Proteins and Peptides

21 June 2013

FDA grants Breakthrough Therapy designation to Novartis’ serelaxin (RLX030) for acute heart failure

21 June 2013

Protalix BioTherapeutics Discloses Three New Compounds in Development

19 June 2013

Amarantus Reports Positive Results on MANF Neuroprotective Properties Demonstrated in Preclinical Study in China

18 June 2013

PhaseBio Expands Clinical Development of Vasomera, an Investigational Treatment for Cardiopulmonary Diseases

18 June 2013

“PRIMARYS” Study Investigators Observed Clinically Relevant Results in an Investigational Phase III Study with Somatuline® Autogel 120 mg in Patients with Acromegaly

18 June 2013

Santarus and Pharming Announce FDA Acceptance for Review of RUCONEST (Recombinant Human C1 Esterase Inhibitor) Biologics License Application

17 June 2013

MannKind Completes Phase 3 Clinical Study of AFREZZA in Patients with Type 2 Diabetes

17 June 2013

Versartis Presents Positive Results From Its First Pediatric Clinical Study of Novel Long-Acting Growth Hormone Treatment at ENDO Annual Meeting

14 June 2013

Victoza safety profile further supported at scientific workshop on pancreatitis, diabetes and pancreatic cancer

14 June 2013

Cangene Announces Withdrawal of Marketing Authorization Application for Investigational Hemophilia Compound IB1001 in Europe

12 June 2013

Derma Sciences Reports Results from DSC127 Pharmacokinetic Study

12 June 2013

Are Biosimilars Too Expensive for Emerging Economies?

11 June 2013

Only FDA Approval Pathway Complications are Holding Back the US Biosimilars Flood

11 June 2013

rEVO Biologics, an LFB Company, Announces Completion of a Dose Ranging Study of a Novel, Recombinant Form of Factor VIIa in Patients with Hemophilia A and B

10 June 2013

Neumedicines Receives an Award of $8.3 Million from BARDA for Continued Development of HemaMax as a Countermeasure to Acute Radiation Exposure

6 June 2013

BioLineRx Enrolls First Patient in Phase 2 Clinical Trial for BL-8040, for Treatment of Leukemia

6 June 2013

BioMarin Initiates Phase 3 Trial for PEG-PAL for the Treatment of PKU

5 June 2013

Galderma Initiates Clinical Development of Novel Muscle Relaxant

4 June 2013

CSL Behring Doses First Patient in Part 3 of Global Phase I/III Pivotal Study of rVIII-SingleChain (Recombinant Single-Chain Factor VIII) for Treatment of Hemophilia A

4 June 2013

La Jolla Pharmaceutical Company Submits IND for LJPC-501

4 June 2013

PROLOR Biotech Initiates Pivotal Phase III Trial Of Its Longer-Acting Version Of Human Growth Hormone

4 June 2013

PhaseBio Initiated Phase 1 Study of Investigational Once-Weekly Basal Insulin for Potential Treatment of Diabetes

4 June 2013

U.S. FDA Grants Priority Review to Bristol-Myers Squibb and AstraZeneca’s Metreleptin, an Investigational Agent for Treatment of Metabolic Disorders Associated with Rare Forms of Lipodystrophy

4 June 2013

Octapharma submits marketing authorization application (MAA) to the EMA for the first truly human recombinant coagulation factor VIII from a human cell line

3 June 2013

Nektar Presents Positive Preclinical Data for NKTR-214, a Novel Cancer Immunotherapy, At the 2013 American Society of Clinical Oncology Annual Meeting

3 June 2013

Halozyme’s Phase 1b Clinical Trial Of PEGPH20 With Gemcitabine Indicates Positive Activity Against Pancreatic Cancer

3 June 2013

Teva’s Lonquex®(XM22 lipegfilgrastim) Recommended for Approval in the EU for the Reduction of Chemotherapy-Induced Neutropenia (CIN)

1 June 2013

MannKind Completes Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes

31 May 2013

Novo Nordisk A/S: Novo Nordisk files for regulatory approval of IDegLira in the EU for the treatment of type 2 diabetes

31 May 2013

Positive CHMP opinion for once-weekly Somatropin Biopartners

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