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NCPA Statement On House Democrats’ Bill On Health Care Reform
Posted by: admin in Pharmacy Drugs on July 23rd, 2009
U.S. House of Representatives Democrats today unveiled their bill for health care reform - the America’s Affordable Health Care Choice of 2009. In response, National Community Pharmacists Association (NCPA) Executive Vice President and CEO Bruce T. Roberts, RPh, issued the following statement:
“Community pharmacists play a critical role in the health care system. NCPA is committed to ensuring that any health reform legislation does two things: First, it should utilize medication therapy management and other pharmacist-delivered health care services to improve patient outcomes and reduce overall costs, such as from improper medication use. Second, and more importantly, Congress should assure that there is a viable community pharmacy infrastructure to deliver quality health care to millions of patients across America.
“This is a sweeping legislative proposal that requires additional, careful review. However, we are pleased that the bill begins to reform the system that will be used to pay pharmacies for generic medications dispensed to Medicaid patients. We need to work with the Congress and the states as this bill moves forward to assure that appropriate payment exists for pharmacists to dispense lower-cost generic medications. For Medicaid beneficiaries in underserved rural or urban areas, community pharmacies are often the sole health care provider.
“We also appreciate the inclusion of provisions that exempt community pharmacists who provide durable medical equipment, such as diabetes testing strips, from duplicative and onerous accreditation and surety bond requirements. This will allow for patients to continue accessing these valuable health care products.
“On these and other matters we will continue working with the House, Senate and White House to ensure that health care reform allows community pharmacies to remain a valuable cog in America’s health system. When that occurs patients will have better outcomes and cost saving can be found.”
Source
The National Community Pharmacists Association
Protalix Holds Pre-NDA Meeting With FDA For PrGCD For The Treatment Of Gaucher Disease
Posted by: admin in Pharmacy Drugs on July 23rd, 2009
Protalix BioTherapeutics, Inc. (NYSE-Amex:PLX), announced that the Company held a pre-NDA meeting with the U.S.
Noven Reports Positive Phase 2 Results For Mesafem™ Non-Hormonal Therapy For Vasomotor Symptoms
Posted by: admin in Pharmacy Drugs on July 23rd, 2009
Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) announced positive top-line results from its Phase 2 clinical study evaluating Mesafem™ (low-dose paroxetine mesylate) for the treatment of vasomotor symptoms (hot flashes) associated with menopause (”VMS”).
This was a multi-center, double-blind, randomized, placebo-controlled Phase 2 efficacy and safety study of Mesafem in the treatment of VMS. The eight-week study, sponsored by Noven, enrolled 102 patients (with 98 patients completing) at ten clinical locations in the U.S. Patients in the active arm of the study received a dose of Mesafem below 10mg once daily. The primary objective of the study was to assess the safety and efficacy of Mesafem for the treatment of VMS. The primary outcome measures were mean changes in frequency and severity of moderate-to-severe hot flashes from baseline to the fourth and eighth weeks of the study.
“Although designed and powered to detect an efficacy signal, we were very pleased to achieve statistical significance in several primary outcome measures, and to identify clear efficacy signals in the others,” said Joel S. Lippman, M.D., Noven’s Vice President - Clinical Development & Chief Medical Officer. “Safety and tolerability of Mesafem were similar to placebo, with no drug-related serious adverse events. In short, Mesafem appears to be efficacious and well-tolerated at the tested dose, and information from this study should permit us to develop and initiate a well-designed and cost-effective Phase 3 clinical program by year-end.”
Peter Brandt, Noven’s President & CEO, said: “Today’s Phase 2 results exceeded all our internal expectations from the standpoints of both efficacy and tolerability. With the data from this study, we plan to expedite Mesafem into Phase 3 development, and to advance our commercialization and partnering strategies, with the goal of making this new non-hormonal treatment option broadly available to women who suffer from VMS, but who are not candidates for, or who have concerns about, hormone therapy.”
Concurrent with this announcement, Noven issued a press release announcing that it had entered into a definitive merger agreement with Hisamitsu Pharmaceutical Co., Inc. That press release is available at http://www.noven.com.
Source
Noven Pharmaceuticals, Inc.