FDA approves new schizophrenia drug
SILVER SPRING, Md. The Food and Drug Administration has approved a new drug for treating schizophrenia, the agency said Thursday.
The FDA announced the approval of Latuda (lurasidone hydrochloride), made by Fort Lee, N.J.-based Sunovion Pharmaceuticals. The drug is approved to treat adults with the disease, a mental illness that causes hallucinations, delusions, paranoia and disordered thinking and behavior.
“Schizophrenia can be a devastating illness requiring lifelong treatment,” said Thomas Laughren, director of the FDA division of psychiatry products. “Some patients do not respond well to certain types of drug therapy, so it is important to have multiple treatment options available."
The drug includes a boxed warning, the highest-level warning that can appear on a drug label, to warn prescribers of the risk of death associated with off-label prescribing of the drug for behavioral problems in elderly people with dementia-related psychosis.
Cigna, Merck Helps band together to stop diabetes
BLOOMFIELD, Conn. An insurance company and a patient assistance program have joined forces to improve medication adherence outcomes of Type 2 diabetes patients.
Cigna and drug maker Merck’s Merck Helps program inked a two-part contract that provided discounts if Cigna customers with diabetes lowered their blood sugar levels, regardless of the medication they were taking, and also provided for additional discounts if people who were prescribed Merck’s drugs Januvia and Janumet took their medications according to their physicians’ instructions. Discounts will be shared in various ways with Cigna employer clients.
Medication adherence was 87% for people taking Januvia (sitagliptin) and Janumet (sitagliptin/metformin), Merck’s oral anti-diabetes medications. The medications are used in conjunction with diet and exercise to improve blood sugar control in adults with Type 2 diabetes, a condition that has reached epidemic proportions in the United States, the companies said.
"Merck is pleased to partner with Cigna on this program," said Sethu Reddy, VP medical affairs at Merck. "As the number of people with diabetes continues to increase in the United States and globally, achieving blood sugar control and increasing adherence to diabetes treatment regimens are important goals for patients with Type 2 diabetes and their doctors."
Added Jeffrey Kang, Cigna’s chief medical officer, "Because Cigna is able to coordinate data and resources within our company, we are better able to support the health needs of the whole person. By integrating medical and pharmacy programs, we can identify people who may need extra support early in the diagnosis and progression of their diabetes, which means customers can potentially stay healthier longer."
Study: Pharmaceutical supply chain could experience more vulnerability
NEW YORK Risks of counterfeiting, contamination and intellectual property theft could increase with the globalization of the pharmaceutical supply chain, according to a new report.
Axendia, an analysis firm focused on life sciences and health care, published a study co-sponsored by PricewaterhouseCoopers in which 50% of surveyed pharmaceutical and life sciences executives said they saw imported raw materials as the greatest vulnerability in the supply chain, with 61% saying contaminated and substandard materials would be the top threat in the next five years. As recently as a decade ago, executives considered counterfeiting and diversion small-scale threats, but a growing number consider them major concerns.
According to the report, such emerging economies as China, India, Mexico and Brazil increasingly are becoming attractive markets for drug companies, but the drive to lower costs also means more raw materials are being sourced and more drugs are being manufactured in them, even though outsourcing drug development to companies in other countries carries operational risks.
“With manufacturing, sourcing and the sale of medical products expected to increase dramatically in the emerging markets, the geographical expansion of the supply chain will make it more difficult to manage, as well the industry’s changing product mix,” PwC pharmaceutical and life sciences advisory services partner Wynn Bailey said. “In order to meet the demands of globalization, the pharmaceutical supply chain will need to become much more flexible, with different manufacturing routes and distribution channels for the different kinds of products.”