PHARMACY

Reports: Dying woman’s plea prompts early release of cancer drug

BY Alaric DeArment

NEW YORK — An online plea for help from a mother dying of breast cancer prompted the manufacturer of an experimental drug to release it early, according to published reports.

In an article posted on its website, CNN told the story of 46-year-old Darlene Gant, a woman with stage-four breast cancer, as she wrote letters to be given to her 11-year-old son on his upcoming birthday, and at future events, such as his high school and college graduations and marriage.

Gant had made a YouTube video asking Roche subsidiary Genentech to release early the drug pertuzumab for compassionate use, a regulatory provision that allows a drug to be released early if no other treatment is available. The company had planned to release the drug in June, following its approval by the Food and Drug Administration, but Gant wasn’t expected to live that long. The FDA still expects to decide whether or not to approve the drug in June, and aside from the compassionate use release, it is not yet available to the public.

In response to the video and an effort by members of the public, Genentech released the drug early, and Gant took her first dose. She now expects to live a few months longer, CNN reported.


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Eisai appoints SVP, general counsel

BY Allison Cerra

WOODCLIFF LAKE, N.J. — Eisai announced that Allen Waxman has joined the company.

Waxman, who has worked at such companies as Kaye Schouler LLP and Pfizer, will serve as SVP and general counsel, where he will be responsible for leading the office of the general counsel and all legal matters for the company in the United States. Waxman also will be a member of the company’s executive committee and also will join others in providing leadership for a number of global legal matters for Eisai.

"We are very pleased to welcome Allen to Eisai," Eisai president and CEO Lonnel Coats said. "Allen’s expertise and leadership will help us continue driving sound, ethical and legally compliant business practices here at Eisai, contributing to our company’s human health care mission to help improve the lives of patients and their families."

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Merck wins patent infringement suits against Mylan

BY Alaric DeArment

WHITEHOUSE STATION, N.J. — Mylan will be barred from marketing a generic version of a Merck cardiovascular drug until the drug’s patent expires, under a court ruling announced Friday.

Merck said the U.S. District Court for the District of New Jersey ruled against Mylan in two patent infringement suits related to the drugs Zetia (ezetimibe) and Vytorin (ezetimibe and simvastatin). Specifically, the court ruled that a patent covering the drug, RE 42,461, is valid and enforceable and enjoined Mylan from launching until the patents expiration in April 2017.

Mylan had been seeking Food and Drug Administration approval for generic versions of Zetia and Vytorin, prompting Merck to file suit against it in December 2009 for Vytorin, and in June 2010 for Zetia.


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