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Bod Australia concludes Phase I trial design for cannabis extract
Natural medicines developer Bod Australia has concluded the design for a Phase I clinical trial of its pharmaceutical grade cannabis extract in combination with a new delivery system. (Source: Drug Development Technology)
Source: Drug Development Technology - August 21, 2017 Category: Pharmaceuticals Source Type: news

Novartis and MMV initiate Phase IIb trial of KAF156 for malaria in Africa
Novartis and Medicines for Malaria Venture (MMV) have initiated a Phase IIb clinical trial of KAF156 to treat multidrug-resistant malaria in Africa. (Source: Drug Development Technology)
Source: Drug Development Technology - August 21, 2017 Category: Pharmaceuticals Source Type: news

MatriSys commences dosing in Phase IIa trial for atopic dermatitis
MatriSys Bioscience has started dosing patients with a lotion containing Staphylococcus hominis (S. hominis) in a Phase IIa clinical trial to treat adults with moderate-to-severe atopic dermatitis (AD). (Source: Drug Development Technology)
Source: Drug Development Technology - August 21, 2017 Category: Pharmaceuticals Source Type: news

Imatinib shows increased survival in ICR ’s Phase III oncology trial
A Phase III clinical trial of imatinib (Glivec) conducted by UK researchers from the Institute of Cancer Research (ICR) and the Royal Marsden NHS Foundation Trust demonstrated increased survival in patients with advanced gastrointestinal stromal tumo … (Source: Drug Development Technology)
Source: Drug Development Technology - August 20, 2017 Category: Pharmaceuticals Source Type: news

Cellectis starts dosing patients in UCART123 ’s Phase I trial for BPDCN
Biopharmaceutical firm Cellectis has started dosing patients in a Phase I clinical trial of its universal chimeric antigen receptor T-cell (UCART) product candidate UCART123 to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN). (Source: Drug Development Technology)
Source: Drug Development Technology - August 20, 2017 Category: Pharmaceuticals Source Type: news

Medivir enrols first patient in combination trial for refractory solid tumours
Swedish pharmaceutical company Medivir has started patient enrolment in a Phase I/II clinical trial of its product candidate birinapant in combination with Merck ’s anti-PD-1 therapy Keytruda (pembrolizumab) for treatment-refractory solid tumours. (Source: Drug Development Technology)
Source: Drug Development Technology - August 20, 2017 Category: Pharmaceuticals Source Type: news

Idhifa (enasidenib) for the Treatment of Acute Myeloid Leukaemia (AML)
Idhifa (enasidenib) is an isocitrate dehydrogenase 2 (IDH2) enzyme inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukaemia (AML). (Source: Drug Development Technology)
Source: Drug Development Technology - August 17, 2017 Category: Pharmaceuticals Source Type: news

Deals this week: NicOx, FibroGen, Omeros
NicOx has announced the private placement of 3.5 million new ordinary shares priced at €7.5 ($8.85) each to raise €26.25m ($30.97m) in total. (Source: Drug Development Technology)
Source: Drug Development Technology - August 17, 2017 Category: Pharmaceuticals Source Type: news

Amgen ’s EBBINGHAUS trial of Repatha shows favourable outcome
Amgen has reported a favourable cognitive function outcome from Phase III EBBINGHAUS clinical trial of Repatha (evolocumab) currently being developed to minimise low-density lipoprotein (LDL) levels. (Source: Drug Development Technology)
Source: Drug Development Technology - August 17, 2017 Category: Pharmaceuticals Source Type: news

M & As this week: Evotec, BioreclamationIVT
German pharmaceutical research company Evotec has acquired US-based drug discovery and development company Aptuit for $300m. (Source: Drug Development Technology)
Source: Drug Development Technology - August 17, 2017 Category: Pharmaceuticals Source Type: news

TRACON Pharmaceuticals reports positive results from Phase Ib/II trial of HCC drug
TRACON Pharmaceuticals has reported positive results from the National Cancer Institute (NCI) Phase Ib/II clinical trial of TRC105 and Nexavar (sorafenib) to treat patients with hepatocellular cancer (HCC). (Source: Drug Development Technology)
Source: Drug Development Technology - August 17, 2017 Category: Pharmaceuticals Source Type: news

Achieve begins cytisine ’s clinical programme for smoking cessation
Achieve Life Sciences has initiated the Cytisine Clinical Development Programme in the US to evaluate the product candidate as a form of treatment for smoking cessation. (Source: Drug Development Technology)
Source: Drug Development Technology - August 16, 2017 Category: Pharmaceuticals Source Type: news

Lexicon announces additional positive Phase III data for diabetes drug
Lexicon Pharmaceuticals has reported additional positive data from its Phase III inTandem2 clinical trial of sotagliflozin in adult type 1 diabetes patients on a background of optimised insulin. (Source: Drug Development Technology)
Source: Drug Development Technology - August 16, 2017 Category: Pharmaceuticals Source Type: news

Iovance commences LN-145 dosing in Phase II trial for cervical cancer
US-based biotechnology firm Iovance Biotherapeutics has commenced patient dosing in its Phase II C-145-04 clinical trial of LN-145 to treat recurrent, metastatic or persistent cervical carcinoma. (Source: Drug Development Technology)
Source: Drug Development Technology - August 16, 2017 Category: Pharmaceuticals Source Type: news

Researchers demonstrate use of breast cancer drug to shrink brain tumours
Researchers from the University of Queensland ’s Institute for Molecular Bioscience in Australia and the Fred Hutchinson Cancer Research Centre in the US have conducted a clinical trial to evaluate a previously approved breast cancer drug palbociclib … (Source: Drug Development Technology)
Source: Drug Development Technology - August 15, 2017 Category: Pharmaceuticals Source Type: news

BMS Phase III ’s combination trial for RCC meets one co-primary endpoint
Bristol-Myers Squibb (BMS) has reported top-line results from the Phase III CheckMate -214 clinical trial of Opdivo (nivolumab) and Yervoy (ipilimumab) combination to treat advanced or metastatic renal cell carcinoma (RCC). (Source: Drug Development Technology)
Source: Drug Development Technology - August 15, 2017 Category: Pharmaceuticals Source Type: news

Vyriad and Sanford Health begin Phase I viro-immunotherapy trial
US-based biopharmaceutical firm Vyriad has initiated a clinical trial at integrated health system Sanford Health to evaluate a genetically engineered virus for destroying therapy-resistant tumours. (Source: Drug Development Technology)
Source: Drug Development Technology - August 15, 2017 Category: Pharmaceuticals Source Type: news

University of Southampton investigates Acerta ’s lymphoma drug
Researchers at the University of Southampton, UK, have initiated a clinical trial to evaluate Acerta Pharma ’s new product candidate acalabrutinib in combination with existing standard therapy called R-CHOP to treat select patients with diffuse large … (Source: Drug Development Technology)
Source: Drug Development Technology - August 14, 2017 Category: Pharmaceuticals Source Type: news

PCI Biotech starts dosing in Phase I extension study for bile duct cancer
Norwegian biopharmaceutical firm PCI Biotech has started dosing patients in a Phase I extension study with fimaCHEM to treat inoperable perihilar bile duct cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - August 14, 2017 Category: Pharmaceuticals Source Type: news

Chiasma and FDA agree on new Phase III trial design for acromegaly drug
The US Food and Drug Administration (FDA) has agreed on biopharmaceutical firm Chiasma ’s new Phase III clinical trial (OPTIMAL) design to evaluate its octreotide capsules product candidate Mycapssa as a maintenance therapy to treat adults with acrome… (Source: Drug Development Technology)
Source: Drug Development Technology - August 13, 2017 Category: Pharmaceuticals Source Type: news

