The Japan Pharmaceutical and Medical Devices Agency (PMDA) has approved Luxturna for the treatment of inherited retinal dystrophies (IRDs) caused by biallelic RPE65 mutations – Novartis

The Japan Pharmaceutical and Medical Devices Agency (PMDA) has approved Novartis’ Luxturna (voretigene neparvovec) for the treatment of inherited retinal dystrophies (IRDs) caused by biallelic RPE65 mutations. The company expects the gene therapy to be used in approximately 15 patients in Japan over five yearsIn the U.S., Luxturna was launched with a list price of $850,000, so Japan is anticipating […]

Novartis divests “front of eye” ophthalmology assets to Bausch + Lomb

Novartis announced that it has signed an agreement to divest ‘front of eye’ ophthalmology assets to Bausch + Lomb, a global eye health company, in a transaction valued up to $2.5 billion, including $1.75 billion in upfront cash, plus additional milestone payments. The deal includes Xiidra, the first approved prescription treatment for the signs and symptoms of dry eye disease, […]

European Commission approval for Cosentyx as first and only IL-17A inhibitor for hidradenitis suppurativa – Novartis

Novartis announced that the European Commission (EC) has approved Cosentyx (secukinumab) for use in adults with active moderate to severe hidradenitis suppurativa (HS) and an inadequate response to conventional systemic HS therapy. “With only one currently approved treatment option, I see HS patients with a tremendous need for alternatives that reduce the disabling physical symptoms of HS, improve the emotional […]

Kisqali significantly reduced the risk of recurrence by 25% across a broad population of patients with early breast cancer; clinically meaningful benefit was consistent .across subgroups – Novartis

Novartis presents positive primary endpoint data from the pivotal Phase III NATALEE trial at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting . Data showed that Kisqali (ribociclib) plus endocrine therapy (ET), compared to ET alone, lowered the risk of cancer recurrence by 25.2% in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative […]

NICE (UK) recommends Adakveo as a treatment for preventing recurrent sickle cell crises – Novartis

Novartis is pleased to announce that eligible patients in England and Wales will soon have routine access to Adakveo (crizanlizumab) under a Managed Access Agreement (MAA). The news comes as the National Institute for Health and Care Excellence (NICE), published the Final Appraisal Determination (FAD) recommending crizanlizumab as an option for preventing recurrent sickle cell crises (two or more vaso-occlusive […]

FDA approves Xolair prefilled syringe for self-injection across all indications – Genentech + Novartis

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