Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 31 n°159

Posts Tagged ‘breast’

36th annual Miami Breast Cancer Conference

Posted by fidest press agency su sabato, 2 febbraio 2019

Physicians’ Education Resource® (PER®), a leading resource for continuing medical education (CME), announces Dr. Gregory Stock and Stephanie Seban as the keynote speakers for the 36th annual Miami Breast Cancer Conference®. This year’s keynote presentations will take place at the Fontainebleau in Miami Beach, Florida.
For 36 years, the Miami Breast Cancer Conference® has brought together surgical, medical and radiation oncologists, as well as geneticists, pathologists, radiologists and supportive-care specialists, to foster awareness of state-of-the-art treatments for all stages and subtypes of breast cancer, provide expert perspectives on areas of clinical uncertainty or controversy, and encourage attendees to engage in cross-team cooperation in their clinics. The four-day interactive conference will explore all aspects of treatment and management of breast cancer, including screening, molecular and genetic testing, detection, primary treatments and patient-support strategies. The conference will also feature a special patient communication workshop, specialized programming on issues related to young women with breast cancer and a discussion about physician burnout.

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Phase III for Orazol (TM)

Posted by fidest press agency su mercoledì, 17 novembre 2010

Dublin, Ireland, (Globe Newswire) — After recent consultation with the FDA in November 2010, Merrion is preparing for its Phase III study for Orazol™. If successful, the Phase III study will allow a new drug application for Orazol to be made under the FDA’s abbreviated approval procedure section 505(b)(2) using a single Phase III study. The study will compare Orazol against placebo as an adjuvant breast cancer treatment with a primary endpoint of Disease Free Survival of patients with breast cancer. If approved, this drug would provide a new treatment, which could improve prognosis, in combination with existing treatments, for early stage breast cancer patients. Merrion has been focused on an oral form of this drug (zoledronic acid) for the bone metastases indication. However this trial would expand Orazol’s potential by allowing Orazol to be used for early treatment of breast cancer in addition to bone metastases for late stage cancer patients. Zoledronic acid has been shown to improve Disease Free Survival in large-scale Phase III clinical studies, involving thousands of breast cancer patients.  Merrion has previously received scientific advice from the Committee for Medicinal Products for Human Use (CHMP) agreeing the approval pathway for Orazol in Europe for the existing bone metastases indication. Following a licensing agreement, Merrion would seek agreement from the CHMP to expand the use of Orazol to earlier stage breast cancer treatment.
Orazol, Merrion’s lead product, is a unique tablet formulation of zoledronic acid, made possible by Merrion’s proprietary GIPET® technology, and for which there are issued US Orazol patents to 2027. Orazol provides an ideal product profile to address the market needs, as a well-tolerated tablet formulation with weekly dosing. http://www.merrionpharma.com

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