J&J completes three late-phase studies of Priligy
WILMINGTON, N.C. Drug maker Johnson & Johnson’s research division finished three phase 3 studies of a drug for treating premature ejaculation, contract research firm PPD confirmed Wednesday.
The studies, by J&J Pharmaceutical Research & Development, increased the number of patients in the clinical data set for the drug Priligy (dapoxetine) to more than 6,000. The company announced its intention to review the new dataset with the Food and Drug Administration.
PPD collaborated with ALZA Corp., an affiliate of J&J division Janssen-Cilag, to develop Priligy, which is approved in Finland, Sweden, Portugal, Austria, Germany, Italy and Spain, but was rejected by the FDA in 2005.
“Our hope is that these data will provide additional safety and efficacy information in support of the Priligy new drug application,” PPD CEO Fred Eshelman said. “We are pleased that our partner Janssen-Cilag continues to obtain clinical data for Priligy in pursuit of additional marketing approvals.”
Aurora Health Care to honor cancer survivors
MILWAUKEE With more people diagnosed with cancer every year but more of them surviving, a nonprofit healthcare system in eastern Wisconsin plans to honor cancer survivors.
Aurora Health Care, which runs the Aurora Pharmacy chain as well as a network of hospitals and clinics, announced Tuesday that it would mark National Cancer Survivors Day on Saturday with several events in three Wisconsin cities.
“There has been great progress in cancer prevention, early detection and treatment that has resulted in ever-increasing numbers of survivors,” Aurora Health Care VP cancer services Joseph Mirro said. “Now that more patients are being cured of their cancer and living longer, there’s a growing number of survivors with unique needs.”
Events will include a walk and run for cancer in Milwaukee, a gathering in Sheboygan and booths offering cancer screenings and information in Oshkosh.
FDA gives tentative approval to generic breast cancer treatment
ROCKVILLE, Md. The Food and Drug Administration has given tentative approval to a generic drug for treating breast cancer.
The drug, Roxane Labs’ letrozole tablets in the 2.5 mg strength, is a generic version of Novartis’ Femara.
Femara had global sales of $1.13 billion in 2008, according to Novartis financial data. Novartis’ patent on the drug will expire in 2011, according to the FDA’s Orange Book.
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Jan-22-2014 05:49 am