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Entasis and GARDP to evaluate zoliflodacin in Phase III trial for drug-resistant gonorrhea
US-based Entasis Therapeutics and the not-for-profit Global Antibiotic Research& Development Partnership (GARDP) have entered a partnership to develop a new treatment for drug-resistant gonorrhea. (Source: Drug Development Technology)
Source: Drug Development Technology - July 6, 2017 Category: Pharmaceuticals Source Type: news

Baxdela ™ (delafloxacin) for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Baxdela ™ (delafloxacin) is a fluoroquinolone antibiotic drug indicated for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI). The drug was discovered and developed by Melinta Therapeutics in partnership with Lig… (Source: Drug Development Technology)
Source: Drug Development Technology - July 6, 2017 Category: Pharmaceuticals Source Type: news

Trovagene selects PRA Health Sciences to conduct Phase lb/ll trial of PCM-075 for AML
US-based biotechnology company Trovagene has chosen global contract research organisation (CRO) PRA Health Sciences to carry out its Phase lb/ll clinical trial of PCM-075, a polo-like kinase 1 (PLK1) inhibitor, to treat patients with acute myeloid le … (Source: Drug Development Technology)
Source: Drug Development Technology - July 6, 2017 Category: Pharmaceuticals Source Type: news

Deals this week: Ritter Pharmaceuticals, Sienna Biopharmaceuticals, Exscientia
Ritter Pharmaceuticals has announced a public offering of class A units to raise $10m. (Source: Drug Development Technology)
Source: Drug Development Technology - July 6, 2017 Category: Pharmaceuticals Source Type: news

Aimmune begins patient enrolment in European Phase lll trial of AR101 for peanut allergy
US-based Aimmune Therapeutics has begun enrolling patients for the European Phase lll ARTEMIS (ARC010) clinical trial of its investigational biologic oral immunotherapy, AR101, to treat peanut allergy. (Source: Drug Development Technology)
Source: Drug Development Technology - July 5, 2017 Category: Pharmaceuticals Source Type: news

Galapagos and Gilead commence Phase II trial of filgotinib for uveitis
Belgian biotechnology firm Galapagos and its collaboration partner Gilead Sciences has commenced a Phase II clinical trial of filgotinib to treat patients suffering from uveitis. (Source: Drug Development Technology)
Source: Drug Development Technology - July 5, 2017 Category: Pharmaceuticals Source Type: news

Ferring reports positive outcome from Phase III trials of fertility drug
Swiss biopharmaceutical company Ferring Pharmaceuticals has reported a positive outcome from the Phase III ESTHER-1 and ESTHER-2 clinical trials of its fertility drug, Rekovelle. (Source: Drug Development Technology)
Source: Drug Development Technology - July 5, 2017 Category: Pharmaceuticals Source Type: news

June ’s top stories: NIH’s Phase I/II trial for chikungunya, Boehringer & Eli Lilly ’s empagliflozin trial
A new Phase I/II clinical trial of MV-CHIKV for the prevention of the chikungunya virus began enrolment, while Boehringer Ingelheim, along with Eli Lilly and Company, made plans to evaluate empagliflozin in a new clinical outcomes trial for chronic k … (Source: Drug Development Technology)
Source: Drug Development Technology - July 4, 2017 Category: Pharmaceuticals Source Type: news

Boehringer reports positive safety profile of Jardiance for type 2 diabetes
Boehringer Ingelheim has reported a positive safety profile of oral Jardiance (empagliflozin) for the treatment of adults with type 2 diabetes. (Source: Drug Development Technology)
Source: Drug Development Technology - July 4, 2017 Category: Pharmaceuticals Source Type: news

BrainStorm chooses Worldwide as CRO for Phase III ALS trial
US-based biotechnology company BrainStorm Cell Therapeutics has chosen Worldwide Clinical Trials as the clinical research organisation (CRO) for its upcoming Phase III clinical trial of NurOwn for treatment of patients with amyotrophic lateral sclero … (Source: Drug Development Technology)
Source: Drug Development Technology - July 4, 2017 Category: Pharmaceuticals Source Type: news

