PHARMACY

Novartis’ Afinitor approved as advanced pancreatic NET treatment

BY Alaric DeArment

EAST HANOVER, N.J. — The Food and Drug Administration has approved a drug made by Novartis as the first treatment for advanced pancreatic neuroendocrine tumors, Novartis said Thursday.

Novartis announced the approval of Afinitor (everolimus), saying it marked the first approval of a drug for advanced pancreatic NET in nearly 30 years. The drug already is approved for treating cancers of the kidneys and brain.

“The FDA approval of Afinitor represents an important step forward for patients with advanced pancreatic NET,” medicine professor James Yao of the University of Texas M.D. Anderson Cancer Center in Houston said on behalf of Novartis. “Patients will now have access to a treatment that has been shown to significantly delay tumor growth and reduce the risk of disease progression.”

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Lilly invests $2.5 million into Grow What Works campaign

BY Allison Cerra

INDIANAPOLIS — Eli Lilly announced its largest-ever education-focused grant.

The drug maker has teamed up with nonprofit group The Mind Trust to launch the Grow What Works campaign, which seeks to raise and invest $18 million in the highest-impact education organizations working in Indianapolis. Lilly invested $2.5 million for the cause.

Since its founding in 2006, The Mind Trust has been strategically building a network of the nation’s best education reform organizations in Indianapolis, Lilly said.

"We believe that providing access to an excellent education for all of our children is the key to our city’s future," Lilly chairman, president and CEO John Lechleiter said. "Lilly has been impressed with the work of The Mind Trust. It has amassed an impressive record of making strategic investments and has become a recognized model for leading education reform. We’re honored to invest in the Grow What Works campaign, and we encourage other organizations to do the same. The Mind Trust is uniquely positioned to be an effective catalyst for education reform in Indianapolis."

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Pfizer: Pristiq reduces hot flashes among postmenopausal women

BY Allison Cerra

WASHINGTON — A major depressive disorder treatment made by Pfizer significantly reduced the number and severity of moderate-to-severe hot flashes in postmenopausal women, compared with placebo, according to a new study.

The efficacy sub-study of 365 patients, conducted over a 12-week period, was part of a year-long, double-blind, placebo-controlled safety trial conducted in the United States and Canada for Pristiq (desvenlafaxine). Patients enrolled in the efficacy sub-study were required to have at least seven bothersome moderate-to-severe hot flashes per day, or 50 bothersome moderate-to-severe hot flashes per week at baseline.

Researchers found that by the fourth week, women treated with Pristiq experienced a 55% reduction in hot flash frequency (average decrease of 6.5 hot flashes per day from a baseline mean of approximately 12 hot flashes per day), compared with a 31% reduction in hot flash frequency (average decrease of 3.6 hot flashes per day from a baseline mean of approximately 12 hot flashes per day) in the placebo group.

At week 12, women in the Pristiq-treated group experienced a 62% reduction in hot flash frequency (average decrease of 7.3 hot flashes per day from a baseline mean of approximately 12 hot flashes per day), compared with a 38% reduction in hot flash frequency (average decrease of 4.5 hot flashes per day from a baseline mean of approximately 12 hot flashes per day) in the placebo group.

The data were presented at the 59th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in Washington, D.C.

Pristiq currently is under review by the Food and Drug Administration to expand its use as a treatment for moderate-to-severe vasomotor symptoms (i.e., hot flashes and night sweats) associated with menopause, Pfizer said.

“Pfizer is committed to women’s health and understands the impact that hot flashes and night sweats related to menopause can have on a woman’s life, and the importance of having options to treat menopausal symptoms,” said Steven Romano, Pfizer SVP and head of medicines development group for the primary care business unit. “If approved by the FDA for this indication, Pristiq will expand the range of effective treatment options available to help manage VMS in the United States.”

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