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Omeros’ OMS721 receives positive opinion from EMA's COMP for treating hematopoietic stem cell transplant

Omeros Corporation announced today that the European Medicines Agency's Committee for Orphan Medicinal Products issued a positive opinion recommending orphan drug designation of OMS721 for treatment in hematopoietic stem cell transplantation.

25 Jul 2018

Pivotal study of dasotraline in adults with binge eating disorder meets primary endpoint

Sunovion Pharmaceuticals Inc. today announced that a study evaluating the efficacy and safety of dasotraline in adults with moderate to severe binge eating disorder met its primary endpoint, demonstrating a statistically significant decrease in number of binge days per week from baseline to Week 12 in the group treated with dasotraline 6 mg/day versus the placebo-treated group.

25 Jul 2018

Phase 3 study of KEYTRUDA monotherapy meets primary endpoint

Merck, known as MSD outside the United States and Canada, announced today that the pivotal Phase 3 KEYNOTE-048 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma, met a primary endpoint of overall survival as monotherapy in patients whose tumors expressed PD-L1.

25 Jul 2018

Pfizer announces FDA approval of biosimilar to Neupogen

Pfizer Inc. today announced that the United States Food and Drug Administration has approved NIVESTYM (filgrastim-aafi), a biosimilar to Neupogen (filgrastim), for all eligible indications of the reference product.

23 Jul 2018

Sage launches new web-based tool that helps explore curated genomic analyses of Alzheimer's

Sage Bionetworks announces the launch of the Agora platform an interactive, web-based tool that allows researchers to explore curated genomic analyses of Alzheimer's Disease, including a list of early candidate target nominations for AD.

20 Jul 2018

AbbVie submits supplemental NDA to FDA for venetoclax to treat acute myeloid leukemia

AbbVie, a research-based global biopharmaceutical company, today announced it submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for venetoclax in combination with a hypomethylating agent or in combination with low-dose cytarabine for the treatment of newly diagnosed patients with acute myeloid leukemia who are ineligible for intensive chemotherapy.

20 Jul 2018

PureTech Health collaborates with Roche to advance oral administration of antisense oligonucleotides

PureTech Health plc, a clinical-stage biopharmaceutical company developing novel medicines focused on the Brain-Immune-Gut Axis, today announced that it has entered into a multiyear collaboration with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc., to advance PureTech's milk-derived exosome platform technology for the oral administration of Roche's antisense oligonucleotide platform.

20 Jul 2018

Ferring announces FDA approval of ZOMACTON for injection in four new pediatric indications

Ferring Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration has approved ZOMACTON for injection in four additional pediatric indications

20 Jul 2018

Kite collaborates with Gadeta to develop novel gamma delta TCR therapies for various cancers

Kite, a Gilead Company, and Gadeta B.V., a privately-held company focused on the discovery and development of novel cancer immunotherapies based on gamma delta T cell receptors, have entered into a strategic collaboration to develop novel gamma delta TCR therapies in various cancers.

19 Jul 2018

Phase 3 study of tanezumab in patients with osteoarthritis pain meets all three co-primary endpoints

Pfizer Inc. and Eli Lilly and Company today announced that a 16-week Phase 3 study in patients with osteoarthritis pain evaluating subcutaneous administration of tanezumab, an investigational humanized monoclonal antibody, met all three co-primary endpoints.

19 Jul 2018

NeuroTrauma Sciences and Henry Ford join hands to advance exosome technology

NeuroTrauma Sciences, LLC, a biopharmaceutical company, and Henry Ford Health System, a non-profit organization, today announce that a newly-formed subsidiary of NTS has entered into multi-year Sponsored Research and License Agreements.

16 Jul 2018

Aeras announces publication of Phase 2 results of two TB vaccines

Aeras, a nonprofit organization dedicated to developing vaccines against tuberculosis (TB), today announced the publication of the full results from a Phase 2, randomized, controlled clinical trial of two TB vaccines-- the currently available BCG vaccine and an investigational vaccine, H4:IC31--in the New England Journal of Medicine (NEJM).

12 Jul 2018

Aurinia’s Phase 2 trial evaluates voclosporin ophthalmic solution for treating dry eye syndrome

Aurinia Pharmaceuticals Inc., a clinical stage biopharmaceutical company focused on the global immunology market, today announced the initiation of its Phase 2 trial evaluating voclosporin ophthalmic solution (VOS) for the treatment of dry eye syndrome (DES).

