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Hits: 239 BAGSVAERD, Denmark I May 28, 2021 I Novo Nordisk today announced the resubmission of a label expansion application to the US Food and Drug Administration (FDA) for the existing marketing authorisation for Ozempic ®, a once-weekly glucagon-like peptide-1 (GLP-1) analogue, to introduce a new dose of 2.0 mg. The resubmission follows the Refusal to File letter received by the FDA on 22 March 2021. The standard review time by the FDA is 10 months. About Novo Nordisk Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to ...

Hits: 447 Treatment naïve Switching from C5 inhibitor Ultomiris® (ravulizumab) EMPAVELI was superior to Soliris for the change from baseline in hemoglobin level at Week 16 in the Phase 3 PEGASUS study 85% of patients treated with EMPAVELI were transfusion free compared to 15% on Soliris at Week 16; EMPAVELI met non-inferiority compared to Soliris on transfusion avoidance WALTHAM, MA, USA I May 14, 2021 I Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the U.S. Food and Drug Administration (FDA)...

Hits: 92 · No unexpected safety findings and no relevant safety differences between zilucoplan and placebo were identified · Phase 3 headline results for generalized myasthenia gravis (gMG) are unchanged expected in Q4 2021 BRUSSELS, Belgium I April 22, 2021 I Based on the initial results of a Phase 2 study investigating zilucoplan in immune-mediated necrotizing myopathy (IMNM), UCB today announced that UCB has decided to not move forward with its IMNM development program.  The phase 2 study with zilucoplan, a peptide inhibitor of complement component 5 (C5), in immune-mediated ne...

Hits: 1213 BENGALURU, India I February 12, 2021 I “This is to inform that Biocon Biologics Ltd., a subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), has announced that Kixelle, a biosimilar Insulin Aspart co-developed with Viatris Inc. (NASDAQ: VTRS), has received marketing authorization approval from the European Commission following the positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. Kixelle, a fast-acting insulin analog indicated for the treatment of diabetes mellitus in adults, adolescents and children ...

Hits: 1900 - Seed investment by Swanbridge Capital and Van Herk Ventures with support from Health~Holland ROTTERDAM, The Netherlands I February 8, 2021 I Pan Cancer T B.V., a biotech spin-off from the Erasmus Medical Center founded by Prof. Dr. Reno Debets (CSO) and Dr. Dora Hammerl (VP R&D), announces the closing of a seed investment and start of operations. Together with Katrien Reynders-Frederix (CEO), the team is committed to the discovery and development of novel TCR therapies against solid tumors such as triple negative breast cancer, bladder cancer, lung cancer, and glioma. Seed in...