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OncoArendi to evaluate OATD-01 in Phase I trial for asthma
Polish biopharmaceutical company OncoArendi Therapeutics is set to conduct a Phase I clinical trial of its lead drug candidate OATD-01 to treat patients suffering from asthma. (Source: Drug Development Technology)
Source: Drug Development Technology - October 9, 2017 Category: Pharmaceuticals Source Type: news

Mundipharma EDO initiates Phase I/II oncology trial of tinostamustine in US
Switzerland-based Mundipharma EDO has initiated a Phase I/II clinical trial of tinostamustine (EDO-S101) to treat patients with advanced solid tumours in the US. (Source: Drug Development Technology)
Source: Drug Development Technology - October 9, 2017 Category: Pharmaceuticals Source Type: news

NanOlogy starts enrolment in Phase II trial of NanoPac for ovarian cancer
US-based pharmaceutical firm NanOlogy has started patient enrolment in a Phase II clinical trial of intraperitoneal (IP) NanoPac (nanoparticle paclitaxel) sterile suspension to treat ovarian cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - October 9, 2017 Category: Pharmaceuticals Source Type: news

Boehringer and Anthem begin trial to study treatment impact on COPD exacerbations
Boehringer Ingelheim has initiated a pragmatic clinical trial (AIRWISE) in partnership with Anthem and its outcomes research subsidiary HealthCore to investigate the impact of commonly prescribed medicines on exacerbations of chronic obstructive pulm … (Source: Drug Development Technology)
Source: Drug Development Technology - October 8, 2017 Category: Pharmaceuticals Source Type: news

Paratek reports positive data from Phase III trial of omadacycline
Paratek Pharmaceuticals has reported positive safety and efficacy data from a Phase III clinical trial (OPTIC) of its investigational antibiotic, omadacycline, for community-acquired bacterial pneumonia (CABP). (Source: Drug Development Technology)
Source: Drug Development Technology - October 8, 2017 Category: Pharmaceuticals Source Type: news

Sun Pharma ’s Phase III trials of Baclofen GRS fail to meet primary endpoint
India-based Sun Pharma Advanced Research (SPARC) has reported top-line results from two Phase III clinical trials of Baclofen GRS to treat spasticity in patients suffering from multiple sclerosis. (Source: Drug Development Technology)
Source: Drug Development Technology - October 8, 2017 Category: Pharmaceuticals Source Type: news

September ’s top stories: Australia’s Zero Childhood Cancer trial, Eisai & Ono ’s liver cancer trial
Australian cancer centres launched a clinical trial under the Zero Childhood Cancer programme for personalised medicine, and Eisai and Ono Pharmaceutical planned to conduct a Phase Ib combination trial for hepatocellular carcinoma (HCC). Drugdevelopm … (Source: Drug Development Technology)
Source: Drug Development Technology - October 5, 2017 Category: Pharmaceuticals Source Type: news

Janssen ’s Phase III trial of rivaroxaban for embolic stroke stopped early
Janssen Research& Development and its development partner Bayer have stopped the Phase III NAVIGATE ESUS clinical trial of Xarelto (rivaroxaban) assessed as a secondary prevention for stroke and systemic embolism in patients who experienced a recent … (Source: Drug Development Technology)
Source: Drug Development Technology - October 5, 2017 Category: Pharmaceuticals Source Type: news

Inovio reports positive results from Zika vaccine clinical trial
Inovio Pharmaceuticals has reported positive safety and immune response results from a first-in-man, multi-centre Phase I trial (ZIKA-001) of its DNA-based vaccine (GLS-5700) for the treatment of Zika virus. (Source: Drug Development Technology)
Source: Drug Development Technology - October 5, 2017 Category: Pharmaceuticals Source Type: news

M & As this week: ImmunoPrecise Antibodies, Ergomed
Canadian antibody development and production services provider ImmunoPrecise Antibodies plans to acquire Netherlands-based contract research organisation QVQ Holding (QVQ) for C$0.74m ($0.59m). (Source: Drug Development Technology)
Source: Drug Development Technology - October 5, 2017 Category: Pharmaceuticals Source Type: news

