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Breaking Down Complex Generics
Pharmaceutical consulting and generic drug professionals: What is your hedge against the increasingly crowded traditional drug markets? (Source: Drug Development Technology)
Source: Drug Development Technology - June 22, 2017 Category: Pharmaceuticals Source Type: news

InDex initiates enrolment for Phase IIb trial of cobitolimod to treat ulcerative colitis
Sweden-based InDex Pharmaceuticals has started patient enrolment in Phase IIb CONDUCT clinical trial of cobitolimod for treatment of patients with ulcerative colitis. (Source: Drug Development Technology)
Source: Drug Development Technology - June 21, 2017 Category: Pharmaceuticals Source Type: news

Immune Pharma starts enrolment in Phase I/II trial of Ceplene for CMML
Immune Pharmaceuticals has started patient recruitment for Phase I/II clinical trial of Ceplene (histamine dihydrochloride) to treat chronic myelomonocytic leukaemia (CMML) patients.   (Source: Drug Development Technology)
Source: Drug Development Technology - June 21, 2017 Category: Pharmaceuticals Source Type: news

New Phase I/II trial indicates positive outcome for Astellas' cancer drug
US researchers at the University of Pennsylvania ’s (Penn) Perelman School of Medicine and Abramson Cancer Centre have reported positive data from a Phase I/II clinical trial of Astellas Pharmaceuticals’ new drug gilteritinib in patients with acute my… (Source: Drug Development Technology)
Source: Drug Development Technology - June 21, 2017 Category: Pharmaceuticals Source Type: news

Genexine to conduct Phase Ib/II combination trial of cervical cancer drug GX-188E
Biotechnology firm Genexine has secured approval from the South Korean Ministry of Food and Drug Safety (MFDS) to conduct a Phase Ib/II trial of GX-188E vaccine in combination with Keytruda (pembrolizumab) in patients with non-resectable cervical can … (Source: Drug Development Technology)
Source: Drug Development Technology - June 20, 2017 Category: Pharmaceuticals Source Type: news

Effector, Pfizer and Merck to initiate Phase II combination trial for colorectal cancer
Effector Therapeutics has signed a clinical collaboration and supply agreement with Pfizer and Merck to initiate a Phase II clinical trial of immuno-oncology drugs combination to treat microsatellite stable colorectal cancer (CRC) patients. (Source: Drug Development Technology)
Source: Drug Development Technology - June 20, 2017 Category: Pharmaceuticals Source Type: news

Hansa Medical begins IdeS dosing in Phase II trial for anti-GBM antibody disease
Swedish biopharmaceutical firm Hansa Medical has begun dosing patients in its Phase II clinical trial of drug candidate IgG degrading enzyme of Streptococcus pyogenes (IdeS), to treat patients with severe anti-GBM antibody disease / Goodpasture ’s dis… (Source: Drug Development Technology)
Source: Drug Development Technology - June 20, 2017 Category: Pharmaceuticals Source Type: news

Synlogic begins dosing in Phase I trial of SYNB1020 to treat hyperammonemia
Synlogic has begun dosing healthy volunteers in its Phase I clinical trial of SYNB1020 for the treatment of hyperammonemia associated with diseases such as urea cycle disorders (UCD) and hepatic encephalopathy (HE). (Source: Drug Development Technology)
Source: Drug Development Technology - June 19, 2017 Category: Pharmaceuticals Source Type: news

GSK ’s Benlysta shows positive outcome in Phase II continuation trial for SLE
GlaxoSmithKline (GSK) reported positive data from the Phase II ten-year continuation clinical trial of Benlysta (belimumab) in combination with standard-of-care for patients suffering from systemic lupus erythematosus (SLE). (Source: Drug Development Technology)
Source: Drug Development Technology - June 19, 2017 Category: Pharmaceuticals Source Type: news

Seattle Genetics stops Phase III trial of leukaemia drug due to high death rate
Biotechnology firm Seattle Genetics has stopped the Phase III CASCADE clinical trial of vadastuximab talirine (SGN-CD33A) in older patients with frontline acute myeloid leukaemia (AML). (Source: Drug Development Technology)
Source: Drug Development Technology - June 19, 2017 Category: Pharmaceuticals Source Type: news

Xencor reports interim positive results from Phase II trial of XmAb5871 for IgG4-RD
Biopharmaceutical firm Xencor has reported interim positive results from the Phase II clinical trial of XmAb5871 for the treatment of patients with active IgG4-Related Disease (IgG4-RD). (Source: Drug Development Technology)
Source: Drug Development Technology - June 18, 2017 Category: Pharmaceuticals Source Type: news

Galera enrols last patient in Phase IIb trial of GC4419 to treat oral mucositis
US-based biotechnology company Galera Therapeutics has concluded enrolment in the Phase IIb clinical trial of GC4419 for the treatment of oral mucositis (OM) in patients with head and neck cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - June 18, 2017 Category: Pharmaceuticals Source Type: news

Novartis reports favourable data from Phase III extension trial of Cosentyx for AS
Novartis has reported positive results from the Phase III MEASURE 1 extension trial of Cosentyx (secukinumab) to treat patients with active ankylosing spondylitis (AS). (Source: Drug Development Technology)
Source: Drug Development Technology - June 18, 2017 Category: Pharmaceuticals Source Type: news

Helsinn and MEI begin dosing in Phase II combination trial to treat MDS
Swiss pharmaceutical group Helsinn and US-based oncology firm MEI Pharma have begun dosing patients in a Phase II clinical trial of pracinostat and azacitidine combination for the treatment of patients with myelodysplastic syndromes (MDS). (Source: Drug Development Technology)
Source: Drug Development Technology - June 15, 2017 Category: Pharmaceuticals Source Type: news

Janssen reports positive long-term results from Phase III trial of sirukumab for RA
Janssen-Cilag International (Janssen) has reported positive long-term results from the Phase III SIRROUND-T clinical trial of sirukumab to treat patients with rheumatoid arthritis (RA). (Source: Drug Development Technology)
Source: Drug Development Technology - June 15, 2017 Category: Pharmaceuticals Source Type: news

M & As this week: CSL, Sunflower Pharmaceutical Group, Immunotech Laboratories
Australian biotherapeutics company CSL has reached an agreement with Chinese healthcare company Humanwell Healthcare Group to acquire an 80% equity stake in the latter ’s subsidiary, Wuhan Zhong Yuan Rui De Biological Products (Ruide). (Source: Drug Development Technology)
Source: Drug Development Technology - June 15, 2017 Category: Pharmaceuticals Source Type: news

RedHill Biopharma commences Phase III trial of RHB-105 to treat H. pylori infection
Israeli-based specialist biopharmaceutical firm RedHill Biopharma has commenced a confirmatory Phase III ERADICATE Hp 2 clinical trial of RHB-105 (Talicia) for the treatment of patients with Helicobacter pylori (H. pylori) infection. (Source: Drug Development Technology)
Source: Drug Development Technology - June 15, 2017 Category: Pharmaceuticals Source Type: news

Deals this week: Vertos Medical, Kiadis Pharma, Oxis International
Vertos Medical has closed a venture financing to raise $28m from MVM Life Science Partners, Leerink Revelation Partners, Pitango Venture Capital, ONSET Ventures and Aweida Venture Partners. (Source: Drug Development Technology)
Source: Drug Development Technology - June 15, 2017 Category: Pharmaceuticals Source Type: news

New Oxford study indicates bleeding risk by aspirin in elderly patients
A new study by scientists at Oxford University, UK, showed that long-term use of aspirin may lead to a high risk of disabling or fatal bleeding in patients aged 75 or older. (Source: Drug Development Technology)
Source: Drug Development Technology - June 14, 2017 Category: Pharmaceuticals Source Type: news

Modra Pharma starts enrolment in Phase II trial of modraDoc006/r for prostate cancer
Netherlands-based oncology drugs developer Modra Pharmaceuticals has started patient enrolment in a Phase II clinical trial of modraDoc006/r to treat patients with metastatic castration-resistant prostate cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - June 14, 2017 Category: Pharmaceuticals Source Type: news

