Novartis’ asciminib has outperformed Pfizer’s Bosulif in a phase 3 chronic myeloid leukemia (CML) study, moving it closer to winning approval of a candidate designed to address drug resistance and intolerance.
Five new medicines, including two with orphan designations, have been recommended for marketing approval by the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
Pfizer’s Bosulif has been approved in the US to treat patients with newly-diagnosed Ph+ chronic myelogenous leukemia.
Pfizer and Avillion have filed applications on both sides of the Atlantic seeking to expand the treatment scope of chronic myeloid leukaemia therapy Bosulif.
Cast in point, Roche’s Perjeta. Used in combo with Herceptin and chemo, the cancer-fighting cocktail didn’t fare well at the agency, at least at first. The drug won EU approval in 2013, but it was not until this month that it secured NICE’s backing to treat early-stage breast cancer.
The National Institute for Health and Care Excellence (NICE) said on Thursday its draft guidance now recommended the company's breast cancer drug Halaven. The move follows an undisclosed price reduction and updated clinical trial data.
In the first about-face since the National Institute for Health and Care Excellence began its overhaul of the overburdened Cancer Drugs Fund, England’s cost watchdogs are recommending Pfizer’s Bosulif, with a new discount, for patients who have few other options.
BCR-ABL Tyrosine Kinase Inhibitors - Risk of Hepatitis B Reactivation
On May 4, 2016, Health Canada issued a Safety Alert announcing the risk of Hepatitis B reactivation in chronic HBV carriers after they receive BCR-ABL Tyrosine Kinase Inhibitors, including Gleevec, manufactured by Novartis and several other generic companies, including Teva, Pharmascience, Apotex, and Actavis.
A top Pfizer ($PFE) executive joined the board of a National Health Service Trust in England, triggering questions about potential conflicts of interest, an NHS-focused news service reported on Wednesday.