Navigation Links
Ortho Biotech Statement on U.S. Food and Drug Administration Oncologic Drugs Advisory Committee Vote
Date:3/13/2008

GAITHERSBURG, Md., March 13 /PRNewswire/ -- Ortho Biotech is concerned by the Advisory Committee's recommendations to restrict access to erythropoiesis-stimulating agents (ESAs) for chemotherapy-induced anemia (CIA) in patients with metastatic breast and head and neck cancer, and patients treated with curative intent. The company believes that fully informed patients and their physicians should have the choice to use this important medication, which is the only therapeutic alternative to blood transfusion.

"Over the past several months, the company provided the FDA with substantial new data that give important insight into the safety of ESAs," said Jay Siegel, M.D., Group President, Research & Development. "We hope that the FDA will now take time to review this substantial body of data before reaching its final decision."

The FDA has not yet reviewed new or follow-up survival data accounting for approximately 50 percent of the 7,444 patients in the company's database. The totality of available data support continuing the option to use ESAs according to the label in patients with chemotherapy-induced anemia (CIA).

Out of a total of 59 controlled studies with survival data, the FDA has focused on eight studies of concern. All eight studies researched investigational uses of the drug, and the PROCRIT(R) (Epoetin alfa) label contains specific warnings against such uses.

In addition, a representative of the Cochrane Collaboration who attended the meeting confirmed that the group is about to generate important new analyses regarding the safety of ESA use in CIA. The FDA should consider these analyses before making its final decision.

The current product labeling prominently reflects all known risks of ESAs, including thrombovascular events (TVEs). TVEs are a plausible explanation for increased mortality observed in studies with high hemoglobin (Hb) targets. When ESA use is targeted to Hb higher than 12 grams per deciliter of blood
'/>"/>

