Bristol-Myers Squibb, AstraZeneca diabetes drug hits speed bump at FDA
PRINCETON, N.J. — The Food and Drug Administration has declined to approve a drug for Type 2 diabetes made by Bristol-Myers Squibb and AstraZeneca, saying it needs additional clinical data, the companies said Thursday.
AstraZeneca and Bristol announced that they had received a complete response letter from the FDA for dapagliflozin. The agency said it would need more data to better weigh the drug’s benefits against its risks. The FDA issues a complete response letter when it has finished reviewing a regulatory approval application, but questions remain that preclude approval of the application in its present form.
The companies said they would work closely with the agency to determine the next steps and were also communicating with health authorities in other countries.
Gilead receives FDA approval for lower-dose HIV drug in children
FOSTER CITY, Calif. — The Food and Drug Administration has approved a lower-dose formulation of a drug made by Gilead Sciences for treating HIV in children, the company said.
Gilead announced the FDA approval of Viread (tenofovir disoproxil fumarate) in the 150-mg, 200-mg and 250-mg strengths combined with other antiretroviral drugs in patients ages 6 to 12 years while also approving an oral powder formulation for children ages 2 to 5 years. The agency approved the drug in the 300-mg strength for adults in 2001 and for patients ages 12 to 17 years in 2010.
"Prenatal HIV testing and antiretroviral interventions during pregnancy have contributed to a dramatic decline in the number of children born with HIV in the United States," Gilead EVP research and development and chief scientific officer Norbert Bischofberger said. "However, there remains an unmet need for heat-stable, taste-neutral pediatric formulations that do not require cold storage, particularly in resource-limited settings, where mother-to-child transmission remains a significant challenge."
Walgreens unveils newly renovated stores in Indianapolis
DEERFIELD, Ill. — Walgreens has transformed 68 locations in the Indianapolis market into health and daily living destinations.
The drug store chain hosted a ribbon-cutting ceremony Thursday at a store located on 16th and Meridian in Indianapolis. On hand at the ceremony were Walgreens president and CEO Greg Wasson, former Indianpolis Colts coach Tony Dungy and Sen. Richard Lugar, R-Ind.
The stores are part of Walgreens’ pilot program that launched last year in Chicago.
“Our new health and daily living stores help people live well, stay well and get well,” Wasson said. “At the core of this approach is our effort to bring the pharmacist out from behind the counter so they can provide more counseling to patients, offer clinical services and answer questions. By advancing the role of the community pharmacist in this way, we believe we can create better health outcomes, prevent hospitalizations and save money for patients, employers, insurers and the health care system.”
The stores now tout the following innovations:
A pharmacist located in front of the pharmacy to offer greater opportunity for patient interaction/consultation and such healthcare services as vaccinations and health testing;
Health Guides: Walgreens staff members who are armed with an iPad and are available to answer product and service questions, help customers navigate the store and their healthcare options and sign up for events. Select stores also have a Health Corner space to host individual or group health and wellness community events;
Fresh food, including fruits and vegetables, meats, prepared salads, sandwiches, wraps, take-and-bake pizzas and other on-the-go meal options; and
An enhanced beauty department display, including one store with a Look Boutique featuring dozens of prestige and niche cosmetic, skin care and hair care brands.
In line with the store openings, Walgreens also announced that it has added six Take Care Clinics in Indianapolis, bringing the total number of Take Care Clinics to 14 in the area. The company noted that board-certified family nurse practitioners and physician assistants at Take Care Clinics treat patients ages 18 months and older for common illnesses, offer preventive services such as vaccines and physicals and are licensed to write prescriptions, when necessary, that can be filled at the patient’s pharmacy of choice.
Earlier this month, Walgreens opened its Chicago flagship store, which included a variety of premium offerings.