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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 drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 45,800 people in 80 countries and markets its products in around 170 countries. Novo Nordisk s B shares are li
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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) has approved EMPAVELI™ (pegcetacoplan), the first and only targeted C3 therapy for treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH)
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 necrotizing myopathy (IMNM) did not show a meaningful effect of
zilucoplan for people living with IMNM. No unexpected safety findings and no relevant safety differences between
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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 aged 1 year and above, has been approved as a 100 units/ml solution for injection in vial and pre-filled pen presentations.
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- 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 investors are Swanbridge Capital and Van Herk Ventures, and the Company is further awarded a Health~Holland grant for a public-private-partnership with Erasmus Medical Center.