12 Jul 2018

New clinical trial to evaluate virotherapy and immunotherapy combination for ovarian, colorectal cancers

Ludwig Cancer Research and the Cancer Research Institute announce the initiation of a clinical trial to evaluate the combination of ONCOS-102, an experimental anti-tumor virotherapy, with the checkpoint blockade antibody IMFINZI (durvalumab) for advanced ovarian and colorectal cancers.

12 Jul 2018

Sartorius Stedim Biotech and Penn State partner to advance teaching, research in biotechnology

Sartorius Stedim Biotech and Penn State University have entered into a collaborative partnership to advance multidisciplinary teaching and research in biotechnology. This long-term relationship will support the education and preparation of the next generation of biotechnology leaders.

From Sartorius 10 Jul 2018

CTI BioPharma announces Phase III results of PIXUVRI combined with rituximab in aggressive B-cell NHL patients

CTI BioPharma Corp. and Servier today announced that the pivotal Phase III study evaluating PIXUVRI® combined with rituximab in comparison to gemcitabine combined with rituximab in patients with aggressive B-cell non-Hodgkin lymphoma did not meet its primary endpoint of improvement of progression-free survival

9 Jul 2018

Cleara Biotech creates three public-private partnerships to discover and develop new therapeutics

Cleara Biotech B.V., a Netherlands-based biopharmaceutical company, announced today the creation of three public-private partnerships to discover and develop new therapeutics.

6 Jul 2018

PMDA approves use of LYNPARZA in patients with BRCA-mutated breast cancer

AstraZeneca and Merck, known as MSD outside the United States and Canada, today announced that Japan's Pharmaceuticals and Medical Devices Agency has approved LYNPARZA tablets for use in patients with unresectable or recurrent BRCA-mutated, human epidermal growth factor receptor 2 -negative breast cancer who have received prior chemotherapy.

2 Jul 2018

New Rekovelle analysis shows AMH is robust predictor of ovarian response to fertility treatment

Ferring Pharmaceuticals announced today a new analysis of data from the Phase 3 ESTHER-1 trial showing that natural variations in anti-Müllerian hormone levels during and between a woman's menstrual cycle have no clinically relevant impact on ovarian response when using AMH to dose Rekovelle for ovarian stimulation.

2 Jul 2018

Ocular Therapeutix resubmits NDA for DEXTENZA

Ocular Therapeutix™, Inc., a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, has announced the resubmission of the Company's New Drug Application to the U.S. Food and Drug Administration for its lead product candidate DEXTENZA™ 0.4mg, for the treatment of ocular pain following ophthalmic surgery.

30 Jun 2018

Biopharmaceutical News and Research

Omeros’ OMS721 receives positive opinion from EMA's COMP for treating hematopoietic stem cell transplant

Pivotal study of dasotraline in adults with binge eating disorder meets primary endpoint

Phase 3 study of KEYTRUDA monotherapy meets primary endpoint

Pfizer announces FDA approval of biosimilar to Neupogen

Sage launches new web-based tool that helps explore curated genomic analyses of Alzheimer's

AbbVie submits supplemental NDA to FDA for venetoclax to treat acute myeloid leukemia

PureTech Health collaborates with Roche to advance oral administration of antisense oligonucleotides

Ferring announces FDA approval of ZOMACTON for injection in four new pediatric indications

Kite collaborates with Gadeta to develop novel gamma delta TCR therapies for various cancers

Phase 3 study of tanezumab in patients with osteoarthritis pain meets all three co-primary endpoints

NeuroTrauma Sciences and Henry Ford join hands to advance exosome technology

Aeras announces publication of Phase 2 results of two TB vaccines

Aurinia’s Phase 2 trial evaluates voclosporin ophthalmic solution for treating dry eye syndrome

New clinical trial to evaluate virotherapy and immunotherapy combination for ovarian, colorectal cancers

Sartorius Stedim Biotech and Penn State partner to advance teaching, research in biotechnology

CTI BioPharma announces Phase III results of PIXUVRI combined with rituximab in aggressive B-cell NHL patients

Cleara Biotech creates three public-private partnerships to discover and develop new therapeutics

PMDA approves use of LYNPARZA in patients with BRCA-mutated breast cancer

New Rekovelle analysis shows AMH is robust predictor of ovarian response to fertility treatment

Ocular Therapeutix resubmits NDA for DEXTENZA

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