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Genzyme Transfers Operations
Genzyme Corp. has ended manufacturing operations at its Allston, Mass., plant for products sold in the United States, and the company has transferred the work to its Waterford, Ireland, plant and a contract manufacturer. The move comes several months after the company entered a consent decree with the Food and Drug Administration for quality violations in manufacturing some of its biggest products - imiglucerase (Cerezyme), agalsidase beta (Fabrazyme), and thyrotropin alfa (Thyrogen) - which the FDA had found to be contaminated with particles of rubber, fiber, and steel. Earlier last year, the company had to shut the Allston factory because of viral contamination. After the consent decree, Genzyme turned over to the government $175 million in unlawful profits from the sale of the products. “Genzyme is working closely with regulatory authorities globally to achieve this goal,” according to a company statement.
Court Upholds Cancer Suit
The Nevada Supreme Court upheld a $58 million award to three women, two of them now deceased, who claimed that Wyeth Pharmaceuticals' hormone replacement drugs – Premarin and Prempro – caused their breast cancer. “The evidence supported the jury's findings that Wyeth was negligent in failing to conduct appropriate studies on breast cancer and that it concealed material facts about its products' safety,” Justice Michael Cherry wrote in the court's opinion. The company had appealed a 2007 ruling, saying that the punitive damages award was excessive. Justice Cherry wrote that while the term “breast cancer” appeared 10 times in the Prempro labeling, “in many instances the term appeared in reassuring statements. …To the contrary, the evidence showed that before Prempro was marketed, there was scientific data that confirmed an increased risk in breast cancer with the prolonged use of estrogen plus progestin.” The case is one of thousands against Wyeth regarding the two drugs.
Texas Diabetes Rate Alarming
One in four (8 million) Texans will be diagnosed with diabetes by 2040 and that will constitute “a significant threat to the financial solvency of the Texas public and private health infrastructure,” according to a report by the nonprofit group Texas Health Institute. The diabetes rate has tripled in young adults in less than a decade, and the obesity rate in that group has doubled. The report also notes racial and ethnic disparities in diabetes rates, complications, and mortality, especially in people along the Texas-Mexico border. Novo Nordisk and Roche Diagnostics financed publication of the report.
Report: Send Technology Home
One solution to two major challenges facing health care systems worldwide could be the expansion of home health care technology, according to a report by the RAND Corporation. “The aging of the world's population and [the] fact that more diseases are treatable will create serious financial and manpower challenges for the world's health care systems,” Dr. Soeren Mattke, lead author and a senior scientist at RAND, said in a statement. It is possible to move technologies ranging from glucose meters to advanced telemedicine devices into homes, “where patients or family members can manage care,” said Dr. Mattke. He and his coauthors admitted in their report that barriers exist, such as insurance coverage, patients' readiness, and their compliance.
Genzyme Transfers Operations
Genzyme Corp. has ended manufacturing operations at its Allston, Mass., plant for products sold in the United States, and the company has transferred the work to its Waterford, Ireland, plant and a contract manufacturer. The move comes several months after the company entered a consent decree with the Food and Drug Administration for quality violations in manufacturing some of its biggest products - imiglucerase (Cerezyme), agalsidase beta (Fabrazyme), and thyrotropin alfa (Thyrogen) - which the FDA had found to be contaminated with particles of rubber, fiber, and steel. Earlier last year, the company had to shut the Allston factory because of viral contamination. After the consent decree, Genzyme turned over to the government $175 million in unlawful profits from the sale of the products. “Genzyme is working closely with regulatory authorities globally to achieve this goal,” according to a company statement.
Court Upholds Cancer Suit
The Nevada Supreme Court upheld a $58 million award to three women, two of them now deceased, who claimed that Wyeth Pharmaceuticals' hormone replacement drugs – Premarin and Prempro – caused their breast cancer. “The evidence supported the jury's findings that Wyeth was negligent in failing to conduct appropriate studies on breast cancer and that it concealed material facts about its products' safety,” Justice Michael Cherry wrote in the court's opinion. The company had appealed a 2007 ruling, saying that the punitive damages award was excessive. Justice Cherry wrote that while the term “breast cancer” appeared 10 times in the Prempro labeling, “in many instances the term appeared in reassuring statements. …To the contrary, the evidence showed that before Prempro was marketed, there was scientific data that confirmed an increased risk in breast cancer with the prolonged use of estrogen plus progestin.” The case is one of thousands against Wyeth regarding the two drugs.
