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
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Regulatory Professionals is one of the fastest growing global integrated regulatory outsourcing providers with a network of 20,000 pharmaceutical professionals globally. Working exclusively within the regulatory functions of Pharmaceutical, Biotechnology, Medical Device, Consumer health / OTC and Diagnostics industries.
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Clovis Oncology’s Rucaparib has been designated as a Breakthrough Therapy by the FDA in prostate cancer, paving the way for a faster review if clinical trials achieves favourable results. The FDA has said that phase 2 data suggest the drug could represent a new therapy option for men whose cancer has progressed despite chemotherapy, and
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