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Trial finds antibody-drug conjugate IMMU-132 shrinks triple negative breast tumours
A clinical trial conducted by the Massachusetts General Hospital Cancer Center, US, demonstrated that the antibody-drug conjugate sacituzumab govitecan (IMMU-132) can target cancer cells and shrink tumours in women with triple negative breast cancer … (Source: Drug Development Technology)
Source: Drug Development Technology - March 16, 2017 Category: Pharmaceuticals Source Type: news

Celerion deploys VCT fingerprint technology at clinical trial facilities
Clinical research solutions provider Celerion has deployed the Verified Clinical Trials (VCT) biometric fingerprint technology to prevent dual enrolment in clinical trials. (Source: Drug Development Technology)
Source: Drug Development Technology - March 16, 2017 Category: Pharmaceuticals Source Type: news

Catalyst Pharmaceuticals reports positive results from MuSK-MG trial of Firdapse to treat MG
Catalyst Pharmaceuticals has reported positive top-line results from the MuSK-MG clinical trial of Firdapse to treat patients with myasthenia gravis (MG). (Source: Drug Development Technology)
Source: Drug Development Technology - March 16, 2017 Category: Pharmaceuticals Source Type: news

Kisqali ® (ribociclib) for the Treatment of HR+/HER2- Metastatic Breast Cancer
Formerly known as LEE011, Kisqali ® (ribociclib) is a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor indicated for the treatment of hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer i … (Source: Drug Development Technology)
Source: Drug Development Technology - March 15, 2017 Category: Pharmaceuticals Source Type: news

AstraZeneca's Lynparza meets primary endpoint in Phase III trial to treat ovarian cancer
AstraZeneca's Lynparza (olaparib) has met its primary endpoint in the Phase III SOLO-2 clinical trial for the treatment of patients with germline BRCA-mutated (gBRCA), platinum-sensitive, relapsed ovarian cancer patients. (Source: Drug Development Technology)
Source: Drug Development Technology - March 15, 2017 Category: Pharmaceuticals Source Type: news

Amgen reports positive top-line results from Phase III trial of Repatha to treat LDL-C
Biotechnology company Amgen has reported positive top-line results from the Phase III clinical trial of Repatha (evolocumab) for the treatment of patients with low-density lipoprotein cholesterol (LDL-C). (Source: Drug Development Technology)
Source: Drug Development Technology - March 15, 2017 Category: Pharmaceuticals Source Type: news

Lung Therapeutics begins Phase Ia/b trial of LTI-01 for pleural effusions in Australia and New Zealand
US-based pharmaceutical company Lung Therapeutics has begun enrolment and dosing in a Phase Ia/b clinical trial of LTI-01 for the treatment of patients with loculated pleural effusions in Australia and New Zealand (NZ). (Source: Drug Development Technology)
Source: Drug Development Technology - March 15, 2017 Category: Pharmaceuticals Source Type: news

Transgene begins dosing in Phase II trial of TG4010 to treat NSCLC
French biotechnology company Transgene has begun dosing patients in a Phase II trial of TG4010 in combination with Bristol-Myers Squibb's Opdivo (nivolumab) to treat metastatic non-small-cell lung cancer (NSCLC). (Source: Drug Development Technology)
Source: Drug Development Technology - March 14, 2017 Category: Pharmaceuticals Source Type: news

Galapagos to investigate filgotinib in two Phase II trials for Crohn's disease
Belgian clinical-stage biotechnology firm Galapagos is set to investigate filgotinib in two Phase II clinical trials for the treatment of small bowel Crohn's disease and fistulising Crohn's disease. (Source: Drug Development Technology)
Source: Drug Development Technology - March 14, 2017 Category: Pharmaceuticals Source Type: news

Zynerba closes enrolment in Phase II trials of ZYN002 for osteoarthritis and epilepsy
US-based specialty pharmaceutical firm Zynerba Pharmaceuticals has closed enrolment in the Phase II STAR 1 and Phase II STOP clinical trials of ZYN002 for the treatment of osteoarthritis and epilepsy. (Source: Drug Development Technology)
Source: Drug Development Technology - March 14, 2017 Category: Pharmaceuticals Source Type: news

BeiGene begins dosing in Phase II trial of BGB-3111 for CLL / SLL treatment in China
BeiGene has begun dosing in a Phase II clinical trial of its investigational drug candidate BGB-3111 for the treatment of patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) in China. (Source: Drug Development Technology)
Source: Drug Development Technology - March 13, 2017 Category: Pharmaceuticals Source Type: news

Sensorion to start Phase II trial of SENS-111 to treat acute vertigo
French biotechnology company Sensorion has obtained the European Heads of Medicines Agencies (HMA) authorisation to start a Phase II trial of its SENS-111 for the treatment of acute severe vertigo through the Voluntary Harmonisation Procedure (VHP). (Source: Drug Development Technology)
Source: Drug Development Technology - March 13, 2017 Category: Pharmaceuticals Source Type: news

Tyrogenex closes enrolment in Phase II trial of X-82 to treat wAMD
US-based biopharmaceutical company Tyrogenex has completed patient enrolment in the Phase II clinical trial (APEX) of X-82 (vorolanib) for the treatment of wet age-related macular degeneration (wAMD). (Source: Drug Development Technology)
Source: Drug Development Technology - March 10, 2017 Category: Pharmaceuticals Source Type: news

M & As this week: Pelican Therapeutics, Thru Pharma
Clinical-stage biopharmaceutical company Heat Biologics has signed a definitive agreement to purchase 80% stake in US-based immuno-oncology company Pelican Therapeutics. (Source: Drug Development Technology)
Source: Drug Development Technology - March 10, 2017 Category: Pharmaceuticals Source Type: news

TiGenix reports positive top-line results from Phase III trial of Cx601 for perianal fistulas
Belgium-based biopharmaceutical company TiGenix has reported positive top-line week 104 results from the Phase III clinical trial (ADMIRE-CD) of Cx601 for the treatment of complex perianal fistulas in patients with Crohn's disease. (Source: Drug Development Technology)
Source: Drug Development Technology - March 10, 2017 Category: Pharmaceuticals Source Type: news

BerGenBio and Merck collaborate for BGB324 and Keytruda evaluation in NSCLC and TNBC
Biopharmaceutical firm BerGenBio has entered a collaborative agreement with Merck (MSD) to evaluate the combination of its BGB324 with Merck's Keytruda (pembrolizumab) to treat patients with advanced non-small-cell lung cancer (NSCLC) and triple-nega … (Source: Drug Development Technology)
Source: Drug Development Technology - March 10, 2017 Category: Pharmaceuticals Source Type: news

Deals this week: Spero Therapeutics, BioCryst Pharmaceuticals, Breath Therapeutics Holding
Spero Therapeutics has announced it has raised $51.7m in a series C financing round led by GV (formerly Google Ventures). (Source: Drug Development Technology)
Source: Drug Development Technology - March 10, 2017 Category: Pharmaceuticals Source Type: news

Qtern (dapagliflozin and saxagliptin) for the Treatment of Type 2 Diabetes
Qtern (dapagliflozin and saxagliptin) is a combination drug with sodium/glucose cotransporter (SGLT) 2 and dipeptidyl peptidase 4 (DPP-4) inhibitors indicated for the treatment of type 2 diabetes. (Source: Drug Development Technology)
Source: Drug Development Technology - March 9, 2017 Category: Pharmaceuticals Source Type: news

Menlo's serlopitant meets endpoints in Phase II trial to treat prurigo nodularis patients
Pharmaceutical company Menlo Therapeutics' serlopitant has met the primary and secondary endpoints in the Phase II clinical trial (TCP-102) for the treatment of pruritus associated with prurigo nodularis. (Source: Drug Development Technology)
Source: Drug Development Technology - March 9, 2017 Category: Pharmaceuticals Source Type: news

