R&D

Resverlogix Provides Groundbreaking Results in Patients with Severe Kidney Impairments Several Key Proteins That Drive Kidney (Renal) Disease and Dialysis Risk are Downregulated After a Single Dose of Apabetalone

January 24, 2017

CALGARY, Alberta, Jan. 23, 2017 /PRNewswire/ — Resverlogix Corp. (“Resverlogix” or the “Company”) (TSX: RVX) today announced preliminary results from the New Zealand based Phase 1 trial with severe kidney (renal) impaired patients. The data showed remarkable results in reducing inflamed protein biomarkers in patients with severe kidney impairment versus healthy control patients. It is […]

Immune Pharmaceuticals Enters a Research Partnership to Develop Mono- and Bispecific Antibodies Against Novel Targets in the Tumor Microenvironment

January 24, 2017

NEW YORK, Jan. 23, 2017 /PRNewswire/ — Immune Pharmaceuticals Inc. (NASDAQ: IMNP), “Immune”, a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of immuno-inflammatory diseases and cancers, announced today that it has entered an exclusive sub-license agreement with SATT Sud-Est, a French Technology Transfer Office, to develop, use, manufacture and commercialize mono- and bispecific […]

Therabron Therapeutics Receives Orphan Drug Designation in the European Union for CG367, Indicated for the Treatment of Bronchiolitis Obliterans Syndrome

January 24, 2017

ROCKVILLE, Md., Jan. 23, 2017 /PRNewswire/ — Therabron Therapeutics, Inc., a clinical-stage biotechnology company dedicated to advancing a new standard in respiratory care, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products has granted Orphan Drug Designation for Therabron’s CG367 program, indicated for the treatment of Bronchiolitis Obliterans Syndrome (BOS). “We […]

Kamada Announces Positive Scientific Advice Response from the European Medicines Agency Focused on Alpha-1 Antitrypsin IV for Treatment of Acute Graft-Versus-Host Disease

January 24, 2017

NESS ZIONA, Israel, Jan. 23, 2017 (GLOBE NEWSWIRE) — Kamada Ltd. (NASDAQ:KMDA) (TASE:KMDA), a plasma-derived protein therapeutics company focused on orphan indications, announced today the positive Scientific Advice response from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) focused on the Company’s development program in Europe for Alpha-1 […]

Aptose Prioritizes Development of CG’806 First-in Class FLT3/BTK Inhibitor

January 24, 2017

SAN DIEGO and TORONTO, Jan. 23, 2017 (GLOBE NEWSWIRE) — Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, today announced it will prioritize its resources toward the development of CG’806, an oral preclinical compound being developed for patients with FLT3-driven acute myeloid […]

Domain Therapeutics and Merck enter into a license and collaboration agreement for development of adenosine receptor antagonists in immuno-oncology

January 24, 2017

Strasbourg, France, January 23, 2017 – Domain Therapeutics today announces that a collaboration and licensing agreement with Merck, a leading science and technology company, has been signed for the development of adenosine receptor antagonist drugs specifically designed for oncology and immuno-oncology.   The agreement will involve close collaboration between Merck and Domain Therapeutics to develop […]

Sunesis Pharmaceuticals Announces Clinical and Regulatory Updates to SNS-062 and Vosaroxin Programs

January 24, 2017

SOUTH SAN FRANCISCO, Calif., Jan. 23, 2017 (GLOBE NEWSWIRE) — Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced clinical and regulatory updates to its two lead programs, SNS-062, a second-generation reversible and non-covalent BTK inhibitor, and vosaroxin, an anti-cancer quinolone derivative currently under review for marketing authorization as a treatment for relapsed/refractory acute myeloid leukemia (AML) in […]

Marinus Announces Positive Preliminary Data From Children With CDKL5 Genetic Disorder

