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Deals this week: Protagen, Spring Bank Pharmaceuticals, Iatric Systems
Protagen and Novartis Pharma have entered an agreement to clinically develop a compound for an autoimmune disease. (Source: Drug Development Technology)
Source: Drug Development Technology - January 6, 2017 Category: Pharmaceuticals Source Type: news

Halozyme Therapeutics reports positive top-line results from HALO 202 study of PEGPH20
US-based biotechnology company Halozyme Therapeutics has reported positive topline results from a combined analysis of two stages of its Phase II HALO 202 study of PEGPH20 in combination with abraxane and gemcitabine to treat pancreatic cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - January 6, 2017 Category: Pharmaceuticals Source Type: news

M & As this week: Northern Biologics, Novartis, Asahi Glass
Northern Biologics has merged with Mosaic Biomedicals with the aim of expanding its pipeline and accelerating the development of MSC-1. (Source: Drug Development Technology)
Source: Drug Development Technology - January 6, 2017 Category: Pharmaceuticals Source Type: news

Gamlen R series Featured in International Journal of Pharmaceutics Paper
'Characterisation of Tableting Properties Measured with a Multi-functional Compaction Instrument for Several Pharmaceutical Excipients and Actual Tablet Formulations' is the latest paper to be published in the International Journal of Pharmaceutics d … (Source: Drug Development Technology)
Source: Drug Development Technology - January 5, 2017 Category: Pharmaceuticals Source Type: news

Gamlen Tablet Press Show Similar Capabilities to Fette 2090 High-Speed Tablet Press
Two formulations compacted on the Gamlen Tablet Press have shown matching results with production data obtained on high-speed rotary tablet press Fette 2090. (Source: Drug Development Technology)
Source: Drug Development Technology - January 5, 2017 Category: Pharmaceuticals Source Type: news

Glenmark receives IND application clearance to begin Phase I trial of GBR 1302-BEAT for HER2+ cancer
The US Food and Drug Administration (FDA) has cleared pharmaceutical company Glenmark ’s investigational new drug (IND) application to begin a phase I trial of GBR 1302-BEAT to treat HER2+ cancers. (Source: Drug Development Technology)
Source: Drug Development Technology - January 5, 2017 Category: Pharmaceuticals Source Type: news

TG Therapeutics begins Phase II trial of TGR-1202 and ibrutinib combination to treat DLBCL
US-based biopharmaceutical company TG Therapeutics has begun its Phase II investigator initiated trial of TGR-1202 in combination with ibrutinib to treat relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL). (Source: Drug Development Technology)
Source: Drug Development Technology - January 5, 2017 Category: Pharmaceuticals Source Type: news

Ogeda reports positive top-line data from Phase IIa trial of fezolinetant to treat menopausal hot flashes
Belgium-based clinical-stage drug discovery company Ogeda has reported positive top-line data from its Phase IIa trial of fezolinetant (ESN364) to treat menopausal hot flashes (HF). (Source: Drug Development Technology)
Source: Drug Development Technology - January 5, 2017 Category: Pharmaceuticals Source Type: news

Ardelyx begins two clinical trials of RDX7675 to treat hyperkalemia
US-based clinical-stage company Ardelyx has begun a Phase III clinical trial and another onset-of-action clinical trial of RDX7675 to treat hyperkalemia. (Source: Drug Development Technology)
Source: Drug Development Technology - January 4, 2017 Category: Pharmaceuticals Source Type: news

Scancell reports positive Phase I/II trial results of SCIB1 to treat malignant melanoma
UK-based Scancell has reported completion of its Phase I/II clinical trial of SCIB1 with positive results while treating patients with Stage III/IV malignant melanoma. (Source: Drug Development Technology)
Source: Drug Development Technology - January 4, 2017 Category: Pharmaceuticals Source Type: news