Deals this week: Ixaltis, Arbutus Biopharma, Gesynta Pharma
French specialist pharmaceutical company Ixaltis has signed an agreement with Swiss biopharmaceutical company Xigen for worldwide rights to a compound being developed by the latter, targeting urogenital diseases. (Source: Drug Development Technology)
Source: Drug Development Technology - October 5, 2017 Category: Pharmaceuticals Source Type: news

Adynxx closes patient enrolment in Phase II trial of post-surgical pain treatment brivoligide
US-based biotechnology firm Adynxx has completed patient enrolment in a Phase II trial (ADYX-004) of its lead product candidate, brivoligide (AYX1), for reducing acute pain and preventing chronic pain following total knee replacement surgery. (Source: Drug Development Technology)
Source: Drug Development Technology - October 4, 2017 Category: Pharmaceuticals Source Type: news

Melior begins dosing MLR-1023 in Phase IIb trial to treat type 2 diabetes
US-based Melior Pharmaceuticals I has begun dosing in a Phase IIb trial aimed at evaluating the efficacy of MLR-1023, an oral insulin sensitizer, in adult patients with uncontrolled type 2 diabetes on metformin therapy. (Source: Drug Development Technology)
Source: Drug Development Technology - October 4, 2017 Category: Pharmaceuticals Source Type: news

Achieve begins multi-dose study of cytisine for smoking cessation
US-based specialist pharmaceutical firm Achieve Life Sciences has begun a multi-dose study to evaluate both pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of cytisine, a plant-based alkaloid with a high-binding affinity to the nicotini … (Source: Drug Development Technology)
Source: Drug Development Technology - October 4, 2017 Category: Pharmaceuticals Source Type: news

Ablynx's trial of aTTP treatment caplacizumab shows positive results
Belgian company Ablynx has reported positive topline results from the Phase III HERCULES trial with caplacizumab to treat acquired thrombotic thrombocytopenic purpura (aTTP). (Source: Drug Development Technology)
Source: Drug Development Technology - October 3, 2017 Category: Pharmaceuticals Source Type: news

AOBiome starts patient enrolment in Phase Ib/IIa trial to treat allergic rhinitis
US-based life sciences firm AOBiome has started enrolling patients in a Phase Ib/IIa clinical trial of its ammonia oxidising bacteria (AOB) product candidate to treat seasonal allergic rhinitis (SAR). (Source: Drug Development Technology)
Source: Drug Development Technology - October 3, 2017 Category: Pharmaceuticals Source Type: news

ImmunoMet begins Phase I cancer trial of OXPHOS Inhibitor IM156
US-based biotechnology firm ImmunoMet Therapeutics has started its Phase I clinical trial for IM156, a potent oxidative phosphorylation (OXPHOS) inhibitor to treat patients with solid tumours.     (Source: Drug Development Technology)
Source: Drug Development Technology - October 3, 2017 Category: Pharmaceuticals Source Type: news

Seres reports positive Phase Ib trial results of SER-287 in UC patients
US-based Seres Therapeutics has reported positive topline results from a Phase Ib placebo-controlled induction trial of SER-287 in patients with mild-to-moderate ulcerative colitis (UC), who were failing current therapies. (Source: Drug Development Technology)
Source: Drug Development Technology - October 2, 2017 Category: Pharmaceuticals Source Type: news

Eisai reports positive Phase III trial data of Lenvima for liver cancer
Eisai has reported positive results from analysis of the subpopulation of subjects in the Greater China region participating in its Phase III REFLECT clinical trial of lenvatinib mesylate (Lenvima) to treat unresectable hepatocellular carcinoma (HCC) … (Source: Drug Development Technology)
Source: Drug Development Technology - October 2, 2017 Category: Pharmaceuticals Source Type: news