January 24, 2017

RADNOR, Pa., Jan. 23, 2017 (GLOBE NEWSWIRE) — Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), today announced positive preliminary data from the initial CDKL5 patients enrolled in its ongoing Phase 2 open-label study evaluating its CNS-selective GABAA modulator, ganaxolone, as a treatment for orphan, genetic disorders. CDKL5 is a severe, rare genetic disorder that results in early-onset, difficult-to-control […]

Inovalon Announces Agreement With Boehringer Ingelheim to Support Outcome-Based Contracting

January 24, 2017

BOWIE, Md., Jan. 23, 2017 (GLOBE NEWSWIRE) — Inovalon (NASDAQ:INOV), a leading technology company providing advanced, cloud-based platforms empowering a data-driven transformation from volume-based to value-based models across the healthcare ecosystem, today announced that it has entered into an agreement with Boehringer Ingelheim Pharmaceuticals Inc., a research-based, global pharmaceutical company, on behalf of Boehringer Ingelheim’s […]

Elite Reports On SequestOx™ FDA End-of-Review Meeting

January 24, 2017

NORTHVALE, N.J., Jan. 23, 2017 (GLOBE NEWSWIRE) — Elite Pharmaceuticals, Inc. (“Elite” or the “Company”) (OTCBB:ELTP) today reported the Company received official minutes from its December 21, 2016 end-of-review meeting with the U.S. Food and Drug Administration (the “FDA”) for the New Drug Application (the “NDA”) for SequestOx™ (oxycodone hydrochloride and sequestered naltrexone hydrochloride). The […]

GeoVax Announces Initiation of HIV Human Clinical Trial

January 24, 2017

ATLANTA, GA – (NewMediaWire) – January 23, 2017 – GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, announced today the initiation of the next human clinical trial of GeoVax’s preventive HIV vaccine, GOVX-B11. The Phase 1 trial (designated HVTN 114) is being conducted by the HIV Vaccine Trials Network (HVTN) and is […]

Merus Announces Closing of Global Strategic Research Collaboration with Incyte to Discover and Develop Bispecific Antibodies

January 24, 2017

UTRECHT, The Netherlands, Jan. 23, 2017 (GLOBE NEWSWIRE) — Merus N.V. (NASDAQ:MRUS) a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics, today announced the closing of its global strategic research collaboration with Incyte Corporation (NASDAQ:INCY) focused on the research, discovery and development of bispecific antibodies utilizing Merus’ proprietary Biclonics® technology platform. The agreement grants Incyte […]

MediciNova Announces Publication of Positive Findings on MN-166 (ibudilast) in Alcohol Dependence

January 24, 2017

LA JOLLA, Calif., Jan. 23, 2017 (GLOBE NEWSWIRE) — MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), today announced that the medical journal Neuropsychopharmacology has published a new article on MN-166 (ibudilast) written by Dr. Lara Ray and colleagues at […]

Tetra BioPharma Announces it Has Entered into a Clinical Research Partnership with Sante Cannabis, Quebec’s Leading Medical Cannabis Institution

January 24, 2017

OTTAWA, ONTARIO–(Marketwired – Jan. 23, 2017) – PhytoPain Pharma Inc. (“PPP”), a subsidiary of Tetra Bio-Pharma Inc. (“TetraBio” or the “Company” or “TBP”) (CSE:TBP)(CSE:TBP.CN) is pleased to announce that it has entered into a clinical research partnership with Santé Cannabis. Under the partnership, Santé Cannabis will be working with PPP to develop the late phase […]

FDA Grants Priority Review for Genentech’s Actemra® (Tocilizumab) Supplemental Biologics License Application for Giant Cell Arteritis, a Form of Vasculitis

January 24, 2017

FDA Grants Priority Review for Genentech’s Actemra® (Tocilizumab) Supplemental Biologics License Application for Giant Cell Arteritis, a Form of Vasculitis ●      Genentech recently announced positive results from a Phase III clinical trial in giant cell arteritis (GCA) ●      There have been no new therapies for GCA in more than 50 years ●      Breakthrough Therapy Designation […]