SOURCE Ortho Biotech
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. ORTHO EVRA(R) Prescribing Information Updated
2. Clinical Data Presented on OrthoGlide(R) Medial Knee Implant
3. The OrthoGlide(TM) Medial Knee Implant Continues to be Accepted as an Alternative to Total Knee Replacement
4. Isis Earns $5 Million Milestone Payment From Ortho-McNeil, Inc. for Initiation of Phase 1 Study of ISIS 325568
5. Ortho Biotech Reiterates Confidence in PROCRIT(R) (Epoetin alfa) Safety and Efficacy When Used According to Label
6. Kibow Biotech Obtains Australian, Chinese and Indian Patents Protecting the Composition and Basic Technology Behind Its Oral Probiotic Formulation for Chronic Kidney Failure
7. Hawaii Biotech Receives Allowance to Perform West Nile Vaccine Clinical Trials
8. Lixte Biotechnology Holdings, Inc. Announces Completion of Private Placement
9. Epeius Biotechnologies Applauds the Belated Scholarship of Their Academic Contemporaries in 2007, As Targeted Gene Therapy Comes of Age in Clinical Medicine
10. ASEAN News: Epeius Biotechnologies Gains Commercial Approval for Rexin-G(R), a Tumor-Targeted Gene-Based Medicine for Metastatic Cancer
11. Sangamo BioSciences and Sigma-Aldrich Announce Nature Biotechnology Study Demonstrating Zinc Finger Technology for Modification of Human Stem Cells
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/1/2015)... Research and Markets ( http://www.researchandmarkets.com/research/pjbxjd/us_aco_it ) ... IT Spending Outlook 2018" report to their offering. ... covered by ACO would grow at a CAGR of ... IT spending has been studied on three main grounds ... on services. Our research provides current market estimation and ...
(Date:5/1/2015)... PRINCETON, N.J. , May 1, 2015 ... it has expanded its current therapeutic focus ... and other serious psychiatric disorders. Braeburn has ... atypical (or second-generation) antipsychotic risperidone for treatment ... risperidone acquisition Braeburn acquires global rights to ...
(Date:5/1/2015)... -- Semler Scientific, Inc. (Nasdaq: SMLR ), an ... markets products that assist healthcare providers in monitoring patients ... the first quarter ended March 31, 2015. ... continued progress with year over year growth of 44% ... said Doug Murphy-Chutorian , M.D., chief executive officer ...
Breaking Medicine Technology:United States ACO IT Spending Outlook 2014-2018 2Braeburn Pharmaceuticals expands pipeline to include two schizophrenia treatments 2Braeburn Pharmaceuticals expands pipeline to include two schizophrenia treatments 3Braeburn Pharmaceuticals expands pipeline to include two schizophrenia treatments 4Semler Reports First Quarter 2015 Financial Results 2Semler Reports First Quarter 2015 Financial Results 3Semler Reports First Quarter 2015 Financial Results 4Semler Reports First Quarter 2015 Financial Results 5
... Life Spine, a medical device company that designs, develops, ... spinal disorders, announced today amidst consolidations in the industry ... its history. As a full line spine company Life ... sacrum. Aileron™, a minimally invasive adjustable InterSpinous ...
... China, Nov. 4, 2011 /PRNewswire-Asia-FirstCall/ -- Mindray Medical International Limited ... marketer of medical devices worldwide, today announced that it will ... fair to be held between November 16 and 19 in ... H2 C07 at the 43rd World Forum of Medicine - ...
Cached Medicine Technology:Mindray Medical to Exhibit at MEDICA 2011 in Dusseldorf, Germany from November 16-19, 2011 2Mindray Medical to Exhibit at MEDICA 2011 in Dusseldorf, Germany from November 16-19, 2011 3
(Date:5/2/2015)... “ ActOn ” was featured on NewsWatch as part of ... and coolest applications on the market for iOS, Android, and ... conducted the app review and shared with viewers how this ... a difference. , In this material world, almost everything is ... money, which is why those things should be prioritized above ...
(Date:5/2/2015)... May 02, 2015 We are pleased ... Delray Recovery Center as one of the Top Workplaces ... in the addiction treatment field for their ethics and ... innovate and to continue their educational efforts. The Delray ... environment, never forgetting their purpose – to help individuals ...
(Date:5/2/2015)... 02, 2015 Kare Visits LLC. launched in ... busy caregivers. Kare Visits offers relief for caregivers by ... facilities. According to the Caregiver Action Network, eight ... of 20 hours a week caring for an elderly or ... to hire a nurse, a caregiver is now empowered to ...
(Date:5/2/2015)... 02, 2015 With the success that Veatch ... proud to welcome Neida Miranda and Alex Shields to the ... has over 41 years of combined experience working with dentists ... the dental field for 8 years. She was certified ... Texas. Customer service, positive attitude and showing the importance of ...
(Date:5/1/2015)... 01, 2015 Pioneer Millworks, the largest ... latest in their reclaimed wood products at the 27th ... Javits Center in NYC this May. Their newest offerings, ... much anticipated texture and color to North America's platform ... of texture and color in the design world and ...
Breaking Medicine News(10 mins):Health News:An Application to Help People Make a Difference Was Featured on NewsWatch Television 2Health News:The Delray Recovery Center Named 2015 Top Workplace 2Health News:Chicagoan Seeks to Transform Industry by Launching an Innovative Elderly Care Solution 2Health News:Veatch Dental Consulting Services Welcomes New Team Members 2Health News:Intensely Textured Reclaimed Wood to be Unveiled at ICFF in NYC by Pioneer Millworks 2Health News:Intensely Textured Reclaimed Wood to be Unveiled at ICFF in NYC by Pioneer Millworks 3
... AstraZeneca (NYSE: AZN ) is aware ... (FDA) posted to its web site -- and subsequently ... Psychopharmacologic Drugs Advisory Committee (PDAC) meeting. The PDAC meeting ... provided in supplemental new drug applications (sNDA) for SEROQUEL ...
... to help men and women from the United Kingdom (UK) and Europe who ... has opened its London center. , ... (PRWEB) April 3, 2009 -- In its continued ... who are thinning and balding, Nu/Hart Hair Clinics , a world leader ...
... April 3 Recently, researchers at the University ... conducted a study of U.S. hospitals and discovered that ... year. The study recommended solutions, including location-based technology, to ... of this study come at a time when Versus ...
... WARSAW, Ind., April 3 Zimmer Holdings, Inc. (NYSE: ... 2009 sales and earnings conference call will be broadcast live ... a.m. Eastern Time. A news release detailing the quarterly ... of the conference call.The live audio webcast can be accessed ...
... radiation dose delivered to patients undergoing coronary CT ... using tube current modulation, according to a study ... PA. , The study included 172 patients ... tube current modulation and 95 patients who were ...
... Researchers from Boston University School of Medicine,s (BUSM) ... traits associated with healthy aging and longevity amongst ... in collaboration with scientists from the National Institute ... the Journal of the American Geriatrics Society ...
Cached Medicine News:Health News:FDA Advisory Committee Documents for SEROQUEL XR Available on AstraZeneca Web Site 2Health News:FDA Advisory Committee Documents for SEROQUEL XR Available on AstraZeneca Web Site 3Health News:FDA Advisory Committee Documents for SEROQUEL XR Available on AstraZeneca Web Site 4Health News:FDA Advisory Committee Documents for SEROQUEL XR Available on AstraZeneca Web Site 5Health News:Nu/Hart, World Leader in Hair Transplants, Opens London Centre 2Health News:Nu/Hart, World Leader in Hair Transplants, Opens London Centre 3Health News:Versus Technology to Showcase Leading Enterprise Patient and Clinical Workflow Solutions at HIMSS 2009 2Health News:Versus Technology to Showcase Leading Enterprise Patient and Clinical Workflow Solutions at HIMSS 2009 3Health News:Versus Technology to Showcase Leading Enterprise Patient and Clinical Workflow Solutions at HIMSS 2009 4Health News:Radiation dose can be reduced for 'triple rule-out' coronary CT angiography 2Health News:Researchers identify personality traits 2
... low profile implantable bipolar fixed screw-in ... either the atrium or the ventricle. ... a screwdriver shape stylet which is ... ring tip and fixation screw are ...
... are implantable bipolar extendable/retractable screw-in permanent ... the atrium or the ventricle. The ... extended or retracted by turning the ... an anti-chattering mechanism for steady pacing ...
The Vitatron Pirouet S+ lead series are endocardial leads with extendable/retractable helical screw designed for reliable fixation and optimal pacing characteristics....
Used to occupy an empty hole which is not being used in an implantablepacemaker header....
Medicine Products: