvable Letter From FDA for Bazedoxifene for the Treatment of Postmenopausal Osteoporosis
10. Wyeth Receives FDA Fast Track Designation for its 13-valent Pneumococcal Conjugate Vaccine for Infants and Toddlers
11. Wyeth Receives Approvable Letter from FDA for TYGACIL for the Treatment of Patients with Community-Acquired Pneumonia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/20/2013)... VIEJO , Kalifornien, 20. Mai 2013 ... bekannt, dass das Unternehmen die CE-Kennzeichnung für ... zur Embolisation von Aneurysmen erhalten hat. Das ... Europa bereits mit der kontrollierten Einführung dieser ... bietet die SL-Produktfamilie auch ein verbessertes Handling, ...
(Date:5/20/2013)... LONDON , BERLIN ... 2013 Arthroscopy Devices Market ... Preference for Minimally Invasive Procedures to Drive Future Growth" ... trends for the six arthroscopy device market segments: arthroscopes, ... arthroscopy radio frequency systems, and arthroscopy visualization systems. The ...
(Date:5/20/2013)... 2013  Neuralstem, Inc. (NYSE MKT: CUR) today reported ... principal investigator, presented updated Phase I data from its ... the treatment of amyotrophic lateral sclerosis (ALS or ... diabetes special medical symposium in Bucharest, Romania ... Therapeutic Advances in Stem Cell Therapy," Dr. Feldman outlined ...
Breaking Medicine Technology:Sequent Medical, Inc. bringt neue SL-Produktfamilie seiner WEB Geräte zur Embolisation von Aneurysmen auf den Markt 2Sequent Medical, Inc. bringt neue SL-Produktfamilie seiner WEB Geräte zur Embolisation von Aneurysmen auf den Markt 3Increasing Prevalence of Osteoarthritis and Preference for Minimally Invasive Procedures to Drive Arthroscopy Devices Market Growth 2Increasing Prevalence of Osteoarthritis and Preference for Minimally Invasive Procedures to Drive Arthroscopy Devices Market Growth 3Increasing Prevalence of Osteoarthritis and Preference for Minimally Invasive Procedures to Drive Arthroscopy Devices Market Growth 4Neuralstem ALS Trial Principal Investigator, Dr. Eva Feldman, Presented Phase I Data At The Neuro Diabetes Medical Symposium In Romania 2Neuralstem ALS Trial Principal Investigator, Dr. Eva Feldman, Presented Phase I Data At The Neuro Diabetes Medical Symposium In Romania 3Neuralstem ALS Trial Principal Investigator, Dr. Eva Feldman, Presented Phase I Data At The Neuro Diabetes Medical Symposium In Romania 4
(Date:5/20/2013)... Wolters Kluwer Health is pleased to ... published journals won 13 ASHPE awards in 10 ... and publications for editorial, design, print and online ... be recognized year after year for delivering high-quality ... with quality, depth, and impact," said Jayne Marks, ...
(Date:5/20/2013)... May 20, 2013 Join Seva Foundation in ... at the Palace of Fine Arts Theater in ... , C.C. White and Shimshai, with host Wavy Gravy. All ... world. , Reserved seats are $40 & $55, ... the artists and a front row seat at the show. ...
(Date:5/20/2013)... HealthEconomics.Com , the global leader ... present a new breakthrough in digital marketing and communications ... the reach of traditional, real-world trade shows and conferences ... feel, and benefits of a physical trade show, but ... hours a day, seven days a week, and three ...
(Date:5/20/2013)... 2013 A new Benefits of Pharmacy ... the creators of the MedEx Pack announced. ... Pharmacy Home Delivery, in order to provide useful details for ... handled. Clyde Furuta, MedEx Direct owner and pharmacist said, ... that with a product like the MedEx Pack, patients can ...
(Date:5/20/2013)... Fresno, CA (PRWEB) May 20, 2013 It’s ... a chance, there’s still time to bust out those dusty ... going to have a little cross-company challenge in the office ... to see who can log the most pledged miles for ... building, but they’ll never share their miles! , *insert battle ...
Breaking Medicine News(10 mins):Health News:Wolters Kluwer Health receives 13 awards from the ASHPE 2Health News:Memorial Day Kirtan Concert Palace of Fine Arts Theater in San Francisco Featuring: Snatam Kaur, Jai Uttal, C.C. White & Shimshai with host Wavy Gravy,May 27th 7:00 PM 2Health News:HealthEconomics.Com Launches HE-Xpo, an Online Virtual Trade Show, Educational Center and Exhibit Hall at Major Pharmaceutical Industry Meeting 2Health News:HealthEconomics.Com Launches HE-Xpo, an Online Virtual Trade Show, Educational Center and Exhibit Hall at Major Pharmaceutical Industry Meeting 3Health News:Benefits of Pharmacy Home Delivery Report Published by MedEx Direct 2
... Quad Will Become the Highest-Selling Antiretroviral in the ... from Decision ResourcesWALTHAM, Mass., May 19 Decision ... advisory firms for pharmaceutical and healthcare issues, finds ... six percent annual growth in the HIV drug ...
... ( www.apieron.com ) significantly strengthened its senior ... Vice President, Sales & Marketing, and Bryan Miller as ... Bubrick has more than 20 years of operational and ... in diabetes management. Prior to joining Apieron, Mr. Bubrick ...
... May 19 New Life Agency filed suit against ... contract.This lawsuit grew out of a previous contractual relationship ... in December 2005. Once New Life Agency assumed direct ... for New Life,s Surrogate Maternity and Cycle Medical Plan(R), ...
... Has 6 Front Range LocationsDENVER, May 19 Clinic ... Solutions, announced today the firm has secured an agreement ... to all Front Range MedExpress Urgent Care locations. ... nationwide reach."This is a key new contract for us," ...
... INTERESTS ARE NOT ALIGNED WITH STOCKHOLDERSADVOCAT BOARD NEEDS TO ... May 19 Bristol Investment Fund, Ltd. ("Bristol") announced ... stockholders of Advocat, Inc. (the "Company") (Nasdaq: ... qualified and independent director nominees, Paul Kessler and Richard ...
... be Issued from Among Intradigm,s Large Collection of ... Intradigm Corporation, a leading developer of targeted, ... issuance of United States patent 7,534,878, titled "Composition ... Cancer and Other Neovascularization Diseases." The issued ...
Cached Medicine News:Health News:Sales of Antiretroviral Agents Will Drive Substantial Six Percent Annual Growth in the HIV Drug Market Through 2013 2Health News:Sales of Antiretroviral Agents Will Drive Substantial Six Percent Annual Growth in the HIV Drug Market Through 2013 3Health News:Apieron Strengthens Senior Leadership With Commercial, Financial Appointments 2Health News:New Life Agency, Inc. Continues to Trial Against Beitler Services, Inc. in Pursuit of Payments for Surrogate Maternity Claims 2Health News:New Life Agency, Inc. Continues to Trial Against Beitler Services, Inc. in Pursuit of Payments for Surrogate Maternity Claims 3Health News:Clinic Service Announces Agreement to Provide Billing Service to MedExpress 2Health News:Support Bristol's Highly Qualified Independent Nominees for Advocat Board 2Health News:Support Bristol's Highly Qualified Independent Nominees for Advocat Board 3Health News:Support Bristol's Highly Qualified Independent Nominees for Advocat Board 4Health News:Support Bristol's Highly Qualified Independent Nominees for Advocat Board 5Health News:Support Bristol's Highly Qualified Independent Nominees for Advocat Board 6Health News:Support Bristol's Highly Qualified Independent Nominees for Advocat Board 7Health News:Support Bristol's Highly Qualified Independent Nominees for Advocat Board 8Health News:Support Bristol's Highly Qualified Independent Nominees for Advocat Board 9Health News:Intradigm Announces Issuance of RNA Interference (RNAi) Patent Covering Potent siRNA Sequence 2Health News:Intradigm Announces Issuance of RNA Interference (RNAi) Patent Covering Potent siRNA Sequence 3
... The 5mm AEM Laparoscopic Instruments incorporate a ... Instruments are shielded and monitored to prevent ... the instrument caused by insulation failure or ... The protective shield built into all AEM ...
... 5mm AEM Laparoscopic Instruments incorporate a layered ... are shielded and monitored to prevent stray ... instrument caused by insulation failure or capacitive ... protective shield built into all AEM Instruments ...
... Instruments incorporate a layered design unique in ... monitored to prevent stray electrosurgical burns along ... insulation failure or capacitive coupling; a well-documented ... into all AEM Instruments provides a neutral ...
... Laparoscopic Instruments incorporate a layered design unique ... and monitored to prevent stray electrosurgical burns ... by insulation failure or capacitive coupling; a ... built into all AEM Instruments provides a ...
Medicine Products: