Proteins and Peptides

11 June 2018

FDA Approves Addition Of Positive Overall Survival Data From Phase 3 ASPIRE Trial To KYPROLIS® (carfilzomib) Label

11 June 2018

OPKO Health Completes Enrollment in Phase 2b Study of OPK88003 to Treat Type 2 Diabetes and Obesity

11 June 2018

AOP Orphan Announces Progress of its European Marketing Authorization Procedure of Ropeginterferon alfa-2b

8 June 2018

Zealand Pharma achieves milestone in first Phase 3 trial with dasiglucagon for the treatment of severe hypoglycemia in diabetes

6 June 2018

Partner Therapeutics (PTx) Announces US FDA Approval of Leukine® (sargramostim) for the Treatment of Acute Radiation Syndrome

5 June 2018

U.S. FDA Approves Mylan and Biocon’s Fulphila™ (pegfilgrastim-jmdb), the First Biosimilar to Neulasta®

4 June 2018

Tarveda Therapeutics Announces Results from Phase 1 Study of PEN-221 Presented at the 2018 American Society for Clinical Oncology (ASCO) Annual Meeting

3 June 2018

Polaris Group Presents Results for Phase 1 Clinical Study with its Lead Therapeutic Candidate ADI-PEG 20 Plus FOLFOX in Hepatocellular Carcinoma

1 June 2018

MYALEPTA® (metreleptin) Receives Positive CHMP Opinion in Patients with Generalized and Partial Lipodystrophy

31 May 2018

Polaris Group Announces Treatment of First Patient in a Phase 2 Study of ADI-PEG 20 Plus Gemcitabine and Docetaxel for Soft Tissue Sarcoma

31 May 2018

Oral semaglutide shows superior improvement in HbA1c vs empagliflozin in the PIONEER 2 trial

29 May 2018

Atox Bio Announces Enrollment of First Patient in Phase 2 Study of Acute Kidney Injury (AKI)

28 May 2018

Octapharma Share Promising Preclinical Data for SubQ-8, a Novel Subcutaneous Recombinant FVIII, at WFH 2018

28 May 2018

Zealand Pharma reports completion of the second and pivotal Phase 3 trial with dasiglucagon for the treatment of severe hypoglycemia

25 May 2018

Splash Pharmaceuticals Announces Dose Escalation in Phase I Clinical Trial in Platinum-resistant Ovarian Cancer Patients

25 May 2018

BioMarin Receives Standard Approval for Palynziq™ (pegvaliase-pqpz) Injection for Treatment of Adults with Phenylketonuria (PKU), a Rare Genetic Disease

25 May 2018

ThromboGenics Enrolls First Patient in Phase 1 Clinical Study Evaluating THR-149, a plasma kallikrein inhibitor, for treatment of Diabetic Macular Edema (DME)

23 May 2018

FDA Accepts Supplemental Biologics License Application (BLA) and Grants Priority Review for Prophylactic and Pediatric Use for Bio Products Laboratory’s Coagadex® (Coagulation Factor X, Human) for Treatment of Hereditary Factor X Deficiency

23 May 2018

Phase 3 Registration Trial for Non-Muscle Invasive Bladder Cancer Achieves 42% Complete Response Rate at Three Months in Carcinoma in Situ Patients

22 May 2018

Aileron Therapeutics Announces Publication of ALRN-6924 Nonclinical Data in T-cell Lymphomas by Researchers at Dana-Farber Cancer Institute

22 May 2018

Bioverativ Presents Preliminary Phase 1/2a Data on BIVV001, the First Factor VIII Therapy to Break Through the VWF Half-Life Ceiling in Hemophilia A

17 May 2018

Obsidian Presents Preclinical Data at ASGCT Showing Advancement of Its Regulated IL12 and IL15 Programs to Enable Safer and More Effective CAR-T Therapies

17 May 2018

Evolus Announces Progress with DWP-450 Regulatory Submissions

15 May 2018

Pfenex Announces Positive Top-Line PF708 Study Results in Osteoporosis Patients, On-Track for Submission of New Drug Application in Third Quarter 2018

15 May 2018

FDA approves first epoetin alfa biosimilar for the treatment of anemia

9 May 2018

Bonti Announces Start of LANTERN-2 Phase 2 Clinical Trial Evaluating EB-001T in Treating Focal Muscle Pain

9 May 2018

Palatin Technologies Presents Positive Preclinical MC1 Receptor Agonist Data at TIDES: Oligonucleotide and Peptide Therapeutics 2018 Meeting in Boston, Massachusetts

9 May 2018

Arch Biopartners Completes Pre-IND Meeting with U.S. FDA on LSALT Peptide for Preventing Acute Kidney Injury in Cardiac Surgery Patients

8 May 2018

Nektar Therapeutics Announces Initiation of a Phase 1b Clinical Study of NKTR-358, a First-in-Class Regulatory T Cell Stimulator, in Patients with Systemic Lupus Erythematosus

8 May 2018

Ascendis Pharma A/S Announces Dosing of First Subjects in Phase 1 Trial of TransCon CNP

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