Proteins and Peptides

31 Aug 2017 Bayer submits Biologics License Application in the U.S. for BAY94-9027 – a long-acting factor VIII for the treatment of Hemophilia A
30 Aug 2017 FDA Accepts BioMarin's Pegvaliase Biologics License Application (BLA) and Grants Priority Review Designation
29 Aug 2017 Victoza® reduces the risk of major cardiovascular events in people with type 2 diabetes with or without prior events
26 Aug 2017 Victoza® approved in the US as the only type 2 diabetes treatment indicated to reduce the risk of major adverse cardiovascular events
24 Aug 2017 Enteris BioPharma Doses First Woman in Phase 2a Clinical Trial of Ovarest™ (oral leuprolide tablet) for Endometriosis
24 Aug 2017 Apellis Pharmaceuticals Announces that APL-2 Met its Primary Endpoint in a Phase 2 Study in Patients with Geographic Atrophy, an Advanced Form of Age-Related Macular Degeneration
23 Aug 2017 Bonti Announces Start of LANTERN-1 Phase 2 Clinical Study Evaluating EB-001 in Reducing Musculoskeletal Pain
23 Aug 2017 Unum Therapeutics Announces Active Investigational New Drug (IND) Application for ACTR087 in Combination with SEA-BCMA in Patients with Relapsed/Refractory Multiple Myeloma
23 Aug 2017 Publication of Clinical Data Demonstrating Low Immunogenicity and Excellent Efficacy of Nuwiq® in Previously Untreated Patients
22 Aug 2017 Phase 1 trials for two novel treatments of obesity and/or diabetes initiated by Zealand partner Boehringer Ingelheim
21 Aug 2017 BioLineRx Announces Regulatory Submission of Phase 3 Registrational Study for BL-8040 in Stem Cell Mobilization
17 Aug 2017 Semaglutide superior to dulaglutide on glucose control and weight loss in people with type 2 diabetes in SUSTAIN 7
15 Aug 2017 U.S. FDA Removes Clinical Hold on CEL-SCI’s Phase 3 Head & Neck Cancer Trial
10 Aug 2017 Bonti Announces Topline Results of EB-001 Phase 2A Clinical Study in Glabellar Lines
10 Aug 2017 Allegro Ophthalmics Announces Positive Topline Results from DEL MAR Phase 2b Stage 2 Trial Evaluating Luminate® in Patients with Diabetic Macular Edema
04 Aug 2017 Portola Pharmaceuticals Announces Resubmission of Biologics License Application for AndexXa® (Andexanet Alfa)
02 Aug 2017 Bolder BioTechnology Announces Initiation of Phase 1 Clinical Trial of BBT-015 for Treating Neutropenia and Acute Radiation Syndrome
01 Aug 2017 Spectrum Pharmaceuticals Announces Completion of Enrollment in the Phase 3 Pivotal Study (ADVANCE) of ROLONTIS™ (eflapegrastim), a Novel Long-Acting GCSF
27 Jul 2017 Novo Nordisk A/S: Victoza® has been approved in the EU as the only GLP-1 with a label to include prevention of cardiovascular events
24 Jul 2017 Eiger Completes Enrollment in Phase 2 LIMT HDV Study of Pegylated Interferon Lambda in Hepatitis Delta Virus Infection
24 Jul 2017 Stealth BioTherapeutics Initiates Phase 2/3 Study of Elamipretide in Patients With Barth Syndrome
22 Jul 2017 Advanced Accelerator Applications Announces Positive CHMP Opinion Recommending Approval of Lutetium 177Lu Oxodotreotide (Lutathera®) for Gastroenteropancreatic Neuroendocrine (GEP-NET) Tumors
21 Jul 2017 Cenegermin Eye Drops Receive European Union Approval: The First Biotechnological Drug Resulting from Dompé Research for the Treatment of Moderate to Severe Neurotrophic Keratitis is Made in Italy
20 Jul 2017 Merck Announces U.S. FDA Grants Tentative Approval for LUSDUNA™ Nexvue™ (insulin glargine injection), a Follow-On Biologic Basal Insulin
20 Jul 2017 Ra Pharmaceuticals Announces Publication of Positive Preclinical Data with RA101295 for the Treatment of Escherichia Coli Sepsis

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