Celyad to begin Phase Ib trial of NKR-2 CAR-T to treat seven cancer indications
Belgium-based biopharmaceutical company Celyad has secured the US Food and Drug Administration (FDA) approval to begin the Phase Ib THINK trial of NKR-2 CAR-T cells for the treatment of five solid cancers and two hematological malignancies. (Source: Drug Development Technology)
Source: Drug Development Technology - March 9, 2017 Category: Pharmaceuticals Source Type: news

St George ’s University of London begins trial of malaria drug artesunate for cancer treatment
St George ’s University of London has begun a clinical trial of common malaria drug artesunate, priced at 70p, for the treatment of cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - March 9, 2017 Category: Pharmaceuticals Source Type: news

Shin-Etsu Purchase Gamlen D Series for Formulation Studies
Provider of a wide range of cellulose ether excipients Shin-Etsu PFMD has purchased a Gamlen D series powder compaction analyser for a laboratory application in Wiesbaden, Germany. (Source: Drug Development Technology)
Source: Drug Development Technology - March 8, 2017 Category: Pharmaceuticals Source Type: news

Gamlen D Series - Advanced Tableting Research Dynamic Compaction Analysis
The Gamlen D Series is a real-time powder compaction analyser in a unique benchtop design. (Source: Drug Development Technology)
Source: Drug Development Technology - March 8, 2017 Category: Pharmaceuticals Source Type: news

Deciphera Pharmaceuticals commences Phase I trial of DCC-3014 for advanced malignancies
Clinical-stage biopharmaceutical firm Deciphera Pharmaceuticals has commenced a Phase I clinical trial of DCC-3014 for the treatment of patients with advanced malignancies. (Source: Drug Development Technology)
Source: Drug Development Technology - March 8, 2017 Category: Pharmaceuticals Source Type: news

Regenxbio commences dosing in Phase I/II trial of RGX-501 to treat HoFH
US-based clinical-stage biotechnology firm Regenxbio has commenced dosing in a Phase I/II clinical trial of its gene therapy RGX-501 to treat homozygous familial hypercholesterolemia (HoFH). (Source: Drug Development Technology)
Source: Drug Development Technology - March 8, 2017 Category: Pharmaceuticals Source Type: news

Immunicum begins enrolment in Phase I/II trial of INTUVAX to treat GIST
Swedish-based biopharmaceutical company Immunicum has commenced enrolment in the Phase I/II clinical trial of INTUVAX for the treatment of patients with gastrointestinal stromal tumour (GIST). (Source: Drug Development Technology)
Source: Drug Development Technology - March 8, 2017 Category: Pharmaceuticals Source Type: news

Malvern March Webinars
Malvern is hosting two webinars this month: Differential scanning calorimetry (robust and powerful physical characterisation of therapeutic protein products) and Cement (composition, structure, and fineness - we are stronger together!). (Source: Drug Development Technology)
Source: Drug Development Technology - March 7, 2017 Category: Pharmaceuticals Source Type: news

February's top stories: Merck's Phase III HIV-1 trial results, NIH's Phase I AGS-v vaccine trial
Merck reported positive results from the Phase III trial of its non-nucleoside reverse transcriptase inhibitor (NNRTI) doravirine (MK-1439) for the treatment of patients with HIV-1 infection, and NIH's NIAID initiated a Phase I trial of vaccine AGS-v … (Source: Drug Development Technology)
Source: Drug Development Technology - March 7, 2017 Category: Pharmaceuticals Source Type: news

Chi-Med's Phase III cancer trial of fruquintinib meets primary endpoint
Biopharmaceutical company Hutchison China MediTech (Chi-Med) has reported top-line results from its Phase III pivotal registration trial (FRESCO) of fruquintinib (HMPL-013) in 416 patients with locally advanced or metastatic colorectal cancer (CRC) i … (Source: Drug Development Technology)
Source: Drug Development Technology - March 7, 2017 Category: Pharmaceuticals Source Type: news