Noxxon Pharma starts dosing in Phase I/II trial of NOX-A12 for cancer
German firm Noxxon Pharma has started dosing patients in a Phase I/II clinical trial of NOX-A12 (olaptesed pegol) in combination with Keytruda (pembrolizumab) to treat metastatic colorectal and pancreatic cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - July 4, 2017 Category: Pharmaceuticals Source Type: news

Bayer begins Phase III programme of vilaprisan to treat uterine fibroids
Bayer has started a Phase III ASTEROID clinical programme of vilaprisan with enrolment of the first patient for treatment of uterine fibroids. (Source: Drug Development Technology)
Source: Drug Development Technology - July 3, 2017 Category: Pharmaceuticals Source Type: news

Oxford University to investigate AZD1775 for bowel cancer
The UK's University of Oxford is set to investigate AstraZeneca ’s experimental drug AZD1775 in a new clinical trial for treatment of patients with bowel cancer.   (Source: Drug Development Technology)
Source: Drug Development Technology - July 3, 2017 Category: Pharmaceuticals Source Type: news

Zealand starts enrolment in Phase III trial of dasiglucagon for hypoglycemia
Denmark-based biotechnology firm Zealand Pharma has started patient enrolment in Phase III clinical trial of dasiglucagon to treat severe hypoglycaemia in diabetic patients. (Source: Drug Development Technology)
Source: Drug Development Technology - July 3, 2017 Category: Pharmaceuticals Source Type: news

Daiichi Sankyo reports top-line results from Phase III trials of mirogabalin
Japanese pharmaceutical firm Daiichi Sankyo has reported top-line results from its Phase III NEUCOURSE and ALDAY clinical trials of mirogabalin to treat post-herpetic neuralgia and fibromyalgia. (Source: Drug Development Technology)
Source: Drug Development Technology - July 2, 2017 Category: Pharmaceuticals Source Type: news

eTheRNA initiates Phase Ib trial of TriMix-MEL for metastatic melanoma
Belgium-based cancer therapies developer eTheRNA Immunotherapies has initiated a Phase Ib clinical trial of TriMix-MEL (ECI-006) to treat patients with metastatic melanoma. (Source: Drug Development Technology)
Source: Drug Development Technology - July 2, 2017 Category: Pharmaceuticals Source Type: news

Aerpio starts dosing in Phase IIb trial of diabetic retinopathy drug
US-based Aerpio Pharmaceuticals has started dosing patients in the Phase IIb (TIME-2b) clinical trial of its product candidate AKB-9778, which could be used to treat patients with non-proliferative diabetic retinopathy. (Source: Drug Development Technology)
Source: Drug Development Technology - July 2, 2017 Category: Pharmaceuticals Source Type: news

An Analysis of Polymer Branching Using GPC / SEC Methodology
Polymer branching has been proven to have a potentially considerable impact on many physical properties of synthesised polymers, such as the disruption of crystallinity and a possible increase in single chain density and chain entanglements. (Source: Drug Development Technology)
Source: Drug Development Technology - July 2, 2017 Category: Pharmaceuticals Source Type: news

NIAID-funded trial shows use of common antimicrobials for MRSA abscesses
A clinical trial funded by the National Institute of Allergy and Infectious Diseases' (NIAID) health division has demonstrated the use of common and inexpensive antimicrobials to heal skin abscesses caused by methicillin-resistant Staphylococcus aure … (Source: Drug Development Technology)
Source: Drug Development Technology - June 29, 2017 Category: Pharmaceuticals Source Type: news

Deals this week: Selecta Biosciences, bluebird bio, TransGenic
Selecta Biosciences intends to raise $50m through private placement of shares of its common stock to be subscribed to by new and existing institutional investors and one of the company ’s board of directors. (Source: Drug Development Technology)
Source: Drug Development Technology - June 29, 2017 Category: Pharmaceuticals Source Type: news

