Biopharmaceutical News and Research

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FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept

Sandoz, a Novartis company and the global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen’s US-licensed Enbrel (etanercept) - a tumor necrosis factor alpha (TNF-α) inhibitor

5 Oct 2015

AMO Pharma raises $25 million in private equity financing

AMO Pharma Limited, a privately held biopharmaceutical company focusing on debilitating diseases with limited or no treatment options, announced today that the company has raised $25 million in private equity financing from Woodford Investment Management.

30 Sep 2015

AbbVie plans to advance ABT-494 to Phase 3 studies in rheumatoid arthritis

AbbVie, a global biopharmaceutical company, today announced that it will advance ABT-494, its internally developed investigational selective JAK1 inhibitor, to Phase 3 studies in rheumatoid arthritis. Following a thorough review of available data, AbbVie will not exercise its right to in-license the Galapagos JAK1 inhibitor, filgotinib.

25 Sep 2015

AbbVie reports positive results from ABT-494 Phase 2 clinical trials in patients with rheumatoid arthritis

AbbVie, a global biopharmaceutical company, today announced results from two Phase 2 clinical trials evaluating its investigational selective JAK1 inhibitor, ABT-494, in patients with inadequate response to either methotrexate or TNF inhibitors.

25 Sep 2015

NNFF's Lifetime Health-Science Achievement Award 2015 goes to John Crew and Ron Najafi

The National Necrotizing Fasciitis Foundation today announced that it has awarded NNFF's Lifetime Health-Science Achievement Award 2015 to John Crew, MD and Ron Najafi, PhD for "Excellence in Innovative Healthcare". Their pioneering work has improved care for patients with life-threatening 'flesh-eating' disease and other types of wounds.

25 Sep 2015

NJIT President Joel Bloom to be honored as Educator of the Year

The Research & Development Council of New Jersey will honor the winners of the 2015 Edison Patent Awards at the 36th Edison Patent Awards Ceremony & Reception on November 12, 2015. Over 50 inventors and 12 New Jersey companies and universities will be recognized at the event.

23 Sep 2015

Palatin Technologies reports net loss of $12.1 million for fourth quarter 2015

Palatin Technologies, Inc., a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, today announced results for its fourth quarter and fiscal year ended June 30, 2015.

21 Sep 2015

BGB324 shows enhanced tumour clearance in mouse carcinoma models

BerGenBio AS, an oncology biopharmaceutical company, has announced new preclinical data on lead compound, BGB324, in combination with immune checkpoint inhibitors, has been presented as a poster at CRI-CIMT-EATI-AACR - The Inaugural International Cancer Immunotherapy Conference: Translating Science into Survival, in New York.

21 Sep 2015

Bionomics’ BNC210 Phase 1 trial for anxiety and depression meets primary endpoint

Bionomics Limited, a biopharmaceutical company focused on the discovery and development of innovative therapeutics for the treatment of diseases of the central nervous system (CNS) and cancer, today reported positive data from the completed Phase 1 multiple ascending dose, placebo controlled clinical trial of BNC210, an orally administered negative allosteric modulator of the alpha-7 nicotinic acetylcholine receptor (alpha-7 receptor) being developed for the treatment of anxiety and depression.

16 Sep 2015

GENFIT develops reliable, non-invasive diagnostic tool for NASH patients

GENFIT, a biopharmaceutical company at the forefront of developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases, that notably affect the liver or the gastrointestinal system, today announces the development of a new reliable and non-invasive diagnostic method, based on the measurement of a novel type of blood biomarker: small non-coding RNA, or miRNA.

16 Sep 2015

Researchers receive NIH grant to test novel drug therapy for Alzheimer's dementia

Johns Hopkins University researchers have received an estimated $7.5 million National Institutes of Health grant to clinically test what would be the first treatment to prevent or delay the onset of Alzheimer's dementia.

16 Sep 2015

AgeneBio's HOPE4MCI Phase 3 trial receives support from NIH

AgeneBio, a biopharmaceutical company developing innovative therapeutics for unserved patients battling neurodegeneration, announced today that its HOPE4MCI Phase 3 clinical trial has received support from the National Institutes of Health.

15 Sep 2015

Aridis' AR-301 granted FDA Fast Track Designation for treatment of pneumonia caused by S. aureus

Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel anti-infectives and immunotherapies for infectious diseases, announced today that the U.S. Food and Drug Administration granted Fast Track Designation to AR-301, the Company's fully human anti-Staphylococcal alpha-toxin IgG1 monoclonal antibody (mAb).

11 Sep 2015

Envision inaugurates 10th Annual Conference, honors outstanding achievements in low vision rehabilitation

Envision, the Wichita, Kan.-based not-for-profit organization that supports those who are blind and visually impaired, officially opened its 10th Annual Conference at The Grand Hyatt in downtown Denver this morning with a session honoring outstanding commitment to improving the quality of life of those who are blind and visually impaired and keynote addresses from two individuals representing the great athletic accomplishments those with vision loss can achieve.

11 Sep 2015

BerGenBio honored with Nordic Stars Award for innovation in Nordic life science community

BerGenBio AS ("BerGenBio" or the "Company"), an oncology biopharmaceutical company, today announces that it has been awarded one of this year's Nordic Stars Awards at the Nordic Life Science Days 2015 conference held in Stockholm, Sweden on 9-10 September, 2015.

11 Sep 2015

DelMar presents updated VAL-083 Phase I/II trial data at GBM2015 meeting

DelMar Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today presented updated clinical data from its Phase I/II study of lead product candidate VAL-083 (dianhydrogalactitol), in patients with refractory glioblastoma multiforme (GBM), at GBM2015: 2nd International Symposium on Clinical and Basic Investigation in Glioblastoma in Toledo, Spain.

10 Sep 2015

CureVac, IAVI team up to advance development, testing of AIDS vaccines

The non-profit International AIDS Vaccine Initiative (IAVI) and biopharmaceutical company CureVac are partnering to accelerate the development of AIDS vaccines, utilizing novel immunogens developed by IAVI and partners, delivered via CureVac's novel messenger RNA (mRNA) technology.

10 Sep 2015

CureVac announces official launch of U.S. operations in Cambridge, MA

CureVac, a clinical-stage biopharmaceutical company pioneering the field of mRNA-based technology, today announced the official launch of its U.S. operations in Cambridge, MA, as the company advances the development of its proprietary mRNA platform technology and multiple, clinical-stage mRNA therapeutics and vaccines.

10 Sep 2015

Inhibiting key protein involved in glucose production may help in treating type 2 diabetes

Some treatments for type 2 diabetes make the body more sensitive to insulin, the hormone that lowers blood sugar. But new research at Washington University School of Medicine in St. Louis suggests a different strategy: slowing the production of glucose in the liver.

4 Sep 2015

Adaptimmune doses first patient in expanded Phase I/II trial of T-cell therapy for synovial sarcoma

Adaptimmune Therapeutics plc, a clinical stage biopharmaceutical company focused on the use of T-cell therapy to treat cancer, today announced that the first patient has been dosed in its expanded Phase I/II trial of its affinity enhanced T-cell receptor therapeutic targeting the NY-ESO-1 cancer antigen in synovial sarcoma patients.

3 Sep 2015

Biopharmaceutical News and Research

FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept

AMO Pharma raises $25 million in private equity financing

AbbVie plans to advance ABT-494 to Phase 3 studies in rheumatoid arthritis

AbbVie reports positive results from ABT-494 Phase 2 clinical trials in patients with rheumatoid arthritis

NNFF's Lifetime Health-Science Achievement Award 2015 goes to John Crew and Ron Najafi

NJIT President Joel Bloom to be honored as Educator of the Year

Palatin Technologies reports net loss of $12.1 million for fourth quarter 2015

BGB324 shows enhanced tumour clearance in mouse carcinoma models

Bionomics’ BNC210 Phase 1 trial for anxiety and depression meets primary endpoint

GENFIT develops reliable, non-invasive diagnostic tool for NASH patients

Researchers receive NIH grant to test novel drug therapy for Alzheimer's dementia

AgeneBio's HOPE4MCI Phase 3 trial receives support from NIH

Aridis' AR-301 granted FDA Fast Track Designation for treatment of pneumonia caused by S. aureus

Envision inaugurates 10th Annual Conference, honors outstanding achievements in low vision rehabilitation

BerGenBio honored with Nordic Stars Award for innovation in Nordic life science community

DelMar presents updated VAL-083 Phase I/II trial data at GBM2015 meeting

CureVac, IAVI team up to advance development, testing of AIDS vaccines

CureVac announces official launch of U.S. operations in Cambridge, MA

Inhibiting key protein involved in glucose production may help in treating type 2 diabetes

Adaptimmune doses first patient in expanded Phase I/II trial of T-cell therapy for synovial sarcoma

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