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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.

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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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Radiopharmaceuticals for prostate cancer to go nuclear with $6.3 bn in sales by 2030

Express Pharma

Radioligand therapies (RLTs) have received prominent attention from major pharmaceutical companies in treating prostate cancer. Pluvicto is indicated for metastatic CRPC (mCRPC) patients previously treated with ADT and taxane chemotherapy. billion by 2030, far outshining Xofigo.

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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%