Hemophilia News and Research

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Hemophilia is a rare, inherited bleeding disorder in which your blood doesn’t clot normally. If you have hemophilia, you may bleed for a longer time than others after an injury. You also may bleed internally, especially in your knees, ankles, and elbows. This bleeding can damage your organs or tissues and, sometimes, be fatal.

FDA approves CSL Behring's sBLA to extend shelf life of Hizentra from 18 to 24 months

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to extend the shelf life of Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, from 18 months to 24 months. Hizentra, the first and only 20 percent subcutaneous immunoglobulin (SCIg) approved in the U.S. by the FDA, is also the first and only SCIg in the U.S. that may be stored at room temperature.

19 Aug 2010

AMT's MAA for LPLD gene therapy product Glybera on schedule

Amsterdam Molecular Therapeutics, a leader in the field of human gene therapy, today announced that the Marketing Authorisation Application (MAA) for Glybera(R) remains on schedule following meetings with the European Medicine Agency (EMA) concerning the Day 120 List of Questions. The company is confident that Glybera(R), a gene therapy product for lipoprotein lipase deficiency (LPLD), remains on track for a regulatory decision by mid-2011.

18 Aug 2010

NYBC calls for blood donations

New York Blood Center, serving more than 20 million people in New York City, Long Island, the Hudson Valley, New Jersey, and parts of Connecticut and Pennsylvania, calls upon the communities it serves to remember your neighbors during this slow, late summer period for blood donations – and schedule a donation appointment or consider sponsoring a blood drive, because patients' needs do not take a summer break.

12 Aug 2010

NovoSeven RT in 8 mg vial for hemophilia A or B with inhibitors receives FDA approval

Novo Nordisk announced today that the U.S. Food and Drug Administration has approved NovoSeven® RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) in an 8 mg vial size, making the hemophilia A or B with inhibitors treatment available in 1, 2, 5 and 8 mg vials. The 8 mg vial allows a rapid initiation and administration of this medication for those patients who need a larger dose. In addition, FDA has also approved the extension of shelf life for all vial sizes from 24 months to 36 months at room temperature (at or below 77 degrees Fahrenheit).

11 Aug 2010

New insight into protein transport mechanism can improve chemotherapy treatments

A new study conducted in the department of Biochemistry and Molecular Biology at Tel Aviv University (TAU) elucidates the way in which toxic, yet essential, copper ions enter human cells. As a chemotherapy drug presumably enters the cells in a similar manner, the results of this study pave the way for the development of improved chemotherapeutic drugs. The groundbreaking work was published in the leading American scientific journal PNAS (Proceedings of the National Academy of Sciences).

10 Aug 2010

FDA approves Pfizer's Prefilled Dual-Chamber Syringe for XYNTHA administration in hemophilia A patients

Pfizer Inc. announced today that the U.S. Food and Drug Administration has granted approval of the use of a Prefilled Dual-Chamber Syringe for administration of XYNTHA® Antihemophilic Factor (Recombinant) Plasma/Albumin-Free to hemophilia A patients. XYNTHA is a recombinant factor VIII product indicated for both the control and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia) and for surgical prophylaxis in patients with hemophilia A.

9 Aug 2010

Rush University Medical Center first to receive Octapharma grant under anniversary program

Octapharma USA today announced the first grant recipient of the Octapharma 25th Anniversary Grants Program is the Rush Hemophilia & Thrombophilia Center at Rush University Medical Center. The Octapharma grants program supports clinical or pre-clinical research focused on human protein therapies in hematology, immune therapy, intensive care and emergency medicine.

3 Aug 2010

Pain Therapeutics second-quarter collaboration revenue decreases to $0.1 million

Pain Therapeutics, Inc., a biopharmaceutical company, today reported second quarter financial results. Net loss for the quarter ended June 30, 2010 was $0.8 million, or $0.02 per share, compared to net loss of $34,000, or $0.00 per share, for the second quarter of 2009. Pain Therapeutics had cash, cash equivalents and marketable securities of $176.2 million, or about $4.14 cash per share, and no debt as of June 30, 2010.

28 Jul 2010

Taiwanese hemophiliacs infected by HIV-contaminated medications petition US Supreme Court

Baum Hedlund announces that Taiwanese hemophiliacs infected by HIV-contaminated medications have petitioned the United States Supreme Court to allow their claims to proceed in California. Their suits contend that California-based defendants illegally used paid plasma donors at high risk for transmitting blood-borne diseases (i.v. drug users, prisoners, and promiscuous urban gay males) to make injected anti-hemophilia medications.

28 Jul 2010

Baxter second-quarter global sales increase 2% to $3.2 billion

Baxter International Inc. today announced its financial results for the second quarter of 2010, reporting earnings in line with the company's previously issued guidance of $0.90 to $0.93 per diluted share.

From Baxter International Inc. 22 Jul 2010

Biogen Idec second-quarter revenues increase 11% to $1.2 billion

Biogen Idec Inc., a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today announced its second quarter 2010 results.

20 Jul 2010

Abbott presents 48-week PROGRESS study results at 28th International AIDS Conference

Abbott today presented 48-week findings comparing an HIV regimen of its protease inhibitor (PI), Kaletra® (lopinavir/ritonavir), and Merck's integrase inhibitor, Isentress® (raltegravir), to a traditional HIV regimen of Kaletra and the nucleotide/nucleoside reverse transcriptase inhibitors (NRTIs) in Truvada® (tenofovir and emtricitabine) in antiretroviral-naive adult patients. Efficacy data were collected over the first 48 weeks of the 96-week PROGRESS (PROtease/InteGRasE Simplification Study) study.

20 Jul 2010

GTC Biotherapeutics regains US commercialization rights to ATryn from Lundbeck

GTC Biotherapeutics, Inc. announced today that it has signed a definitive agreement whereby the Company has regained US commercialization rights to ATryn from Lundbeck, Inc., a wholly owned subsidiary of H. Lundbeck A/S in Denmark.

17 Jul 2010

Second issue of Novo Nordisk BlueSheet highlights information on diabetes

Novo Nordisk Inc., a global healthcare company and leader in diabetes care, today announced the second issue of the Novo Nordisk BlueSheet, a resource for information on diabetes and chronic disease, highlighting key issues in diabetes prevention, detection, treatment and care.

13 Jul 2010

Bayer HealthCare announces over $2.5M for largest awards program in hemophilia

Bayer HealthCare announced today that it awarded more than $2.5 million in funding to 19 recipients from 10 countries through its Bayer Hemophilia Awards Program (BHAP). BHAP is the largest awards program of its kind in hemophilia, providing funds that support clinical and basic research, encourage new physicians to enter the field and enable continuing education for caregivers around the world.

12 Jul 2010

Biogen Idec, Swedish Orphan Biovitrum present results from rFIXFc Phase 1/2a study in hemophilia B

Biogen Idec and Swedish Orphan Biovitrum AB today announced results from a Phase 1/2a open-label, dose-escalation, safety and pharmacokinetic study of the companies' long-lasting, fully-recombinant factor IX Fc fusion protein (rFIXFc) in hemophilia B patients. The data, which were presented at the World Federation of Hemophilia Congress in Buenos Aires, Argentina, on July 11, 2010, showed that rFIXFc was well tolerated and demonstrated an approximately three-fold increase in half-life compared to historical data for existing therapies.

12 Jul 2010

Biogen Idec, Swedish Orphan Biovitrum announce advancement of rFVIIIFc into registrational study

Biogen Idec and Swedish Orphan Biovitrum today announced that they plan to advance the companies' long-lasting, fully-recombinant factor VIII Fc fusion protein (rFVIIIFc) into a registrational clinical trial in people with hemophilia A. The decision to advance the program is based on promising data from a Phase 1/2a open-label, cross-over, multi-center, dose-escalation study that evaluated the safety and pharmacokinetics of an intravenous injection of rFVIIIFc in 16 previously-treated patients with severe hemophilia A.

12 Jul 2010

Pfizer to present results of hemophilia studies at WFH 2010 Congress

Pfizer Inc, the world's leading biopharmaceutical company, today announced that the results of a number of hemophilia studies will be presented at the World Federation of Hemophilia 2010 Congress taking place July 10-14, 2010, in Buenos Aires, Argentina. Key research includes a pre-clinical evaluation of recombinant factor Xa as a potential new approach to restoring hemostasis, as well as a study assessing the potential for an engineered recombinant factor VIIa molecule to improve therapeutic outcomes in mouse models of hemophilia.

9 Jul 2010

Bayer HealthCare to present BAY86-6150 rFVIIa Phase I clinical data at XXIX WFH International Congress

Phase I clinical data for BAY86-6150, a novel recombinant factor VIIa protein (rFVIIa) being developed by Bayer HealthCare, will be presented at the XXIX International Congress of the World Federation of Hemophilia (WFH) to be held in Buenos Aires, Argentina from Saturday, July 10-Wednesday, July 14.

9 Jul 2010

Scientists identify potential disease genes in humans and mice

An international consortium of scientists of Helmholtz Zentrum München and the University of Toronto has identified previously unknown potential disease genes in humans and mice. Genes on the X chromosome, which regulate embryonic development, are the focus of the current publication in the renowned journal Genome Research. Men have only one X chromosome, and therefore mutations on this chromosome disproportionately affect males, frequently leading to serious diseases such as hemophilia, muscular dystrophy and mental retardation.

7 Jul 2010

Hemophilia News and Research

Further Reading

FDA approves CSL Behring's sBLA to extend shelf life of Hizentra from 18 to 24 months

AMT's MAA for LPLD gene therapy product Glybera on schedule

NYBC calls for blood donations

NovoSeven RT in 8 mg vial for hemophilia A or B with inhibitors receives FDA approval

New insight into protein transport mechanism can improve chemotherapy treatments

FDA approves Pfizer's Prefilled Dual-Chamber Syringe for XYNTHA administration in hemophilia A patients

Rush University Medical Center first to receive Octapharma grant under anniversary program

Pain Therapeutics second-quarter collaboration revenue decreases to $0.1 million

Taiwanese hemophiliacs infected by HIV-contaminated medications petition US Supreme Court

Baxter second-quarter global sales increase 2% to $3.2 billion

Biogen Idec second-quarter revenues increase 11% to $1.2 billion

Abbott presents 48-week PROGRESS study results at 28th International AIDS Conference

GTC Biotherapeutics regains US commercialization rights to ATryn from Lundbeck

Second issue of Novo Nordisk BlueSheet highlights information on diabetes

Bayer HealthCare announces over $2.5M for largest awards program in hemophilia

Biogen Idec, Swedish Orphan Biovitrum present results from rFIXFc Phase 1/2a study in hemophilia B

Biogen Idec, Swedish Orphan Biovitrum announce advancement of rFVIIIFc into registrational study

Pfizer to present results of hemophilia studies at WFH 2010 Congress

Bayer HealthCare to present BAY86-6150 rFVIIa Phase I clinical data at XXIX WFH International Congress

Scientists identify potential disease genes in humans and mice

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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