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

Pharmacy Times

The Orange Book is the reference, and it allows the FDA to declare something [to be] therapeutically equivalent. The FDA Approval Process Within the FDA approval process, the 505(b)(1) new drug application (NDA) submission pathway is the pathway by which new drugs are able to seek approval.

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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

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Immunotherapy treatment enhances lymphoma survival, landmark study shows

European Pharmaceutical Review

While standard of care (chemotherapy in addition to radiation in certain cases) for the disease offers a cure rate of more than 80 percent, “the 20 percent who are not cured have a long road ahead,” stated Wilmot Cancer Institute Director and lead study investigator, Dr Jonathan Friedberg , MMSc, University of Rochester Medical Center, US. “The

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FDA approves Biostar’s Phase II/III plans with utidelone injectable for NSCLC

Pharmaceutical Technology

Synthetic biology biopharma Biostar Pharma announced is ready to advance its utidelone injectable (UTD1) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), following approval from the US Food and Drug Administration (FDA) for the study. as the secondary endpoints. ORR, 81.0% DCR (disease control rate), 4.37

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Low-Priced Oncology Disruptors: The Cuckoo in the PD-1/PD-L1 Nest or the Runt of the Clutch?

pharmaphorum

Indeed, in the US, the FDA has recently declined approval of Lilly’s sintilimab (Tyvyt), driven in part by a vote 14-1 against approval by the Oncologic Drugs Advisory Committee, owing to the availability of China-only data1. Single Technology Appraisal: Sugemalimab with chemotherapy for untreated metastatic non-small-cell lung cancer ID4001.

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Advancing microbiome innovation

European Pharmaceutical Review

The recent FDA approvals of two microbiome products in the US, in November 2022 and April 2023, 1-2 represent a significant milestone, maturing the industry and paving the way for advancement and regulatory clearance of additional microbiome products in broader indications. Internet] Pharmaceutical Technology. cited 2024Feb].

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2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients

ISPE

The first keynote speaker was Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US FDA. He presented on “Quality: A Key Ingredient for Stable Pharmaceutical Supply Chains.”. Director, Office of Pharmaceutical Quality. Tue, 11/01/2022 - 06:49.

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