Specialty Pharmacy

PRINCETON, N.J. — Dr. Reddy’s Laboratories announced on Wednesday that it has received Food and Drug Administration approval to launch doxorubicin hydrochloride liposome injection, a therapeutic equivalent generic version of Janssen Products’ Doxil (doxorubicin hydrochloride liposome injection), for intravenous use, in the United States market.

The product is indicated to treat ovarian cancer.

Jackson, Miss.-based Transcript Pharmacy has enjoyed stellar growth for several years running, culminating the company being named to Inc. Magazine’s top growth lists five times. Drug Store News reached out Transcript Pharmacy president Cliff Osbon for an exclusive interview to learn more about the company and its impressive year-over-year growth. 

WASHINGTON — The Food and Drug Administration on Wednesday expanded the approved use of Vertex Pharmaceuticals’ Kalydeco (ivacaftor) for treating cystic fibrosis. According to the FDA, the approval triples the number of rare gene mutations that the drug can now treat, expanding the indication from the treatment of 10 mutations, to 33, adding it based its decision, in part, on the results of laboratory testing, which it used in conjunction with evidence from earlier human clinical trials.

LAKE ZURICH, Ill. — Fresenius Kabi announced on Tuesday the immediate availability in the United States of its first-to-market generic of Genzyme’s Clolar (clofarabine injection). Fresenius Kabi’s clofarabine injection is available as a single dose vial containing 20 mg per 20 mL clofarabine.

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.

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.”

JACKSON, Miss. — Transcript Pharmacy has been reaccredited for an additional three-year period by URAC, an independent, nonprofit healthcare accrediting organization that establishes quality standards for the health care industry. This second term of accreditation falls under URAC’s Specialty Pharmacy 3.0 standards.

 “This recognition demonstrates that the level of care and quality of services we offer bring significant benefits to the patients that we serve,” said Transcript Pharmacy president Cliff Osbon.

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.