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Novo Nordisk resubmits once-weekly semaglutide 2.0 mg for the treatment of type 2 diabetes for US regulatory approval | Proteins and Peptides

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...
I Novo Nordisk Drug Administration Novo Nordisk Denmarki May Therapeutic Protein Binding Proteins

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Apellis Announces U.S. Food and Drug Administration (FDA) Approval of EMPAVELI™ (pegcetacoplan) for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH) | Proteins and Peptides

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 an...
United States Cedric Francois Drug Administration Advisory Committee On Immunization Practices I Apellis Pharmaceuticals Inc Apellis Pharmaceuticals

UCB's zilucoplan shows no relevant effect in immune-mediated necrotizing myopathy (IMNM) | Proteins and Peptides

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...
Bruxelles Capitale Seanm Healey Iris Loew Friedrich Belgiumi April Chief Medical Officer Half Year Results

Sirnaomics' Spin-Off RNAimmune Secures $10 Million Seed Financing to Advance its mRNA-Based Vaccine and Therapeutic Development | Vaccines

Hits: 137 GAITHERSBURG, MD, USA and GUANGZHOU, China I April 21, 2021 I RNAimmune, Inc., a biopharmaceutical company specializing in discovery and development of mRNA-based therapeutics and vaccines, announced today execution of definitive agreements for a seed round financing of $10 million. RNAimmune is a spin-off entity from Sirnaomics, a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer and fibrotic diseases. Smooth River and Hong Kon...
United States Hong Kong Hongrun Los Angeles Patrick Lu University Of California Rnaimmune Inc

Global Peptide Drug Conjugate Market Opportunity 2026 US Europe Japan South Korea Sales Forecast 2026

Global Peptide Drug Conjugate Market and Clinical Trials Insight 2026 Report Highlights: First FDA Approved Peptide Drug Conjugate: Pepaxto (Melphalan Flufenamide) Pepaxto Clinical and Commercial Insight: Dosage, Patent, Price, Sales Forecast Peptide Drug Conjugate Sales Opportunity: US, Europe, Japan and South Korea Global Peptide Drug Conjugate Clinical Pipeline: > 20 Drugs Clinical Trials Insight by Company, Country, Indication Patent Insight of Peptide Drug Conjugates Profile and Clinical P...
South Korea Pepaxto Melphalan Flufenamide Peptide Drug Conjugate Market Clinical Trials Insight Peptide Drug Conjugate Melphalan Flufenamide

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