Content about Blood disorders

August 9, 2012

The Food and Drug Administration has approved a new drug for treating a rare type of leukemia, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare type of leukemia, the agency said Thursday.

The FDA approved South San Francisco, Calif.-based Talon Therapeutics' Marqibo (vincristine sulfate liposome), an injectable drug for Philadelphia chromosome-negative acute lymphoblasic leukemia, or Ph-negative ALL.

July 31, 2012

Abon Pharmaceuticals is challenging the patent protection on an injected drug used to treat leukemia in children and adolescents, the company said Tuesday.

NORTHVALE, N.J. — Abon Pharmaceuticals is challenging the patent protection on an injected drug used to treat leukemia in children and adolescents, the company said Tuesday.

Abon said it filed with the Food and Drug Administration for regulatory approval of clofarabine in the 1 mg-per-mL strength. The drug is a generic version of Genzyme's Clolar, used to treat relapsed or refractory acute lymphoblastic leukemia in patients ages one to 21 years, who already have undergone at least two regimens.

July 23, 2012

The Food and Drug Administration has approved a new drug for treating multiple myeloma, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating multiple myeloma, the agency said Friday.

July 9, 2012

Specialty pharmacy provider BioRx has acquired another specialty pharmacy provider based in Minnesota, BioRx said Monday.

CINCINNATI — Specialty pharmacy provider BioRx has acquired another specialty pharmacy provider based in Minnesota, BioRx said Monday.

BioRx, based in Cincinnati and specializing in such bleeding disorders as hemophilia, announced the purchase of Savage, Minn.-based Coagulife, which provides similar services.

May 29, 2012

BioPlus Specialty Pharmacy has appointed a new person to head its bleeding disorders program, the company said Tuesday.

ALTAMONTE SPRINGS, Fla. — BioPlus Specialty Pharmacy has appointed a new person to head its bleeding disorders program, the company said Tuesday.

BioPlus announced the promotion of Shelley Moore to the position of national director of hemophilia. Moore already has served as head of the company's bleeding disorders program for Tennessee and has six years' nursing experience and a career specialty in bleeding disorders.

May 9, 2012

Seattle Genetics and Takeda's cancer drug subsidiary have started a late-stage clinical trial for a lymphoma drug, the companies said Wednesday.

BOTHELL, Wash. — Seattle Genetics and Takeda's cancer drug subsidiary have started a late-stage clinical trial for a lymphoma drug, the companies said Wednesday.

Seattle Genetics and Millennium announced the start of a phase-3 trial of Adcetris (brentuximab vedotin) in patients relapsed cutaneous T-cell lymphoma that expresses the CD30 cell membrane protein. The study will enroll more than 120 patients who will be divided into two groups, one of which will receive Adcetris and another that will receive methotrexate or bexarotene.

April 20, 2012

Merck is testing two means of treating patients with chronic hepatitis C for anemia, a common side effect of certain treatments for the viral infection, the drug maker said.

BARCELONA, Spain — Merck is testing two means of treating patients with chronic hepatitis C for anemia, a common side effect of certain treatments for the viral infection, the drug maker said.

Merck announced results of a phase-3 study comparing two strategies for managing anemia and how they affect the curing of hepatitis C in patients taking Victrelis (boceprevir) with Pegintron (peginterferon alfa-2b) and ribavirin.

March 28, 2012

The Food and Drug Administration has approved a new treatment for anemia in patients with chronic kidney disease.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for anemia in patients with chronic kidney disease.

The FDA announced the approval of Affymax's Omontys (peginesatide), a drug belonging to the class known as erythropoiesis-stimulating agents, designed to aid the formation of red blood cells.

March 7, 2012

The Food and Drug Administration has declined to approve a drug made by Eisai for leukemia in certain elderly patients, the drug maker said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has declined to approve a drug made by Eisai for leukemia in certain elderly patients, the drug maker said.

Eisai said the FDA delivered it a complete response letter for the chemotherapy drug Dacogen (decitabine) in patients ages 65 years and older with acute myeloid leukemia who are not candidates for induction therapy. The FDA delivers a complete response letter when questions remain about an regulatory application that preclude approval, usually due to insufficient clinical trial data.

March 6, 2012

Takeda Pharmaceutical's cancer drug unit has started a late-stage clinical trial of a drug for treating a rare form of lymphoma, the company said.

CAMBRIDGE, Mass. — Takeda Pharmaceutical's cancer drug unit has started a late-stage clinical trial of a drug for treating a rare form of lymphoma, the company said.

The unit, Millennium, announced the start of a phase-3 trial to evaluate MLN8237 in patients with relapsed or refractory peripheral T-cell lymphoma, an aggressive non-Hodgkin's lymphoma.

January 12, 2012

Drug maker Octapharma USA has appointed David Holliday as VP commercial development, the company said.

HOBOKEN, N.J. — Drug maker Octapharma USA has appointed David Holliday as VP commercial development, the company said.

December 7, 2011

Prescribers, patients and specialty care centers no longer will be required to enroll in safety monitoring programs for two drugs used to treat low platelet counts, following changes to their risk evaluation and mitigation strategies.