Viamet reports positive Phase II data for vulvovaginal candidiasis drug
Viamet Pharmaceuticals has reported positive results from a Phase II clinical trial (REVIVE) of VT-1161 to treat recurrent vulvovaginal candidiasis (RVVC) patients. (Source: Drug Development Technology)
Source: Drug Development Technology - August 13, 2017 Category: Pharmaceuticals Source Type: news

Cyclodextrin slows NPC progression in new Washington University trial
A new clinical trial conducted by Washington University School of Medicine in St Louis and the National Institutes of Health (NIH) in the US has shown that a drug called cyclodextrin slows progression of Niemann-Pick type C (NPC) disease. (Source: Drug Development Technology)
Source: Drug Development Technology - August 13, 2017 Category: Pharmaceuticals Source Type: news

Immunicum starts enrolment in US for Phase II oncology trial
Swedish biopharmaceutical firm Immunicum has started patient enrolment in the US for the ongoing Phase II MERECA clinical trial of its drug candidate ilixadencel to treat renal cell carcinoma. (Source: Drug Development Technology)
Source: Drug Development Technology - August 10, 2017 Category: Pharmaceuticals Source Type: news

UK researchers report positive data from new diabetes trial
Researchers from King ’s College London and Cardiff University in the UK have reported positive results from the new MonoPepT1De clinical trial using immunotherapy for type 1 diabetes. (Source: Drug Development Technology)
Source: Drug Development Technology - August 10, 2017 Category: Pharmaceuticals Source Type: news

Biotecnol and Cancer Research UK to assess Tb535H for solid tumours
Immune-oncology firm Biotecnol and Cancer Research UK have entered a collaboration agreement to evaluate Tb535H in clinical trials to treat patients suffering from solid tumours. (Source: Drug Development Technology)
Source: Drug Development Technology - August 10, 2017 Category: Pharmaceuticals Source Type: news

M & As this week: SELLAS Life Sciences Group, Cempra
SELLAS Life Sciences Group has signed a definitive agreement to merge with Galena Biopharma. (Source: Drug Development Technology)
Source: Drug Development Technology - August 10, 2017 Category: Pharmaceuticals Source Type: news

Deals this week: HitGen, Calithera Biosciences, Esperion Therapeutics
HitGen has signed an agreement with LEO Pharma to use its advanced technology platform to discover new small molecules. (Source: Drug Development Technology)
Source: Drug Development Technology - August 10, 2017 Category: Pharmaceuticals Source Type: news

Allegro ’s Phase IIb stage 2 trial for DME drug meets primary endpoint
Biotechnology firm Allegro Ophthalmics has reported positive top-line results from the DEL MAR Phase IIb stage 2 clinical trial of luminate as a sequential therapy to treat diabetic macular edema (DME) patients. (Source: Drug Development Technology)
Source: Drug Development Technology - August 9, 2017 Category: Pharmaceuticals Source Type: news

TapImmune broadens TPIV200 ’s Phase II trial for ovarian cancer
US-based immuno-oncology firm TapImmune has amended the Phase II clinical trial of its therapeutic peptide vaccine TPIV200 following discussions with the US Food and Drug Administration (FDA). (Source: Drug Development Technology)
Source: Drug Development Technology - August 9, 2017 Category: Pharmaceuticals Source Type: news

WIN Consortium to conduct targeted tri-therapy trial for NSCLC
French non-profit healthcare network WIN Consortium (WIN) is set to conduct a clinical trial (SPRING) of a new three targeted therapies combination as first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC), following appro … (Source: Drug Development Technology)
Source: Drug Development Technology - August 9, 2017 Category: Pharmaceuticals Source Type: news

MAVYRET ™ (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C
MAVYRET ™ (glecaprevir/pibrentasvir) was developed by US-based biopharmaceutical company AbbVie as a pan-genotypic treatment for adults suffering from chronic hepatitis C virus (HCV) infection across six major genotypes (GT1 to GT6). (Source: Drug Development Technology)
Source: Drug Development Technology - August 8, 2017 Category: Pharmaceuticals Source Type: news

