FDA approves new Bydureon formulation, auto-injector
SILVER SPRING, Md. — The Food and Drug Administration has approved an auto-injector and new formulation of a once-weekly treatment for Type 2 diabetes from AstraZeneca. Bydureon BCise offers a single-dose auto-injector for adults with Type 2 diabetes whose blood sugar is uncontrolled on one or more oral medicines.
Bydureon BCise features a continuous-release delivery system that provides consistent levels of the product’s active ingredient, exenatide, to help patients maintain glycemic control, the company said. The new formulation in the Bydureon BCise device also has shown the ability to reduce blood sugar levels alongside weight loss, despite not being a weight loss medication.
“We know that physicians have established longstanding confidence in the significant HbA1c reduction Bydureon provides their patients to help achieve consistent control, with the added benefit of weight loss,” AstraZeneca US president and EVP North America Ruud Dobber said. “With the approval of Bydureon BCise, we’re now introducing a new formulation in an improved, easy-to-use device, that will help enhance the patient experience.”
The company plans to launch Bydureon BCise in the first quarter of 2018 while keeping the Bydureon pen available for patients.
Publix opens 3 pharmacies as part of 3-phase BayCare Health System partnership
LAKELAND, Fla. — Publix is laying the foundations of a three-part partnership with BayCare Health System with the opening of three pharmacies, each of which is located inside a BayCare hospital. Publix is set to open pharmacies at two more hospitals, which will mark 10 Publix pharmacies in BayCare facilities. Each pharmacy will offer prescriptions when patients are discharged, as well as access to specialty medications and refills at any Public pharmacy location.
“Opening BayCare in-hospital pharmacies is part of the exciting collaboration we announced in March,” Publix VP pharmacy operations Fred Ottolino said. “It isn’t just about filling prescriptions as patients leave the hospital; it’s about providing a continuum of convenient medical care. As our relationship grows, we hope to bring even more care options to both BayCare patients and Publix customers.”
The pharmacies are the first step in a three-pronged partnership between Public and Baycare. By 2018, Publix locations throughout Florida’s Pinellas, Pasco, Hillsborough and Polk counties will be outfitted with BayCare HealthHub kiosks that offer self-service biometric screenings for such information as blood pressure, pulse, weight and body mass index, offering patients the option of sending the results directly to their physicians.
“We are excited about this important step in providing seamless, connected care that improves health and care delivery,” BayCare EVP/COO Glenn Waters said. “Our care doesn’t end when a patient leaves a BayCare hospital and neither should our medication management for our patients. The Publix operation of on-site hospital retail pharmacies will facilitate the opportunity for continuity of medication management as patients are discharged from our hospitals.”
And in the next two years, Public locations in the four counties will house roughly 25 walk-in telehealth clinics for non-urgent medical care through a private room with teleconferencing and medical diagnostic equipment.
“Having an additional option for non-urgent medical care in Publix stores provides a quick and easy alternative for customers to seek treatment for non-urgent conditions,” Ottolino said. We are excited to partner with BayCare to provide this innovative offering as we continue to expand our pharmacy services.”
Imprimis to launch compounded Restasis alternative
SAN DIEGO — Opthalmology-focused company Imprimis Pharmaceuticals will be offering a compounded cyclosporine-based formulation to treat dry eye disease, the company announced Thursday. The products will be packaged in multi-use bottles and include Klarity Drops, a formulation developed by ophthalmologist Dr. Richard Lindstrom.
“We believe dry eye disease patients can benefit from unique customized medications that are not commercially available,” Imprimis CEO Mark Baum said. “While physicians who use compounded cyclosporine formulations have anecdotally known this for many years, there is now published data that demonstrates the clinical value of topical Cyclosporine formulations at concentrations greater than those currently available in commercially available medications. We are pleased to be able to offer affordable customized cyclosporine formulations that are designed for patients' individual needs.”
The company said the initial prescription will cost 99 cents for a one-month supply, with refills starting at $79 per month, including shipping.
“Imprimis has long championed issues of access, affordability and competition. While there are an estimated 30 million Americans suffering from dry eye disease, only a small fraction of these patients receive therapy,” Baum said. “We believe that affordability can affect access to needed medications, and it is our hope that our formulations will allow more patients to gain access to a high quality customized cyclosporine treatment option.”
On Tuesday, a Texas judge invalidated Allergan’s patent claims on Restasis — and in the wake of the ruling, Allergan has said it will work to protect its intellectual property.
“Allergan remains committed to vigorously defending the intellectual property of our products, which allows us to continue to invest in developing and bringing forward new medicines for millions of patients,“ Allergan chief legal officer Robert Bailey said Tuesday.