Gamlen Instruments-Benchtop Tablet Manufacture Instruments, Research Analysers, and Formulation Training for Drug Development
Gamlen Instruments provides high-performance manufacturing and research instruments to support the creation of innovative drug products. (Source: Drug Development Technology)
Source: Drug Development Technology - January 4, 2017 Category: Pharmaceuticals Source Type: news

Saniona reports positive results from Phase IIa trial of Tesomet to treat type 2 diabetes
Denmark-based biotech company Saniona has reported positive results from its Phase IIa clinical trial of Tesomet to treat type 2 diabetes. (Source: Drug Development Technology)
Source: Drug Development Technology - January 4, 2017 Category: Pharmaceuticals Source Type: news

2016: The year's biggest Drug Development Technology stories
NIAID began a new HIV vaccine study in South Africa and Eli Lilly ’s Phase III trial of Alzheimer disease drug failed. Drugdevelopment-technology wraps-up the key headlines from 2016. (Source: Drug Development Technology)
Source: Drug Development Technology - January 3, 2017 Category: Pharmaceuticals Source Type: news

Incyte begins Phase II REACH-1 trial of ruxolitinib combined with corticosteroids to treat GVHD
US-based biopharmaceutical company Incyte has commenced its Phase II REACH-1 pivotal trial of ruxolitinib (Jakafi) combined with corticosteroids to treat steroid-refractory acute graft-versus-host disease (GVHD). (Source: Drug Development Technology)
Source: Drug Development Technology - January 3, 2017 Category: Pharmaceuticals Source Type: news

NIH reports positive results from Phase I trial of selumetinib to treat pediatric neural tumours
The US National Institutes of Health (NIH) has reported positive results from its Phase I clinical trial of selumetinib to treat children with the common genetic disorder neurofibromatosis type 1 (NF1) and plexiform neurofibromas. (Source: Drug Development Technology)
Source: Drug Development Technology - January 3, 2017 Category: Pharmaceuticals Source Type: news

BeiGene commences Phase I trial of BGB-A317 in China to treat solid tumours
Clinical-stage biopharmaceutical company BeiGene has commenced its Phase I clinical trial of BGB-A317 in China to treat advanced solid tumours. (Source: Drug Development Technology)
Source: Drug Development Technology - January 3, 2017 Category: Pharmaceuticals Source Type: news

Season ’s Greetings
Drugdevelopment-technology.com will be taking a short break over the holiday season. (Source: Drug Development Technology)
Source: Drug Development Technology - December 23, 2016 Category: Pharmaceuticals Source Type: news

UK approves Prima BioMed to initiate Phase II b trial of IMP321 to treat metastatic breast cancer
Australian biotechnology firm Prima BioMed has secured approval from the UK ’s Competent Authority and Ethics Committee to begin a Phase II b, active immunotherapy paclitaxel (AIPAC) trial of its IMP321 drug to treat metastatic breast cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - December 22, 2016 Category: Pharmaceuticals Source Type: news

BeiGene begins Phase I trial of BGB-290 in China to treat solid tumours
US-based clinical-stage biopharmaceutical company BeiGene has begun its Phase I clinical trial of BGB-290 in China to treat advanced solid tumours. (Source: Drug Development Technology)
Source: Drug Development Technology - December 22, 2016 Category: Pharmaceuticals Source Type: news

NIAID initiates Phase III HPTN 083 trial of anti-HIV drug
The National Institute of Allergy and Infectious Diseases (NIAID) in the US has initiated the Phase III HPTN 083 trial of cabotegravir and truvada to treat men and transgender women with HIV. (Source: Drug Development Technology)
Source: Drug Development Technology - December 22, 2016 Category: Pharmaceuticals Source Type: news

Janssen reports positive results in Phase III combination trial to treat HIV
Janssen Sciences Ireland (Janssen) has reported positive results in the first of the two Phase III studies that evaluate the safety and efficacy of switching virologically suppressed patients from a three or four drug anti-retroviral regimen to the t … (Source: Drug Development Technology)
Source: Drug Development Technology - December 21, 2016 Category: Pharmaceuticals Source Type: news

