Navigation Links
FDA Grants Priority Review for Schering-Plough's Peginterferon Alfa-2b for the Adjuvant Treatment of Patients With Stage III Melanoma
Date:1/31/2008

ell counts, including leukopenia (low white blood cell count), thrombocytopenia (low platelet count) and neutropenia (low neutrophil count); thyroiditis (inflammation of the thyroid gland); and autoimmunity (production of antibodies against the body's own tissues.)

Depression and suicidal behavior, including suicidal ideation, suicidal attempts and completed suicides, have been reported in association with treatment with alfa interferons.

Important Safety Information Regarding U.S. Labeling for PEGINTRON(TM) Alpha interferons, including PEGINTRON(TM) and INTRON(R) A, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many, but not all cases, these disorders resolve after stopping PEGINTRON(TM) and/or INTRON(R) A therapy.

Contraindications

PEGINTRON(TM) is contraindicated in patients with hypersensitivity to PEGINTRON(TM) or any other component of the product, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score >6 [class B and C]) in cirrhotic CHC patients before or during treatment. INTRON(R) A (Interferon alfa-2b, recombinant) for Injection is contraindicated in patients with hypersensitivity to INTRON(R) A or any component of the product, autoimmune hepatitis, and decompensated liver disease.

Incidence of adverse events

There are no new adverse events specific to PEGINTRON(TM) as compared to INTRON(R) A; however, the incidence of some (eg, injection site reactions, fever, rigors, nausea) were higher. The most common adverse events associated with PEGINTRON(TM) were "flu-like" symptoms, occurring in approximately 50% of patients, which may decrease in severity as treatment continues. Application site disorders were common (47%), but all wer
'/>"/>

SOURCE Schering-Plough Corporation
Copyright©2008 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4 5 6

Related biology technology :