Threshold Pharma begins dosing of cancer drugs evofosfamide and ipilimumab in Phase I trial
US-based biopharmaceutical firm Threshold Pharmaceuticals has begun dosing patients in a Phase I clinical trial of evofosfamide in combination with ipilimumab to treat various cancers. (Source: Drug Development Technology)
Source: Drug Development Technology - June 14, 2017 Category: Pharmaceuticals Source Type: news

Boehringer and Lilly to assess empagliflozin for chronic kidney disease
Boehringer Ingelheim, in collaboration with Eli Lilly and Company, is set to evaluate empagliflozin in a new clinical outcomes trial to treat patients suffering from chronic kidney disease. (Source: Drug Development Technology)
Source: Drug Development Technology - June 13, 2017 Category: Pharmaceuticals Source Type: news

Janssen reports positive results from CANVAS programme of canagliflozin
Janssen-Cilag International has reported positive results from the CANVAS programme of INVOKANA (canagliflozin) in combination with standard-of-care to address a combined risk of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non … (Source: Drug Development Technology)
Source: Drug Development Technology - June 13, 2017 Category: Pharmaceuticals Source Type: news

TiGenix initiates Phase III trial of Cx601 to treat perianal fistulas
Belgium-based biopharmaceutical firm TiGenix has marked the initiation of a Phase III clinical trial of Cx601 for the treatment of complex perianal fistulas in Crohn's disease patients with its first European investigator meeting. (Source: Drug Development Technology)
Source: Drug Development Technology - June 13, 2017 Category: Pharmaceuticals Source Type: news

Seres begins Phase III trial of SER-109 to treat recurrent C. difficile infection
US-based microbiome therapeutics developer Seres Therapeutics has begun a Phase III clinical trial of SER-109 for the treatment of patients suffering from multiple recurrent clostridium difficile (C. difficile) infection. (Source: Drug Development Technology)
Source: Drug Development Technology - June 12, 2017 Category: Pharmaceuticals Source Type: news

GSK and MMV report positive headline results from two Phase III trials of tafenoquine
GlaxoSmithKline (GSK) and Swiss-based Medicines for Malaria Venture (MMV) have reported positive headline results from two Phase III clinical trials of tafenoquine to prevent a relapse of malaria caused by Plasmodium vivax (P. vivax). (Source: Drug Development Technology)
Source: Drug Development Technology - June 12, 2017 Category: Pharmaceuticals Source Type: news

Sanofi and Regeneron ’s two Phase IIIb/IV trials of alirocumab meet primary endpoint
Sanofi and Regeneron Pharmaceuticals have reported positive results from the Phase IIIb/IV DM-INSULIN and DM-DYSLIPIDEMIA clinical trials of Praluent (alirocumab) to treat patients with diabetes and hypercholesterolemia. (Source: Drug Development Technology)
Source: Drug Development Technology - June 12, 2017 Category: Pharmaceuticals Source Type: news

Lexicon ’s Phase III trial of sotagliflozin for type 1 diabetes meets primary endpoint
US-based biopharmaceutical firm Lexicon Pharmaceuticals has reported positive top-line results from the Phase III inTandem3 clinical trial of sotagliflozin to treat type 1 diabetes patients on any background insulin therapy. (Source: Drug Development Technology)
Source: Drug Development Technology - June 11, 2017 Category: Pharmaceuticals Source Type: news

Merck and Pfizer report positive results from two Phase III trials of ertugliflozin
Merck and Pfizer have reported positive results from the Phase III VERTIS MET and VERTIS SITA clinical trials of ertugliflozin for patients with type 2 diabetes. (Source: Drug Development Technology)
Source: Drug Development Technology - June 11, 2017 Category: Pharmaceuticals Source Type: news