Zynerba ’s Phase II epilepsy trial of ZYN002 fails to meet primary endpoint
Zynerba Pharmaceuticals has reported top-line results from the Phase II STAR 1 clinical trial of ZYN002 to treat adult epilepsy patients with focal seizures. (Source: Drug Development Technology)
Source: Drug Development Technology - August 8, 2017 Category: Pharmaceuticals Source Type: news

Amylyx begins dosing in Phase II trial of AMX0035 for ALS
Amylyx Pharmaceuticals has begun dosing patients in the Phase II CENTAUR clinical trial of its therapeutic candidate, AMX0035, to treat those with amyotrophic lateral sclerosis (ALS). (Source: Drug Development Technology)
Source: Drug Development Technology - August 8, 2017 Category: Pharmaceuticals Source Type: news

Rebiotix starts enrolment in Phase III trial of RBX2660 for C. diff infection
US-based clinical-stage microbiome firm Rebiotix has started patient enrolment in a Phase III clinical trial of RBX2660 to prevent recurrent Clostridium difficile (C. diff) infection. (Source: Drug Development Technology)
Source: Drug Development Technology - August 8, 2017 Category: Pharmaceuticals Source Type: news

MyoKardia ’s Phase II trial for oHCM drug meets endpoints
MyoKardia has reported positive top-line results from the first cohort of its Phase II PIONEER-HCM clinical trial of mavacamten in patients with symptomatic, obstructive hypertrophic cardiomyopathy (oHCM). (Source: Drug Development Technology)
Source: Drug Development Technology - August 7, 2017 Category: Pharmaceuticals Source Type: news

Calithera begins Phase II trial of CB-839 to treat renal cell carcinoma
Pharmaceutical firm Calithera Biosciences has begun a Phase II clinical trial of CB-839 in combination with Afinitor (everolimus) ‎ for the treatment of patients with renal cell carcinoma (RCC). (Source: Drug Development Technology)
Source: Drug Development Technology - August 7, 2017 Category: Pharmaceuticals Source Type: news

UCL research indicates use of diabetes drug in Parkinson ’s disease
University College London (UCL) has carried out a study that indicated the potential of a common diabetes drug called exenatide as a disease-modifying therapy for treating Parkinson ’s disease. (Source: Drug Development Technology)
Source: Drug Development Technology - August 7, 2017 Category: Pharmaceuticals Source Type: news

Ritter ’s RP-G28 mitigates lactose intolerance symptoms in Phase IIb/III trial
US-based Ritter Pharmaceuticals has reported positive additional results from a Phase IIb/III trial of its product candidate RP-G28 in patients suffering from lactose intolerance (LI). (Source: Drug Development Technology)
Source: Drug Development Technology - August 6, 2017 Category: Pharmaceuticals Source Type: news

July ’s top stories: NCI and COG’s paediatric precision cancer trial, AstraZeneca’s NSCLC trial results
NIH ’s unit NCI and the COG initiated patient enrolment in a paediatric Phase II clinical trial to evaluate targeted cancer medicines, and AstraZeneca reported positive results from the FLAURA trial of Tagrisso to treat patients with locally advanced … (Source: Drug Development Technology)
Source: Drug Development Technology - August 6, 2017 Category: Pharmaceuticals Source Type: news

Eli Lilly ’s lasmiditan meets Phase III trial endpoints for migraine
Eli Lilly and Company has reported positive results from the Phase III SPARTAN clinical trial of lasmiditan for the acute treatment of migraines. (Source: Drug Development Technology)
Source: Drug Development Technology - August 6, 2017 Category: Pharmaceuticals Source Type: news