Daiichi Sankyo begins enrolment in Phase IIIb trial of edoxaban to treat atrial fibrillation
Japanese-based pharmaceutical firm Daiichi Sankyo has begun enrolment in the Phase IIIb ENTRUST-AF PCI clinical trial of edoxaban for the treatment of atrial fibrillation patients who have undergone percutaneous coronary intervention (PCI) with stent … (Source: Drug Development Technology)
Source: Drug Development Technology - March 7, 2017 Category: Pharmaceuticals Source Type: news

Merck reports positive data from Phase Ib trial of M1095 in psoriasis patients
Ablynx ’s partner Merck has presented new data from a Phase Ib trial of the bi-specific anti-IL-17A/F Nanobody (M1095; ALX-0761) in patients with psoriasis. (Source: Drug Development Technology)
Source: Drug Development Technology - March 7, 2017 Category: Pharmaceuticals Source Type: news

BeiGene begins dosing in Phase II trial of BGB-3111 to treat MCL in China
Clinical-stage biopharmaceutical firm BeiGene has begun dosing in its Phase II clinical trial of BGB-3111 for the treatment of patients with mantle-cell lymphoma (MCL) in China. (Source: Drug Development Technology)
Source: Drug Development Technology - March 6, 2017 Category: Pharmaceuticals Source Type: news

Celgene reports positive results in Phase IV trial of Otezla to treat moderate plaque psoriasis
US-based Celgene has reported positive results in a Phase IV trial (Unveil) that evaluates its oral, phosphodiesterase 4 (PDE4) inhibitor Otezla (apremilast) in patients with moderate plaque psoriasis with a body surface area (BSA) of 5% to 10%. (Source: Drug Development Technology)
Source: Drug Development Technology - March 6, 2017 Category: Pharmaceuticals Source Type: news

Janssen reports positive results from two Phase III trials of guselkumab in plaque psoriasis
Janssen Research& Development has reported positive results from two Phase III clinical trials of guselkumab for the treatment of adults with moderate-to-severe plaque psoriasis. (Source: Drug Development Technology)
Source: Drug Development Technology - March 6, 2017 Category: Pharmaceuticals Source Type: news

Pharmatest Joins Biocom and Science Exchange Life Science Organisations in California
Pharmatest Services has announced it has joined two California-based organisations Biocom and Science Exchange. (Source: Drug Development Technology)
Source: Drug Development Technology - March 3, 2017 Category: Pharmaceuticals Source Type: news

Audentes begins Phase I/II run-in study of AT342 to treat Crigler-Najjar Syndrome
US-based biotechnology firm Audentes Therapeutics has begun the run-in study (LUSTRO) for Phase I/II clinical trial (VALENS) of AT342 for the treatment of patients with Crigler-Najjar Syndrome. (Source: Drug Development Technology)
Source: Drug Development Technology - March 3, 2017 Category: Pharmaceuticals Source Type: news

Roche reports positive results from Phase III trial of perjeta combination therapy in breast cancer
Roche has reported positive results from the Phase III (APHINITY) clinical trial of perjeta (pertuzumab) in combination with herceptin (trastuzumab) and chemotherapy for the treatment of patients with breast cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - March 3, 2017 Category: Pharmaceuticals Source Type: news

Deals this week: Corbus Pharmaceuticals Holdings, Dermira, Vycellix
US-based clinical-stage pharmaceutical company Corbus Pharmaceuticals Holdings intends to raise up to $27.2m in gross proceeds through the private placement of 3.8 million shares of its common stock. (Source: Drug Development Technology)
Source: Drug Development Technology - March 3, 2017 Category: Pharmaceuticals Source Type: news

M & As this week: Genesis Biotechnology Group, Betta Pharmaceuticals
Genesis Biotechnology Group has completed the acquisition of PharmOptima, which will enable the former to provide its customers a single point-of-contact for the development and co-ordination of their unique pre-clinical drug development programme. (Source: Drug Development Technology)
Source: Drug Development Technology - March 3, 2017 Category: Pharmaceuticals Source Type: news

Alecensa (alectinib) for Treatment of ALK-positive Non-small Cell Lung Cancer
Alecensa (alectinib) is a kinase inhibitor intended for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). (Source: Drug Development Technology)
Source: Drug Development Technology - March 2, 2017 Category: Pharmaceuticals Source Type: news

