Proteins and Peptides

30 May 2013

FDA Accepts Vimizim BLA and Grants Priority Review Designation

30 May 2013

Teva Announces FDA Acceptance of sNDA for a Higher Concentration Dose of COPAXONE Given Three Times a Week

29 May 2013

New Data on FORTEO® (teriparatide [rDNA origin] injection) Show Increased Bone Mineral Density in Men with Glucocorticoid-Induced Osteoporosis

29 May 2013

FDA Approves Broadly Inclusive Phase IIa ALS Clinical Trial with GM604, a Biotechnology Innovation

29 May 2013

Zealand and Helsinn announce Helsinn’s decision to advance the development of elsiglutide into Phase IIb for the prevention of chemotherapy-induced diarrhea

28 May 2013

FDA Grants Breakthrough Therapy Designation to Asfotase Alfa for Perinatal-, Infantile- and Juvenile-Onset Hypophosphatasia (HPP)

23 May 2013

Novo Nordisk reports 8% weight loss in phase 3a obesity trial with liraglutide 3 mg

23 May 2013

Promedior Presents Encouraging Results from Clinical Study of PRM-151 in Patients with Idiopathic Pulmonary Fibrosis

22 May 2013

Grifols study demonstrates higher dose of PROLASTIN-C increases levels of alpha1-PI to within normal range in patients with AAT deficiency

22 May 2013

Protalex Reports Positive Interim Review of Phase 1b Trial of PRTX-100 in Rheumatoid Arthritis by Independent Data Safety Monitoring Committee

21 May 2013

Oncopeptides Secures Venture Funding for Phase II Trial of Melflufen in Multiple Myeloma Patients

21 May 2013

Synergy Pharmaceuticals Presents Plecanatide Results From a Large Multicenter Clinical Study at Late-Breaking Abstract Session During Digestive Disease Week 2013

21 May 2013

Biogen Idec Submits Application to FDA for Approval of PLEGRIDY (Peginterferon Beta-1a) in Multiple Sclerosis

20 May 2013

Synageva’s Sebelipase Alfa Receives Breakthrough Therapy Designation for Early Onset LAL Deficiency from the U.S. Food and Drug Administration

20 May 2013

R-Tech Ueno: Start of the Patient Enrollment of a Phase I/II Clinical Study of Recombinant Human Serum Albumin-Containing Ophthalmic Solution (Development Code: RU-101) in US for the Treatment of Severe Dry Eye

17 May 2013

Oramed Receives FDA Clearance to Initiate Oral Insulin Trials in the U.S.

17 May 2013

Novo Nordisk reports positive results from first phase 3 trial with long-acting factor IX for treatment of haemophilia B

16 May 2013

Ultragenyx Advances Clinical Development of UX003 for the Treatment of Mucopolysaccharidosis Type 7 (MPS 7)

16 May 2013

Stem Cell Therapeutics Announces Completion of Dosing in Phase I Study of TTI-1612 in Patients With Interstitial Cystitis/Bladder Pain Syndrome

13 May 2013

FDA Accepts Biogen Idec’s Biologics License Application for First Long-Lasting Factor VIII Therapy for Hemophilia A

10 May 2013

Lexicon Advances LX4211 In Type 1 Diabetes Phase 2 Trial

10 May 2013

RECOTHROM Becomes the First and Only Topical Thrombin Indicated for Use in Children Greater Than or Equal to One Month of Age

9 May 2013

Synageva BioPharma(TM) Announces One Year of Treatment Data with Sebelipase Alfa in Late Onset LAL Deficiency

8 May 2013

Portola Announces Its Factor Xa Inhibitor Antidote PRT4445 Produces Rapid, Sustained and Dose-Related Reversal of the Anticoagulant Activity of Eliquis(R) in Phase 2 Study

7 May 2013

Aileron Therapeutics Successfully Completes First-Ever Stapled Peptide Clinical Trial

6 May 2013

Sub-Group Analysis Shows Investigational Metreleptin Treatment Demonstrated Reductions in HbA1c, Triglycerides and Liver Function Tests in Pediatric Patients with Lipodystrophy During a 12-Month Period

5 May 2013

Bayer Provides Update on Phase II/III Trial of BAY 86-6150

1 May 2013

Clinical Results for Oramed’s Oral Diabetes Treatment Published in Peer Reviewed Journal PLOS ONE

1 May 2013

DiaMedica Announces Initiation of Phase I/II Clinical Trial for Potential First-in-Class Treatment of Type 2 Diabetes

30 April 2013

Journal of Clinical Endocrinology & Metabolism Publishes Positive Versartis Phase I Data

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