Pharnext completes patient enrolment in Phase lll trial of PXT3003 to treat CMT1A
French biopharmaceutical company Pharnext has completed the enrolment of patients for its new Phase lll PLEO-CMT trial of PXT3003 for the treatment of Charcot-Marie-Tooth disease type 1A (CMT1A). (Source: Drug Development Technology)
Source: Drug Development Technology - December 21, 2016 Category: Pharmaceuticals Source Type: news

ContraVir reports positive Phase IIa trial data of tenofovir exalidex to treat Hepatitis B infection
US-based biopharmaceutical company ContraVir has reported positive data from its ongoing Phase IIa trial of tenofovir exalidex (TXL) to treat Hepatitis B infection. (Source: Drug Development Technology)
Source: Drug Development Technology - December 21, 2016 Category: Pharmaceuticals Source Type: news

Loxo Oncology reports positive results from Phase I study of larotrectinib to treat TRK fusion cancers
US-based biopharmaceutical company Loxo Oncology has reported positive results from its Phase I study of larotrectinib (LOXO-101) to treat tropomyosin receptor kinase (TRK) fusion cancers. (Source: Drug Development Technology)
Source: Drug Development Technology - December 20, 2016 Category: Pharmaceuticals Source Type: news

ENYO Pharma conducts Phase I clinical trial of EYP001 to treat hepatitis infection
French biopharmaceutical company ENYO Pharma is conducting its Phase I single and multiple ascending dose trial of EYP001 to treat Chronic Hepatitis B (CHB) Virus infection. (Source: Drug Development Technology)
Source: Drug Development Technology - December 20, 2016 Category: Pharmaceuticals Source Type: news

GSK and Innoviva begin Phase III Captain study of triple combination therapy to treat asthma
GlaxoSmithKline (GSK) and Innoviva have initiated a Phase III Captain study of a triple combination therapy consisting of fluticasone furoate / umeclidinium / vilanterol (FF/UMEC/VI) compared to dual combination therapy of Relvar / Breo (FF/VI) to tr … (Source: Drug Development Technology)
Source: Drug Development Technology - December 20, 2016 Category: Pharmaceuticals Source Type: news

Catalyst begins enrolment for second Phase III LMS-003 trial of Firdapse to treat LEMS
US-based biopharmaceutical company Catalyst has begun enrolment for its second Phase III LMS-003 clinical trial of Firdapse to treat Lambert-Eaton myasthenic syndrome (LEMS). (Source: Drug Development Technology)
Source: Drug Development Technology - December 19, 2016 Category: Pharmaceuticals Source Type: news

Kiadis Pharma receives approval to begin Phase I/II trial of ATIR201 to treat thalassemia
Netherlands-based Kiadis Pharma has secured regulatory approval from the UK ’s Medicines and Healthcare products Regulatory Agency (MHRA) and Ethics Committees of the Royal Manchester Children’s Hospital and the Birmingham Children’s Hospital to initi… (Source: Drug Development Technology)
Source: Drug Development Technology - December 19, 2016 Category: Pharmaceuticals Source Type: news

Soliqua 100/33 for the Treatment of Type 2 Diabetes
Developed by Sanofi, Soliqua 100/33 (insulin glargine& Lixisenatide injection) is indicated for the treatment of Type 2 diabetes. (Source: Drug Development Technology)
Source: Drug Development Technology - December 19, 2016 Category: Pharmaceuticals Source Type: news

Noxxon to collaborate with Merck for Phase I/II trial of NOX-A12 and Keytruda to treat cancer
German clinical-stage biopharmaceutical company Noxxon has signed a collaboration agreement with Merck to conduct a Phase I/II clinical trial of NOX-A12 and Keytruda to treat solid tumours unresponsive to checkpoint inhibitor monotherapy. (Source: Drug Development Technology)
Source: Drug Development Technology - December 19, 2016 Category: Pharmaceuticals Source Type: news

