Review Designation of Mogamulizumab’s Biologics License Application
While Zika virus causes devastating damage to the brains of developing fetuses, it one day may be an effective treatment for glioblastoma, a deadly form of brain cancer. New research from Washington University School of Medicine in St. Louis and the University of California San Diego School of Medicine shows that the virus kills brain cancer stem cells, the kind of cells most resistant to standard treatments.
Medeor Therapeutics announced it had closed on an oversubscribed Series B financing worth $57 million. The round was led by RA Capital Management. New investors included Sofinnova Ventures and 6 Dimensions Capital. They were joined by existing investors Vivo Capital and WuXi Healthcare Ventures.
New technologies, therapies and medicines are emerging; this includes regenerative medicine, more personalised treatments, as well as the development of nanomedicines. The Commission is committed to monitoring scientific progress and to constantly review Community legislation in the light of new developments so as to make safe, novel treatments available to patients as early as possible.
A study has found an unexpected new drug target for acute myeloid leukaemia (AML) that could open new avenues to develop effective treatments against this potentially lethal disease. Researchers from the Wellcome Trust Sanger Institute, the Gurdon Institute and their collaborators show that inhibiting the METTL3 gene destroys human and mouse AML cells without harming non-leukaemic blood cells.
Seasonal affective disorder (SAD) is a type of depression that comes and goes with the four seasons, typically manifesting during the cold autumn and winter months, when the days are shorter, darker, and chillier.
Janssen-Cilag International NV announced that the European Commission (EC) has approved TREMFYA® (guselkumab) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. Guselkumab is the first biologic that selectively blocks interleukin (IL)-23, a key driver of the immune inflammatory response in psoriasis.
Gilead Sciences, Inc. (NASDAQ: GILD) announced that the China Food and Drug Administration (CFDA) has approved Sovaldi® (sofosbuvir 400mg), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. Sovaldi was approved for the treatment of adults and adolescents (aged 12 to 18 years) infected with HCV genotype 1, 2, 3, 4, 5 or 6 as a component of a combination antiviral treatment regimen. Sovaldi is the first Gilead HCV medicine approved in China.
Roche’s Erivedge will indeed no longer be funded on the National Health Service(NHS) as a treatment for skin cancer after cost regulators issued final guidance ruling that it is not cost effective.
Allergan plc (NYSE: AGN) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for VRAYLAR™ (cariprazine) for the maintenance treatment of adults with schizophrenia. VRAYLAR is also approved in the U.S. in adults for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder.
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