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Society Welcomes ‘Yes’ Vote To Charter Changes
Posted by: admin in Pharmacy Drugs on July 26th, 2009
The Royal Pharmaceutical Society of Great Britain pledged to continue to build a
professional leadership body fit for the 21st century after members voted to accept the changes
to the Society’s Royal Charter in the Special Resolution Ballot.
The ballot was the highest turnout achieved in recent years, with 10,698 votes cast in total,
equating to a 22.3% voter turnout. Of those voting, 77.7% of members agreed to accept the
Charter changes.
President Steve Churton said “I’m delighted that members have shown overwhelming
confidence in the new body and made their commitment to the future of the profession.
“We now have the strong mandate from members for the changes we need to bring about.
Changes that members have asked for through the Clarke Inquiry, the Transitional Committee
and the Charter consultation process. We will be doing this with the continued engagement of
a wide range of professional groups within pharmacy and the active involvement of over 200
pioneers who have agreed to help us with the design of the new body’s products and services.
“The new body will see greater autonomy for the National Pharmacy Boards, which will be able
to influence and respond to devolved healthcare policy more effectively than at present, and
ensure close engagement with the needs and aspirations of the membership in England,
Scotland and Wales.
“It is anticipated that the Charter changes will be brought into force when the Society’s current
regulatory functions transfer to the new General Pharmaceutical Council (GPhC) in 2010.
“I urge as many pharmacists as possible to get involved in the process of building our new
leadership body and help shape the future of the profession. We have a unique opportunity to
create a vibrant and dynamic new organisation that will provide essential support for
pharmacists, become a badge of true professionalism and make a lasting difference to the
lives of pharmacists and their patients.”
Notes
Number of eligible voters: 48,115
Votes cast by post: 6,966
Votes cast online: 2,573
Votes cast by text: 564
Votes cast by telephone: 603
Total number of votes cast: 10,706
Turnout: 22.3%
Number of votes found to be invalid: 8
Total number of valid votes to be counted: 10,698
Result:
Number voting Yes: 8,309 (77.7% of the valid vote)
Number voting No: 2,389 (22.3% of the valid vote)
Total 10,698 (100% of the valid vote)
All data supplied by Electoral Reform Services
Next steps:
- The result will be presented to the next Society Council meeting on Wednesday 29th July.
- The changes will then be submitted to the Privy Council. The Privy Council determine their
own timetable, but it is hoped that approval for the changes will be given by the end of
2009.
- The Charter changes will come into being when regulation transfers to General
Pharmaceutical Council in April 2010.
Source
Royal Pharmaceutical Society of Great Britain
Poniard Pharmaceuticals Announces Positive Cardiac Safety Data From Picoplatin Phase 1 Trial Supporting NDA Filing
Posted by: admin in Pharmacy Drugs on July 26th, 2009
Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on innovative oncology therapies, announced results from a Phase 1 cardiac safety study of picoplatin, a new generation platinum-based chemotherapy agent and the Company’s lead product candidate. The Company worked collaboratively with the U.S. Food and Drug Administration (FDA) to design this study, which is required for new chemical entities.
This study evaluated the cardiac safety of picoplatin by determining its effect on the cardiac QT/QTc interval by using time-matched pharmacokinetics and electrocardiograms (ECGs). A total of 45 patients with advanced solid malignancies received 150 mg/m2 picoplatin. The trial was conducted at seven clinical sites in the United States. Results showed no clinical cardiac-related events. In addition, no evidence of a clinically relevant trend in any ECG parameter was demonstrated.
“With these new picoplatin safety data, we continue to make progress toward our goal of initiating the filing in 2009 of a New Drug Application for picoplatin as a second-line treatment for small cell lung cancer, with approval and commercialization targeted for 2010,” said Robert De Jager, M.D., chief medical officer of Poniard. “More than 1,100 cancer patients have received picoplatin in clinical studies to date. Additional safety and anticipated efficacy data from our ongoing Phase 3 SPEAR study will provide a strong database to support the NDA filing.”
The Company plans to present data from the Phase 1 cardiac safety trial at a medical conference later this year.
