|
Ischemia Albumin Blood (IMA) Test : USFDA Clearance To Market The Albumin Cobalt Binding (ACB) Test
ISCHEMIA Technologies Inc has received US Food and Drug Administration (FDA) clearance to market the Albumin Cobalt Binding (ACB) test for detection of Ischemia Modified Albumin (IMA). IMA is a serum biomarker that can be used as an aid to the early evaluation of acute coronary syndromes (ACS) prior to heart attack in patients presenting with chest pain suggestive of cardiac origin. The ACB test uses a small amount of blood drawn from a patient, which is then run on a chemistry instrument commonly available in hospital laboratories.
Chest pain is the second most common reason for visiting an emergency department (ED) in the US. The challenge for emergency physicians is to determine which patients have ACS, and which can be safely discharged home. Currently available test such as electrocardiography (ECG) and other biomarkers such as troponin are limited in their impact on making "rule-out" decisions in the ED. This decision process often takes from 8 to 24 hours, and costs Medicare and insurance companies thousands of dollars per visit.
"For several years, the clinical community has been looking for a reliable, inexpensive test to determine which chest pain patients can be sent home safely," explained Robert Jesse, associate professor of cardiology at the Medical College of Virginia, which was on of twenty research sites involved in clinical studies of IMA.
"Studies showed that IMA, when used in conjunction with ECG and troponin, correctly identified low-risk patients who could be discharged safely using test results from patient presentation, without the need for more extensive testing in the ED."
[Ref: Pharmabiz 06/03/2003]
Hospital Information Package : WIPRO Health Science To Review
WIPRO Health Science (WHS) is taking a re-look at its product business, reports Asha Rai in Bangalore. WHS has a hospital information package called HIRepS. This ERP software for hospital management was acquired by Wipro last year when it bought GE Medical Systems Information Technology, for a consideration of around $6m.
[Ref: Economic Times, 14/03/2003]
Spurious Drugs : Expert Panel Formed
The government on Wednesday said an expert committee had been set up under the chairmanship of RA Mashelkar to look into various issues related to drugs control administration to tackle the menace of spurious drugs. To curb the incidence of spurious drugs, Drug Controller General of India (DCGI) has also asked state drug controllers to take measures like setting up of separate intelligence-cum-legal machinery with police assistance, minister of state for health and family welfare, A Raja said.
[Ref: Economic Times]
Cardiac Operations: India Inc. Spends Rs. 2000 Crore annually
DON'T let your heart skip a beat! By a rough estimate, corporates and executives to-gather could be spending in the region of Rs 2,000 crore on heart surgeries every year. Half of the Total number of cardiac surgeries or interventions relate to the white collar segment.
"Executives most commonly suffer from stress, diabetes and high blood pressure. All these spark off heart diseases. Every year, the country sees around one lakh bypass surgeries and one lakh more angioplasties. This sector is worth about Rs 4,000 crore as an industry annually and 50% of this is flowing in from the corporate class," Dr Bimal Chhajer, cardiologist.
[Ref: Economic Times, 17/12/2002]
Roche to buy Swiss surgical co for $1.2bn
SWISS pharmaceuticals and diagnostics company Roche Holding said it agreed to buy Disetronic Holding, a Swiss maker of insulin pumps, in a deal valued at 1.6bn Swiss francs ($1.18bn or 1.09bn euros).
Roche said it plans to offer two non-voting Roche shares and 670 francs in cash for one Disetronic share, which it said represents a 55% premium to Disetronic's Friday closing price.
Roche said the proposed deal will make it a leader in integrated diabetes management. It added that staff overlap will be minimal.
The Disetronic's Infusion Systems division will become part of Roche Diagnostics Diabetes Care unit.
This division of Disetronic had sales of 178m francs in the first nine months of its '02-'03 business year.
Roche will not acquire the smaller of Disetronic's two divisions, Disetronic Injection systems, which had nine-month sales of 62m francs. This division will be sold to Disetronic founder and chairman Willy Michel, who is a major share-holder, and will continue to operate as an independent company. - Reuters
[Ref: Economic Times, 11/02/2003]
Pharmacopoeia Commission to be set
THE long-awaited Indian Pharmacopoeia Commission (IPC) is likely to come into being in April. The health ministry has moved a Cabinet note proposing setting up the IPC with an initial cost of Rs 15 crore, after vetting of the proposal by the Planning Commission, sources said.
The IPC would be semi-autonomous in character and based in New Delhi. The Commission is supposed to sustain itself after a few years, with revenues from sale of publications and pharmaceutical reference samples.
For the first seven to eight years, that is, up to the time IPC is able to fend for itself, government would give it the required funding support.
A few technical experts and financial advisors to the health ministry would from the commission's board.
"Ideally, there should be a new edition of the Pharmacopoeia every fifth year and an addendum every year. However, this is not possible with the current set-up. With setting up of the IP Commission, we hope Indian Pharmacopoeia would be in conformity with the guidelines of International Conference on Harmonisation," an IP committee member said.
Meanwhile, the IP Committee would publish the standard monographs for 20 odd products, as an addendum to the IP next week. This would include 11 anti-retroviral (anti-HIV/AIDS) active pharma ingredients and 7 anti-retroviral finished dosage forms.
"Leading HIV/AIDS drug manufactures like Ranbaxy, Cipla, Aurobindo Pharma were supportive in framing of the monographs, some of them providing their facilities sans any price to the committee," the IP committee member said.
India will be the first country to specify the pharmacopoeia norms for such a large number of anti-retroviral drugs, he said. The measure would significantly unburden generic AIDS drug exporters as the entry into export markets would be easier.
IP standards to be published soon include those for anti-retroviral APIs.
[Ref: Economic Times, 18/01/2003] |