Inovio initiates Phase III trial of VGX-3100 to treat HPV-related cervical pre-cancer
Inovio Pharmaceuticals has initiated its Phase III REVEAL clinical programme of VGX-3100 for the treatment of cervical dysplasia associated with human papillomavirus (HPV), following a clinical hold removal by the US Food and Drug Administration (FDA … (Source: Drug Development Technology)
Source: Drug Development Technology - June 11, 2017 Category: Pharmaceuticals Source Type: news

Truxima (rituximab) for the Treatment of Cancer
ruxima ™ (rituximab) is the first biosimilar monoclonal antibody (mAb) approved for the treatment of haematological cancers, including diffuse large B-cell lymphoma, follicular lymphoma, chronic lymphocytic leukaemia, and rheumatoid arthritis, as well… (Source: Drug Development Technology)
Source: Drug Development Technology - June 8, 2017 Category: Pharmaceuticals Source Type: news

Deals this week: Marina Biotech, Strekin, H. Lundbeck
Marina Biotech has acquired Prestalia, a drug indicated for the treatment of hypertension to low blood pressure from Symplmed Pharmaceuticals. (Source: Drug Development Technology)
Source: Drug Development Technology - June 8, 2017 Category: Pharmaceuticals Source Type: news

Aveo Oncology ’s tivozanib enters Phase II part of TiNivo trial for RCC
US-based biopharmaceutical firm Aveo Oncology ’s oral drug candidate tivozanib has advanced into the Phase II part of the Phase I/II TiNivo clinical trial to treat advanced renal cell carcinoma (RCC). (Source: Drug Development Technology)
Source: Drug Development Technology - June 8, 2017 Category: Pharmaceuticals Source Type: news

M & As this week: UCB Pharma, China Meheco
Beryllium Discovery has become a fully owned subsidiary of UK-based pharmaceutical company UCB Pharma, with the latter acquiring the remaining stake in the former. (Source: Drug Development Technology)
Source: Drug Development Technology - June 8, 2017 Category: Pharmaceuticals Source Type: news

Hitachi and MD Anderson to investigate IMPT versus IMRT for oropharyngeal cancer
Japanese-based Hitachi's subsidiary Hitachi Healthcare Americas has signed an agreement to collaborate with the University of Texas MD Anderson Cancer Centre to evaluate the intensity-modulated proton beam therapy (IMPT) in a clinical trial for oroph … (Source: Drug Development Technology)
Source: Drug Development Technology - June 8, 2017 Category: Pharmaceuticals Source Type: news

Alkermes commences Phase III trial of ALKS 3831 in young adults with schizophrenia
Irish biopharmaceutical firm Alkermes has commenced a supportive Phase III ENLIGHTEN-Early clinical trial of ALKS 3831 in young adults with schizophrenia, schizophreniform or bipolar I disorder. (Source: Drug Development Technology)
Source: Drug Development Technology - June 8, 2017 Category: Pharmaceuticals Source Type: news

Pharmatest Ltd Establishes New US-Based Subsidiary Pharmatest LLC
Pharmatest Services LLC is newly established US based contract research organization (CRO) operating in Massachusetts. It offers preclinical efficacy services in oncology and skeletal diseases. The company is a fully owned subsidiary of Pharmatest Se … (Source: Drug Development Technology)
Source: Drug Development Technology - June 8, 2017 Category: Pharmaceuticals Source Type: news

SYSTAG Company Video
SYSTAG specialises in measurements and control technology in laboratory automation. It's state-of-the-art technology offers high-quality automation solutions for the global pharmaceutical industry. (Source: Drug Development Technology)
Source: Drug Development Technology - June 8, 2017 Category: Pharmaceuticals Source Type: news

Alectinib and dacomitinib show potential in separate trials for lung cancer
Data from two separate Phase III clinical trials of lung cancer drugs that target different gene faults in the disease, alectinib (Alecensa) and dacomitinib, indicated promise when compared to existing medication. (Source: Drug Development Technology)
Source: Drug Development Technology - June 7, 2017 Category: Pharmaceuticals Source Type: news