SILVER SPRING, Md. — Prescribers, patients and specialty care centers no longer will be required to enroll in safety monitoring programs for two drugs used to treat low platelet counts, following changes to their risk evaluation and mitigation strategies.

November 18, 2011

The Food and Drug Administration has approved a new chemotherapy drug for treating acute lymphoblastic leukemia, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new chemotherapy drug for treating acute lymphoblastic leukemia, the agency said Friday.

The FDA announced the approval of EUSA Pharma's Erwinaze (asparaginase Erwinia chrysanthemi) to treat patients with ALL who have developed an allergy to E. coli-derived asparaginase and pegaspargase chemotherapy drugs.

November 16, 2011

The Food and Drug Administration has approved a new drug for treating a rare bone disease, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare bone marrow disease, the agency said Wednesday.

October 14, 2011

The Food and Drug Adminsitration has approved a drug made by ApoPharma for a complication resulting from treatments for a genetic condition that causes anemia, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Adminsitration has approved a drug made by ApoPharma for a complication resulting from treatments for a genetic condition that causes anemia, the agency said Friday.

The FDA announced the approval of Ferriprox (deferiprone), used to treat patients with iron overload due to blood transfusions for thalassemia, a blood disorder. Patients with the disease have excess iron in their bodies because of the frequent blood transfusions they must receive that can lead to iron overload, a condition that can be fatal.

August 19, 2011

The Food and Drug Administration has approved a new biotech drug for treating two types of lymphoma, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new biotech drug for treating two types of lymphoma, the agency said Friday.

April 28, 2011

Bayer HealthCare Pharmaceuticals and the World Federation of Hemophilia announced Thursday a three-year extension of Bayer’s sponsorship agreement with the WFH.

MONTVILLE, N.J. — Bayer HealthCare Pharmaceuticals and the World Federation of Hemophilia announced Thursday a three-year extension of Bayer’s sponsorship agreement with the WFH.

The agreement calls for Bayer to serve as the sole sponsor of the WFH’s International Hemophilia Training Centre program and provide support for other activities of the organiztion, such as its website and Congress. The program trains healthcare professionals in developing countries in diagnosis and management of hemophilia and related bleeding disorders.

April 1, 2011

The Food and Drug Administration has approved a generic treatment for iron deficiency anemia made by Watson Pharmaceuticals, Watson said Thursday.

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic treatment for iron deficiency anemia made by Watson Pharmaceuticals, Watson said Thursday.

The drug maker announced the approval of Nulecit (sodium ferric gluconate complex in sucrose), an injectable and generic version of Sanofi-Aventis’ Ferrlecit.

The drug is used to treat iron deficiency anemia in adults and children ages 6 years and older undergoing chronic hemodialysis and receiving supplemental epoetin therapy.

March 21, 2011

Patients with bleeding disorders could be eligible for a scholarship from a specialty pharmacy provider that specializes in treating them.

RALEIGH, N.C. — Patients with bleeding disorders could be eligible for a scholarship from a specialty pharmacy provider that specializes in treating them.

MedPro Rx announced Sunday that patients with such disorders as hemophilia and von Willebrand disease attending college and active in their communities could be eligible for its Education Is Power scholarship program.

February 28, 2011

The Food and Drug Administration has approved a GlaxoSmithKline drug for a rare blood disorder, GSK said Friday.

PHILADELPHIA — The Food and Drug Administration has approved a GlaxoSmithKline drug for a rare blood disorder, GSK said Friday.

The drug maker announced the approval of Promacta (eltrombopag) for chronic immune thrombocytopenic purpura, or ITP, in patients who have not responded adequately to other therapies. Chronic ITP results in increased destruction of inadequate production of platelets in the blood, creating an increased risk of bruising and bleeding.

The FDA granted Promacta orphan drug designation in May 2008 and accelerated approval in November 2008.

February 23, 2011

Drug maker Gilead Sciences plans to buy out a privately owned Seattle company that makes treatments for cancer and inflammatory diseases, Gilead said Tuesday.

FOSTER CITY, Calif. — Drug maker Gilead Sciences plans to buy out a privately owned Seattle company that makes treatments for cancer and inflammatory diseases, Gilead said Tuesday.

The Foster City, Calif.-based company will buy Calistoga Pharmaceuticals for $375 million, plus additional milestone payments of up to $225 million.

December 6, 2010

A drug made by Amgen maintained blood platelet counts in patients with an autoimmune bleeding disorder, according to results of a five-year study released Sunday.

ORLANDO, Fla. — A drug made by Amgen maintained blood platelet counts in patients with an autoimmune bleeding disorder, according to results of a five-year study released Sunday.

November 15, 2010

The Food and Drug Administration has granted orphan drug designation to a drug for treating...

SAN DIEGO — The Food and Drug Administration has granted orphan drug designation to a drug for treating sickle cell disease.

 

October 31, 2010

The U.S. subsidiary of a Swiss biotech company has started a late-stage trial of a...

October 27, 2010

The Food and Drug Administration has approved a new usage for a blood cancer drug,...