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FDA Rejects Two Gilead HIV Drugs as Standalone Products

Washington (Reuters) – Gilead Sciences Inc said on Monday that U.S. health rejected two of its HIV drugs as standalone therapies, citing deficiencies in documentation and validation of certain quality testing procedures. Gilead said it is working with U.S. Food and Drug Administration to address the questions raised in the rejection letter in order to […]

Life Sciences Firm Entegrion Lands Global Partner

Research Triangle Park, N.C. — Blood technologies company Entegrion is partnering with an Italian company to develop and commercialize Resusix, Entegrion’s freeze-dried human plasma. Under the deal, Kedrion Melville gains exclusive worldwide rights to commercialize Resusix. Entegrion, based in Research Triangle Park, will collaborate with Kedrion on clinical development of the product. Clinical trials are […]

New CDC Division of Blood Disorders Director

Dr. Lisa Richardson will be joining the Division of Blood Disorders as the Division Director on April 8, 2013. Dr. Lisa C. Richardson is a medical officer at the Centers for Disease Control and Prevention in Atlanta, Georgia. Dr. Richardson most recently served as the Associate Director of Science in the Division of Cancer Prevention […]

FDA Accepts Biogen Idec’s License Application for First Long-Lasting Factor Therapy for Hemophilia B

WESTON, Mass.-Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) has accepted the company`s Biologics License Application (BLA) for the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of hemophilia B and granted the company a standard review timeline. Recombinant FIXFc is the first product candidate in […]

CNN: Researchers Say Toddler Cured of HIV

(CNN) — It’s a potential game changer in the fight against HIV, and doctors say it happened almost by accident. A baby with the virus that causes AIDS was given high doses of three antiretroviral drugs within 30 hours of her birth. Doctors knew the mother was HIV positive and administered the drugs in hopes […]

White House Petition: Help Save Lives of Millions With Hepatitis C

Dear Friends, We need your help in order to get this cure for Hepatitis C. · Over 170 million people worldwide have Hepatitis C (HCV) · Hepatitis C now kills more people than AIDS · Hepatitis C is now the leading reason for liver transplants The cure was developed by two drug companies together, but […]

Gilead Sciences Petition: Stop Withholding This Cure for Hepatitis C

TO: Supporters and Friends of People with Bleeding Disorders and HCV: Previously we described the situation in which Gilead Sciences, a drug development firm, likely found a cure …. and walked away from it, solely for the business reasons.  Explanation: they own only half of the successful drug combination and they don’t want to split […]

Hemophilia Association of NY Request Proposals for Research Grants

Bleeding Disorders FVIII Research, excluding inhibitors research Proposals should involve laboratory scientist/clinician collaboration and may be multi-institutional. Designed to facilitate an eventual clinical trial. If at that time the project is ready for clinical trial, further funding may be available to support that trial. ELIGIBILITY: Applicants must hold an M.D., Ph.D. or equivalent degree and […]

New England Journal of Medicine:Inhibitor Development in Severe Hemophilia A Patients

NEJM Article, Factor VIII Products and Inhibitor Development in Severe Hemophilia A BACKGROUND For previously untreated children with severe hemophilia A, it is unclear whether the type of factor VIII product administered and switching among products are associated with the development of clinically relevant inhibitory antibodies (inhibitor development). METHODS We evaluated 574 consecutive patients with severe […]

FDA: Metal-on-Metal Hip Implants: Safety Communication – Updated Safety Recommendations

AUDIENCE: Orthopaedic surgery, Radiology, Risk Manager ISSUE: FDA notified healthcare professionals that it is providing updated safety information and recommendations to patients and health care providers, based on the FDA’s current assessment of metal-on-metal hip implants, including the benefits and risks, the evaluation of the published literature, and the results of the June 2012 Orthopaedic […]

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