Proteins and Peptides

08 Mar 2019 FDA Accepts Supplemental Biologics License Applications (sBLAs) for BOTOX® (onabotulinumtoxinA) for Pediatric Patients with Upper and Lower Limb Spasticity
07 Mar 2019 Baxter Announces U.S. FDA Approval and Launch of Ready-to-Use Cardiovascular Medicine Eptifibatide
06 Mar 2019 Zealand Pharma doses first patient in Phase 3 trial with dasiglucagon for the treatment of congenital hyperinsulinism
05 Mar 2019 I-Mab Biopharma Announces the Achievement of First Patient Dosing in Phase 1b/2a China Trial of TJ107 for Cancer and Chemotherapy-induced Lymphopenia
05 Mar 2019 Lilly to Introduce Lower-Priced Insulin
05 Mar 2019 Ascendis Pharma Announces Once-weekly TransCon™ Growth Hormone Demonstrated Superiority on Primary Endpoint Compared to a Daily Growth Hormone in Phase 3 heiGHt Trial for Pediatric Growth Hormone Deficiency
04 Mar 2019 Ozempic® superior in lowering blood sugar and weight vs placebo, both in combination with SGLT-2 inhibitors
02 Mar 2019 Hansa Biopharma Announces European Medicines Agency Accepts Marketing Authorization Application for IDEFIRIX™ (imlifidase)
02 Mar 2019 Novo Nordisk files for a label update for Fiasp® to the EMA and the FDA seeking approval for use in children and adolescents
02 Mar 2019 BioMarin Receives Positive CHMP Opinion in Europe for Palynziq® (pegvaliase Injection) for Treatment of Patients with Phenylketonuria (PKU) Aged 16 and Older
27 Feb 2019 Alkermes Initiates Clinical Study of ALKS 4230 Administered Subcutaneously in Patients With Advanced Solid Tumors
26 Feb 2019 U.S. FDA Grants Breakthrough Therapy Designation (“BTD”) to Amicus’ AT-GAA in Late Onset Pompe Disease
24 Feb 2019 PharmaEssentia and AOP Orphan Receive EU Approval of Besremi™ (Ropeginterferon Alfa-2b) for Treatment of Polycythemia Vera (PV) in EU
24 Feb 2019 Bexion Pharmaceuticals Announces the Opening of Phase I Part 3 First-in-Human Trial Using BXQ-350 for the Treatment of Cancer
24 Feb 2019 Phoenix Tissue Repair Doses First Patient in Phase 1/2 Clinical Trial of PTR-01 (BBP-589) for Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)
21 Feb 2019 Foresee Pharmaceuticals Announces Successful Topline Results from Phase 3 Registration Study of LMIS 25 mg in Prostate Cancer
21 Feb 2019 AzurRx BioPharma Announces First Patients Dosed in Phase II OPTION Clinical Trial
20 Feb 2019 Novo Nordisk receives US FDA approval of ESPEROCT® (turoctocog alfa pegol, N8-GP)
20 Feb 2019 Pfenex Announces FDA Acceptance of NDA for PF708
18 Feb 2019 Clinical Data Presented from PIVOT-02 Study of Bempegaldesleukin (NKTR-214) with Nivolumab in Metastatic Urothelial Carcinoma Patients at the 2019 ASCO Genitourinary Cancers Symposium
14 Feb 2019 DiaMedica Therapeutics Doses First Patient in Phase 1b Clinical Study of DM199 in Patients with Chronic Kidney Disease
13 Feb 2019 Clinigen to acquire US rights to Proleukin
13 Feb 2019 BioArctic's Product Candidate SC0806 for Treatment of Patients With Complete Spinal Cord Injury is now in Phase 2
12 Feb 2019 Ascendis Pharma Initiates Global Phase 2 Trial for TransCon PTH in Adult Subjects with Hypoparathyroidism
07 Feb 2019 Medicenna Presents Promising Clinical Data from Phase 2b Recurrent Glioblastoma Trial of MDNA55

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