Psoriasis drug demonstrates positive outcome in two Phase III trials
A biologic agent known as tildrakizumab has demonstrated a positive outcome in two Phase III trials conducted by Harvard Medical School ’s Beth Israel Deaconess Medical Centre (BIDMC) in the US to treat patients with plaque psoriasis. (Source: Drug Development Technology)
Source: Drug Development Technology - June 7, 2017 Category: Pharmaceuticals Source Type: news

ArQule begins dosing of ARQ 092 in Phase I/II trial for overgrowth diseases
US-based biopharmaceutical firm ArQule has begun dosing patients with ARQ 092 in a Phase I/II clinical trial to treat patients with rare overgrowth diseases. (Source: Drug Development Technology)
Source: Drug Development Technology - June 7, 2017 Category: Pharmaceuticals Source Type: news

Upcoming Events Malvern
Malvern has announced a number of webinars that will take place throughout June. (Source: Drug Development Technology)
Source: Drug Development Technology - June 7, 2017 Category: Pharmaceuticals Source Type: news

Prostate cancer trial shows improved survivability with additional hormone therapy
The Phase II/III clinical trial (STAMPEDE) currently being conducted by the University of Birmingham, UK, has demonstrated improved survivability of 37% with the use of an additional hormone therapy to treat prostate cancer patients. (Source: Drug Development Technology)
Source: Drug Development Technology - June 6, 2017 Category: Pharmaceuticals Source Type: news

Janssen reports positive follow-up data from Phase III trial of Imbruvica for CLL
Janssen-Cilag International (Janssen) has reported positive data from a four-year follow-up period of its Phase III RESONATE trial of Imbruvica (ibrutinib) to treat relapsed / refractory (R/R) chronic lymphocytic leukaemia (CLL) patients. (Source: Drug Development Technology)
Source: Drug Development Technology - June 6, 2017 Category: Pharmaceuticals Source Type: news

New Phase I/II trial of MV-CHIKV for chikungunya begins enrolment
A new Phase I/II clinical trial of MV-CHIKV sponsored by the National Institutes of Health ’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) for the prevention of the chikungunya virus has begun enrolling healthy adult subjects at… (Source: Drug Development Technology)
Source: Drug Development Technology - June 6, 2017 Category: Pharmaceuticals Source Type: news

MorphoSys initiates Phase III trial of MOR208 and bendamustine for DLBCL
German biotechnology firm MorphoSys has initiated patient enrolment for the Phase III part of the Phase II/III B-MIND clinical trial of MOR208 and bendamustine combination to treat diffuse large B-cell lymphoma (DLBCL). (Source: Drug Development Technology)
Source: Drug Development Technology - June 5, 2017 Category: Pharmaceuticals Source Type: news

Janssen reports positive results from two Phase III combination trials of Darzalex
Janssen Research& Development has reported positive results from the updated Phase III CASTOR and POLLUX clinical trials of Darzalex (daratumumab) combined with bortezomib and dexamethasone or lenalidomide and dexamethasone to treat patients with mu … (Source: Drug Development Technology)
Source: Drug Development Technology - June 5, 2017 Category: Pharmaceuticals Source Type: news

New ovarian cancer drug found to shrink tumours in women
An early clinical trial of a new targeted treatment called ONX-0801 has demonstrated a positive outcome in ovarian cancer patients. (Source: Drug Development Technology)
Source: Drug Development Technology - June 5, 2017 Category: Pharmaceuticals Source Type: news

Top Six Ways to Prevent Particle Sizing Failures with Laser Diffraction
Particle size defines the performance of a wide range of different products, including cement, paint, ink, metal powders, cosmetics, food, and drink. (Source: Drug Development Technology)
Source: Drug Development Technology - June 5, 2017 Category: Pharmaceuticals Source Type: news

May's top stories: Funders and NGOs agreed on new standards, Actinogen's Xanamem in Phase II
Medical research funders and international NGOs agreed to implement the new WHO standards for clinical trials, and Actinogen Medical began patient enrolment and dosing in the Phase II XanADu clinical trial of Xanamem for the treatment of Alzheimer ’s … (Source: Drug Development Technology)
Source: Drug Development Technology - June 4, 2017 Category: Pharmaceuticals Source Type: news