SELLAS and Merck to begin Phase I/II cancer combination clinical trial
Biopharmaceutical firm SELLAS Life Sciences Group has entered a clinical trial collaboration and supply agreement with Merck to conduct a combination clinical trial targeting multiple cancer types.   (Source: Drug Development Technology)
Source: Drug Development Technology - October 2, 2017 Category: Pharmaceuticals Source Type: news

bluebird bio starts treatment in Phase I trial for multiple myeloma
bluebird bio has started treating patients in a Phase I clinical trial (CRB-402) of its investigational candidate bb21217 for relapsed or refractory multiple myeloma. (Source: Drug Development Technology)
Source: Drug Development Technology - October 1, 2017 Category: Pharmaceuticals Source Type: news

Abivax ’s ABX464 found to reduce HIV viral reservoir in blood
Abivax has reported positive top-line data from the first cohort of Phase IIa ABX464-005 clinical trial of its drug candidate ABX464 in patients with HIV. (Source: Drug Development Technology)
Source: Drug Development Technology - October 1, 2017 Category: Pharmaceuticals Source Type: news

Noxopharm initiates Phase Ib trial of NOX66 for prostate cancer
Australia-based Noxopharm has initiated a Phase Ib clinical trial of NOX66 in metastatic castrate-resistant prostate cancer patients who do not have remaining standard therapeutic options. (Source: Drug Development Technology)
Source: Drug Development Technology - September 28, 2017 Category: Pharmaceuticals Source Type: news

Chiasma begins enrolment in Phase III trial for acromegaly
Chiasma has started patient enrolment in Phase III CHIASMA OPTIMAL clinical trial of its product candidate Mycapssa (octreotide capsules) as a maintenance therapy to treat adults with acromegaly. (Source: Drug Development Technology)
Source: Drug Development Technology - September 28, 2017 Category: Pharmaceuticals Source Type: news

Genelux begins dosing in Phase II ovarian cancer trial
US-based oncolytic immunotherapy developer Genelux has started dosing patients in a Phase II clinical trial (VIRO-15) of its clinical-stage candidate GL-ONC1 to treat recurrent ovarian cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - September 28, 2017 Category: Pharmaceuticals Source Type: news

Deals this week: MediciNova, Confo Therapeutics, Intra-Cellular Therapies
US-based biopharmaceutical company MediciNova plans to raise up to $200m by issuing securities on occasion. (Source: Drug Development Technology)
Source: Drug Development Technology - September 28, 2017 Category: Pharmaceuticals Source Type: news

M & As this week: Ardena Group, Sumitomo Chemical
Belgian contract development and manufacturing organisation Ardena Group has completed the acquisition of Netherlands-based bioanalytical contract laboratory services provider Analytical Biochemical Laboratory. (Source: Drug Development Technology)
Source: Drug Development Technology - September 28, 2017 Category: Pharmaceuticals Source Type: news

Preclinical Oncology Models for Testing Immunotherapies
4T1 is a triple-negative mouse breast cancer cell line. Pharmatest utilises a 4T1 cell line with stable expression of green fluorescent protein (GFP) enabling easy and efficient detection of whole-body tumour burden. (Source: Drug Development Technology)
Source: Drug Development Technology - September 28, 2017 Category: Pharmaceuticals Source Type: news

Aduro Biotech starts dosing in Phase Ib combination trial for oncology
Aduro Biotech has started dosing patients in a Phase Ib clinical trial of its drug candidate ADU-S100 (MIW815) in combination with Novartis ’ PDR001 to treat advanced / metastatic solid tumours or lymphomas. (Source: Drug Development Technology)
Source: Drug Development Technology - September 27, 2017 Category: Pharmaceuticals Source Type: news

BioLineRx launches Phase Ib/II combination trial for acute myeloid leukaemia
Israeli biopharmaceutical firm BioLineRx has launched a Phase Ib/II clinical trial (BATTLE) of BL-8040 in combination with Genentech ’s anti-PDL1 immunotherapy atezolizumab (Tecentriq) in patients suffering from acute myeloid leukaemia (AML). (Source: Drug Development Technology)
Source: Drug Development Technology - September 27, 2017 Category: Pharmaceuticals Source Type: news

