Medical Tidbits,Today, the U.S. Food and Drug Administration finalized its efforts to streamline the process used by physicians to request expanded access, often called “compassionate use,” to investigational drugs and biologics

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Today, the U.S. Food and Drug Administration finalized its efforts to streamline the process used by physicians to request expanded access, often called “compassionate use,” to investigational drugs and biologics for their patients. As a physician, I understand the importance of being able to access investigational treatments for a patient when there are no other options to treat their serious disease or condition.

Access to investigational treatments requires the active cooperation of the FDA, industry, and health care professionals in order to be successful. But we know that navigating that process can be challenging and time consuming, and we are committed to reducing the procedural burdens on physicians and patients whenever possible. read more

What It’s Like to Be a Working Woman in Japan

Two years ago, I arrived in Japan from Australia with a stomach full of butterflies—and not just because it was a new job, a new country and a new culture for me. I was also four months pregnant. Given all the things I’d heard about Japan—including its legendary long working hours—I was worried about how I would be perceived. Would it be frowned upon that I took maternity leave? How long could I take off without upsetting my colleagues? – read more

ASTRAZENECA COMPLETES US LICENSING AGREEMENT WITH IRONWOOD PHARMACEUTICALS FOR LESINURAD

AstraZeneca today announced that it has completed the licensing agreement with Ironwood Pharmaceuticals for the exclusive US rights to Zurampic (lesinurad) and the fixed-dose combination of lesinurad and allopurinol. Zurampic is approved in the US, in combination with a xanthine oxidase inhibitor, for the treatment of hyperuricemia associated with uncontrolled gout. The fixed-dose combination will be submitted for regulatory review in the second half of 2016.

EISAI INC. ENTERS INTO COLLABORATION AGREEMENT TO CO-PROMOTE EISAI’S ANTICANCER AGENT LENVIMA® IN COMBINATION WITH EVEROLIMUS AS TREATMENT FOR ADVANCED RENAL CELL CARCINOMA IN THE UNITED STATES

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its U.S. subsidiary Eisai Inc. has entered into an agreement with Novartis Pharmaceuticals Corporation (Novartis), a U.S. affiliate of Novartis AG (Headquarters: Basel, Switzerland, CEO: Joseph Jimenez), to collaborate on commercial and medical affairs activities (including the provision of scientific evidence to healthcare professionals) for Eisai’s in-house developed novel anticancer agent Lenvima® (lenvatinib mesylate) and the anticancer agent everolimus in the United States. read more

MiNA Therapeutics Announces Initiation of Phase I Clinical Study of MTL-CEBPA in Patients with Liver Cancer | EON: Enhanced Online News

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