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WASHINGTON —  Sangamo Therapeutics announced on Tuesday that the Food and Drug Administration has granted Fast Track designation to SB-525, the company's clinical stage cDNA gene therapy candidate for hemophilia A, which is being developed as part of an exclusive, global collaboration and license agreement with Pfizer.

The FDA's Fast Track designation is designed to facilitate the development and expedite the review of drugs and biologics to treat serious conditions and fill an unmet medical need.

WASHINGTON — National Association of Chain Drug Stores president and CEO Steven C. Anderson, participated in a listening session on Thursday following an invitation by Health and Human Services Secretary Tom Price.

WASHINGTON — An amendment to improve generic drug competition has been approved as part of the Food and Drug Reauthorization Act, U.S. Sen. Susan Collins (R-Maine) told The Associated Press.

Collins said the amendment was approved May 11 at a Senate Health, Education, Labor and Pensions Committee business meeting, adding the measure is part of an investigation into "aggressive price hikes" in prescription drugs, and it will improve generic drug competition to help make prices lower.

ALEXANDRIA, Va. – The National Community Pharmacists Association on Thursday urged Senate Republicans to keep a number of important prescription drug-related provisions as they consider House passage of H.R. 1628, the American Health Care Act.

“Prescription drug coverage is an essential health benefit,” stated Douglas Hoey, CEO NCPA. “Any meaningful drug coverage should include patient choice of pharmacy and access to face-to-face counseling with a community pharmacist they know and trust.”

WASHINGTON — EMD Serono, the biopharmaceutical business of Merck KGaA and Pfizer announced that the Food and Drug Administration has approved Bavencio (avelumab) Injection for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

WASHINGTON — By a vote of 57 to 42 (with one Senator not voting), the Senate on Tuesday confirmed the nomination of Scott Gottlieb, of Connecticut, to be commissioner of the Food and Drug Administration, Department of Health and Human Services

ST. LOUIS — Express Scripts on Monday launched Inside Rx, a new, partially owned subsidiary that applies Express Scripts' purchasing power to expand affordable access to brand and generic medications for patients in need. According to Express Scripts, Inside Rx has partnered with GoodRx to deliver average savings of 34% on prescription medications for the uninsured and those who experience high out-of-pocket costs for their prescription medications.

EAST HANOVER, N.J. — Novartis announced that the Food and Drug Administration has approved the Kisqali Femara Co-Pack (ribociclib tablets; letrozole tablets) for the treatment of hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in postmenopausal women. According to Novartis, the Kisqali Femara Co-Pack is the first, and only currently available, combination pack with two prescription products in advanced breast cancer.