M & As this week: Pfizer, KDB Capital
Pfizer has acquired 50% stake in IGNITE Immunotherapy. Pursuant to the acquisition, Pfizer will hold 50% equity investment in IGNITE and be responsible for providing research and development funding for three years. (Source: Drug Development Technology)
Source: Drug Development Technology - December 16, 2016 Category: Pharmaceuticals Source Type: news

vTv Therapeutics reports positive topline data from Phase II trial of TTP273 to treat Type 2 diabetes
US-based clinical-stage biopharmaceutical company vTv Therapeutics has reported positive topline results from its Phase II trial of TTP273 to treat Type 2 diabetes. (Source: Drug Development Technology)
Source: Drug Development Technology - December 16, 2016 Category: Pharmaceuticals Source Type: news

Successful Strategies International-Customized Project Management and Leadership Development Courses
For ten years Successful Strategies International (SSI) has been delivering quality and cost-effective training to organizations around the globe.   We are a successful training, leadership and mentori... (Source: Drug Development Technology)
Source: Drug Development Technology - December 16, 2016 Category: Pharmaceuticals Source Type: news

Deals this week: Applied BioMath, Mironid, ApoGen Biotechnologies
Applied BioMath and Tusk Therapeutics NV have entered a co-development agreement to quantify and analyse the drug properties and select pre-clinical drug candidates within immuno-oncology. (Source: Drug Development Technology)
Source: Drug Development Technology - December 16, 2016 Category: Pharmaceuticals Source Type: news

Knopp Biosciences reports positive data from pilot study of dexpramipexole to treat HES
US-based drug discovery and development company Knopp Biosciences has reported positive data from its pilot study of dexpramipexole to treat patients with hypereosinophilic syndromes (HES). (Source: Drug Development Technology)
Source: Drug Development Technology - December 16, 2016 Category: Pharmaceuticals Source Type: news

Cancer Research UK reports positive Phase III OAK trial of atezolizumab in treating lung cancer
Cancer Research UK has reported that the Phase III OAK clinical trial of atezolizumab (Tecentriq) conducted by German-based University Goettingen to treat patients with lung cancer has achieved positive results. (Source: Drug Development Technology)
Source: Drug Development Technology - December 15, 2016 Category: Pharmaceuticals Source Type: news

Zealand Pharma begins Phase IIa trial of dasiglucagon in artificial pancreas system to treat hypoglycaemia
Denmark-based Zealand Pharma (Zealand) has begun its Phase IIa clinical trial of dasiglucagon in a dual-hormone artificial (or bionic) pancreas system from Beta Bionics for hypoglycaemia. (Source: Drug Development Technology)
Source: Drug Development Technology - December 15, 2016 Category: Pharmaceuticals Source Type: news

CTT begins Phase I trial of CTT1057 to treat men with high-risk metastatic prostate cancer
US-based biotechnology firm Cancer Targeted Technology (CTT) has begun its Phase I clinical trial of CTT1057 in men with high-risk metastatic prostate cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - December 14, 2016 Category: Pharmaceuticals Source Type: news

Achaogen reports positive Phase III EPIC and CARE trials of plazomicin to treat cUTI and CRE
US-based biopharmaceutical company Achaogen has reported positive results from its Phase III EPIC registration trial and Phase III CARE trial of plazomicin to treat patients with complicated urinary tract infections (cUTI) and carbapenem-resistant En … (Source: Drug Development Technology)
Source: Drug Development Technology - December 14, 2016 Category: Pharmaceuticals Source Type: news

MorphoSys begins Phase II COSMOS trial of MOR208 combined with idelalisib to treat CLL or SLL
German biotechnology company MorphoSys has initiated its Phase II COSMOS trial of MOR208 combined with idelalisib (Zydelig) to treat adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). (Source: Drug Development Technology)
Source: Drug Development Technology - December 14, 2016 Category: Pharmaceuticals Source Type: news

