Anemia News and Research

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Anemia is a decrease in normal number of red blood cells (RBCs) or less than the normal quantity of hemoglobin in the blood. However, it can include decreased oxygen-binding ability of each hemoglobin molecule due to deformity or lack in numerical development as in some other types of hemoglobin deficiency. The three main classes of anemia include excessive blood loss (acutely such as a hemorrhage or chronically through low-volume loss), excessive blood cell destruction (hemolysis) or deficient red blood cell production (ineffective hematopoiesis). Anemia is the most common disorder of the blood. There are several kinds of anemia, produced by a variety of underlying causes. Anemia can be classified in a variety of ways, based on the morphology of RBCs, underlying etiologic mechanisms, and discernible clinical spectra, to mention a few.

FDA approves Supplemental New Drug Application for DOXIL

Centocor Ortho Biotech Products, L.P. today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its Supplemental New Drug Application (sNDA) for DOXIL (doxorubicin HCI liposome injection) in combination with docetaxel for the treatment of women with locally advanced and metastatic breast cancer.

10 Sep 2009

Improving childhood immunization campaigns could reduce sickle-cell deaths in Africa, Study finds

By offering all children in Africa vaccines that protect against bacterial infections, researchers say the number of deaths among children living with sickle-cell anemia could be reduced, Reuters reports. An estimated 200,000 children in Africa annually are born with sickle-cell anemia, a genetic disease "in which red blood cells deform into a sickle shape and cluster, blocking blood flow and causing pain, vulnerability to infections and organ damage."

10 Sep 2009

Affymax to complete Hematide Phase 3 clinical study by the end of 2009

Affymax, Inc. today announced that it has notified clinical trial sites to complete treatment of patients in the Phase 3 clinical program for the investigational drug, Hematide, by the end of 2009.

10 Sep 2009

Merck's GARDASIL receives approval from FDA Advisory Committee

Merck & Co., Inc. announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee agreed that efficacy, immunogenicity and safety data from clinical trials in males support the use of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] in boys and men 9 through 26 years of age for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11.

10 Sep 2009

Securities class action lawsuit filed against Repros Therapeutics

Feazell & Tighe, L.L.P. announces that a securities class action lawsuit has been filed in the United States District Court for the Southern District of Texas on behalf of all persons or entities who purchased or otherwise acquired the common stock of Repros Therapeutics Inc. (“Repros” or the “Company”) (Nasdaq:RPRX), between July 1, 2009 and August 3, 2009, inclusive (the “Class Period”).

5 Sep 2009

AMAG shareholders to receive rights to purchase shares under Rights Plan

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that its Board of Directors has adopted a Shareholder Rights Plan (“Rights Plan”) under which all shareholders of record as of September 17, 2009 will receive rights to purchase shares of a new series of Preferred Stock.

5 Sep 2009

Takeda receives FDA response regarding NDA for fixed-dose combination of alogliptin and ACTOS

Takeda Pharmaceutical Company Limited ("Takeda") today announced that its wholly owned subsidiary, Takeda Global Research & Development Center, Inc. (U.S.), received on September 2 (U.S. TIME), a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for the fixed-dose combination (FDC) of alogliptin and ACTOS(R) (pioglitazone HCl).

4 Sep 2009

New treatment for vaso-occlusive crisis in sickle cell patients

GlycoMimetics, Inc. (GMI), a clinical-stage biotechnology company that is developing a new class of glycobiology-based therapies for a broad range of indications, today announced that a pilot study of the company’s lead candidate, GMI-1070, is underway in sickle cell patients. The first patients in this pilot study were treated at Children’s Hospital & Research Center Oakland in California.

4 Sep 2009

Also in global health news: Africa measles eradication; water, food security in South Asia; MDR-TB in Mumbai; SADC summit; U.S. Cuba embargo

WHO Regional Director for Africa Luis Gomes Sambo said Tuesday during the 59th Session of the WHO Regional Committee for Africa in Kigali, Rwanda, that measles could be eradicated from the continent by 2020, citing an 89 percent reduction in the number of deaths caused by measles between 2000 and 2007, Angencia AngolaPress reports.

4 Sep 2009

Adding screens to homes can cut malaria risk, study says

A study conducted in the Republic of The Gambia found that adding screens to the windows and doors of houses can help reduce the number of malaria-carrying mosquitoes inside and prevent anaemia in children, CBCnews.ca reports (9/2).

4 Sep 2009

Mosquito screens prevent malaria

Trials of a screen-based malaria prevention programme in 500 homes in The Gambia, Africa, have led to a 50 per cent reduction in malaria transmission and anaemia in children. A child dies from malaria in Africa every 30 seconds and infection can lead to an increased risk of anaemia, which can also prove fatal. Yet to date, screens have often been ignored in favour of using drugs and insecticides.