Texas Diabetes Rate Alarming
One in four (8 million) Texans will be diagnosed with diabetes by 2040 and that will constitute “a significant threat to the financial solvency of the Texas public and private health infrastructure,” according to a report by the nonprofit group Texas Health Institute. The diabetes rate has tripled in young adults in less than a decade, and the obesity rate in that group has doubled. The report also notes racial and ethnic disparities in diabetes rates, complications, and mortality, especially in people along the Texas-Mexico border. Novo Nordisk and Roche Diagnostics financed publication of the report.
Report: Send Technology Home
One solution to two major challenges facing health care systems worldwide could be the expansion of home health care technology, according to a report by the RAND Corporation. “The aging of the world's population and [the] fact that more diseases are treatable will create serious financial and manpower challenges for the world's health care systems,” Dr. Soeren Mattke, lead author and a senior scientist at RAND, said in a statement. It is possible to move technologies ranging from glucose meters to advanced telemedicine devices into homes, “where patients or family members can manage care,” said Dr. Mattke. He and his coauthors admitted in their report that barriers exist, such as insurance coverage, patients' readiness, and their compliance.
Genzyme Transfers Operations
Genzyme Corp. has ended manufacturing operations at its Allston, Mass., plant for products sold in the United States, and the company has transferred the work to its Waterford, Ireland, plant and a contract manufacturer. The move comes several months after the company entered a consent decree with the Food and Drug Administration for quality violations in manufacturing some of its biggest products - imiglucerase (Cerezyme), agalsidase beta (Fabrazyme), and thyrotropin alfa (Thyrogen) - which the FDA had found to be contaminated with particles of rubber, fiber, and steel. Earlier last year, the company had to shut the Allston factory because of viral contamination. After the consent decree, Genzyme turned over to the government $175 million in unlawful profits from the sale of the products. “Genzyme is working closely with regulatory authorities globally to achieve this goal,” according to a company statement.
Court Upholds Cancer Suit
The Nevada Supreme Court upheld a $58 million award to three women, two of them now deceased, who claimed that Wyeth Pharmaceuticals' hormone replacement drugs – Premarin and Prempro – caused their breast cancer. “The evidence supported the jury's findings that Wyeth was negligent in failing to conduct appropriate studies on breast cancer and that it concealed material facts about its products' safety,” Justice Michael Cherry wrote in the court's opinion. The company had appealed a 2007 ruling, saying that the punitive damages award was excessive. Justice Cherry wrote that while the term “breast cancer” appeared 10 times in the Prempro labeling, “in many instances the term appeared in reassuring statements. …To the contrary, the evidence showed that before Prempro was marketed, there was scientific data that confirmed an increased risk in breast cancer with the prolonged use of estrogen plus progestin.” The case is one of thousands against Wyeth regarding the two drugs.
Texas Diabetes Rate Alarming
One in four (8 million) Texans will be diagnosed with diabetes by 2040 and that will constitute “a significant threat to the financial solvency of the Texas public and private health infrastructure,” according to a report by the nonprofit group Texas Health Institute. The diabetes rate has tripled in young adults in less than a decade, and the obesity rate in that group has doubled. The report also notes racial and ethnic disparities in diabetes rates, complications, and mortality, especially in people along the Texas-Mexico border. Novo Nordisk and Roche Diagnostics financed publication of the report.
Report: Send Technology Home
One solution to two major challenges facing health care systems worldwide could be the expansion of home health care technology, according to a report by the RAND Corporation. “The aging of the world's population and [the] fact that more diseases are treatable will create serious financial and manpower challenges for the world's health care systems,” Dr. Soeren Mattke, lead author and a senior scientist at RAND, said in a statement. It is possible to move technologies ranging from glucose meters to advanced telemedicine devices into homes, “where patients or family members can manage care,” said Dr. Mattke. He and his coauthors admitted in their report that barriers exist, such as insurance coverage, patients' readiness, and their compliance.