News

FDA grants accelerated approval to Beleodaq

BY Ryan Chavis

SILVER SPRING, Md. — The Food and Drug Administration on Thursday announced approval for Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), which is a rare and fast-growing type of non-Hodgkin lymphoma (NHL).

The drug works by stopping enzymes that contribute to T-cells becoming cancerous. It's indicated for patients whose disease has returned post-treatment or those patients who did not respond to previous treatment.

“This is the third drug that has been approved since 2009 for the treatment of peripheral T-cell lymphoma,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval expands the number of treatment options available to patients with serious and life-threatening diseases.”

In 2014, the National Cancer Institute estimates that 70,800 Americans will be diagnosed with NHL and 18,900 will die. PTCL makes up about 10% to 15% of NHLs in North America, the agency said.

 

Beleodaq is marketed by Spectrum Pharmaceuticals.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

News

Novartis shipping 30 million doses of influenza vaccine well ahead of 2014-2015 season

BY Michael Johnsen

CAMBRIDGE, Mass. — Novartis on Wednesday announced that it has begun shipment of its seasonal influenza vaccines to customers in the U.S. market for the 2014-2015 season. Novartis plans to ship a minimum of 30 million doses of vaccines (Flucelvax and Fluvirin). 
 
Flucelvax, which is approved for use in adults 18 years of age and older, is manufactured with cell-culture technology, a modern, alternative production method for influenza vaccines to the traditional egg-based production method. 
 
Fluvirin is indicated for persons 4 years and older.
 
Novartis is the only influenza vaccine manufacturer to use production technologies based on cell-culture (Flucelvax) as well as eggs (Fluvirin), the company stated.
 

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

News

Impax Labs acquires two generic products from Actavis

BY Michael Johnsen

HAYWARD, Calif. — Impax Labs on Wednesday announced that it has acquired from Actavis two generic products for cash consideration. Financial terms of the agreement were not disclosed.
 
The acquisition includes one product marketed under an abbreviated new drug application — Ursodiol tablet — and one approved aNDA that is not yet marketed — Lamotrigine orally disintegrating tablet.
 
"The acquisition of these products from Actavis is just one example of our ongoing strategy of expanding our product offerings and portfolio with strategic business development projects," said Fred Wilkinson, president and CEO Impax Laboratories. "Successful implementation of our M&A and business development activities should complement our internal development programs and provide further long-term growth for the company."

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES