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Ra Pharmaceuticals begins dosing in Phase II trials of RA101495 to treat PNH
US-based Ra Pharmaceuticals has begun dosing patients in the Phase II clinical programme of its RA101495 for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). (Source: Drug Development Technology)
Source: Drug Development Technology - April 26, 2017 Category: Pharmaceuticals Source Type: news

The Medicines Company and Alnylam to initiate Phase III clinical programme of inclisiran
The Medicines Company and Alnylam Pharmaceuticals have entered an agreement with the US Food and Drug Administration (FDA) for the Phase III clinical programme of inclisiran to treat atherosclerotic cardiovascular disease (ASCVD) and familial hyperch … (Source: Drug Development Technology)
Source: Drug Development Technology - April 26, 2017 Category: Pharmaceuticals Source Type: news

Can-Fite to begin Phase III trial of piclidenoson in Israel to treat rheumatoid arthritis
Biotechnology company Can-Fite BioPharma has obtained approval from the Institutional Review Board (IRB) of Barzilai Medical Center in Israel, to begin patient enrolment in the Phase III ACRobat clinical trial of piclidenoson for the treatment of rhe … (Source: Drug Development Technology)
Source: Drug Development Technology - April 26, 2017 Category: Pharmaceuticals Source Type: news

Malvern to Host Webinar on Using Multi-Setection size-exclusion chromatography to Evaluate Biosimilarity
Malvern has announced it will be hosting a new webinar presenting size-exclusion chromatography (SEC) data and discussing the impact of different formulations and external stress conditions on Monoclonal antibodies and biosimilar molecules. (Source: Drug Development Technology)
Source: Drug Development Technology - April 26, 2017 Category: Pharmaceuticals Source Type: news

SillaJen and Transgene commence enrolment in Europe for Phase III trial of Pexa-Vec
South Korean-based biotherapeutics firm SillaJen and French biotechnology firm Transgene have commenced patient enrolment in Europe for the ongoing Phase III PHOCUS clinical trial of Pexa-Vec to treat advanced liver cancer or hepatocellular carcinoma … (Source: Drug Development Technology)
Source: Drug Development Technology - April 25, 2017 Category: Pharmaceuticals Source Type: news

ObsEva commences Phase III trials of OBE2109 to treat uterine fibroids
Swiss-based biopharmaceutical firm ObsEva has commenced its Phase III clinical trial programme of OBE2109 to treat uterine fibroids (UF). (Source: Drug Development Technology)
Source: Drug Development Technology - April 25, 2017 Category: Pharmaceuticals Source Type: news

Capricor reports positive top-line results from Phase I/II trial of CAP-1002 for DMD
US-based biotechnology firm Capricor Therapeutics has reported positive top-line six-month results from the Phase I/II HOPE clinical trial of CAP-1002 to treat duchenne muscular dystrophy (DMD). (Source: Drug Development Technology)
Source: Drug Development Technology - April 25, 2017 Category: Pharmaceuticals Source Type: news

Bristol-Myers Squibb's BMS-986036 meets primary endpoint in Phase II trial to treat NASH
Bristol-Myers Squibb (BMS) has reported positive results from a Phase II clinical trial of BMS-986036 to treat non-alcoholic steatohepatitis (NASH) patients. (Source: Drug Development Technology)
Source: Drug Development Technology - April 24, 2017 Category: Pharmaceuticals Source Type: news

American Regent begins enrolment in Phase III trial of Injectafer to treat heart failure
Japanese pharmaceutical firm Daiichi Sankyo's division, American Regent, has begun patient enrolment in the Phase III HEART-FID clinical trial of Injectafer (ferric carboxymaltose) for the treatment of heart failure with iron deficiency. (Source: Drug Development Technology)
Source: Drug Development Technology - April 24, 2017 Category: Pharmaceuticals Source Type: news

Tiziana to initiate Phase II trial of milciclib in Israel to treat hepatocellular carcinoma
UK-based biotechnology firm Tiziana Life Sciences has received approval for the initiation of its Phase II clinical trial of milciclib in Israel to treat refractory hepatocellular carcinoma (HCC). (Source: Drug Development Technology)
Source: Drug Development Technology - April 24, 2017 Category: Pharmaceuticals Source Type: news

Jounce begins Phase II portion of Phase I/II trial of JTX-2011 to treat solid tumours
Immunotherapy company Jounce Therapeutics has begun patient enrolment in the Phase II portion of its Phase I/II ICONIC trial of JTX-2011 for the treatment of advanced solid tumours. (Source: Drug Development Technology)
Source: Drug Development Technology - April 23, 2017 Category: Pharmaceuticals Source Type: news

BeiGene begins dosing in Phase II trial of BGB-A317 in China to treat cHL
Biopharmaceutical company BeiGene has begun dosing patients in its Phase II clinical trial of BGB-A317 in China for the treatment of classical Hodgkin lymphoma (cHL). (Source: Drug Development Technology)
Source: Drug Development Technology - April 23, 2017 Category: Pharmaceuticals Source Type: news

Atara and Merck to investigate ATA129 + Keytruda for EBV-associated NPC
Biopharmaceutical firm Atara Biotherapeutics has entered a clinical trial collaboration agreement with Merck to evaluate the combination of its ATA129 with Keytruda (pembrolizumab) for the treatment of patients with nasopharyngeal carcinoma (NPC) ass … (Source: Drug Development Technology)
Source: Drug Development Technology - April 23, 2017 Category: Pharmaceuticals Source Type: news

Determining Characterisations of Biopharmaceutical Stability with DSC
An important parameter in production, manufacturing, formulation, and long-term storage, protein stability has large effects on biopharmaceutical products and higher stability means for greater profits and less product waste. (Source: Drug Development Technology)
Source: Drug Development Technology - April 23, 2017 Category: Pharmaceuticals Source Type: news

Lion Biotechnologies and MD Anderson to investigate TIL therapy in solid tumour trials
Lion Biotechnologies has entered a multi-year strategic alliance agreement with the University of Texas MD Anderson Cancer Center to investigate its tumour-infiltrating lymphocyte (TIL) therapy in multi-arm clinical trials to treat ovarian and pancre … (Source: Drug Development Technology)
Source: Drug Development Technology - April 20, 2017 Category: Pharmaceuticals Source Type: news

Boehringer begins enrolment in Phase III trial of nintedanib for fibrosing lung diseases
US-based Boehringer Ingelheim Pharmaceuticals has begun patient enrolment in the Phase III progressive fibrosing interstitial lung disease (PF-ILD) clinical trial of nintedanib to treat various progressive fibrosing lung diseases, excluding idiopathi … (Source: Drug Development Technology)
Source: Drug Development Technology - April 20, 2017 Category: Pharmaceuticals Source Type: news

Clearside concludes enrolment in Phase I/II trial of CLS-TA to treat DME
US-based biopharmaceutical firm Clearside Biomedical has concluded patient enrolment in the exploratory Phase I/II HULK trial of CLS-TA to treat diabetic macular edema (DME). (Source: Drug Development Technology)
Source: Drug Development Technology - April 20, 2017 Category: Pharmaceuticals Source Type: news

Deals this week: Galapagos, Bristol-Myers Squibb, Zymeworks
Belgium-based clinical-stage biotechnology company Galapagos has announced the pricing for its proposed offering of American depository shares (ADS) to raise funds for its general corporate purposes, new and ongoing research and development (R&D) act … (Source: Drug Development Technology)
Source: Drug Development Technology - April 20, 2017 Category: Pharmaceuticals Source Type: news

M & As this week: Nivalis Therapeutics, Medidata Solutions
Nautilus Merger Sub, a subsidiary of US-based pharmaceutical company, Nivalis Therapeutics, has reached a reverse takeover agreement to acquire Alpine Immune Sciences. (Source: Drug Development Technology)
Source: Drug Development Technology - April 20, 2017 Category: Pharmaceuticals Source Type: news

Abide doses first patient in Phase Ib trial of ABX-1431 to treat tourette syndrome
US-based Abide Therapeutics has started dosing patients in a Phase Ib clinical trial of ABX-1431 for the treatment of tourette syndrome (TS). (Source: Drug Development Technology)
Source: Drug Development Technology - April 19, 2017 Category: Pharmaceuticals Source Type: news

AbbVie's veliparib fails to meet primary endpoints in two Phase III combination trials
AbbVie has reported top-line results from two Phase III clinical trials of its veliparib in combination with chemotherapy regimen to treat squamous non-small-cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC). (Source: Drug Development Technology)
Source: Drug Development Technology - April 19, 2017 Category: Pharmaceuticals Source Type: news

Bavarian Nordic commences Phase II combination trial for prostate cancer
Danish-based biotechnology firm Bavarian Nordic has commenced a Phase II clinical trial of Prostvac (rilimogene) in combination with Yervoy (ipilimumab) and / or Opdivo (nivolumab) to treat localised prostate cancer patients. (Source: Drug Development Technology)
Source: Drug Development Technology - April 19, 2017 Category: Pharmaceuticals Source Type: news

Immunovaccine starts dosing in Phase Ib/II trial of DPX-E7 to treat HPV-related cancers
Canadian-based biopharmaceutical company Immunovaccine has started dosing patients in a Phase Ib/II trial of its vaccine DPX-E7 for the treatment of incurable human papillomavirus (HPV) related oropharyngeal, cervical and anal cancers. (Source: Drug Development Technology)
Source: Drug Development Technology - April 18, 2017 Category: Pharmaceuticals Source Type: news

GeNeuro starts Phase IIa trial of GNbAC1 in Australia to treat Type 1 diabetes
Swiss-based GeNeuro has started a Phase IIa clinical trial of GNbAC1 in Australia for the treatment of Type 1 diabetes (T1D) patients. (Source: Drug Development Technology)
Source: Drug Development Technology - April 18, 2017 Category: Pharmaceuticals Source Type: news

Novartis and Allergan to conduct Phase IIb trial to treat NASH
Swiss healthcare firm Novartis has entered a clinical trial agreement with Irish pharmaceutical company Allergan to conduct a Phase IIb trial of FXR agonist and cenicriviroc (CVC) combination to treat non-alcoholic steatohepatitis (NASH). (Source: Drug Development Technology)
Source: Drug Development Technology - April 18, 2017 Category: Pharmaceuticals Source Type: news

Gamlen Study: Breaking Anisotropic Rod-Shaped Particles
Gamlen presents a study conducted by V. Penkavova1, L. Kulaviak1, M.C. Ruzicka1, M. Puncochar, and P. Zamostny on the 'Beaking of Anisotropic Rod-Saped Particles'. (Source: Drug Development Technology)
Source: Drug Development Technology - April 18, 2017 Category: Pharmaceuticals Source Type: news

OncoMed's tarextumab fails to meet endpoints in Phase II trial for small-cell lung cancer
US-based OncoMed Pharmaceuticals' tarextumab (anti-Notch2/3, OMP-59R5) has not met the endpoints in a Phase II clinical trial to treat patients with extensive-stage, small-cell lung cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - April 17, 2017 Category: Pharmaceuticals Source Type: news

Medicenna begins dosing in Phase IIb trial of MDNA55 to treat rGB
Medicenna Therapeutics' subsidiary Medicenna BioPharma has begun dosing patients in the Phase IIb trial of its MDNA55 to treat recurrent glioblastoma (rGB). (Source: Drug Development Technology)
Source: Drug Development Technology - April 17, 2017 Category: Pharmaceuticals Source Type: news

Genentech reports positive interim data from Phase III trial of emicizumab for haemophilia A
Roche's biotechnology subsidiary Genentech has reported positive interim results from the Phase III HAVEN 2 clinical trial of emicizumab for the treatment of children with haemophilia A and inhibitors to factor VIII. (Source: Drug Development Technology)
Source: Drug Development Technology - April 17, 2017 Category: Pharmaceuticals Source Type: news

Ingrezza (valbenazine) for the Treatment of Tardive Dyskinesia
Ingrezza (valbenazine) is first and only US Food and Drug Administration (FDA) approved vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of adults with Tardive dyskinesia (TD). (Source: Drug Development Technology)
Source: Drug Development Technology - April 17, 2017 Category: Pharmaceuticals Source Type: news

Reasons to Upgrade to a MicroCal PEAQ-DSC System
Differential Scanning Calorimetry (DSC) is a tool for protein stability characterisation in drug development. Its data is used to advance stable and developable proteins into the pipeline, while optimising process and formulation conditions to mainta … (Source: Drug Development Technology)
Source: Drug Development Technology - April 16, 2017 Category: Pharmaceuticals Source Type: news

Deals this week: Axovant Sciences, Ferring International, Takeda Pharmaceutical Company
Axovant Sciences has announced an equity offering to raise $100m in gross proceeds, along with a 30-day option to underwriters to purchase up to an additional $15m worth of its common stock shares. (Source: Drug Development Technology)
Source: Drug Development Technology - April 13, 2017 Category: Pharmaceuticals Source Type: news

Characterisation Information of Critical Excipients for Sourcing Critical Raw Materials
The increasing complexity of large molecule and cell-based therapeutics calls for an evolution in our understanding of the impurity and functional contributions of each formulation component. (Source: Drug Development Technology)
Source: Drug Development Technology - April 13, 2017 Category: Pharmaceuticals Source Type: news

BMS and Apexigen to assess Opdivo + APX005M combination for NSCLC
Bristol-Myers Squibb (BMS) has entered a clinical collaboration with biopharmaceutical firm Apexigen to assess the combination of Opdivo (nivolumab) with APX005M for the treatment of advanced solid tumours. (Source: Drug Development Technology)
Source: Drug Development Technology - April 12, 2017 Category: Pharmaceuticals Source Type: news

Themis begins Phase I trial of MV-ZIKA-101 against Zika virus
Austrian-based biotech firm Themis Bioscience has begun the Phase I trial of its Zika vaccine MV-ZIKA-101 in healthy subjects. (Source: Drug Development Technology)
Source: Drug Development Technology - April 12, 2017 Category: Pharmaceuticals Source Type: news

Transgene starts Phase II trial of Pexa-Vec and cyclophosphamide for breast cancer and STS
French-based biotechnology firm Transgene has started dosing patients in the Phase II stage of the METROmaJX clinical trial of Pexa-Vec and metronomic cyclophosphamide combination for the treatment of advanced solid tumours such as breast cancer and … (Source: Drug Development Technology)
Source: Drug Development Technology - April 12, 2017 Category: Pharmaceuticals Source Type: news

Case Study: Compaction Behaviour of Orally Dispersable Mini-Tablets
This whitepaper describes a method for performing dynamic powder compaction analysis and for measuring tensile fracture strength of tablets. (Source: Drug Development Technology)
Source: Drug Development Technology - April 12, 2017 Category: Pharmaceuticals Source Type: news

Investigating Tablet Problems
If you are looking for a better way to identify and study tableting problems, the secret lies in the design of a conventional tablet press. (Source: Drug Development Technology)
Source: Drug Development Technology - April 12, 2017 Category: Pharmaceuticals Source Type: news

Austedo (deutetrabenazine) for the Treatment of Chorea
Austedo ™ (deutetrabenazine) is a vesicular monoamine transporter 2 (VMAT 2) inhibitor indicated for the treatment of chorea associated with Huntington’s disease (HD). (Source: Drug Development Technology)
Source: Drug Development Technology - April 11, 2017 Category: Pharmaceuticals Source Type: news

Rebiotix's RBX2660 demonstrates positive outcome in Phase II trial for C. diff. infection
Microbiome company Rebiotix has reported a positive outcome for RBX2660 from the Phase II PUNCH clinical trial for the prevention of recurrent Clostridium difficile (C. diff.) infection. (Source: Drug Development Technology)
Source: Drug Development Technology - April 11, 2017 Category: Pharmaceuticals Source Type: news

Alexo starts dosing in Phase I trial of ALX148 to treat solid tumours and lymphoma
Immuno-oncology company Alexo Therapeutics has started dosing patients in the Phase I clinical trial of a fusion protein ALX148 for the treatment of solid tumours and lymphoma. (Source: Drug Development Technology)
Source: Drug Development Technology - April 11, 2017 Category: Pharmaceuticals Source Type: news

Inotek closes enrolment in Phase II trial of trabodenoson + latanoprost for glaucoma
Inotek Pharmaceuticals has closed patient enrolment in the Phase II clinical trial of fixed-dose combination (FDC) of trabodenoson and latanoprost to treat patients with glaucoma. (Source: Drug Development Technology)
Source: Drug Development Technology - April 11, 2017 Category: Pharmaceuticals Source Type: news

NHS' anti-HIV drug PrEP approved in Scotland, UK
The Scottish Medicines Consortium (SMC), UK, has approved the supply of Emtricitabine / tenofovir disoproxil (Truvada) by the National Health Service (NHS) to prevent HIV in the nation. (Source: Drug Development Technology)
Source: Drug Development Technology - April 10, 2017 Category: Pharmaceuticals Source Type: news

Ovid commences Phase I trial of OV101 to treat Angelman / Fragile X syndromes
Biopharmaceutical firm Ovid Therapeutics has commenced the Phase I clinical trial of OV101 for the treatment of adolescents with Angelman syndrome or Fragile X syndrome. (Source: Drug Development Technology)
Source: Drug Development Technology - April 10, 2017 Category: Pharmaceuticals Source Type: news

Kura Oncology begins dosing in Phase I trial of KO-947 for non-hematological malignancies
US-based biopharmaceutical firm Kura Oncology has begun dosing patients in its Phase I clinical trial of KO-947 for the treatment of relapsed and / or refractory, non-hematological malignancies. (Source: Drug Development Technology)
Source: Drug Development Technology - April 10, 2017 Category: Pharmaceuticals Source Type: news

Zejula (niraparib) for the Treatment of Ovarian Cancer
Zejula ™ (Niraparib) is a poly adenosine diphosphate (ADP) ribose polymerase (PARP) inhibitor approved for the treatment of adult patients with ovarian cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - April 9, 2017 Category: Pharmaceuticals Source Type: news

AnaptysBio starts dosing subjects in Phase I trial of ANB019 for inflammatory disorders
US-based biotechnology firm AnaptysBio has started dosing healthy subjects in a Phase I trial of ANB019 for inflammatory disorders such as generalised pustular psoriasis (GPP) and palmo-plantar pustular psoriasis (PPP). (Source: Drug Development Technology)
Source: Drug Development Technology - April 9, 2017 Category: Pharmaceuticals Source Type: news

AbbVie reports positive results from Phase IIb trial of elagolix for uterine fibroids
AbbVie and Neurocrine Biosciences have reported positive results from a Phase IIb clinical trial of elagolix to minimise menstrual bleeding in women with uterine fibroids. (Source: Drug Development Technology)
Source: Drug Development Technology - April 9, 2017 Category: Pharmaceuticals Source Type: news

New Phase II trial begins in West Africa to assess various Ebola vaccine candidates
A new Phase II clinical trial has begun in West Africa to evaluate three vaccination strategies for the prevention of Ebola virus. (Source: Drug Development Technology)
Source: Drug Development Technology - April 9, 2017 Category: Pharmaceuticals Source Type: news

Deals this week: Opthea, AnGes MG, Sentien Biotechnologies
Australian-based biotechnology company Opthea intends to raise A$10m ($7.63m) in gross proceeds from the rights offering of shares entitling holders to purchase one share for every 14 existing shares in the company. (Source: Drug Development Technology)
Source: Drug Development Technology - April 6, 2017 Category: Pharmaceuticals Source Type: news