Content about Coagulation system

December 23, 2013

The Food and Drug Administration has approved a new treatment made by Danish drug maker Novo Nordiskfor a rare, genetic bleeding disorder, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment made by Danish drug maker Novo Nordiskfor a rare, genetic bleeding disorder, the agency said Monday.

October 17, 2013

The Food and Drug Administration has approved a new drug made by Novo Nordisk for treating hemophilia A, the Danish drug maker said.

BAGSVÆRD, Denmark — The Food and Drug Administration has approved a new drug made by Novo Nordisk for treating hemophilia A, the Danish drug maker said.

Novo Nordisk announced the approval of Novoeight (turoctocog alfa), a recombinant coagulation factor VIII, for adults and children with hemophilia, a disease caused by factor VIII deficiency that results in uncontrollable bleeding.

June 27, 2013

The Food and Drug Administration has approved what's being called the first therapy of its kind to prevent bleeding episodes.

SILVER SPRING, Md. — The Food and Drug Administration has approved what's being called the first therapy of its kind to prevent bleeding episodes.

The FDA announced Thursday the approval of Westlake Village, Calif.-based Baxter Healthcare Corp.'s Rixubis (coagulation factor IX [recombinant]) for patients with hemophilia B age 16 years and older. The treatment is used for controlling and preventing bleeding episodes, management of patients after surgery and routine use to prevent or reduce the frequency of bleeding episodes.

April 30, 2013

The Food and Drug Administration has approved a drug that reverses the effects of anticoagulant drugs in patients who have suffered acute major bleeding, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug that reverses the effects of anticoagulant drugs in patients who have suffered acute major bleeding, the agency said.

The FDA announced the approval of CSL Behring's Kcentra (prothrombin complex concentrate [human]) for the urgent reversal of vitamin K antagonist, or VKA drugs such as warfarin.

January 7, 2013

Biogen Idec is seeking Food and Drug Administration approval for a hemophilia drug that it called the first of its kind.

WESTON, Mass. — Biogen Idec is seeking Food and Drug Administration approval for a hemophilia drug that it called the first of its kind.

The drug maker announced that it had submitted a regulatory application for recombinant factor IX Fc fusion protein, or rFIXFc, which it called the first long-lasting factor IX therapy for hemophilia B.

July 11, 2012

Days after its acquisition of Coagulife, specialty pharmacy provider BioRx has received limited distribution rights to a treatment for a bleeding disorder described as one of the rarest in the world.

CINCINNATI — Days after its acquisition of Coagulife, specialty pharmacy provider BioRx has received limited distribution rights to a treatment for a bleeding disorder described as one of the rarest in the world.

The company, which specializes in treating bleeding disorders, said Wednesday that it had received the rights for Corifact (factor XIII concentrate [human]), a treatment made by CSL Behring for congenital Factor XIII deficiency. The drug received approval from the Food and Drug Administration in February 2011.

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 4, 2011

The Food and Drug Administration has cleared the way for the return to market of a drug for treating immunodeficiency diseases following its recall by the manufacturer in response to patients developing internal blood clots.

HOBOKEN, N.J. — The Food and Drug Administration has cleared the way for the return to market of a drug for treating immunodeficiency diseases following its recall by the manufacturer in response to patients developing internal blood clots.

April 26, 2011

The Food and Drug Administration has approved a new storage option for a hemophilia A treatment made by Bayer HealthCare Pharmaceuticals, the drug maker said.

WAYNE, N.J. — The Food and Drug Administration has approved a new storage option for a hemophilia A treatment made by Bayer HealthCare Pharmaceuticals, the drug maker said.

Bayer announced that Kogenate FS (antihemophilic factor [recombinant]) now can be stored at room temperature, up to 77 degrees, for up to one year. Previously, it could be stored at room temperature for three months, and most Factor VIII products must be stored in a refrigerator.

April 8, 2011

Danish drug maker Novo Nordisk has received the Corporate Leadership Award from the National Hemophilia Foundation in response to its research and development efforts for the disease, the company said Friday.

PRINCETON, N.J. — Danish drug maker Novo Nordisk has received the Corporate Leadership Award from the National Hemophilia Foundation in response to its research and development efforts for the disease, the company said Friday.

Novo Nordisk president Jurek Gruhn accepted the award at the NHF’s Inaugural Spring Soiree Benefit in New York Thursday. Novo Nordisk makes NovoSeven RT (coagulation factor VIIa [recombinant], room temperature stable), used to treat hemophilia A and B.

February 24, 2011

Novo Nordisk has filed for approval of a treatment for a rare genetic bleeding disorder, the Danish drug maker said Wednesday.

PRINCETON, N.J. — Novo Nordisk has filed for approval of a treatment for a rare genetic bleeding disorder, the Danish drug maker said Wednesday.

The company submitted to the Food and Drug Administration its application for recombinant factor XIII compound, for congenital factor XIII deficiency. Current treatments for FXIII deficiency use products derived from human blood plasma, which carries the risk of contamination.

February 2, 2011

A collection of relatively new products helped drive up sales and profits at Novo Nordisk, the Danish drug maker said Wednesday.

BAGSVÆRD, Denmark — A collection of relatively new products helped drive up sales and profits at Novo Nordisk, the Danish drug maker said Wednesday. 

Sales increased by 22% in the North American markets when measured in local currencies, and by 29% when measured in Danish kroner, the company said. Operating profits were $3.5 billion, a 16% increase over 2009.

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.

October 31, 2010

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

August 2, 2010

The Food and Drug Administration has given orphan drug designation to a treatment for an...

May 12, 2010

A drug for treating the bleeding disorder von Willebrand disease has become available, manufacturer Octapharma...

January 24, 2010

Bayer Schering Pharma will halt a mid-stage clinical trial of an investigational treatment for hemophilia,...

January 17, 2010

Prospective college students living with bleeding disorders have a chance to receive a scholarship from...