Nicox provides clinical and regulatory update for NCX 470 for IOP lowering

January 24, 2017

January 24, 2017   Sophia Antipolis, France     Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, today provided certain regulatory and clinical updates for NCX 470, its novel nitric oxide (NO) donating bimatoprost analog being developed for intraocular pressure (IOP) lowering.   Increased IOP is one of the principal risk factors of […]

FDA approves IND to support Vectura’s wholly-owned programme VR647 in paediatric asthma

January 24, 2017

Chippenham, UK – 24 January 2017: Vectura Group plc (LSE: VEC) (“Vectura”, “the Group”), an industry-leading device and formulation business for inhaled airways disease, has received an Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) to conduct a Phase 1 clinical trial with VR647. VR647 Wholly-owned “smart” nebuliser programme in […]

Atlantic Healthcare receives FDA agreement to initiate rolling submission of its New Drug Application for alicaforsen in the treatment of pouchitis

January 24, 2017

Cambridge, UK, and Raleigh, NC; 24 January 2017. Atlantic Healthcare plc, an emerging trans-Atlantic pharmaceutical company with a core focus on gastrointestinal (GI) disorders, announces that it has received agreement from the U.S. Food and Drug Administration (FDA) to initiate a rolling submission of its New Drug Application (NDA) for alicaforsen to treat pouchitis, a […]

Enanta Announces EMA Grants Accelerated Assessment, Validates Marketing Authorization Application for AbbVie’s Investigational HCV Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of All Major Genotypes (GT1-6) of Chronic Hepatitis C

January 24, 2017

WATERTOWN, Mass.–(BUSINESS WIRE)–Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that AbbVie’s marketing authorization application (MAA) for its investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of all major chronic hepatitis C virus (HCV) genotypes, has […]

Image Analysis Group Partners with Boston Medical Center/Boston University School of Medicine(BMC/BUSM)to Create Premiere Clinical Trials Management and Analytical Team

January 24, 2017

(London and Boston, January 17, 2017) Image Analysis Group(IAG)  announced today that they have partnered with a new CRO spun out by BMC/BUSM Radiology to provide life sciences, biotech, medical device and pharmaceutical clients with expert clinical research services in imaging. This partnership will offer IAG’s proprietary cloud-based platform Dynamika for clinical trial data management, […]

RNA-Seq 2017

January 23, 2017

The Alliance for Regenerative Medicine Launches Standards Coordinating Body to Advance Development and Establishment of Industry-Wide Standards

January 23, 2017

WASHINGTON, DC–(Marketwired – Jan 19, 2017) –   The Alliance for Regenerative Medicine (ARM) today announced the formal launch of the international Standards Coordinating Body for regenerative medicines (SCB), a public-private partnership for coordinating, prioritizing and supporting standards that advances process, measurement and analytical techniques to support the global availability of products across the gene and […]

Newly Created Standards Coordinating Body Seeks to Advance Development and Establishment of Regenerative Medicine Standards

January 23, 2017

WASHINGTON, DC–(Marketwired – Jan 19, 2017) – The international Standards Coordinating Body for regenerative medicines (SCB), in coordination with the Alliance for Regenerative Medicine (ARM), today announced its formal launch as a public-private partnership for coordinating, prioritizing and supporting standards that advances process, measurement and analytical techniques to support the global availability of products across […]

Prima BioMed Commences Randomised Phase IIb Clinical Trial for IMP321 in Breast Cancer

January 23, 2017

SYDNEY, AUSTRALIA–(Marketwired – Jan 19, 2017) – Prima BioMed Ltd (ASX: PRR) (NASDAQ: PBMD) (“Prima” or the “Company”) today announced the first patient has been dosed as part of the enlarged randomised phase of its AIPAC Phase IIb clinical trial for IMP321 in metastatic breast cancer. The randomised phase of AIPAC (Active Immunotherapy PAClitaxel) will […]

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