FDA has agreed to fast-track its regulatory review of Novartis’ capmatinib in a hard-to-treat form of lung cancer. Novartis said it has applied for capmatinib, developed in partnership with Incyte, to be marketed as a MET inhibitor for first line and previously treated patients with locally advanced or metastatic MET exon 14 skipping (METex14) mutated
Novartis is seeking approval from EU and US for use of experimental multiple sclerosis therapy, siponimod, to treat secondary progressive forms of MS. Secondary progressive multiple sclerosis (SPMS) is where the disease causes continuous worsening of neurological function over time, independent of relapses. Most people with relapsing remitting forms of MS will eventually go on
AstraZeneca’s durvalumab has been approved in Europe for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC). The decision enables doctors to prescribe the drug for adults with stage III NSCLC whose tumours express PD-L1 on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT). The
This month’s report specifically looks at the Regulatory Affairs sector and notes many interesting occurrences within the levels of vacancies available over the past 12 months and focuses on any noteworthy changes that has occurred.
FDA are conducting a priority review of MSD’s Keytruda, a treatment for adult and paediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This application is based on data from the Phase II KEYNOTE-017 trial, which showed an objective response rate of 56% at 14.9 months in patients taking the immunotherapy, including
European Medicines Agency has approved a label extension for UCB’s Cimzia allowing it to be used for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. The approval makes Cimzia, the first Fc-free, PEGylated anti-TNF treatment option for use in moderate-to-severe plaque psoriasis “and marks the entry of UCB into immuno-dermatology, where
A partnership between Greater Manchester and NICE that was created with the aim of improving the health of the local population has been extended for another three years. A Memorandum of Understanding has been agreed between NICE, Health Innovation Manchester and The University of Manchester outlining a shared commitment to boosting health through research, informing
Gilenya, which the FDA first approved in adults back in 2010, has had its approval expanded to treat relapsing multiple sclerosis (MS) in children and adolescents over the age of 10 years. This is the first FDA approval of a drug to treat MS in paediatric patients. “For the first time, we have an FDA-approved
The FDA have issued a complete response letter concerning Pfizer’s filing for a biosimilar version of Roche’s blockbuster cancer drug Herceptin. The FDA asked for more technical information, but Pfizer emphasised that it does not relate to safety or clinical data contained in the application. Although more information was not released, Pfizer said it is
Rigel Pharmaceuticals has obtained its first FDA approval, with a green light to market Tavalisse for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have failed to respond to previous treatment. Chronic ITP is a rare autoimmune disease where the immune system destroys platelets, which are necessary for normal blood
