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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

Acceleron begins dosing in Phase II trial of ACE-083 to treat CMT
Acceleron Pharma has started dosing patients in a Phase II clinical trial of its therapeutic candidate ACE-083 for the treatment of Charcot-Marie-Tooth disease (CMT) patients. (Source: Drug Development Technology)
Source: Drug Development Technology - August 1, 2017 Category: Pharmaceuticals Source Type: news

Generex combines AE37 with Merck ’s Keytruda in Phase II trial for TNBC
Generex Biotechnology has signed a clinical trial collaboration agreement through its Antigen Express division to combine its cancer vaccine AE37 with Merck ’s Keytruda (pembrolizumab) in a Phase II clinical trial for patients with triple-negative bre… (Source: Drug Development Technology)
Source: Drug Development Technology - August 1, 2017 Category: Pharmaceuticals Source Type: news

FlexyPAT as a Calorimeter
FlexyPAT is a modular process automation technology that enables automated, customer-specific lab reactor systems to be implemented cost-effectively. With FlexyPAT, you have a strong and flexible tool. (Source: Drug Development Technology)
Source: Drug Development Technology - August 1, 2017 Category: Pharmaceuticals Source Type: news

Idorsia reports positive results from Phase II programme of insomnia drug
Swiss biopharmaceutical firm Idorsia has reported positive results from a Phase II programme of ACT-541468 to treat patients suffering from insomnia. (Source: Drug Development Technology)
Source: Drug Development Technology - July 31, 2017 Category: Pharmaceuticals Source Type: news

BMS and Clovis to initiate Phase II and III combination trials for oncology
Bristol-Myers Squibb (BMS) has signed a clinical collaboration agreement to investigate the combination of its Opdivo (nivolumab) with Clovis Oncology ’s Rubraca in a Phase II and two Phase III clinical trials to treat various types of tumours. (Source: Drug Development Technology)
Source: Drug Development Technology - July 31, 2017 Category: Pharmaceuticals Source Type: news

Glenmark ’s Phase IIa study of atopic dermatitis drug shows improved symptoms
Glenmark Pharmaceuticals has reported positive results from the Phase IIa clinical trial of its investigational candidate GBR 830 in patients with atopic dermatitis. (Source: Drug Development Technology)
Source: Drug Development Technology - July 31, 2017 Category: Pharmaceuticals Source Type: news

Boehringer Ingelheim initiates interchangeability trial of BI 695501 and Humira
Boehringer Ingelheim has initiated patient enrolment in an interchangeability clinical trial (VOLTAIRE-X) of its product candidate BI 695501 and the US-marketed formulation of 40mg/0.8mL Humira. (Source: Drug Development Technology)
Source: Drug Development Technology - July 30, 2017 Category: Pharmaceuticals Source Type: news

AstraZeneca ’s Tagrisso improves progression-free survival in Phase III NSCLC trial
AstraZeneca has reported positive results from the Phase III FLAURA trial of Tagrisso (osimertinib) to treat patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC). (Source: Drug Development Technology)
Source: Drug Development Technology - July 30, 2017 Category: Pharmaceuticals Source Type: news

Cytokinetics evaluates CK-2127107 in Phase II trial to treat ALS
US-based Cytokinetics has started a Phase II FORTITUDE-ALS clinical trial of CK-2127107 for the treatment of patients with amyotrophic lateral sclerosis (ALS). (Source: Drug Development Technology)
Source: Drug Development Technology - July 30, 2017 Category: Pharmaceuticals Source Type: news

Gamlen Appoints ABL & E as Distributor
Gamlen Instruments has appointed ABL&E as the exclusive distributor for Gamlen Instruments in Eastern Europe. (Source: Drug Development Technology)
Source: Drug Development Technology - July 28, 2017 Category: Pharmaceuticals Source Type: news

Genentech ’s Actemra meets primary and secondary endpoints in Phase III trial for GCA
Genentech has reported positive results from the Phase III GiACTA clinical trial of Actemra (tocilizumab) to treat adults with giant cell arteritis (GCA). (Source: Drug Development Technology)
Source: Drug Development Technology - July 27, 2017 Category: Pharmaceuticals Source Type: news

OncoQuest starts enrolment in Phase I/II ovarian cancer trial
Canada-based OncoQuest has started enrolling patients in a Phase I/II clinical trial to evaluate the combination of its antibody oregovomab with Hiltonol as a treatment for ovarian cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - July 27, 2017 Category: Pharmaceuticals Source Type: news

Vosevi ™ for the Retreatment of Chronic Hepatitis C Virus Infection
Vosevi ™ (Sofosbuvir/Velpatasvir/Voxilaprevir) is a direct-acting antiviral (DAA) indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults with genotypes one to six. (Source: Drug Development Technology)
Source: Drug Development Technology - July 27, 2017 Category: Pharmaceuticals Source Type: news

Deals this week: eFFECTOR Therapeutics, VenatoRx Pharmaceuticals, Kezar Life Sciences
US-based biotech company eFFECTOR Therapeutics has secured $38.6m in a series C venture financing round led by Pfizer Venture Investments (PVI). (Source: Drug Development Technology)
Source: Drug Development Technology - July 27, 2017 Category: Pharmaceuticals Source Type: news

M & As this week: BriaCell Therapeutics, Lentigen Technology
BriaCell Therapeutics plans to acquire Sapientia Pharmaceuticals through its subsidiary BriaCell Therapeutics (BriaCell USA). (Source: Drug Development Technology)
Source: Drug Development Technology - July 27, 2017 Category: Pharmaceuticals Source Type: news

Verona Pharma begins RPL554 dosing in Phase IIb trial for COPD
UK-based biopharmaceutical firm Verona Pharma has begun dosing patients in a Phase IIb clinical trial of RPL554 as a maintenance treatment for patients with chronic obstructive pulmonary disease (COPD). (Source: Drug Development Technology)
Source: Drug Development Technology - July 26, 2017 Category: Pharmaceuticals Source Type: news

Retrophin doses first patient in Phase III trial of RE-024 for PKAN
Retrophin has started dosing patients in a Phase III Fosmetpantotenate Replacement Therapy (FORT) clinical trial of RE-024 to treat patients with pantothenate kinase-associated neurodegeneration (PKAN). (Source: Drug Development Technology)
Source: Drug Development Technology - July 26, 2017 Category: Pharmaceuticals Source Type: news

Neon Therapeutics and Apexigen start Phase IIb combination trial for melanoma
Immuno-oncology firm Neon Therapeutics has partnered with biopharmaceutical company Apexigen to investigate its NEO-PV-01 in combination with APX005M in a Phase IIb trial to treat patients with metastatic melanoma. (Source: Drug Development Technology)
Source: Drug Development Technology - July 26, 2017 Category: Pharmaceuticals Source Type: news