Omeros reports positive results from Phase II trial of OMS721 in thrombotic microangiopathy
US-based biopharmaceutical company Omeros has reported positive results from its ongoing Phase II clinical trial of OMS721 for the treatment of patients with hematopoietic stem-cell transplant-associated thrombotic microangiopathy (HCT-TMA). (Source: Drug Development Technology)
Source: Drug Development Technology - March 2, 2017 Category: Pharmaceuticals Source Type: news

Accera's AC-1204 fails to show positive outcome in Phase III trial for Alzheimer's disease
CNS therapeutics company Accera's AC-1204 has failed to demonstrate a positive outcome in the Phase III trial for the treatment of patients with mild-to-moderate Alzheimer's disease. (Source: Drug Development Technology)
Source: Drug Development Technology - March 2, 2017 Category: Pharmaceuticals Source Type: news

Myovant Sciences commences Phase III trial of relugolix to treat advanced prostate cancer
Clinical-stage biopharmaceutical company Myovant Sciences has commenced a Phase III clinical trial (HERO) of relugolix for the treatment of advanced prostate cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - March 2, 2017 Category: Pharmaceuticals Source Type: news

An Introduction to Successful Strategies International
This video outlines some of the project management training and certification, and professional assistance, offered by SSI. (Source: Drug Development Technology)
Source: Drug Development Technology - March 1, 2017 Category: Pharmaceuticals Source Type: news

NoNO begins Phase III trial of NA-1 to treat acute ischemic stroke
Canadian-based biotechnology company NoNO has begun the Phase III clinical trial (ESCAPE-NA-1) of NA-1 for the treatment of patients with acute ischemic stroke (AIS). (Source: Drug Development Technology)
Source: Drug Development Technology - March 1, 2017 Category: Pharmaceuticals Source Type: news

Sunovion reports positive top-line results from Phase III trial of latuda for bipolar depression
US-based biopharmaceutical company Sunovion Pharmaceuticals has reported positive top-line results from its Phase III clinical trial of latuda (lurasidone HCl) for the treatment of depression associated with bipolar I disorder (bipolar depression). (Source: Drug Development Technology)
Source: Drug Development Technology - March 1, 2017 Category: Pharmaceuticals Source Type: news

ASIT reports positive outcome from Phase III trial of gp-ASIT+ in allergic rhinitis by pollen
Belgian clinical-stage biopharmaceutical firm ASIT Biotech has reported positive results from its Phase III clinical trial of gp-ASIT+ for the treatment of patients with grass pollen-induced allergic rhinitis. (Source: Drug Development Technology)
Source: Drug Development Technology - March 1, 2017 Category: Pharmaceuticals Source Type: news

NUI Galway initiates Phase I trial of daratumumab in Irish patients with multiple myeloma
The National University of Ireland (NUI) Galway has initiated the Phase I clinical trial of daratumumab combination therapy in Irish patients for the treatment of multiple myeloma. (Source: Drug Development Technology)
Source: Drug Development Technology - February 28, 2017 Category: Pharmaceuticals Source Type: news

Merck ’s letermovir meets primary endpoint in Phase III trial to prevent CMV infection
Healthcare firm Merck has reported positive results from the Phase III clinical trial of anti-viral drug letermovir to prevent cytomegalovirus (CMV) infection in recipients of bone marrow transplant. (Source: Drug Development Technology)
Source: Drug Development Technology - February 28, 2017 Category: Pharmaceuticals Source Type: news

Exelixis and Roche partner for Phase Ib trial of cabozantinib+atezolizumab in solid tumours
Biopharmaceutical firm Exelixis has collaborated with healthcare firm Roche to evaluate the combination of cabozantinib and atezolizumab in a Phase Ib clinical trial to treat patients with metastatic solid tumours. (Source: Drug Development Technology)
Source: Drug Development Technology - February 28, 2017 Category: Pharmaceuticals Source Type: news