3 Sep 2009

Millennium's sNDA to be reviewed by the FDA

The Takeda Oncology Company today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s supplemental new drug application (sNDA) based on long- term overall survival (OS) data from the landmark VISTA1 trial examining the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

3 Sep 2009

Study identifies key compound that quickens recovery from life-threatening blood cell shortages

A key compound resupplies bone marrow with fast-acting stem cells that can more quickly rekindle blood cell production, according to a study published online today in the journal Blood. While the study was in mice, in the study authors say it has the potential to increase survival among patients with life-threatening blood cell shortages.

3 Sep 2009

FDA: Randomized clinical trial necessary to better interpret Clolar’s efficacy and safety in adult AML

Genzyme Corporation (Nasdaq: GENZ) announced today that the FDA’s Oncologic Drugs Advisory Committee voted 9 to 3 that a randomized, controlled trial is needed to support the currently proposed label expansion for Clolar® (clofarabine) in adult myeloid leukemia (AML). The committee found that the single-arm clinical study results submitted to support the label expansion showed Clolar was an active agent in acute AML patients, but concluded that a randomized clinical trial should be necessary to better interpret Clolar’s efficacy and safety in the proposed patient population.

2 Sep 2009

Children's Hospital Oakland converts to Masimo Rainbow SET Pulse CO-Oximetry technology

Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and Low-Perfusion pulse oximetry, announced today that Children's Hospital & Research Center Oakland has completed its system-wide conversions to Masimo Rainbow SET Pulse CO-Oximetry technology.

2 Sep 2009

Cimzia approved for treating adult patients with rheumatoid arthritis

UCB Canada Inc. announced today that Health Canada has approved Cimzia, the only PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

1 Sep 2009

Rite Aid pharmacies to offer regular seasonal flu shots throughout the flu season

Many Rite Aid pharmacists have already been giving regular seasonal flu shots following the Centers for Disease Control and Prevention (CDC) advice that anyone who wishes to reduce the risk of getting the regular seasonal flu get a flu shot as soon as they are available.

31 Aug 2009

FDA approves the usage of Valcyte for preventing CMV disease in pediatric patients

Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Valcyte(R) (valganciclovir hydrochloride) for the prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant patients (4 months to 16 years of age) at high risk of developing CMV disease.

31 Aug 2009

Genzyme’s supplemental NDA for treating adult AML with Clolar to be discussed by the FDA

Genzyme Corporation (Nasdaq: GENZ) announced today that its supplemental New Drug Application for Clolar® (clofarabine) will be discussed Tuesday, September 1 at a public meeting of the FDA’s Oncologic Drugs Advisory Committee in Silver Spring, Maryland. The panel is expected to consider the clinical trial results Genzyme submitted to support the approval and labeling of Clolar to treat older adult patients with acute myeloid leukemia (AML), the most common type of acute leukemia in adults.

29 Aug 2009

Medgenics' EPODURE tissue Biopumps platform technology effective in maintaining hemoglobin levels

Medgenics is pleased to announce that one of the patients, who was treated with the Company’s EPODURE tissue Biopumps almost 11 months ago, continues to be effectively treated for anemia without a single erythropoietin (EPO) injection. This patient (#2) was dependent on frequent injections of the therapeutic protein (EPO) for the 18 months prior to receiving a single administration of 3 tiny EPODURE tissue Biopumps in the Company’s phase I/II anemia trial in Israel.

27 Aug 2009

Anemia News and Research

Further Reading

FDA approves Supplemental New Drug Application for DOXIL

Improving childhood immunization campaigns could reduce sickle-cell deaths in Africa, Study finds

Affymax to complete Hematide Phase 3 clinical study by the end of 2009

Merck's GARDASIL receives approval from FDA Advisory Committee

Securities class action lawsuit filed against Repros Therapeutics

AMAG shareholders to receive rights to purchase shares under Rights Plan

Takeda receives FDA response regarding NDA for fixed-dose combination of alogliptin and ACTOS

New treatment for vaso-occlusive crisis in sickle cell patients

Also in global health news: Africa measles eradication; water, food security in South Asia; MDR-TB in Mumbai; SADC summit; U.S. Cuba embargo

Adding screens to homes can cut malaria risk, study says

Mosquito screens prevent malaria

Millennium's sNDA to be reviewed by the FDA

Study identifies key compound that quickens recovery from life-threatening blood cell shortages

FDA: Randomized clinical trial necessary to better interpret Clolar’s efficacy and safety in adult AML

Children's Hospital Oakland converts to Masimo Rainbow SET Pulse CO-Oximetry technology

Cimzia approved for treating adult patients with rheumatoid arthritis

Rite Aid pharmacies to offer regular seasonal flu shots throughout the flu season

FDA approves the usage of Valcyte for preventing CMV disease in pediatric patients

Genzyme’s supplemental NDA for treating adult AML with Clolar to be discussed by the FDA

Medgenics' EPODURE tissue Biopumps platform technology effective in maintaining hemoglobin levels

Event guide: 4th Extra-Hepatic Lipid-Based Nanoparticles Delivery Summit eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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