Bydureon reply submitted to FDA
INDIANAPOLIS — Drug makers Eli Lilly, Amylin Pharmaceuticals and Alkermes are giving their long-acting form of an injected drug for Type 2 diabetes another try at the Food and Drug Administration.
The three companies announced Thursday that they had submitted an official reply to the FDA, concerning the agency’s decision to not approve Bydureon (exenatide), an extended-release version of the drug Byetta. In October, the FDA delivered a complete response letter to the companies, meaning that it had completed review of the original regulatory application, but questions remained that precluded final approval.
The companies expect to receive a response from the FDA in the next two weeks, while review could take up to six months.
MinuteClinic enters clinical affiliation with Henry Ford Health System
WOONSOCKET, R.I., and DETROIT — Henry Ford Health System is working to increase its capacity to serve patients in metropolitan Detroit through a new collaborative effort with CVS Caremark’s MinuteClinic.
MinuteClinic has 10 walk-in clinics inside select CVS/pharmacy stores in Southeast Michigan and is exploring additional locations in the Detroit metropolitan area.
The new affiliation will connect Henry Ford physicians, as on-call medical directors, to the 10 Southeast Michigan locations of MinuteClinic. In addition, MinuteClinic and Henry Ford will collaborate on educating patients and helping them to manage chronic diseases. Henry Ford physicians will accept patients who need a level of care that is not provided at MinuteClinic.
"Henry Ford Health System has demonstrated an outstanding commitment to improving the health and well-being of a diverse community of patients, and shares MinuteClinic’s mission to make access to high-quality healthcare services more accessible for area citizens," said Andrew Sussman, president of MinuteClinic and SVP and associate chief medical officer for CVS Caremark. "Our team of nurse practitioners looks forward to collaborating with Henry Ford’s physicians to develop a clinical care network that meets the growing healthcare needs in the Detroit metro area."
MinuteClinic and Henry Ford will be developing a plan to provide clinical data integration to streamline communication for each person’s care. With patient permission, MinuteClinic will share medical histories and visit summaries with other Henry Ford locations in Southeast Michigan. And MinuteClinic will continue its standard practice of sending visit summaries to the patient’s primary care doctor, usually within 24 hours.
This affiliation will not create a financial relationship between MinuteClinic and HFHS. Medical directors will be paid for their services directly by MinuteClinic.
Lilly aims to educate consumers on how drug maker collaborates with physicians
INDIANAPOLIS — Eli Lilly has launched its physician payment registry, a website that enables visitors to search payments to individual U.S.-based physicians and the institutions or research organizations that receive payments on behalf of a physician.
The drug maker said that its website, which is in line with its corporate integrity agreement with the U.S. government, aims to show how the company works with U.S. physicians and compensates them for their services and how these collaborations benefit patient care.
How it works: Payments are reported in several categories, including research-related payments, educational programs and other services, such as commercial consulting. The registry also discloses noncash forms of value provided (e.g., business meals), as well as travel expenses paid by Lilly when a physician is performing services for the company. The company noted that 63% of payments reported on the registry are related to research, including clinical studies for investigational medicines.
"When healthcare professionals work together with the pharmaceutical industry, patients benefit from our combined expertise," Lilly’s U.S. medical division VP Jack Harris said. "Through these collaborations, we are able to develop innovative medicines, improve health education and better understand patients’ needs. Without our joint efforts, new medicines could never reach the millions of patients who need better treatment options for diseases, such as cancer, diabetes, depression and Alzheimer’s."
Click here to view the physician payment registry.