Perrigo gets tentative FDA nod for Acanya generic
SILVER SPRING, Md. — Perrigo has received tentative approval from the Food and Drug Administration for its generic of Acanya (clindamycin phosphate, 1.2%, and benzoyl peroxide, 2.5%), the company announced Monday. Perrigo has previously settled litigation with Valeant Pharmaceuticals North America and Dow Pharmaceuticals concerning the product.
The drug is indicated to treat acne vulgaris in patients ages 12 years and older. It had U.S. sales of roughly $57 million for the 12 months ended July 2017, Perrigo said.
"The [research and development] team continues its efforts to achieve regulatory approvals for important new products,” Perrigo EVP and president Rx pharmaceuticals John Wesolowski said. This tentative approval reflects our continued dedication to developing extended topical products for patients."
Pharmacy joins expanded roster of TelaCare offerings
FISHERS, Ind. — Telemedicine company TelaCare is expanding the access of specialty care its users have access to — including pharmacists. The company on Friday announced the addition of pharmacists consultations, as well as consultations with dentists, optometrists, dietitians, sports medicine and alternative medicine professionals, to its offerings.
“Many Americans are without access to quality care today, and now for the first time ever, patients seeking virtual care will have even greater access and more care options thanks to this unique specialty offering from TelaCare," CEO Larry Jones said. “Primary care physicians, behavioral counseling and now pharmacists, dentists, optometrists, dietitians, sports medicine and alternative medicine professionals are further integrated into the TelaCare system, supporting our approach to patient-centered health care and enabling members to benefit from a closed-loop continuum of care.”
TelaCare’s solutions include a smartphone and tablet app, as well as kiosks and web apps for computers. The company said the expansion was a move that would increase engagement and make it easier for patients to access health care.
"Adding these additional telemedicine services to our patients at no additional charge helps us to build upon our goal of offering a broad suite of solutions to our employer and health plan partners, all with a common goal of providing consumers with better access to high quality care at a lower cost," Jones said.
FDA approves first biosimilar cancer treatment
SILVER SPRING, Md. — The Food and Drug Administration has approved the first biosimilar approved to treat cancer, Amgen’s Mvasi (bevacizumab-awwb), a biosimilar of Avastin.
“Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high, is an important way to help spur competition that can lower healthcare costs and increase access to important therapies,” FDA commissioner Dr. Scott Gottlieb said. “We’ll continue to work hard to ensure that biosimilar medications are brought to the market quickly, through a process that makes certain that these new medicines meet the FDA’s rigorous gold standard for safety and effectiveness.”
The drug is indicated to treat five types of cancer, including in combination with chemotherapy for non-squamous non-small cell lung cancer, in combination with chemotherapy for metastatic colorectal cancer, glioblastoma, metastatic renal cell carcinoma in combination with interferon alfa and in combination with chemotherapy for persistent, recurrent, or metastatic carcinoma of the cervix.
"The approval of Mvasi marks a significant milestone for healthcare practitioners and patients as the first anti-cancer biosimilar approved in the United States," Amgen EVP research and development Dr. Sean Harper said. "With decades of experience in oncology and biologics, Amgen continues to expand its biosimilar and oncology portfolios, and Mvasi has the potential to advance access to high-quality, targeted cancer therapy.”