Biopharmaceutical News and Research

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enGene, Janssen Biotech sign agreement to develop and commercialize new IBD therapies

enGene, Inc. a gene therapy company focused on development of therapeutics using its proprietary "Gene Pill" and enema gene delivery platform, today announced that it has entered into a definitive agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop and commercialize new therapies for inflammatory bowel disease (IBD).

14 Oct 2015

XTL signs agreement with Yeda to amend development milestones for lupus treatment

XTL Biopharmaceuticals Ltd., a clinical-stage biopharmaceutical company focused on the development and commercialization of pharmaceutical products for the treatment of unmet clinical needs with a focus on treatments for autoimmune diseases, today announced that it has reached agreement with Yeda Research and Development Company Ltd. to amend the development milestones in the License Agreement signed between the parties in January 2014 for the development of hCDR1 for the treatment of systemic lupus erythematosus (SLE).

13 Oct 2015

Clinical study data on Mallinckrodt's H.P. Acthar Gel to be presented at ACR 2015

Mallinckrodt plc, a leading specialty biopharmaceutical company, today announced that data from a pilot study for its H.P. Acthar Gel (repository corticotropin injection) will be presented at the American College of Rheumatology 2015 Annual Meeting to be held November 7-11 in San Francisco.

8 Oct 2015

Bionomics, Merck extend collaboration to develop drug candidates for treatment of chronic and neuropathic pain

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 announced that it has extended its strategic collaboration with Merck & Co., Inc., Kenilworth NJ., (known as MSD outside the United States and Canada) for the discovery and development of drug candidates for the treatment of chronic and neuropathic pain.

8 Oct 2015

Genocea announces positive data in Phase 2 trial evaluating GEN-003 for the treatment of genital herpes

Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, has announced positive results from a planned interim analysis of data collected six months after dosing from its ongoing Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes. At its best performing dose of 60 µg per protein / 75 µg of Matrix-M2TM adjuvant, GEN-003 demonstrated a statistically significant 58 percent reduction from baseline in the viral shedding rate (p < 0.0001), the primary endpoint of the study.

7 Oct 2015

New white paper on active-ULD performance from CSafe Global

CSafe Global, the world's largest producer of actively controlled mobile refrigeration units for biopharmaceutical and healthcare applications, has released a white paper highlighting the problems and risk associated with using poorly maintained container stock.

7 Oct 2015

VWR announces acquisition of Purification Technologies

VWR, a leading, global, independent provider of laboratory products, services and solutions, announced today that it has acquired Purification Technologies Inc., a specialty solvent company that performs high volume purification of selected high purity solvents. This acquisition will enhance VWR's growing laboratory and production chemical manufacturing portfolio to better support its laboratory and biopharmaceutical manufacturing customers.

7 Oct 2015

OLFUS study supports safety, efficacy of DBV's Viaskin Peanut patch in children with peanut allergy

DBV Technologies, a clinical-stage specialty biopharmaceutical company, today announced that topline findings from the first 12 months of the OLFUS-VIPES study, or OLFUS, support the long-term safety and efficacy of Viaskin Peanut for the treatment of peanut allergy.

7 Oct 2015

Tarix Orphan's TXA127 granted FDA Fast Track Designation for treatment of DMD patients

Tarix Orphan LLC, a privately held biopharmaceutical company focused on the treatment of rare neuromuscular disorders and connective tissue diseases, today announced that the U.S. Food and Drug Administration has granted Fast Track Designation to TXA127 (angiotensin 1-7) to reduce skeletal muscle damage and fibrosis and thereby improve muscle strength in Duchenne Muscular Dystrophy (DMD) patients.

6 Oct 2015

First patients screened in Axovant's phase 3 study of RVT-101

Axovant Sciences Ltd., a leading clinical-stage biopharmaceutical company focused on the treatment of dementia, today announced the first patients screened in MINDSET, a confirmatory global phase 3 study of Axovant's lead product candidate, RVT-101. Axovant also announced that the company and the U.S. Food and Drug Administration have agreed to a Special Protocol Assessment (SPA) supporting this phase 3 program.

6 Oct 2015

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

Biopharmaceutical News and Research

enGene, Janssen Biotech sign agreement to develop and commercialize new IBD therapies

XTL signs agreement with Yeda to amend development milestones for lupus treatment

Clinical study data on Mallinckrodt's H.P. Acthar Gel to be presented at ACR 2015

Bionomics, Merck extend collaboration to develop drug candidates for treatment of chronic and neuropathic pain

Genocea announces positive data in Phase 2 trial evaluating GEN-003 for the treatment of genital herpes

New white paper on active-ULD performance from CSafe Global

VWR announces acquisition of Purification Technologies

OLFUS study supports safety, efficacy of DBV's Viaskin Peanut patch in children with peanut allergy

Tarix Orphan's TXA127 granted FDA Fast Track Designation for treatment of DMD patients

First patients screened in Axovant's phase 3 study of RVT-101

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

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