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Atara Biotherapeutics Announces Second Quarter 2021 Financial Results and Operational Progress

Atara Biotherapeutics Announces Second Quarter 2021 Financial Results and Operational Progress
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CNM-Au8 Raises Brain Energy Metabolism of RRMS Patients in Trial

CNM-Au8 Raises Brain Energy Metabolism of RRMS Patients in Trial
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Investegate |NOVARTIS AG CHF0.50(REGD) Announcements | NOVARTIS AG CHF0.50(REGD): Novartis receives positive CHMP opinion for Kesimpta®* (ofatumumab), a self-administered treatment for adult patients with relapsing multiple sclerosis

(ofatumumab)
Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that provides the flexibility of self-administration for adults with RMS. It is an anti-CD20 monoclonal antibody (mAb) self-administered by a once-monthly injection, delivered subcutaneously
1,3. Initial doses of Kesimpta are given at Weeks 0, 1 and 2, with the first injection performed under the guidance of a healthcare professional. As shown in preclinical studies, Kesimpta is thought to work by binding to a distinct epitope on the CD20 molecule inducing potent B-cell lysis and depletion
8. The selective mechanism of action and subcutaneous administration of Kesimpta allows precise delivery to the lymph nodes, where B-cell depletion in MS is needed, and preclinical studies have shown that it may preserve the B-cells in the spleen ....

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Novartis receives positive CHMP opinion for Kesimpta®* (ofatumumab), a self-administered treatment for adult patients with relapsing multiple sclerosis

(ofatumumab)
Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that provides the flexibility of self-administration for adults with RMS. It is an anti-CD20 monoclonal antibody (mAb) self-administered by a once-monthly injection, delivered subcutaneously
1,3. Initial doses of Kesimpta are given at Weeks 0, 1 and 2, with the first injection performed under the guidance of a healthcare professional. As shown in preclinical studies, Kesimpta is thought to work by binding to a distinct epitope on the CD20 molecule inducing potent B-cell lysis and depletion
8. The selective mechanism of action and subcutaneous administration of Kesimpta allows precise delivery to the lymph nodes, where B-cell depletion in MS is needed, and preclinical studies have shown that it may preserve the B-cells in the spleen ....

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CHMP Issues Positive Opinion Recommending Ofatumumab in Relapsing Multiple Sclerosis

Press release content from Globe Newswire. The AP news staff was not involved in its creation.
CHMP Issues Positive Opinion Recommending Ofatumumab in Relapsing Multiple Sclerosis
Genmab A/SJanuary 29, 2021 GMT
Company Announcement
Novartis receives positive CHMP opinion for subcutaneous ofatumumab for adult patients with relapsing forms of multiple sclerosis
Opinion based on Phase 3 ASCLEPIOS I and II studies
Copenhagen, Denmark; January 28, 2021 – Genmab A/S (Nasdaq: GMAB) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization of subcutaneous ofatumumab for the treatment of relapsing forms of multiple sclerosis (RMS) in adults with active disease defined by clinical or imaging features. Novartis submitted the Marketing Authorization Application for ofatumumab in this indication in January 2020. Ofatumumab is bein ....

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