Foamix commences dosing in Phase III trial for acne drug
Foamix Pharmaceuticals has commenced patient dosing in a Phase III clinical trial (FX2017-22) of its product candidate FMX101 in patients with moderate-to-severe acne. (Source: Drug Development Technology)
Source: Drug Development Technology - August 6, 2017 Category: Pharmaceuticals Source Type: news

VM BioPharma begins dosing in Phase III trial of VM202 for NHU and PAD
Korean biopharmaceutical company ViroMed ’s US division VM BioPharma has begun dosing patients with VM202 in a Phase III clinical trial to treat non-healing diabetic foot ulcers (NHU) and associated peripheral artery disease (PAD). (Source: Drug Development Technology)
Source: Drug Development Technology - August 3, 2017 Category: Pharmaceuticals Source Type: news

FDA accepts Bellerophon ’s Phase IIb design for INOpulse in PH-ILD
The US Food and Drug Administration (FDA) has accepted Bellerophon Therapeutics ’ study design for the Phase IIb clinical trial of INOpulse in patients with Interstitial Lung Disease (ILD) associated pulmonary hypertension (PH). (Source: Drug Development Technology)
Source: Drug Development Technology - August 3, 2017 Category: Pharmaceuticals Source Type: news

First patient receives BCX7353 dosing in BioCryst ’s Phase II trial for HAE
US-based BioCryst Pharmaceuticals has started dosing patients in the Phase II ZENITH-1 exploratory clinical trial of BCX7353 to treat patients with hereditary angioedema (HAE). (Source: Drug Development Technology)
Source: Drug Development Technology - August 3, 2017 Category: Pharmaceuticals Source Type: news

M & As this week: Woden Venture Capital, Evotec
Woden Venture Capital (Woden) plans to acquire biotechnology company ACCUM Therapeutics for C$4.5m ($3.6m). (Source: Drug Development Technology)
Source: Drug Development Technology - August 3, 2017 Category: Pharmaceuticals Source Type: news

Deals this week: Milestone Pharmaceuticals, Homology Medicines, Ultragenyx Pharmaceutical
Canadian cardiovascular drug development company Milestone Pharmaceuticals has secured $55m through a series C funding round led by Novo Holdings. (Source: Drug Development Technology)
Source: Drug Development Technology - August 3, 2017 Category: Pharmaceuticals Source Type: news

DBV Technologies enrols first patient in Phase III peanut allergy trial
French biopharmaceutical firm DBV Technologies has started patient enrolment in a Phase III EPITOPE clinical trial of Viaskin Peanut to treat peanut allergy in young children. (Source: Drug Development Technology)
Source: Drug Development Technology - August 2, 2017 Category: Pharmaceuticals Source Type: news

Flex Pharma begins Phase II trial of FLX-787 for ALS in US
Flex Pharma has begun a Phase II clinical trial (COMMEND) of FLX-787 in the US to treat patients suffering from motor neuron disease (MND) with a focus on amyotrophic lateral sclerosis (ALS). (Source: Drug Development Technology)
Source: Drug Development Technology - August 2, 2017 Category: Pharmaceuticals Source Type: news

Helsinn and MEI Pharma begin dosing in Phase III combination trial for AML
Swiss pharmaceutical group Helsinn and US-based oncology firm MEI Pharma have begun dosing patients in a Phase III clinical trial of pracinostat and azacitidine combination to treat adults with newly diagnosed acute myeloid leukaemia (AML). (Source: Drug Development Technology)
Source: Drug Development Technology - August 2, 2017 Category: Pharmaceuticals Source Type: news

Mallinckrodt ’s Phase IV registry for PPHN medicine starts enrolment
Mallinckrodt Pharmaceuticals has started patient enrolment in a Phase IV registry (PaTTerN) to evaluate INOMAX (nitric oxide) gas inhalation to treat persistent pulmonary hypertension of the newborn (PPHN). (Source: Drug Development Technology)
Source: Drug Development Technology - August 1, 2017 Category: Pharmaceuticals Source Type: news