Progressive Multifocal Leukoencephalopathy News and Research

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Genentech and Biogen Idec submit applications to FDA for Rituxan in chronic lymphocytic leukemia

Genentech, Inc. and Biogen Idec today announced that the companies submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Rituxan (rituximab) plus standard chemotherapy for people with previously untreated or treated chronic lymphocytic leukemia (CLL).

20 May 2009

Withdrawal of Raptiva from U.S. market

Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), has announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market.

8 Apr 2009

Study of Rituxan (rituximab) in lupus nephritis misses primary endpoint

Genentech, Inc. and Biogen Idec has announced that a Phase III study of Rituxan (rituximab) plus mycophenolate mofetil (MMF) and corticosteroids in patients with lupus nephritis did not meet its primary endpoint of significantly reducing disease activity at 52 weeks.

11 Mar 2009

FDA issues warning on psoriasis drug Raptiva (efalizumab)

The U.S. Food and Drug Administration has issued a public health advisory concerning three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva (efalizumab).

20 Feb 2009

Multiple sclerosis drug natalizumab may reduce immunity

A drug used to treat multiple sclerosis might make some patients vulnerable to brain infection by reducing the number of immune cells there, researchers at UT Southwestern Medical Center have found.

16 Dec 2008

Rituxan in combination with chemo improves survival in chronic lymphocytic leukemia

Genentech, Inc. and Biogen Idec have announced that two global Phase III studies in chronic lymphocytic leukemia (CLL), CLL8 and REACH, showed Rituxan (rituximab) plus chemotherapy significantly increased the time patients lived without their disease advancing, as defined by the primary endpoint of progression-free survival (PFS), when compared to chemotherapy alone.

8 Dec 2008

FDA approves new labeling for psoriasis drug Raptiva

The U.S. Food and Drug Administration today announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA's post-market surveillance.

19 Oct 2008

Brain molecule from endothelial cells may be a new target for treatment of multiple sclerosis

In the February issue of Nature Immunology, the team provides fresh answers concerning the role of novel adhesion molecules in the pathogenesis of MS, a chronic autoimmune disease of the nervous system that affects approximately 55,000 young adults in Canada.

23 Jan 2008

FDA approves Tysabri to treat Crohn's disease

The U.S. Food and Drug Administration has approved Tysabri (natalizumab) for the treatment of moderate-to-severe Crohn's disease in patients with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn's disease therapies.

14 Jan 2008

Central nervous system infections after heart transplants

Central nervous system infections develop infrequently following heart transplants but are a significant predictor of death, according to an article posted online today that will appear in the December 2007 print issue of Archives of Neurology, one of the JAMA/Archives journals.

9 Oct 2007

Disease activity increases after multiple sclerosis patients stop natalizumab

People with multiple sclerosis who stop taking the drug natalizumab may experience a rebound increase in disease activity, according to a study published September 12, 2007, in the online edition of Neurology, the medical journal of the American Academy of Neurology.

13 Sep 2007

Natalizumab returns to market

Just months after receiving FDA approval, natalizumab, a medication for the treatment of multiple sclerosis (MS) and other inflammatory disorders, was voluntarily withdrawn by its manufacturers after three patients developed a brain infection known as Progressive Multifocal Leukoencephalopathy (PML).

28 May 2007

Newly discovered WU virus may explain some respiratory infections

An ongoing effort to identify the microorganisms that make us sick has discovered a new virus potentially linked to unexplained respiratory infections.

18 May 2007

Study of unexplained respiratory infections leads researchers to new virus

An ongoing effort to identify the microorganisms that make us sick has discovered a new virus potentially linked to unexplained respiratory infections.

17 May 2007

Rituximab reduces disease activity in multiple sclerosis

A new drug under investigation shows a reduction in disease activity in multiple sclerosis (MS), according to two studies that will be presented at the American Academy of Neurology's 59th Annual Meeting in Boston. The drug reduced disease activity as indicated by MRI scans.

2 May 2007

Natalizumab (Tysabri) reduces vision loss in MS patients

According to a study that appears in the April 17 issue of Neurology, researchers at the University of Pennsylvania School of Medicine have found that natalizumab (TYSABRI), a drug that slows disability and reduces relapse rates in patients with multiple sclerosis (MS), also reduces vision loss in patients with relapsing MS.

17 Apr 2007