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Regenacy Pharmaceuticals partners with CMTA to advance ricolinostat for treating hereditary neuropathy

Regenacy Pharmaceuticals, LLC, a clinical-stage biopharmaceutical company developing breakthrough treatments for diabetic and other peripheral neuropathies, today announced a collaboration with the Charcot-Marie-Tooth Association, a registered non-profit organization serving the hereditary neuropathy patient community, to validate the role of HDAC6 in multiple forms of Charcot-Marie-Tooth disease and evaluate the efficacy of ricolinostat, a selective HDAC6 inhibitor, in animal models.

2 Aug 2018

BrainScope receives second consecutive nomination for 2018 Prix Galien USA Awards

BrainScope today announced its second consecutive nomination for the 2018 Annual Prix Galien USA Awards for "Best Medical Technology" product.

2 Aug 2018

Researchers characterize production process for standardized monoclonal antibody

Researchers have taken the first step towards developing a method for the production of a standardized monoclonal antibody (mAb).

1 Aug 2018

High Throughput Biophysical Screening for Development and Formulation of Biologics

In this interview, John Champagne, Ph.D. Senior Applications Scientist and Northeast Regional Manager for Wyatt Technology, talks to News-Medical about

From Waters | Wyatt Technology 1 Aug 2018

Researchers engineer three cell lines to produce nonproprietary versions of NISTmAb

When the National Institute of Standards and Technology issued the world's first standardized monoclonal antibody in July 2016, the exhaustively analyzed protein known as NISTmAb was intended as a valuable tool for biopharmaceutical companies.

1 Aug 2018

European Commission approves Pfizer’s first oncology biosimilar

Pfizer Inc. today announced the European Commission has approved TRAZIMERA, a biosimilar to Herceptin (trastuzumab), for the treatment of human epidermal growth factor overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

31 Jul 2018

Alnylam’s patisiran receives positive opinion from CHMP for treating hATTR amyloidosis

Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced today that the Committee for Medicinal Products for Human Use has adopted a Positive Opinion recommending marketing authorization of patisiran for the treatment of hereditary transthyretin-mediated amyloidosis in adults with stage 1 or stage 2 polyneuropathy.

27 Jul 2018

Research findings may offer new path to treat or prevent neurodegenerative diseases

Aging vessels connecting the brain and the immune system play critical roles in both Alzheimer's disease and the decline in cognitive ability that comes with time, new research reveals.

26 Jul 2018

Experts describe role of quantitative systems pharmacology in first-in-human clinical trials

Certara, the global leader in model-informed drug development, regulatory science, market access and real-world evidence services, announced today that Clinical Pharmacology & Therapeutics has published its "Letter to the Editor" describing the important role that quantitative systems pharmacology can play in defining dosing criteria for first-in-human clinical trials, together with the European Medicines Agency's response.

26 Jul 2018

CNDA approves KEYTRUDA for treatment of advanced melanoma

Merck, known as MSD outside the United States and Canada, today announced that KEYTRUDA, Merck's anti-PD-1 therapy, has been approved by the China National Drug Administration for the treatment of adult patients with unresectable or metastatic melanoma following failure of one prior line of therapy.

26 Jul 2018

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

Biopharmaceutical News and Research

Regenacy Pharmaceuticals partners with CMTA to advance ricolinostat for treating hereditary neuropathy

BrainScope receives second consecutive nomination for 2018 Prix Galien USA Awards

Researchers characterize production process for standardized monoclonal antibody

High Throughput Biophysical Screening for Development and Formulation of Biologics

Researchers engineer three cell lines to produce nonproprietary versions of NISTmAb

European Commission approves Pfizer’s first oncology biosimilar

Alnylam’s patisiran receives positive opinion from CHMP for treating hATTR amyloidosis

Research findings may offer new path to treat or prevent neurodegenerative diseases

Experts describe role of quantitative systems pharmacology in first-in-human clinical trials

CNDA approves KEYTRUDA for treatment of advanced melanoma

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

eBook: Using iPSCs models for human disease research and drug discovery eBook

Advancing Neuroscience Research Through Collaboration and Patient-Centered Innovation

The impact of vibration on microscopy

How Omics Technologies Are Transforming Biological Research and Drug Discovery

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