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Proteins and Peptides

28 Mar 2018 Mylan and Biocon Receive Approvals from the European Commission and TGA Australia for Semglee™, Biosimilar Insulin Glargine
28 Mar 2018 FDA approves inclusion of data on cardiovascular outcomes and severe hypoglycaemia in the Tresiba® label
26 Mar 2018 Eiger Announces First Patient Dosed in Phase 2 PREVENT Study of Exendin 9-39 in Patients Suffering from Post-Bariatric Hypoglycemia
26 Mar 2018 Protagonist Therapeutics Discontinues Phase 2b PROPEL Trial of PTG-100 for the Treatment of Ulcerative Colitis following Interim Analysis
26 Mar 2018 AMAG Pharmaceuticals Submits a New Drug Application to the U.S. Food and Drug Administration for Bremelanotide for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in Premenopausal Women
24 Mar 2018 OPKO Health Enrolls First Patient in Phase 2b Study of OPK88003 to Treat Type 2 Diabetes
24 Mar 2018 CSL Behring Announces First Patient Enrollment in Phase 3 Clinical Trial of CSL112 to Assess Reduction of Early Recurrent Cardiovascular Events in Heart Attack Survivors
22 Mar 2018 BioArctic Receives Regulatory Approval in Norway for a Clinical Study in Patients With Complete Spinal Cord Injury
21 Mar 2018 Zealand Pharma's first Phase 3 trial with dasiglucagon for treatment of severe hypoglycemia successfully meets its primary objective
19 Mar 2018 Semaglutide injection phase 2 data presented at ENDO demonstrated significant weight loss in adults with obesity
14 Mar 2018 FDA Accepts for Filing Supplemental Biologics License Application (sBLA) for Xeomin® (incobotulinumtoxinA) in Adult Patients with Sialorrhea
13 Mar 2018 Savara Initiates Phase 2a Clinical Study of Molgradex for the Treatment of NTM Lung Infection
13 Mar 2018 BioSpecifics Technologies Corp. Announces Presentation of Interim Data from Phase 1 Study of CCH for the Treatment of Uterine Fibroids at 65th Annual Scientific Meeting of the Society for Reproductive Investigation
12 Mar 2018 Anthera Pharmaceuticals Reports Top Line Data from the RESULT Phase 3 Clinical Study of Sollpura
10 Mar 2018 AM-Pharma Announces Phase II Study Results of recAP in Sepsis-Associated Acute Kidney Injury
06 Mar 2018 Lyric Completes Enrollment in Phase 2 PROMOTE Study of LP101 (Ulimorelin) in Enteral Feeding Intolerance
06 Mar 2018 Symic Bio Announces Results of Locally-Administered Therapeutic SB-030 in Preclinical Model of Vascular Intervention
06 Mar 2018 Shire launches MyPKFit for Advate® [antihemophilic factor (recombinant)] in the U.S.
06 Mar 2018 Proteon Therapeutics Completes Enrollment in PATENCY-2, Phase 3 Clinical Trial of Investigational Vonapanitase
03 Mar 2018 STADA: EMA started the evaluation of resubmitted marketing authorisation application for biosimilar pegfilgrastim
02 Mar 2018 European Authorities Approve JHL Biotech's Clinical Trial Application for Dornase Alfa Biosimilar to Affordably Manage Symptoms of Cystic Fibrosis
28 Feb 2018 U.S. FDA Accepts Shire's Biologics License Application for Calaspargase Pegol (Cal-PEG) for Acute Lymphoblastic Leukemia (ALL)
27 Feb 2018 Novo Nordisk files for regulatory approval of long-acting factor VIII (N8-GP) in the US and the EU for treatment of haemophilia A
25 Feb 2018 Kineret® (anakinra) Receives a Positive Opinion from CHMP for the Treatment of Still's Disease
22 Feb 2018 Ferring Pharmaceuticals and MSD Announce Completion of Largest Clinical Trial Ever Conducted in Postpartum Haemorrhage

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