Axovant ’s Phase III trial of Alzheimer's disease drug fails to meet primary endpoints
Axovant Sciences has reported negative top-line results from its Phase III MINDSET clinical trial of intepirdine conducted to treat mild-to-moderate Alzheimer's disease (AD). (Source: Drug Development Technology)
Source: Drug Development Technology - September 27, 2017 Category: Pharmaceuticals Source Type: news

US and UK researchers launch trial to study treatment approaches for multiple sclerosis
Researchers at the University of Nottingham and Nottingham University Hospitals NHS Trust, UK, have collaborated with a team from the Cleveland Clinic in Ohio, US, for a clinical trial for the treatment of multiple sclerosis (MS). (Source: Drug Development Technology)
Source: Drug Development Technology - September 26, 2017 Category: Pharmaceuticals Source Type: news

Xhance ™ (fluticasone propionate) for the Treatment of Nasal Polyps
Xhance ™ (fluticasone propionate / previously known as OPN-375), a synthetic trifluorinated corticosteroid, is indicated for the treatment of nasal polyps in patients aged 18 years or older. (Source: Drug Development Technology)
Source: Drug Development Technology - September 26, 2017 Category: Pharmaceuticals Source Type: news

AstraZeneca reports positive data from Phase III trial of Bevespi Aerosphere
AstraZeneca has reported positive top-line results from the Phase III PINNACLE 4 clinical trial of Bevespi Aerosphere to treat moderate to very severe chronic obstructive pulmonary disease (COPD). (Source: Drug Development Technology)
Source: Drug Development Technology - September 26, 2017 Category: Pharmaceuticals Source Type: news

argenx initiates Phase II trial of ARGX-113 to treat pemphigus vulgaris
Belgium-based biotechnology firm argenx has initiated a Phase II clinical trial of its investigational agent, ARGX-113, to treat patients with pemphigus vulgaris (PV). (Source: Drug Development Technology)
Source: Drug Development Technology - September 26, 2017 Category: Pharmaceuticals Source Type: news

Prometic to conduct PBI-4050 ’s Phase II/III trial for IPF in US
Canada-based Prometic Life Sciences has secured investigational new drug (IND) approval from the US Food and Drug Administration (FDA) to evaluate its drug candidate PBI-4050 in a Phase II/III clinical trial to treat idiopathic pulmonary fibrosis (IP … (Source: Drug Development Technology)
Source: Drug Development Technology - September 25, 2017 Category: Pharmaceuticals Source Type: news

Daiichi Sankyo studies esaxerenone in Phase III trial for diabetic nephropathy
Japanese pharmaceutical firm Daiichi Sankyo has started a Phase III clinical trial (ESAX-DN) of its product candidate esaxerenone to treat diabetic nephropathy in the country. (Source: Drug Development Technology)
Source: Drug Development Technology - September 25, 2017 Category: Pharmaceuticals Source Type: news

Auris Medical concludes enrolment in Phase III trial of Keyzilen for tinnitus
Swiss biopharmaceutical firm Auris Medical has concluded patient enrolment in a Phase III clinical trial (TACTT3) of its product candidate Keyzilen to treat acute and post-acute inner ear tinnitus. (Source: Drug Development Technology)
Source: Drug Development Technology - September 25, 2017 Category: Pharmaceuticals Source Type: news

Allergan reports positive Phase IIb two-year data from liver fibrosis trial
Allergan has reported positive top-line two-year results from its Phase IIb CENTAUR clinical trial of Cenicriviroc (CVC) to treat liver fibrosis in adults suffering from non-alcoholic steatohepatitis (NASH). (Source: Drug Development Technology)
Source: Drug Development Technology - September 24, 2017 Category: Pharmaceuticals Source Type: news

Versartis ’ Phase III trial of somavaratan fails to meet endpoint for GHD
US-based biopharmaceutical firm Versartis has reported results from a Phase III clinical trial (VELOCITY) of somavaratan (VRS-317) to treat paediatric patients with growth hormone deficiency (GHD). (Source: Drug Development Technology)
Source: Drug Development Technology - September 24, 2017 Category: Pharmaceuticals Source Type: news

