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GSK, Amicus to develop, commercialize Amigal

BY Alaric DeArment

CRANBURY, N.J. British drug maker GlaxoSmithKline will work with U.S.-based Amicus Therapeutics to develop a drug for a rare genetic disease.

 

The two companies announced a deal to develop and commercialize Amigal (migalastat hydrochloride), a treatment for Fabry disease. Under the deal, GSK will pay Amicus $30 million upfront, as well as milestone payments of up to $170 million and royalties on future sales.

 

 

Fabry disease is a lysosomal storage disorder resulting from deficiencies of the enzyme alpha-galactosidase A. Lack of the enzyme results in buildup of a lipid called globotriaosylceramide, or GL-3, which is believed to cause the disease’s symptoms, such as pain, kidney failure and increased risk of heart attack and stroke. The disease affects 5,000 to 10,000 people worldwide.

 

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FDA OKs expanded use of Sprycel

BY Alaric DeArment

SILVER SPRING, Md. The Food and Drug Administration has approved a new usage for a blood cancer drug, the agency said Thursday.

The FDA approved Bristol-Myers Squibb’s Sprycel (dasatinib) for treating chronic phase chronic myeloid leukemia that contains the so-called Philadelphia chromosome, also called Ph+ CP-CML. The FDA originally approved the drug in June 2006 for patients with CP-CML for whom treatment with Novartis’ Gleevec (imatinib) had failed. CML results from an overabundance of blood stem cells developing into abnormal forms of white blood cells called granulocytes, which build up in the blood and bone marrow and crowd out healthy white and red blood cells and platelets, creating risk for infections, anemia and unexpected bleeding.

“These drugs have dramatically changed the lives of patients with CML,” FDA Office of Oncology Drug Products director Richard Pazdur said. “Results from additional CML studies continue to demonstrate the importance of studying cancer drugs in the earlier stages of the disease.”

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Bic improves its pens with new technology

BY Allison Cerra

SHELTON, Conn. Bic celebrated the official launch of its Easy-Glide System ink technology, which has been incorporated into its Velocity retractable, Atlantis retractable and Pro+ ball pens.

The technology provides up to 35% smoother writing compared with current Bic pen ink systems, the company said.

To help celebrate the event, Bic is kicking off its "Get a Clue" event Nov. 3 and 4 at Vanderbilt Hall in Grand Central Terminal, which invites consumers to help solve a gigantic crossword puzzle and learn more about how Bic ballpoint pens are made.

"This event is a fun way for commuters, many of whom do crossword puzzles during their train ride to Manhattan each day, to spend a few minutes to help us complete a gigantic crossword puzzle," said Joseph Franzino, senior brand manager at Bic Consumer Products USA, a division of Bic USA. "In addition to the crossword puzzle and free samples of the Bic Velocity retractable ball pen, commuters will also receive coupons for Bic stationery products and have the chance to receive free giveaways and participate in a fun sensory box activity to see how smooth they are at guessing what is in the boxes."

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