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Aprea Therapeutics enrols first patients for Phase II study of APR-246 for ovarian cancer treatment
Aprea Therapeutics   has enrolled its   first patients in   Phase II of an   ongoing clinical study of APR-246, a potential   treatment of high-grade serous ovarian cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - October 10, 2016 Category: Pharmaceuticals Source Type: news

Malvern to Demonstrate New Nanoparticle-Size and Concentration Measurer in Webinar
Malvern has announced it will be demonstrating the NanoSight NS3000, which uses Nanoparticle Tracking Analysis (NTA) to measure nanoparticles and concentrates. (Source: Drug Development Technology)
Source: Drug Development Technology - October 10, 2016 Category: Pharmaceuticals Source Type: news

Vaccinex and Merck KGaA to evaluate VX15/2503 and Avelumab in non-small cell lung cancer
Vaccinex has signed a collaboration agreement with Germany-based Merck KGaA to analyse VX15/2503 in combination with avelumab. (Source: Drug Development Technology)
Source: Drug Development Technology - October 9, 2016 Category: Pharmaceuticals Source Type: news

Kite Pharma enrols first patient in ZUMA-6
Kite Pharma has enrolled the first patient of ZUMA-6, a Phase 1b/2 clinical study of KTE-C19 in combination with Genentech ’s anti-PD-L1 cancer immunotherapy atezolizumab. (Source: Drug Development Technology)
Source: Drug Development Technology - October 9, 2016 Category: Pharmaceuticals Source Type: news

ARCA biopharma initiates randomisation of first European patients in GENETIC-AF Phase 2B/3 trial
ARCA biopharma has announced the randomisation of the first European patients in the GENETIC-AF Phase 2B/3 clinical trial. (Source: Drug Development Technology)
Source: Drug Development Technology - October 9, 2016 Category: Pharmaceuticals Source Type: news

Ocrevus (ocrelizumab) for the Treatment of Multiple Sclerosis
Ocrevus (ocrelizumab), developed by Genentech, a member of Roche Group, is indicated for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis. (Source: Drug Development Technology)
Source: Drug Development Technology - October 6, 2016 Category: Pharmaceuticals Source Type: news

eptember's top stories: Oncternal begins dosing TK216 trial, Trial of medical cannabis begins, Canada
Oncternal Therapeutics has begun dosing patients in its Phase I clinical trial of TK216 to treat Ewing sarcoma and Tilray and University of British Columbia have begun patient enrolment in Canada ’s first Phase II clinical trial of medical cannabis to… (Source: Drug Development Technology)
Source: Drug Development Technology - October 6, 2016 Category: Pharmaceuticals Source Type: news

Karus Therapeutics announces dosing of first patients with KA2237 in clinical study
Karus Therapeutics, a company into the development of innovative, orally active medicines with breakthrough potential in the treatment of cancer, has announced that the first patients have been dosed in a Phase I study for its lead candidate, KA2237. (Source: Drug Development Technology)
Source: Drug Development Technology - October 6, 2016 Category: Pharmaceuticals Source Type: news

CymaBay Therapeutics to commence Phase 2 study of MBX-8025 in primary biliary cholangitis
US-based clinical-stage biopharmaceutical company CymaBay Therapeutics announces its plans to initiate the next Phase 2 study of MBX-8025 in the subjects with primary biliary cholangitis (PBC). (Source: Drug Development Technology)
Source: Drug Development Technology - October 6, 2016 Category: Pharmaceuticals Source Type: news

Report: Global percutaneous coronary interventions market forecast to reach $8 billion by 2022
The percutaneous coronary interventions market is projected to grow at a steady compound annual growth rate of 3.5% globally, according to a report by GlobalData. (Source: Drug Development Technology)
Source: Drug Development Technology - October 6, 2016 Category: Pharmaceuticals Source Type: news

Deals this week: ClearLight Diagnostics, Mitsubishi Tanabe Pharma Corporation, Samsung Biologics
ClearLight Diagnostics and Oregon Health and Science University Centre for Spatial Systems Biomedicine (OCSSB) have entered a co-development agreement to analyse the tumour micro-environment and resistance associated interactions in pancreatic cancer … (Source: Drug Development Technology)
Source: Drug Development Technology - October 6, 2016 Category: Pharmaceuticals Source Type: news

Viking initiates Phase II trial of VK2809 to treat hypercholesterolemia and NAFLD
US-based clinical-stage biopharmaceutical company Viking Therapeutics has initiated its Phase II clinical trial of VK2809 to treat primary hypercholesterolemia and non-alcoholic fatty liver disease (NAFLD). (Source: Drug Development Technology)
Source: Drug Development Technology - October 5, 2016 Category: Pharmaceuticals Source Type: news

Ocular begins enrolment in first Phase III trial of OTX-TP to treat glaucoma and ocular hypertension
US-based biopharmaceutical company Ocular Therapeutix has started enrolling in its first of two planned Phase III clinical trials of OTX-TP to treat glaucoma and ocular hypertension. (Source: Drug Development Technology)
Source: Drug Development Technology - October 5, 2016 Category: Pharmaceuticals Source Type: news

Alkermes begins supportive clinical study of ALKS 3831 to treat schizophrenia
Irish-based biopharmaceutical company Alkermes has begun its supportive clinical study of ALKS 3831 for the treatment of schizophrenia. (Source: Drug Development Technology)
Source: Drug Development Technology - October 4, 2016 Category: Pharmaceuticals Source Type: news

Infirst reports positive top-line data from Phase III FLARE study of BC1054 to treat knee pain
UK-based Infirst Healthcare has reported positive top-line data from its Phase III IFH-2014-002 FLARE study of BC1054 to treat knee pain. (Source: Drug Development Technology)
Source: Drug Development Technology - October 4, 2016 Category: Pharmaceuticals Source Type: news

Allegro completes patient enrolment in PACIFIC Phase IIb clinical trial of Luminate
US-based biotechnology company Allegro Ophthalmics has completed enrolment of its PACIFIC Phase IIb clinical trial of Luminate (ALG-1001) in resulting posterior vitreous detachment (PVD) within patients with non-proliferative diabetic retinopathy (DR … (Source: Drug Development Technology)
Source: Drug Development Technology - October 4, 2016 Category: Pharmaceuticals Source Type: news

Janssen reports positive outcome from Voyage I trial of guselkumab to treat plaque psoriasis
Johnson& Johnson ’s Janssen Research& Development has reported a positive outcome from the first of the three pivotal Phase III Voyage I studies of guselkumab compared with adalimumab to treat adults with moderate-to-severe plaque psoriasis. (Source: Drug Development Technology)
Source: Drug Development Technology - October 3, 2016 Category: Pharmaceuticals Source Type: news

Braeburn and Camurus begin enrolment in Phase III trial of CAM2038 to treat chronic low back pain
US-based Braeburn Pharmaceuticals and Swedish biotechnology firm Camurus has begun enrolling for its Phase III trial of CAM2038 in patients with moderate-to-severe chronic low back pain who are currently being treated with opioids. (Source: Drug Development Technology)
Source: Drug Development Technology - October 3, 2016 Category: Pharmaceuticals Source Type: news

Quantum Genomics achieves positive Phase IIa trial top-line results of QGC001 in treating hypertension
French-based bio-pharmaceutical company Quantum Genomics has reported positive top-line data from its Phase IIa trial of QGC001 to treat hypertension (high blood pressure). (Source: Drug Development Technology)
Source: Drug Development Technology - October 2, 2016 Category: Pharmaceuticals Source Type: news

Eisai begins Phase III CLEAR Study of lenvatinib as first-line therapy for RCC
Japanese-based pharmaceutical company Eisai has commenced its Phase III CLEAR Study of Lenvima (lenvatinib) combined with Keytruda (pembrolizumab) and Lenvima with everolimus against sunitinib to treat advanced renal cell carcinoma (RCC) in the first … (Source: Drug Development Technology)
Source: Drug Development Technology - October 2, 2016 Category: Pharmaceuticals Source Type: news

Aurinia reports positive AURA –LV study outcome of voclosporin in treating lupus nephritis
Canadian-based clinical stage bio-pharmaceutical company Aurinia has reported positive results from its AURA –LV study of voclosporin in combination with mycophenolate mofetil against placebo to treat lupus nephritis (LN). (Source: Drug Development Technology)
Source: Drug Development Technology - October 2, 2016 Category: Pharmaceuticals Source Type: news

What Is Differential Scanning Calorimetry (DSC)?
Differential Scanning Calorimetry (DSC) measures the heat change during denaturation of biothermal samples, particularly engineered proteins and biopharmaceutical products. (Source: Drug Development Technology)
Source: Drug Development Technology - September 30, 2016 Category: Pharmaceuticals Source Type: news

Deals this week: Peakdale Molecular, Bristol-Myers Squibb, Ironwood Pharmaceuticals
Peakdale Molecular and Cresset BioMolecular Discovery have entered an agreement to further expand the former ’s integrated drug discovery services. (Source: Drug Development Technology)
Source: Drug Development Technology - September 29, 2016 Category: Pharmaceuticals Source Type: news

Amgen reports positive data from Phase III trial of erenumab to treat episodic migraine
US-based Amgen has reported positive top-line data from its Phase III ARISE Study of erenumab for the treatment of   episodic migraine. (Source: Drug Development Technology)
Source: Drug Development Technology - September 29, 2016 Category: Pharmaceuticals Source Type: news

Neurim begins enrolment in Phase II trial of piromelatine to treat mild Alzheimer ’s disease
Israeli drug-development firm Neurim Pharmaceuticals has begun enrolling patients in its Phase II recognition study of piromelatine for mild Alzheimer ’s disease (AD). (Source: Drug Development Technology)
Source: Drug Development Technology - September 29, 2016 Category: Pharmaceuticals Source Type: news

Ibrance (palbociclib) for the Treatment of Metastatic Breast Cancer
Ibrance (palbociclib) is an oral formulation developed by Pfizer for the treatment of metastatic breast cancer in women with disease progression post endocrine therapy. (Source: Drug Development Technology)
Source: Drug Development Technology - September 29, 2016 Category: Pharmaceuticals Source Type: news

AcelRx begins Phase III IAP312 study of Zalviso to manage acute post-operative pain
US-based specialist pharmaceutical company AcelRx has begun its Phase III IAP312 study of Zalviso to treat moderate-to-severe acute post-operative pain in adult patients in a hospital setting. (Source: Drug Development Technology)
Source: Drug Development Technology - September 28, 2016 Category: Pharmaceuticals Source Type: news

Bristol-Myers Squibb and Nektar collaborate to test Opdivo and NKTR-214 combination
Bristol-Myers Squibb (BMY) and Nektar Therapeutics (NKTR) have entered a new clinical collaboration to test the combination of Opdivo (nivolumab) and NKTR-214 to treat five tumour types and seven other indications. (Source: Drug Development Technology)
Source: Drug Development Technology - September 28, 2016 Category: Pharmaceuticals Source Type: news

Drug Labeling Types
Understanding the various types of drug product labeling is an essential component of maintaining labeling compliance. Our most recent paper describes the different types of Drug Labeling and includes reference to the regulatory basis for each. (Source: Drug Development Technology)
Source: Drug Development Technology - September 28, 2016 Category: Pharmaceuticals Source Type: news

BeyondSpring begins enrolment in Phase Ib/II trial of plinabulin and nivolumab combination for NSCLC
US-based biopharmaceutical company BeyondSpring has enrolled the first patient in its Phase Ib/II trial of plinabulin combined with nivolumab to treat metastatic non-small-cell lung cancer (NSCLC). (Source: Drug Development Technology)
Source: Drug Development Technology - September 27, 2016 Category: Pharmaceuticals Source Type: news

GW Pharmaceuticals reports positive Phase III trial results of Epidiolex to treat Lennox-Gastaut syndrome
UK-based GW Pharmaceuticals has reported positive data from its Phase III clinical trial of Epidiolex (cannabidiol or CBD) to treat seizures associated with Lennox-Gastaut syndrome (LGS). (Source: Drug Development Technology)
Source: Drug Development Technology - September 27, 2016 Category: Pharmaceuticals Source Type: news

Aerpio Therapeutics begins Phase Ia trial of AKB-4924 to treat IBD
US-based clinical-stage biopharmaceutical company Aerpio Therapeutics has begun its Phase Ia clinical trial of AKB-4924 to treat inflammatory bowel disease (IBD). (Source: Drug Development Technology)
Source: Drug Development Technology - September 27, 2016 Category: Pharmaceuticals Source Type: news

Faraday begins first-in-human Phase I trial of FDY-5301 as elemental reducing agent
US-based biopharmaceutical company Faraday has initiated its first in-human Phase I clinical trial of FDY-5301 as an elemental reducing agent (ERA). (Source: Drug Development Technology)
Source: Drug Development Technology - September 26, 2016 Category: Pharmaceuticals Source Type: news

Corvus reports positive pre-clinical and preliminary biomarker data from Phase I/Ib trial of CPI-444
US-based clinical-stage biopharmaceutical company Corvus has reported positive pre-clinical and preliminary biomarker data from its ongoing Phase I/Ib trial of CPI-444, both as a single agent and combined with Genentech ’s Tecentriq (atezolizumab) to … (Source: Drug Development Technology)
Source: Drug Development Technology - September 26, 2016 Category: Pharmaceuticals Source Type: news

Is a Consultant Required to Review a Quality Management System (QMS) or Submit a 510(k) Application?
Is it your first time submitting a 510(k) application for a class II medical device? Are you thinking you have a Quality Management System (QMS) in place and experience with drug submissions, so this should be easy? (Source: Drug Development Technology)
Source: Drug Development Technology - September 26, 2016 Category: Pharmaceuticals Source Type: news

Is a Consultant Required to Revew a Quality Management System (QMS) or Submit a 510(k) Application
Is it your first time submitting a 510(k) application for a class II medical device? Are you thinking you have a Quality Management System (QMS) in place and experience with drug submissions, so this should be easy? (Source: Drug Development Technology)
Source: Drug Development Technology - September 26, 2016 Category: Pharmaceuticals Source Type: news

Alnylam reports positive initial data from Phase I/II study of ALN-GO1 to treat PH1
US-based biopharmaceutical company Alnylam has reported positive initial data from its ongoing Phase I/II study of ALN-GO1 to treat Primary Hyperoxaluria Type 1 (PH1). (Source: Drug Development Technology)
Source: Drug Development Technology - September 25, 2016 Category: Pharmaceuticals Source Type: news

Tocagen begins enrolment in Phase Ib trial of Toca 511 and Toca FC to treat metastatic cancers
US-based clinical-stage, cancer-selective immunotherapy company Tocagen has enrolled the first patient in its Phase Ib Toca 6 study of Toca 511 (vocimagene amiretrorepvec) combined with Toca FC (extended-release 5-fluorocytosine) to treat metastatic … (Source: Drug Development Technology)
Source: Drug Development Technology - September 25, 2016 Category: Pharmaceuticals Source Type: news

Syros begins Phase II clinical trial of SY-1425 to treat AML and MDS
US-based Syros Pharmaceuticals has initiated its Phase II clinical trial of SY-1425 by dosing the first patient suffering from relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). (Source: Drug Development Technology)
Source: Drug Development Technology - September 25, 2016 Category: Pharmaceuticals Source Type: news

Deals this week: Merck, Zydus Cadila Healthcare Limited, AbbVie
Merck& Co and JenKem Technology have entered a distribution agreement to make Jenkem ’s polyethylene glycol (PEG) products available for biomedical applications. (Source: Drug Development Technology)
Source: Drug Development Technology - September 22, 2016 Category: Pharmaceuticals Source Type: news

M & As this week: Allergan, Cannabis Care Canada
Allergan plans to expand its gastrointestinal research and development (R&D) pipeline and strengthen its position in non-alcoholic steatohepatitis through the acquisition of Tobira Therapeutics. (Source: Drug Development Technology)
Source: Drug Development Technology - September 22, 2016 Category: Pharmaceuticals Source Type: news

AstraZeneca and Microsoft to develop new drug technology for cancer
AstraZeneca has collaborated with Microsoft to develop new technology for drug intervention for a personalised treatment of cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - September 22, 2016 Category: Pharmaceuticals Source Type: news

Report: Rapid changes to drive osteoarthritis market to $10.5bn by 2024
Rapid changes such as the launch of new biologic therapies and novel drugs, increasing number of patients, and advancements in imaging techniques to facilitate drug development will drive the osteoarthritis market to $10.5bn in value by 2024, says a … (Source: Drug Development Technology)
Source: Drug Development Technology - September 22, 2016 Category: Pharmaceuticals Source Type: news

Kadmon doses first patient in Phase 2 trial of KD025 to treat chronic graft-versus-host disease
Kadmon Holdings has dosed the first patient under a Phase 2 clinical trial of KD025, which is its rho-associated coiled-coil kinase 2 (ROCK2) inhibitor   to treat chronic graft-versus-host disease (cGVHD). (Source: Drug Development Technology)
Source: Drug Development Technology - September 22, 2016 Category: Pharmaceuticals Source Type: news

Cerecor completes enrolment in phase II trial of CERC-301 to treat MDD
US-based clinical-stage biopharmaceutical company Cerecor has completed patient enrolment in its Phase II clinical trial of CERC-301, Clin301-203, as an oral, rapidly acting adjunctive treatment of major depressive disorder (MDD). (Source: Drug Development Technology)
Source: Drug Development Technology - September 21, 2016 Category: Pharmaceuticals Source Type: news

Epizyme collaborates with Foundation Medicine for Phase II trial of tazemetostat
US-based clinical-stage biopharmaceutical company Epizyme has collaborated with genomic analysis diagnostics firm Foundation Medicine to support patient identification and enrolment for its ongoing Phase II clinical trial of tazemetostat in patients … (Source: Drug Development Technology)
Source: Drug Development Technology - September 21, 2016 Category: Pharmaceuticals Source Type: news

Bexion begins Phase I trial of BXQ-350 to treat advanced solid tumours
US-based biotech company Bexion Pharmaceuticals has begun its Phase I trial of BXQ-350 to treat advanced solid tumours. (Source: Drug Development Technology)
Source: Drug Development Technology - September 20, 2016 Category: Pharmaceuticals Source Type: news

Mast Therapeutics announces top-line Phase III trial data of vepoloxamer to treat sickle cell disease
US-based biopharmaceutical company Mast Therapeutics has reported top-line data from its Phase III EPIC study of vepoloxamer (MST-188) to treat patients with sickle cell disease experiencing vaso-occlusive crisis (VOC). (Source: Drug Development Technology)
Source: Drug Development Technology - September 20, 2016 Category: Pharmaceuticals Source Type: news

BioLineRx begins Phase IIa COMBAT trial of BL-8040 and Keytruda combination to treat pancreatic cancer
Israeli-based BioLineRx has begun its Phase IIa COMBAT trial of BL-8040 in combination with KEYTRUDA (pembrolizumab) to treat metastatic pancreatic cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - September 20, 2016 Category: Pharmaceuticals Source Type: news

Cynata receives UK MHRA approval for Phase I trial of CYP-001 to treat GvHD
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval to Australian stem-cell and regenerative medicine company, Cynata Therapeutics, to continue its Phase I clinical trial of CYP-001 to treat steroid-resistant graft- … (Source: Drug Development Technology)
Source: Drug Development Technology - September 19, 2016 Category: Pharmaceuticals Source Type: news