1. Mirus Bio Awarded Grants & Contracts of Over $5 Million
2. FDA Grants Orphan Drug Designation to TREANDA, an Investigational Treatment for Chronic Lymphocytic Leukemia
3. Anesiva Grants Specific-Use License of Its Needle-Free Drug Delivery Technology to Particle Therapeutics for Diabetes Drug
4. NIH grants $750,000 to develop device to determine temperature of neonates brain
5. Edwards Lifesciences Grants UC Irvine $5 Million to Establish the Edwards Lifesciences Center for Advanced Cardiovascular Technology
6. Radius Grants Major Pharmaceutical Company Exclusive Option to License BA058 for Osteoporosis
7. Poniard Pharmaceuticals Announces European Commission Grants Orphan Medicinal Product Designation to Picoplatin for Treatment of Small Cell Lung Cancer
8. CV Therapeutics Reports Option Grants Under Nasdaq Marketplace Rule 4350
9. NASDAQ Panel Grants Merge Technologies Additional Time to Regain Compliance
10. FDA Grants Resverlogix Approval to Commence a Phase 1 Clinical Trial for RVX-208
11. Maryland Stem Cell Commission Issues Nationwide Request for Applications for New Post-Doctoral Fellowship Grants
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/14/2009)... Dec. 14 Vermillion, Inc. (Pink ... announced William C. Wallen, Ph.D. Chief Scientific ... for IDEXX Laboratories, will be joining its ... bankruptcy plan. ,, "Bill brings more ... in diagnostics and biotechnology," said Gail Page, ...
(Date:12/14/2009)... Scientific Corporation (NYSE: BSX ) today announced ... aggregate principal amount of its senior notes under the ... of $850 million of 4.50 percent notes due January ... 2020 and $300 million of 7.375 percent notes due ... net proceeds for general corporate purposes, including prepaying its ...
(Date:12/14/2009)... ThermoFab, a US-based thermoforming company, has completed the delivery of ... sheet metal to a plastic enclosure with a smaller footprint ... ... Shirley, MA (PRWEB) December 14, 2009 -- ThermoFab, a US-based ... Flow Tester – helping Brookfield move from sheet metal to ...
(Date:12/11/2009)... 10, 2009 miRagen Therapeutics, Inc., a biopharmaceutical ... innovative microRNA-based therapeutics for cardiovascular and muscle disease, ... microRNA-206 (miR-206) plays a crucial role in the ... Gehrig,s disease) and in neuromuscular synaptic regeneration in ... 11 issue of the journal Science , ...
Breaking Biology Technology:Vermillion Announces Appointment of William C. Wallen, Ph.D. to Board of Directors 2Vermillion Announces Appointment of William C. Wallen, Ph.D. to Board of Directors 3Vermillion Announces Appointment of William C. Wallen, Ph.D. to Board of Directors 4Boston Scientific Announces Completion of $2 Billion Senior Notes Offering 2Boston Scientific Announces Completion of $2 Billion Senior Notes Offering 3Thermofab Helps Brookfield Engineering Move To A Compact Custom Plastic Enclosure 2miRagen announces discovery of key microRNA implicated in Lou Gehrig's disease 2
... 30 Luminex Corporation,(Nasdaq: LMNX ) today ... Partners Healthcare Conference to be held September 5 ... by Patrick J. Balthrop, president and chief,executive officer, ... at 1:30 p.m. Eastern time on Thursday, September ...
... /Xinhua-PRNewswire/ -- Mindray Medical,International Limited (NYSE: MR ... devices in China with a rapidly growing international,presence, ... Co-Chief Executive,Officer, Ms. Joyce Hsu, Chief Financial Officer ... will attend the Merrill Lynch Global,Pharmaceutical, Biotech & ...
... the leading online,source for life science careers ... the 11th edition of the Biotech Bay(TM) ... promotional Hotbed Map and also,functional components to ... development initiatives of Northern California. Novartis Vaccines,and ...
Other Biology Technology:Luminex Corporation to Present at Thomas Weisel Partners Healthcare Conference 2Mindray to Present at Merrill Lynch Global Pharmaceutical, Biotech & Medtech Conference 2BioSpace and BayBio Launch 11th Edition of Biotech Bay(TM) Hotbed Map Campaign 2
(Date:12/14/2009)... an international team that has used DNA samples from ... of North America,s woolly mammoths and ancient horses. , ... Sciences professor Duane Froese and his colleagues counters an ... and teeth. That analysis concluded that more than half ... disappeared about 13,000 years ago. , In the ...
(Date:12/14/2009)... as a clean-burning, renewable fuel that could help wean ... caused by ozone, compared with gasoline, especially in winter, ... , Ozone production from both gasoline and E85, ... percent ethanol, is greater in warm sunny weather than ... because heat and sunlight contribute to ozone formation. But ...
(Date:12/14/2009)... to date of the proteins in a species of ... to how similar regeneration could be induced in humans. ... Indiana University-Purdue University Indianapolis and colleagues investigated over three ... type of salamander that has the unique natural ability ... the hope that this knowledge will contribute to a ...
Breaking Biology News(10 mins):Ethanol-powered vehicles generate more ozone than gas-powered ones 2Ethanol-powered vehicles generate more ozone than gas-powered ones 3IUPUI researchers tackle protein mechanisms behind limb regeneration 2Anthem Life 26 Disability Insurance Company Offers The Healing Book to Help Young Life Insurance Beneficiaries Cope With Losing a Loved One 56277 1Anthem Life 26 Disability Insurance Company Offers The Healing Book to Help Young Life Insurance Beneficiaries Cope With Losing a Loved One 56277 2TOMORROW 3A Lets Get It Done 3A Organizing for America to Host Spanish Language Forum on Health Insurance Reform Now in Tucson with Rep Raul Grijalva 56274 1TOMORROW 3A Lets Get It Done 3A Organizing for America to Host Spanish Language Forum on Health Insurance Reform Now in Tucson with Rep Raul Grijalva 56274 2Fruit Even Healthier Than Thought 3A Study 56271 1
... Medical Institute (HHMI) scientists has peeled back some of the ... selectively to control critical events of development. The new insights ... of Dicer, an enzyme that enables cells to dissect genetic ... January 13, 2005, issue of the journal Science by an ...
... Institute (HHMI) scientists has peeled back some of the mystery ... to control critical events of development. The new insights arise ... Dicer, an enzyme that enables cells to dissect genetic material ... 13, 2005, issue of the journal Science by an HHMI ...
... the University of Minnesota Medical School have discovered a new ... properties of primitive stem cells. , Umbilical cord ... can only produce cells found in blood. The new ... with the characteristics of more primitive stem cells that have ...
Other Biology News:Advanced genomics and proteomics improve the diagnosis and treatment of a deadly lung disease 2Advanced genomics and proteomics improve the diagnosis and treatment of a deadly lung disease 3Advanced genomics and proteomics improve the diagnosis and treatment of a deadly lung disease 4Molecule does more than slice and dice RNA 2Molecule does more than slice and dice RNA 3Molecule does more than slice and dice RNA 4
... Each glass slide in this set ... antibodies in triplicate, for a total ... house-keeping proteins as internal control. Antibodies ... as angiogenesis, apoptosis, cell cycle progression, ...
...
...
Kit for testing the ability of a compound to simulate lipolysis in cultured human adipocytes. Kit contains controls, buffers and reagents for detecting glycerol and non-esterified free fatty acids. A...
Biology Products: