European Haemophilia Consortium (EHC)

FDA Panel Endorses ’Quad’ Pill for HIV

Sun, 13 May 2012 07:35:00 +0200

SILVER SPRING, Md. -- The FDA’s Antiviral Drugs Advisory Committee has voted 13 to 1 to recommend approval of Gilead Sciences’ new single-pill, once-daily regimen for HIV treatment. full story

Source: medpagetoday

Europe's biosimilars market could reach $3.99B in 5 years

Sun, 13 May 2012 07:28:00 +0200

The European biosimilars market is forecast to grow to $3.99 billion in 2017 from $172 million in 2010, according to a Frost & Sullivan report. That is equivalent to compound growth of 56.7% a year. The expiration of patents for blockbuster biologics is expected to drive the growth. PharmaTimes (U.K.)

Source: AABBsmartbrief

Calif. tattoo, piercing parlors to be subject to inspections

Sun, 13 May 2012 07:15:00 +0200

Tattoo and body-piercing establishments in California will face new standards and inspections in compliance with the state's Safe Body Art Act. The policy will be implemented in July. The move is intended to reduce the risk of blood-borne infections from tattoos and body-piercing procedures. The Fresno Bee (Calif.)

Source: AABBsmartbrief

Vermont House calls on FDA to revise policy on MSM blood donations

Sun, 13 May 2012 07:08:00 +0200

The Vermont House has passed a resolution asking the FDA to revise its blood donor deferral policy for men who have sex with men. The resolution proposes the implementation of a one-year deferral period for MSM following last sexual contact. The Examiner (Washington, D.C.)/The Associated Press

Source: AABBsmartbrief

FDA Enters the ’Mad Cow’ Investigation

Sun, 13 May 2012 07:05:00 +0200

WASHINGTON -- The FDA said it has joined the U.S. Department of Agriculture’s investigation of a confirmed case of bovine spongiform encephalopathy (BSE) in a California dairy cow. full story
Source: medpagetoday

FDA warns against combining hepatitis C treatment, some HIV drugs

Sun, 29 Apr 2012 08:12:00 +0200

The FDA is revising the label of boceprevir, a recently approved hepatitis C treatment, to warn about co-administration with certain HIV medicines. Taking boceprevir with some HIV drugs, including ritonavir, might increase the level of either virus in the blood, the agency said. Chicago Tribune/Reuters

Source: AABBsmartbrief

BSE is confirmed in Calif. dairy cow

Sun, 29 Apr 2012 08:09:00 +0200

The USDA has confirmed a California dairy cow had bovine spongiform encephalopathy. USDA Chief Veterinary Officer Dr. John Clifford said the meat was not headed for the food supply. USA TODAY (4/25), MSNBC/The Associated Press (4/24), Reuters

Source: AABBsmartbrief

Orphan-drug status is sought for hepatitis D treatment

Sun, 29 Apr 2012 08:06:00 +0200

Medgenics sought orphan-drug status from the FDA for its hepatitis D treatment Infradure. The firm expects the designation to be confirmed next quarter. Proactive Investors

Source: AABBsmartbrief

Strong demand seen for hemophilia, immune therapies

Sun, 29 Apr 2012 07:57:00 +0200

Baxter International reported strong demand for devices and therapies for hemophilia, trauma and immune disorders, as well as for anesthesia products. Baxter is planning to build a facility in Georgia to broaden its plasma business. Fox Business/Dow Jones Newswires

Source; AABBsmartbrief

Hemophilia B drug submitted for FDA approval

Sun, 29 Apr 2012 07:52:00 +0200

Inspiration Biopharmaceuticals submitted IB1001 for consideration by the FDA. The bleeding-prevention therapy is an intravenous recombinant factor IX product for patients with hemophilia B. Mass High Tech (Boston)

Source: AABBsmartbrief