Mydayis for the Treatment of Attention Deficit Hyperactivity Disorder
Mydayis is a CNS stimulant drug indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 13 years and above. (Source: Drug Development Technology)
Source: Drug Development Technology - June 29, 2017 Category: Pharmaceuticals Source Type: news

AstraZeneca and Chi-Med begin Phase III trial of savolitinib for PRCC
AstraZeneca and Hutchison China MediTech (Chi-Med) have started a Phase III SAVOIR clinical trial of savolitinib to treat patients with papillary renal cell carcinoma (PRCC). (Source: Drug Development Technology)
Source: Drug Development Technology - June 29, 2017 Category: Pharmaceuticals Source Type: news

M & As this week: NantCell, Shanghai No1 Pharmacy
NantCell has signed a definitive agreement to acquire Altor BioScience for a purchase consideration of approximately $290m. (Source: Drug Development Technology)
Source: Drug Development Technology - June 29, 2017 Category: Pharmaceuticals Source Type: news

CytomX starts dosing in Phase I/II trial of CX-2009 to treat solid tumours
US-based biopharmaceutical firm CytomX Therapeutics has started dosing patients in a Phase I/II clinical trial (PROCLAIM CX-2009) of CX-2009 for the treatment of patients with select advanced solid tumours. (Source: Drug Development Technology)
Source: Drug Development Technology - June 29, 2017 Category: Pharmaceuticals Source Type: news

MabVax begins dosing of MVT-1075 in Phase I cancer therapy trial
US-based biotechnology firm MabVax Therapeutics has started dosing patients in a Phase I clinical trial of MVT-1075 to treat patients with CA19-9 positive malignancies such as pancreatic, colon and lung cancers. (Source: Drug Development Technology)
Source: Drug Development Technology - June 28, 2017 Category: Pharmaceuticals Source Type: news

Genkyotex starts enrolment in Phase II trial of GKT831 to treat PBC
French company Genkyotex has started patient enrolment in a Phase II clinical trial of GKT831 for the treatment of patients with primary biliary cholangitis (PBC). (Source: Drug Development Technology)
Source: Drug Development Technology - June 28, 2017 Category: Pharmaceuticals Source Type: news

Gemphire reports positive top-line results from Phase IIb trial of HoFH drug
US-based Gemphire Therapeutics has reported positive top-line results from a Phase IIb clinical trial (COBALT-1) of gemcabene to treat patients with homozygous familial hypercholesterolemia (HoFH). (Source: Drug Development Technology)
Source: Drug Development Technology - June 28, 2017 Category: Pharmaceuticals Source Type: news

Sitka Biopharma to initiate Phase I trial of STK-01 to treat bladder cancer
Canada-based biotechnology firm Sitka Biopharma has entered an agreement with Cancer Research UK and Cancer Research Technology (CRT) to start a Phase I clinical trial of STK-01 for treatment of patients with bladder cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - June 27, 2017 Category: Pharmaceuticals Source Type: news

Verona to study RPL554 in Phase IIb trial for COPD in five European countries
UK-based biopharmaceutical firm Verona Pharma has secured regulatory approval to start a Phase IIb clinical trial of RPL554 in patients with chronic obstructive pulmonary disease (COPD) in the UK, Germany, Romania, Bulgaria and the Czech Republic. (Source: Drug Development Technology)
Source: Drug Development Technology - June 27, 2017 Category: Pharmaceuticals Source Type: news

Teva and Xenon ’s Phase II trial of TV-45070 for PHN fails to meet endpoints
Teva Pharmaceutical Industries and Xenon Pharmaceuticals have reported top-line data from a Phase II clinical trial of TV-45070 to treat patients suffering from post-herpetic neuralgia (PHN), with the drug failing to meet required endpoints. (Source: Drug Development Technology)
Source: Drug Development Technology - June 27, 2017 Category: Pharmaceuticals Source Type: news

