Biopharmaceutical News and Research

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Celmatix and Ferring announce genomics collaboration aimed at uncovering new insights into ovarian biology

Ferring Pharmaceuticals and Celmatix today announced an ambitious genomics collaboration aimed at uncovering new insights into ovarian biology and accelerating the development of personalized interventions in reproductive medicine and women's health.

30 Aug 2018

FDA accepts Bristol-Myers Squibb’s application for Sprycel for treating pediatric leukemia

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration accepted its supplemental Biologics License Application for Sprycel (dasatinib) in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.

30 Aug 2018

EC grants marketing authorization for ONPATTRO (patisiran) in Europe

Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced today that the European Commission (EC) has granted marketing authorization for ONPATTRO (patisiran) for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis in adults with stage 1 or stage 2 polyneuropathy.

30 Aug 2018

Drug used for chest pain does not decrease chance of first occurrence of ventricular arrhythmias

A clinical trial of more than 1,000 patients with implantable cardioverter defibrillators found that the drug ranolazine was safe but didn't significantly decrease the likelihood of the first occurrence of ventricular tachycardia, ventricular fibrillation or death in this high-risk population.

29 Aug 2018

Scientists publish study results of AAV therapy product for treatment of RHO-adRP

Ophthotech Corporation announced today that scientists at the University of Pennsylvania and University of Florida published proof-of-concept study results on an adeno-associated virus gene therapy product candidate for the treatment of rhodopsin-mediated autosomal dominant retinitis pigmentosa licensed by Ophthotech.

22 Aug 2018

RDMD raises $3 million in seed funding to accelerate rare disease research, drug development

RDMD, a healthcare technology company dedicated to accelerating research for patients with rare diseases, today announced that it has raised $3 million in seed financing.

20 Aug 2018

Harbour Biomed and Kelun-Biotech collaborate to develop, commercialize anti-PD-L1 antibody

Harbour BioMed today announced it has entered into an exclusive strategic partnership with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. to develop and commercialize A167, an anti-PD-L1 antibody in Phase 2 clinical development, worldwide outside of the Greater China region.

20 Aug 2018

New polyclonal immunotherapy successfully neutralizes Ebola virus

SAB Biotherapeutics, Inc., a clinical-stage biopharmaceutical company, today announced that its anti-Ebola immunotherapy (SAB-139) provided "100% protection against a lethal dose of the Ebola virus" in a recent animal study published in The Journal of Infectious Diseases.

15 Aug 2018

One-two punch of powerful antibodies may be best way to stop Ebola virus

A one-two punch of powerful antibodies may be the best way to stop Ebola virus, reports an international team of scientists in the journal Cell.

10 Aug 2018

EMA grants orphan designation to selumetinib for treatment of neurofibromatosis type 1

AstraZeneca and Merck, known as MSD outside the U.S. and Canada, today announced that the European Medicines Agency (EMA) has granted orphan designation to selumetinib, a MEK 1/2 inhibitor, for the treatment of neurofibromatosis type 1 (NF1).

3 Aug 2018

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

Biopharmaceutical News and Research

Celmatix and Ferring announce genomics collaboration aimed at uncovering new insights into ovarian biology

FDA accepts Bristol-Myers Squibb’s application for Sprycel for treating pediatric leukemia

EC grants marketing authorization for ONPATTRO (patisiran) in Europe

Drug used for chest pain does not decrease chance of first occurrence of ventricular arrhythmias

Scientists publish study results of AAV therapy product for treatment of RHO-adRP

RDMD raises $3 million in seed funding to accelerate rare disease research, drug development

Harbour Biomed and Kelun-Biotech collaborate to develop, commercialize anti-PD-L1 antibody

New polyclonal immunotherapy successfully neutralizes Ebola virus

One-two punch of powerful antibodies may be best way to stop Ebola virus

EMA grants orphan designation to selumetinib for treatment of neurofibromatosis type 1

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

Event guide: 3rd EHS for Biopharma Summit eBook

Advancing Intracellular Delivery with LumiPore®

How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

The role of UV-Vis in biopharma QC

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