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FDA warns 14 pharmaceutical companies about short internet ads lacking risk information

FDA has warned 14 major pharmaceutical firms about brief Internet advertisements that could have misled patients because they did not include information about health risks related to the drugs, according to letters posted to the agency's Web site Friday, the Wall Street Journal reports.

6 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

Stromedix awarded U.S. patent for antibody-based therapeutics

Stromedix, Inc., a biotechnology company focused on innovative therapies for fibrosis and fibrotic organ failure, announced today that the U.S. Patent Office has granted patent number US 7,465,449, which broadly covers monoclonal antibodies to integrin ávâ6, including compositions related to its lead product, STX-100.

23 Jan 2009

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 accepts Zevalin supplemental biologics license application

Cell Therapeutics, Inc. (CTI) has announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review, and has granted priority review status for, the supplemental Biologics License Application (sBLA) for use of Zevalin ([90Y]-ibritumomab tiuxetan) as consolidation therapy for patients with follicular B-cell non-Hodgkin's lymphoma who achieve a response to first-line therapy. Priority review is granted by the FDA for a treatment that addresses a significant unmet medical need.

1 Dec 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

Renewed search for lupus treatments and cure

For the first time in decades, a significant number of clinical trials are being conducted to seek a treatment, perhaps even a cure, for lupus, a chronic and potentially fatal autoimmune disease that affects more than 1.5 million Americans -- 10,000 in Los Angeles County alone.

4 Oct 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

Lawmakers have proposed 'witch's brew' of biotech bills

Lawmakers in recent months "have stirred up a witch's brew of initiatives that is cause for some concern -- not only for the biotech industry, but for all Americans," James Mullen, president and CEO of Biogen and chair of the Biotechnology Industry Organization, writes in a Wall Street Journal opinion piece.

1 May 2007

New discoveries about stem cells in leukemia, breast and colon cancer

Recent discoveries about the role of stem cells in cancer have altered the landscape of cancer research. With each new study, scientists are learning more about cancer-initiating properties of stem cells at organ sites and throughout the body.

19 Apr 2007

MS sufferers relieved as drug Tysabri goes back on the market

The Food and Drug Administration in the U.S. has given it's approval for the multiple sclerosis drug Tysabri to be put back on the market.

6 Jun 2006

FDA approves resumed marketing of Tysabri

The Food and Drug Administration (FDA) today approved an application for resumed marketing of Tysabri (natalizumab) subject to a special restricted distribution program.

5 Jun 2006

MS sufferers lobby for return of Tysabri

Despite the deaths of two people among the thousands treated with a promising multiple sclerosis drug, MS patients are trying to persuade the U.S. government to allow the drug back onto the market.

8 Mar 2006

Extensive study of natalizumab

Scientists have completed an extensive study of more than 3,000 patients who received a promising anti-inflammatory drug, natalizumab, that was linked to three cases of a serious brain infection in large clinical trials halted in early 2005.

7 Mar 2006

Trials on MS drug Tysabri renews hope for sufferers

According to the results of two new trials the multiple sclerosis (MS) drug Tysabri significantly reduces the progression of the disease.

5 Mar 2006

FDA approves Rituxan (Rituximab)

Rituxan is the first treatment for RA that selectively targets immune cells known as CD20-positive B-cells. Through this unique mechanism of action, Rituxan may affect multiple pathways by which B-cells are believed to contribute to the initiation and development of RA.

1 Mar 2006

Withdrawn MS drug works for Crohn's sufferers

Researchers say that a multiple sclerosis drug that was withdrawn from the market for safety reasons, has shown some effectiveness against the painful bowel disorder Crohn's disease.

3 Nov 2005

Multiple sclerosis drug Tysabri could be back on the market later in the year

The drug Tysabri which was approved by the Food and Drug Administration (FDA) for the treatment of multiple sclerosis in November 2004, was taken off the market in late February, after two cases of progressive multifocal leukoencephalopathy, or PML, appeared in patients given the drug during clinical trials.

9 Jun 2005

Radioimmunotherapy streamlines non-Hodgkin's lymphoma treatment

Researchers at the Keck School of Medicine of the University of Southern California and colleagues have found a way to streamline a new form of treatment for patients with non-Hodgkin's lymphoma.

18 May 2005

Increased scrutiny of new multiple sclerosis-fighting drugs after Tysabri withdrawal

The removal of Tysabri from the market soon after its introduction is expected to increase scrutiny of other similar drugs in development for multiple sclerosis (MS), says ECRI, a leading, independent health services research agency.

11 Apr 2005