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Archive for the 'Food and Drug Administration' Category

Regeneron drug shown to aid gout patients

September
3

Regeneron Pharmaceuticals Inc. said today clinical studies have shown its Arcalyst drug to be effective in reducing incidents of sudden pain in patients with gout, a form of arthritis.

In tests of 83 patients, Arcalyst reduced the number of gout flares 81 percent in patients prescribed allopurinol, a drug used to reduced the amount of excess uric acid in the blood that is known to trigger acute spasms of joint pain and inflammation, the Eastview-based biopharmaceutical company said.

None of the patients experienced any side effects from Arcalyst, an injected drug. The successful completion of the Phase 2 clinical trial opens the door for Phase 3 studies, which Regeneron expects to begin early next year, it said.

Arcalyst, Regeneron’s only marketable drug, was approved earlier this year for treatment of a rare auto-inflammatory condition known as CAPS. Shares of Regeneron rose nearly 6 percent in trading today to end at $21.80 a share, up $1.22.

Posted by David Schepp on Wednesday, September 3rd, 2008 at 4:43 pm |
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Barr confirms patent challenge

July
29

Barr Pharmaceuticals Inc. confirmed today that its Pomona-based subsidiary, Barr Laboratories Inc., has challenged four patents held by Amgen Inc. for its Sensipar drug, used by dialysis patients to treat side-effects of the treatment.

Barr said it filed an Abbreviated New Drug Application with the Food and Drug Administration on March 10, the first date the agency could accept such an application for the kidney drug.

On Monday, Amgen, along with patent partners Brigham and Women’s Hospital Inc. and NPS Pharmaceuticals Inc., filed suit against Barr and Israeli drug-maker Teva Pharmaceutical Industries Ltd. for planning to sell generic Sensipar before the expiration of patent protection.

Sensipar recorded $377 million in U.S. sales during the 12 months ending May, Barr said.

Teva, the world’s largest generic-drug maker, is buying Montvale, N.J.-based Barr for $9 billion, the companies said jointly earlier this month.

Shares of Barr were down fractionally in noontime trading to $65.81 a share.

Posted by David Schepp on Tuesday, July 29th, 2008 at 11:11 am |
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Emisphere reports upbeat results in drug tests

July
28

Emisphere Technologies Inc. said today new study results show an oral form of vitamin B12 that the company is developing reduced the amount of time it took for the body to absorb the nutrient, while increasing the amount of the nutrient that was absorbed.

Developing an effective oral form of the nutrient may save millions of Americans from painful injections, needed to ensure they get adequate levels of vitamin B12.

The study, which involved 20 men divided into four groups, showed vitamin B12 absorption was 10 times higher in those given a supplement using Emisphere’s eligen technology, according to the Cedar Knolls, N.J.-based company, which employs 60 workers in research and development at the Landmark at Eastview office complex.

Eligen, which the company has been developing in some form for years, essentially chaperons the nutrient through the digestive system, where it would otherwise be destroyed, into the bloodstream.

Data from the study hold “real promise for improving the way we approach vitamin B12 supplementation,” said Donald W. Jacobsen, professor of molecular medicine at Case Western Reserve University in Cleveland.

At least 5 million people a year in the United States receive some 40 million B-12 injections to treat a range of debilitating diseases.

Shares of the company at midday were up by nearly 7 percent to $3.29 a share.

Posted by David Schepp on Monday, July 28th, 2008 at 11:09 am |
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Business in the Burbs is our online news blog about businesses based or operating in the Lower Hudson Valley. Visitors here will also find items of interest to consumers in the region. Most contributions are from business reporters and editors covering Westchester, Rockland and Putnam counties.

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