Genentech and Epizyme to study tazemetostat in Phase Ib/II combination trial for NSCLC
Roche Group ’s biotechnology subsidiary Genentech has expanded clinical collaboration with biopharmaceutical firm Epizyme to investigate the combination of atezolizumab (Tecentriq) and tazemetostat in a Phase Ib/II clinical trial to treat non-small-ce… (Source: Drug Development Technology)
Source: Drug Development Technology - June 26, 2017 Category: Pharmaceuticals Source Type: news

Durect concludes enrolment in PERSIST trial of non-opioid analgesic
US-based biopharmaceutical company Durect has concluded patient enrolment in its Phase III PERSIST clinical trial of Posimir (Saber-Bupivacaine) for pain relief following surgery. (Source: Drug Development Technology)
Source: Drug Development Technology - June 26, 2017 Category: Pharmaceuticals Source Type: news

Xenetic Biosciences enrols first patient in Phase II trial of XBIO-101 for endometrial cancer
US-based biopharmaceutical firm Xenetic Biosciences has started patient enrolment in its Phase II clinical trial of XBIO-101 (sodium cridanimod) and progestin therapy combination to treat patients with endometrial cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - June 26, 2017 Category: Pharmaceuticals Source Type: news

Bial and Eisai report positive results from Phase II trial of Zebinix for epilepsy
Bial and Eisai have reported a positive outcome from a Phase II clinical trial (Study 208) of Zebinix (eslicarbazepine acetate) in children with focal-onset epilepsy. (Source: Drug Development Technology)
Source: Drug Development Technology - June 25, 2017 Category: Pharmaceuticals Source Type: news

DelMar Pharma to initiate Phase III trial of VAL-083 to treat GBM
Canadian-based cancer therapies developer DelMar Pharmaceuticals is set to initiate a Phase III STAR-3 clinical trial of VAL-083 for the treatment of patients with refractory glioblastoma multiforme (GBM), following the approval from Institutional Re … (Source: Drug Development Technology)
Source: Drug Development Technology - June 25, 2017 Category: Pharmaceuticals Source Type: news

Deals this week: Dova Pharmaceuticals Inc, Gamida Cell Ltd, Onxeo SA
US-based clinical-stage pharmaceutical company Dova Pharmaceuticals Inc is intending to raise between $60.93m and $69.06m through an initial public offering (IPO) of 4,062,500 shares of its common stock. (Source: Drug Development Technology)
Source: Drug Development Technology - June 22, 2017 Category: Pharmaceuticals Source Type: news

M & As this week: Shanghai ChemPartner Co, Cell Medica, BBI Group Holding
ShangPharma Corporation's contract research subsidiary Shanghai ChemPartner Co Ltd is set to merge with Quantum Hi-Tech (China) Biological Co Ltd. (Source: Drug Development Technology)
Source: Drug Development Technology - June 22, 2017 Category: Pharmaceuticals Source Type: news

Novartis reports positive top-line data from Phase III trial of cardiovascular drug
Novartis has reported positive top-line results from the Phase III CANTOS clinical trial of ACZ885 (canakinumab) and standard-of-care combination to address cardiovascular risk in patients who survived a heart attack. (Source: Drug Development Technology)
Source: Drug Development Technology - June 22, 2017 Category: Pharmaceuticals Source Type: news

Chi-Med commences Phase I/II trial of HMPL-453 for solid tumours
Hutchison China MediTech (Chi-Med) has commenced a Phase I/II clinical trial of HMPL-453 in China for the treatment of solid tumours in patients carrying fibroblast growth factor receptor (FGFR) genetic alteration. (Source: Drug Development Technology)
Source: Drug Development Technology - June 22, 2017 Category: Pharmaceuticals Source Type: news

CTD Holdings starts enrolment in Phase I/II trial of Trappsol Cyclo for NPC
US-based biotechnology firm CTD Holdings has started patient enrolment in the Phase I/II clinical trial of Trappsol Cyclo to treat patients suffering from Niemann-Pick disease type C (NPC) in Europe. (Source: Drug Development Technology)
Source: Drug Development Technology - June 22, 2017 Category: Pharmaceuticals Source Type: news

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