About Picoplatin
Picoplatin is a new generation platinum-based chemotherapy agent that is in clinical development for multiple cancer indications, treatment combinations and by two routes of administration. It is designed to overcome platinum resistance associated with chemotherapy in solid tumors. Study data to date suggest that picoplatin has an improved safety profile relative to existing platinum-based cancer therapies. Results to date suggest that hematologic events are common but manageable. Kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) are less frequent and less severe than is commonly observed with other platinum chemotherapy drugs.
Poniard is currently evaluating the efficacy and safety of picoplatin in small cell lung cancer in a pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial that is being conducted under a Special Protocol Assessment with the FDA. The Company reached its enrollment target in this international, multi-center, randomized, controlled trial in March 2009. Poniard is also evaluating picoplatin in a Phase 2 clinical trial in patients with colorectal cancer and in a Phase 2 clinical trial in patients with castration-resistant prostate cancer. Oral picoplatin has been evaluated in a Phase 1 clinical trial in solid tumors.
About Poniard Pharmaceuticals
Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative oncology products to impact the lives of people with cancer.
(C) 2009 Poniard Pharmaceuticals, Inc. All Rights Reserved.
Poniard and Poniard Pharmaceuticals are trademarks of Poniard Pharmaceuticals, Inc.
This release contains forward-looking statements, including statements regarding the Company’s business objectives and strategic goals, drug development plans, and the potential safety and efficacy of its products in development, and commercialization. The Company’s actual results may differ materially from those indicated in these forward-looking statements based on a number of factors, including risks and uncertainties associated with the Company’s research and development activities; the results of clinical testing; the receipt and timing of FDA and other required regulatory approvals; the market’s acceptance of the Company’s proposed products; the Company’s anticipated operating losses, need for future capital and ability to obtain future funding; competition from third parties; the Company’s ability to preserve and protect intellectual property rights; the Company’s dependence on third-party manufacturers and suppliers; the Company’s lack of sales and marketing experience; the Company’s ability to attract and retain key personnel; changes in technology, government regulation and general market conditions; and the risks and uncertainties described in the Company’s current and periodic reports filed with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2008 and its Quarterly Report on Form 10-Q for the period ended March 31, 2009. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update any forward-looking statement to reflect new information, events or circumstances after the date of this release or to reflect the occurrence of unanticipated events.
Source: Poniard Pharmaceuticals, Inc
Daily Potassium Citrate Wards Off Kidney Stones In Seizure Patients On High-fat Diet
Posted by: admin in Pharmacy Drugs on July 26th, 2009
Children on the high-fat ketogenic diet to control epileptic seizures can prevent the excruciatingly painful kidney stones that the diet can sometimes cause if they take a daily supplement of potassium citrate the day they start the diet, according to research from Johns Hopkins Children’s Center.
A report on the work is published in the August issue of Pediatrics.
“We can confidently say this is a safe and powerful way to prevent kidney stones, and it should become part of standard therapy in all ketogenic dieters, not just those who already show elevated urine calcium levels,” says senior investigator Eric Kossoff, M.D., a pediatric neurologist at Hopkins Children’s. “If you wait, it might be too late.”
The ketogenic diet, believed to work by initiating biochemical changes that eliminate seizure-triggering short circuits in the brain’s signaling system, is given to many children whose seizures do not respond to medications. But the diet, which consists of high-fat foods with very few carbohydrates, causes a buildup of calcium in the urine and the formation of kidney stones in about 6 percent of those on it.
Hopkins Children’s adopted the preventive treatment with potassium citrate two years ago, and doctors now believe this one major side effect of the diet is a thing of the past, allowing more children to remain on the diet for longer.
Potassium citrate taken twice daily, either as powder sprinkled on food or dissolved in water, is believed to inhibit stone formation.
In their study of 301 children treated for epilepsy with the ketogenic diet at Hopkins Children’s the researchers found that those who got potassium citrate twice daily were seven times less likely to develop kidney stones one of 106 (0.9 percent) developed a kidney stone compared to 13 out of 195 (6.7 percent) who were given potassium citrate only after testing positive for elevated levels of blood calcium. Most children received one 30-milliequivalent packet (about 1, 170 milligrams or 0.04 ounces) of potassium citrate twice daily.
Although rarely serious, kidney stones can cause significant pain, along with kidney and urinary tract infections, and may require surgery.
The research was funded in part by the NIH and the Carson Harris Foundation.
Source: Johns Hopkins Medicine