Ophthotech reports Phase III trials of Fovista to treat wet AMD fail to meet primary endpoint
US-based biopharmaceutical company Ophthotech has reported that its two pivotal Phase III clinical trials of Fovista (pegpleranib) failed to meet its pre-specified primary endpoint while treating wet age-related macular degeneration (AMD). (Source: Drug Development Technology)
Source: Drug Development Technology - December 13, 2016 Category: Pharmaceuticals Source Type: news

University of Miami reports positive Phase II trial result of arimoclomol to treat ALS
University of Miami Miller School of Medicine has reported positive data from its Phase II trial of arimoclomol to treat amyotrophic lateral sclerosis (ALS). (Source: Drug Development Technology)
Source: Drug Development Technology - December 13, 2016 Category: Pharmaceuticals Source Type: news

Corcept Therapeutics reports positive Phase I/II trial data of CORT125281 to treat TNBC
US-based pharmaceutical company Corcept Therapeutics has reported positive data from its Phase I/II trial of CORT125281 by adding mifepristone to the compound to treat patients with metastatic triple-negative breast cancer (TNBC). (Source: Drug Development Technology)
Source: Drug Development Technology - December 13, 2016 Category: Pharmaceuticals Source Type: news

Malvern Experts to Host 'Festive' Webinar Personally Answering Letters to Father Characterisation
Malvern has announced it will host a live-panel webinar for the discussion of challenges submitted in an online form on the company's website. (Source: Drug Development Technology)
Source: Drug Development Technology - December 12, 2016 Category: Pharmaceuticals Source Type: news

AstraZeneca reports results of subgroup analysis from Phase III FALCON trial
AstraZeneca has reported results from a pre-specified subgroup analysis of the positive Phase III FALCON trial, indicating that treatment effects in terms of progression-free survival (PFS) were mostly consistent across the subgroups analysed with so … (Source: Drug Development Technology)
Source: Drug Development Technology - December 12, 2016 Category: Pharmaceuticals Source Type: news

Soligenix reports positive long-term follow-up results from its Phase 2 clinical trial of SGX942
Soligenix has announced the long-term follow-up data results from its Phase 2 clinical trial with SGX942 (dusquetide), a first-in-class Innate Defense Regulator (IDR), in the treatment of oral mucositis (OM) in head and neck cancer patients undergoin … (Source: Drug Development Technology)
Source: Drug Development Technology - December 12, 2016 Category: Pharmaceuticals Source Type: news

EIP Pharma announces positive results with neflamapimod in two Phase IIa clinical trials of Alzheimer's disease
EIP Pharma has secured proof-of-mechanism for neflamapimod (previously named VX-745), with the results of two recently completed Phase IIa clinical trials that indicated significant Alzheimer's disease-relevant pharmacological activity. (Source: Drug Development Technology)
Source: Drug Development Technology - December 12, 2016 Category: Pharmaceuticals Source Type: news

Valeant reports positive results from IDP-118 Phase III clinical study
Valeant Pharmaceuticals has reported positive results from a Phase III clinical study to evaluate the safety of IDP-118 (halobetasol propionate and tazarotene) lotion in the treatment of plaque psoriasis. (Source: Drug Development Technology)
Source: Drug Development Technology - December 9, 2016 Category: Pharmaceuticals Source Type: news

Deals this week: Sanofi, Breckenridge Pharmaceuticals, VBI Vaccines
Sanofi and JHL Biotech have entered an agreement to expand their presence and develop modern therapies for patients in China. (Source: Drug Development Technology)
Source: Drug Development Technology - December 9, 2016 Category: Pharmaceuticals Source Type: news

Merck reports positive HRQoL in phase 3 KEYNOTE-024 trial of KEYTRUDA (pembrolizumab)
Merck (MSD) has reported positive health-related quality of life (HRQoL) findings from an exploratory analysis from the phase 3 KEYNOTE-024 trial investigating the use of KEYTRUDA (pembrolizumab) for the treatment of patients with metastatic non-smal … (Source: Drug Development Technology)
Source: Drug Development Technology - December 9, 2016 Category: Pharmaceuticals Source Type: news