Remove Biosimilars Remove Chemotherapy Remove Dosage
article thumbnail

New Frontline BTK Inhibitor Strategy Gains FDA Approval in Untreated Mantle Cell Lymphoma

Pharmacy Times

Because of its aggressive nature, MCL is typically treated with combination chemotherapy at diagnosis. For this application, the FDA collaborated with the Australian Therapeutic Goods Administration, Health Canada, and Switzerland’s Swissmedic.

article thumbnail

The Value of a Medically Integrated Pharmacy to Maximize Cost Avoidance and Reduce Waste of Oral Oncolytic Medications

Pharmacy Times

Subscribe Now!

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

Additionally, ANDA submissions should extrapolate the RLD safety and effectiveness data for drugs with the same active ingredients, dosage forms, strengths, routes, and labeling. In the 505(j) ANDA approval pathway, on the other hand, submissions can be multisource generic drugs; however, this pathway requires bioequivalence to the RLD.

article thumbnail

Prevalence of Dosage Modifications and Impact on Response Milestone Among Patients With CML Treated With Imatinib Using RWD

Pharmacy Times

A group of experts will present an encore abstract titled " Prevalence of Dosage Modifications and Impact on Response Milestone Among Patients With CML Treated With Imatinib Using Real-World Data " at the 2025 Oncology Pharmacists Connect (OPC) meeting in Austin, Texas, from June 19 to 20.

Dosage 26
article thumbnail

Unicorns Don’t Exist: Rethinking the Generalist Model in Oncology Pharmacy

Pharmacy Times

For effective patient care, we need smart people to design workflows for operationalizing 505(b)(2) drugs, integrating the next biosimilar we have to stock, and managing the compounding of a new hazardous drug. We need people to coordinate and track prior authorizations, write persuasive appeal letters, and keep patients updated.

article thumbnail

FDA Approves Meloxicam Injection For Moderate-to-Severe Pain in Adults

Pharmacy Times

1 "[Meloxicam injection] demonstrates our commitment to improving patient care by providing an alternate dosage form for pain management," Ron Scarboro, chief executive officer at Azurity Pharmaceuticals, said in a press release. December 21, 2004. Subscribe Now!

article thumbnail

CAR T and Beyond: The Expanding Pipeline and Promise of Cell Therapies

Pharmacy Times

Trends Pharmacol Sci. 2024;45(5):406-418. doi:10.1016/j.tips.2024.03.004