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CVS Caremark Charity Classic golf tournament held in R.I.

BY Antoinette Alexander

WOONSOCKET, R.I. — The CVS Caremark Charity Classic kicked off June 23, bringing together 20 of the world’s top golfers who team up to help raise millions of dollars for area charities.

The event, held at the Rhode Island Country Club in Barrington, R.I., ran from June 23 to 25.


(CVS Caremark president and CEO Larry Merlo (center) with the LPGA’s Lexi Thompson and local news anchor at WPRI-TV, Patrick Little)

Tournament week began with the Pepsi Pro-Am on June 23, followed by the two-day tournament on June 24 and 25. Golfers headlining the Pro-Am event included tournament co-host Billy Andrade as well as main field pro Lexi Thompson. 

Since 1999, the CVS Caremark Charity Classic has driven more than $16 million to charities around the region, providing funding for a variety of programs serving children, families and people in transition throughout Southeastern New England.
 

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Drug for nephropathic cystinosis receives seven years’ exclusivity

BY Alaric DeArment

NOVATO, Calif. — The Food and Drug Administration has given special designation to a drug made by Raptor Pharmaceuticals for a rare metabolic disease.

Raptor said the FDA granted it orphan product exclusivity for Procysbi (cysteamine bitartrate) delayed-release capsules for managing nephropathic cystinosis in patients aged 6 and older. Nephropathic cystinosis is a rare, life-threatening lysosomal storage disorder that causes toxic accumulation of an amino acid called cystine in the body’s cells, tissues and organs, leading to progressive and irreversible tissue damage and organ failure. An estimated 500 patients in the United States have the disease.

"This decision was the outcome of a productive and cooperative process with the FDA," Raptor chief business officer Thomas Daley said. "We believe the issuance of orphan drug exclusivity highlights an appreciation that Procysbi is an important new therapeutic option for nephropathic cystinosis patients."

The drug was approved in April, and the exclusivity period lasts for seven years. Under normal circumstances, the FDA gives a pharmaceutical drug an exclusivity period of five years, meaning generic drug makers must wait until the exclusivity period has expired before they may file for approval of a generic version.

 

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Reports: Drug makers may get approval for generic eye drug without clinical trials

BY Alaric DeArment

NEW YORK — Drug makers may be allowed to seek approval for a generic version of an eye drug made by Allergan based on lab tests rather than clinical trials, according to published reports.

In a draft guidance released Friday, the FDA said that due to the efficacy profile of Allergan’s drug for dry eyes Restasis (cyclosporine) ophthalmic emulsion, it wouldn’t be effective for companies to conduct clinical trials to determine the efficacy of a generic version.

According to reports, Allergan expects Restasis to have sales of up to $890 million this year. The FDA approved Restasis in December 2002, and its patent will expire in May 2014, according to FDA records.

 

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