AbbVie and BMS to investigate combination therapy in solid tumour trials
AbbVie and Bristol-Myers Squibb (BMS) have entered a clinical trial collaboration to assess ABBV-399 in combination with Opdivo (nivolumab) to treat patients with non-small-cell lung cancer (NSCLC). (Source: Drug Development Technology)
Source: Drug Development Technology - September 24, 2017 Category: Pharmaceuticals Source Type: news

Cavion starts enrolment in Phase II trial of CX-8998 for essential tremor
US-based biotechnology firm Cavion has started patient enrolment in a Phase II clinical trial (T-CALM Study) of CX-8998 to treat essential tremor (ET). (Source: Drug Development Technology)
Source: Drug Development Technology - September 21, 2017 Category: Pharmaceuticals Source Type: news

Shire reports positive data from Phase III trial of Intuniv for ADHD
Irish biotechnology firm Shire and its Japanese partner Shionogi have reported positive top-line results from a Phase III clinical trial of Intuniv (guanfacine hydrochloride prolonged release) in adults with attention deficit hyperactivity disorder ( … (Source: Drug Development Technology)
Source: Drug Development Technology - September 21, 2017 Category: Pharmaceuticals Source Type: news

Aliqopa (copanlisib) for the Treatment of Relapsed Follicular Lymphoma
Aliqopa (copanlisib) is a novel intravenous phosphatidylinositol-3-kinase (PI3K) inhibitor indicated for the treatment of adult patients with relapsed follicular lymphoma (FL). (Source: Drug Development Technology)
Source: Drug Development Technology - September 21, 2017 Category: Pharmaceuticals Source Type: news

Audentes commences dosing in Phase I/II trial for myotubular myopathy
US-based biotechnology firm Audentes Therapeutics has commenced patient dosing in the Phase I/II ASPIRO clinical trial of its product candidate AT132 to treat X-linked myotubular myopathy (XLMTM). (Source: Drug Development Technology)
Source: Drug Development Technology - September 21, 2017 Category: Pharmaceuticals Source Type: news

Deals this week: Nabriva Therapeutics, LifeMine Therapeutics, Aldeyra Therapeutics
Nabriva Therapeutics plans to raise $80m through an underwritten public offering of shares of its common stock. (Source: Drug Development Technology)
Source: Drug Development Technology - September 21, 2017 Category: Pharmaceuticals Source Type: news

AgeneBio to study AGB101 in Phase III trial to treat MCI due to AD
US-based pharmaceutical firm AgeneBio is set to investigate its therapeutic agent AGB101 in a Phase III clinical trial (HOPE4MCI) for the treatment of mild cognitive impairment due to Alzheimer ’s disease (MCI due to AD). (Source: Drug Development Technology)
Source: Drug Development Technology - September 20, 2017 Category: Pharmaceuticals Source Type: news

Parker Institute begins dosing in Phase Ib/II combination trial for pancreatic cancer
The Parker Institute for Cancer Immunotherapy and Cancer Research Institute in the US have started dosing patients in a Phase Ib/II clinical trial to investigate the combination of standard chemotherapy and immunotherapy for the treatment of pancreat … (Source: Drug Development Technology)
Source: Drug Development Technology - September 20, 2017 Category: Pharmaceuticals Source Type: news

Transgene starts dosing in Phase Ib/II combination trial for HPV-positive cancers
Transgene has started dosing patients in a Phase Ib/II clinical trial of TG4001 in combination with avelumab to treat human papillomavirus type 16 positive (HPV-16+) recurrent or metastatic cancers. (Source: Drug Development Technology)
Source: Drug Development Technology - September 20, 2017 Category: Pharmaceuticals Source Type: news

Janssen reports positive long-term Phase III data of Tremfya for plaque psoriasis
Janssen Research& Development has reported new positive two-year results from the open-label extension of the Phase III VOYAGE 1 trial of Tremfya (Guselkumab) to treat moderate-to-severe plaque psoriasis. (Source: Drug Development Technology)
Source: Drug Development Technology - September 19, 2017 Category: Pharmaceuticals Source Type: news