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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 2022, based upon a complaint filed by a pharmaceutical company, CMS was asked to reevaluate the SSA section that establishes the J-code,” Soefje said.

FDA 65
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NICE recommends innovative breast cancer drug

European Pharmaceutical Review

An important advance in treating breast cancer The pharmaceutical company shared that its oral small molecule poly (ADP-ribose) polymerase (PARP) inhibitor is indicated in adults who have had an anthracycline or a taxane, or both, if suitable, and endocrine therapy in patients with hormone receptor (HR)-positive breast cancer, if suitable.

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NICE backs two new breast cancer drugs for NHS use

pharmaphorum

. “We’ll continue to demand more for people affected by breast cancer, working with the Government, NHS England, NICE and pharmaceutical companies to ensure new, clinically effective treatments reach patients as quickly as possible, at a fair price for the NHS,” she added.

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

Pharmaceutical Technology

Designated as BG01-2202, this latest trial will be an open-label, randomised, controlled clinical study of UTD1 versus chemotherapy drug docetaxel. A Phase III study to evaluate UTD1 versus docetaxel in patients that have failed chemotherapy with a platinum-containing regimen is also currently underway in China. ORR, 81.0%

FDA 52
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Revitalising in-hospital drug manufacturing

Hospital Pharmacy Europe

New responsibilities, new arenas The potential for in-hospital manufacturing is further developing due to the new responsibilities assigned to hospital pharmacy staff, such as centralised preparation of chemotherapies and drugs for clinical trials, extemporaneous production of radiopharmaceuticals and cellular therapies, to name but a few.