Proteins and Peptides

12 August 2016

Phase II results with dasiglucagon (ZP4207) support its potential for use in a ready-to-use rescue pen to treat severe hypoglycemia in diabetes

10 August 2016

Coherus BioSciences Submits 351(k) Biologics License Application to U.S. Food and Drug Administration for CHS-1701 (Pegfilgrastim Biosimilar Candidate)

10 August 2016

Cardiome Announces XYDALBA™ Single Dose Infusion Approval by European Medicines Agency

5 August 2016

Merck Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for MK-1293, an Investigational Follow-On Biologic Insulin Glargine

1 August 2016

Ipsen Announces FDA Approval of Dysport® (abobotulinumtoxinA) for Injection for the Treatment of Lower Limb Spasticity in Children Aged Two and Older

30 July 2016

First Patient Enrolled in Mallinckrodt Phase 3 Terlipressin Trial

28 July 2016

Sanofi Receives FDA Approval of AdlyxinTM for Treatment of Adults with Type 2 Diabetes

26 July 2016

CSL Behring Presents Phase III Data for IDELVION® for Hemophilia B at the World Federation of Hemophilia 2016 World Congress

26 July 2016

Eisai And Halozyme Initiate Phase 1b/2 Clinical Trial With First Patient Dosing Of Eribulin In Combination With PEGPH20

25 July 2016

Halozyme Resumes Patient Enrollment And Dosing In PEGPH20 Clinical Trial With KEYTRUDA

21 July 2016

Mylan and Biocon Announce Regulatory Submission for Proposed Biosimilar Pegfilgrastim Accepted for Review by European Medicines Agency

20 July 2016

Aeglea BioTherapeutics Provides Update on AEB1102 Clinical Program in Rare Diseases and Cancer

19 July 2016

Hansa Medical Initiates Pivotal Multicenter Study in the US with IdeS for Treatment of Refractory Highly Sensitized Kidney Patients

18 July 2016

U.S. FDA Approves CSL Behring’s Berinert® as the First and Only Pediatric Treatment for Hereditary Angioedema (HAE)

18 July 2016

Pharming Announces Positive Results from Randomized Controlled Trial with RUCONEST® for HAE Prophylaxis

15 July 2016

Ultragenyx Announces Positive Topline Data from Phase 3 Study of Recombinant Human Beta-Glucuronidase in Mucopolysaccharidosis Type 7

14 July 2016

Panther Biotechnology Announces the Initiation of Formal Development of Transferrin Doxorubicin Conjugate

14 July 2016

Alexion Presents New SBC-103 (rhNAGLU enzyme) Phase 1/2 Data on Brain MRI and Neurocognitive Assessments in Patients with Mucopolysaccharidosis IIIB (MPS IIIB)

11 July 2016

Coherus Announces Positive Topline Results for CHS-1701 (Pegfilgrastim Biosimilar Candidate) Pharmacokinetic and Pharmacodynamic Biosimilarity Study

7 July 2016

Akari Therapeutics Announces Positive Interim Update from Phase Ib Trial Demonstrating Sustained Complement Inhibition Using Once-Daily Subcutaneous Maintenance Dosing with Coversin

7 July 2016

Shire Receives Extension of Market Authorization in Europe for Revestive▼ (Teduglutide) for the Treatment of Paediatric Patients with Short Bowel Syndrome (SBS)

7 July 2016

Sanofi Genzyme Begins Pivotal Phase 2/3 Trial of Olipudase Alfa for Adult Patients with Acid Sphingomyelinase Deficiency

6 July 2016

Cinfa Biotech announces positive top-line clinical data of pegfilgrastim biosimilar candidate B12019

4 July 2016

European Commission Approves Extended Indication For Amgen’s Kyprolis® (Carfilzomib) For The Treatment Of Relapsed Multiple Myeloma Patients

30 June 2016

Shire Announces Top-Line Results for Phase 2 Trial of SHP607 in Extremely Premature Infants

29 June 2016

Aurinia Announces 24 Week Remission Rates from the First Seven Patients in its Open Label AURION Study in Lupus Nephritis (LN)

28 June 2016

Glide Technologies Announces Successful Clinical Proof-of-Concept Study with its Novel Octreotide Solid Dose Formulation Delivered via SDI

27 June 2016

Tarix Orphan Announces Positive Results with TXA127 in Animal Model of Dystrophic Epidermolysis Bullosa (DEB)

27 June 2016

Stealth BioTherapeutics Initiates Two Phase 2 Trials Evaluating Elamipretide for the Treatment of Heart Failure

23 June 2016

Apellis Announces Positive Results from Phase 1 Clinical Trials of APL-2, a C3 Complement Inhibitor

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