GSK Vaccines set to bring Shingrix, the latest shingles vaccination innovation, to market
LONDON — GlaxoSmithKline on Friday announced that the Food and Drug Administration has approved Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 50 years and older. Shingrix is a non-live, recombinant subunit vaccine given intramuscularly in two doses.
"Shingrix represents a significant scientific advancement in the field of vaccinology," stated Thomas Breuer, SVP and chief medical officer, GSK Vaccines. "The vaccine has shown over 90% efficacy across all age groups in the prevention of shingles, a painful and potentially serious disease that affects one in tnree people in the United States. The risk and severity of shingles increases with age as the immune system loses the ability to mount a strong and effective response to infection. Shingrix was developed specifically to overcome the age-related decline in immunity."
Following this approval from FDA, and pending a recommendation from ACIP, Shingrix will be available shortly.
On Oct. 13, Shingrix was approved in Canada for the prevention of shingles (herpes zoster) in people aged 50 years or older. Regulatory filings in the European Union, Australia and Japan are underway.
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.”