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Roche announced that the European Commission (EC) has granted marketing authorisation for OCREVUS® (ocrelizumab) for patients with active relapsing forms of multiple sclerosis defined by clinical or imaging features and for patients with early primary progressive multiple sclerosis in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity. Multiple sclerosis (MS) affects approximately 700,000 people in Europe, of which around 96,000 have the highly disabling primary progressive form.Most people with MS have a relapsing form (RMS) or primary progressive MS (PPMS) at diagnosis.
Novartis announced results from the head-to-head CLARITY study demonstrating the superiority of Cosentyx® (secukinumab) compared to Stelara®* (ustekinumab) in delivering clear and almost clear skin in adults with moderate-to-severe plaque psoriasis at 12 weeks. The study results show 66.5% and 72.3% of patients treated with Cosentyx (p < 0.0001) achieved both co-primary endpoints PASI 90 and IGA mod 2011 0/1, respectively, compared to 47.9% and 55.4% patients, respectively, treated with Stelara®* (p < 0.0001). At Week 12, patients receiving Cosentyx had significantly greater PASI 100 responses (key secondary objective) compared to those taking Stelara®* (38.1% vs. 20.1%, respectively; p < 0.0001). The study findings, which support previously presented data from the CLEAR study demonstrating the superiority of Cosentyx to Stelara®* in achieving sustained skin clearance (PASI 90 response rates) at 52 weeks, were presented as an abstract today at the Winter Clinical Dermatology Conference in Hawaii.
Sandoz, a Novartis division and the global leader in biosimilar medicines, announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA), submitted under the 351 (k) pathway, for proposed biosimilar adalimumab to the reference medicine, Humira®*.
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