PHARMACY

Regeneron Pharmaceuticals, Geisinger Health System form partnership in major genetics initiative

BY Alaric DeArment

TARRYTOWN, N.Y. — A drug maker has started a program to find the genetic determinants of human disease and speed the discovery and development of new drugs. The program includes a five-year project that it said would be one of the largest of its kind in terms of the number of patients involved.

Regeneron Pharmaceuticals and Geisinger Health System, which serves about 3 million patients, have recruited more than 100,000 patient volunteers for the project, in which Geisinger will collect samples from them and Regeneron will perform sequencing and genotyping to generate genomic data. The goal of the project is to improve patient care and help drug discovery and development.

"Genetics has been at the core of our research efforts at Regeneron since its early days," Regeneron president and chief scientific officer George Yancopoulos said. "In fact, our first [Food and Drug Administration-approved] therapy treats a rare genetic disorder, and the target of one of our product candidates in late-stage development that acts to lower LDL cholesterol was identified using human genetics. With the tremendous recent advances in DNA sequencing, we believe that now is the time to increase our commitment to and invest in human genetics research."

Regeneron will use its research and functional biology capabilities to find associations between genes and disease, while Geisinger will collect samples using its MyCode repository and electronic medical records.

The collaboration between the two companies is part of a larger human genetics initiative through Regeneron’s subsidiary, the Regeneron Genetics Center, which also has partnerships in place with the National Institutes of Health’s National Human Genome Research Institute, and plans are in place to develop relationships with other academic, government and medical systems.

"Regeneron has always believed in the power of genetics to help shape our understanding of disease and to guide development of novel therapeutics," Yancopoulos said. "However, there have been major limitations that have prevented optimal utilization of human genetics at a large scale. We believe that we can now address these limitations and that now is the time to increase our investment in human genetics."

 

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PHARMACY

FDA cites Ranbaxy plant for possible violations

BY Alaric DeArment

GURGAON, India — The Food and Drug Administration has found possible violations of agency regulations at a manufacturing plant in India owned by drug maker Ranbaxy Labs, the company said Monday.

Ranbaxy said it received a Form 483 from the FDA, a statement issued to a company’s management after it has inspected a plant and found conditions that may violate the agency’s regulations, and that products produced therein could be hazardous to people who use them. The plant in question is in Toansa, in India’s Punjab region.

"Ranbaxy continues to improve its systems and processes and remains fully committed to upholding the highest standards that patients, prescribers, regulators and all other stakeholders expect from the Company," a statement from the drug maker read. "Ranbaxy stays firmly committed to its philosophy of ‘Quality and Patients First.’"

In September, the FDA barred importation of drugs from the company’s plant in Mohali, also in Punjab, through an import alert, meaning customs officials can seize drugs from the plant when they reach the U.S. border. The agency said the alert would remain in effect until Ranbaxy complied with the FDA’s current good manufacturing practices, or CGMP. Two other Ranbaxy plans in India, Paonta Sahib and Dewas, have been under import alerts since 2008.

 

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PHARMACY

Reports: Mich. governor signs bill allowing medical marijuana at pharmacies, conditional on federal approval

BY Alaric DeArment

NEW YORK — Gov. Rick Snyder of Michigan has signed into law a bill that will allow medical marijuana to be sold in pharmacies if the federal government legalizes it for that purpose, according to published reports.

As 2013 drew to an end, both houses of Michigan’s state legislature passed a bill that would allow pharmacies to sell medical marijuana, but only if the federal government allows it. Currently, the Drug Enforcement Administration classifies marijuana as a Schedule I controlled substance, meaning it is an illegal drug with no officially recognized medical purpose. Nevertheless, 21 states and the District of Columbia have laws allowing it for medical purposes, while Colorado and Washington have legalized it for recreational use as well.

Legalization of the federal level would address the precarious legal limbo in which legal medical marijuana dispensaries dwell. A New York Times report published Saturday examined one major issue that dispensaries face, which is how to handle money. The dispensaries are forced to store their money in cash on the premises and also do all their business in cash, as banks — even state-chartered ones — generally refuse to give them accounts for fear of being accused by the federal government of money laundering, thus making it difficult for the dispensaries to accept credit cards.

 

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