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Active Biotech, Ipsen reach €10m milestone in Phase III study of tasquinimod
Active Biotech and Ipsen have announced the recruitment of 600 patients in randomized, placebo-controlled Phase III study of tasquinimod in metastatic castrate-resistant prostate cancer (CRPC) patients.
Contract Research & Services > Clinical Trials > News
Contract Research & Services > Clinical Trials > News
Cellectis introduces human iPS derived hepatocyte product
Cellectis stem cells, a business unit of Cellectis Group, has introduced hiPS-HEP, a human iPS derived hepatocyte product.
Drug Research > Drug Discovery & Development > News
Drug Research > Drug Discovery & Development > News
Sucampo reports positive data from lubiprostone drug trials
Sucampo Pharmaceuticals' Amitiza (lubiprostone) drug has showed efficacy in treating irritable bowel syndrome associated with constipation (IBS-C) in the two pivotal Phase 3 studies.
Contract Research & Services > Clinical Trials > News
Contract Research & Services > Clinical Trials > News
Watson confirms filing of ANDA for generic version of Lo Loestrin Fe with FDA
Watson Pharmaceuticals has confirmed the filing of ANDA with FDA by Watson Laboratories seeking approval to market Norethindrone Acetate/Ethinyl Estradiol and Ethinyl Estradiol and Ferrous Fumarate Tablets, 1mg/0.01mg and 0.01mg and 75mg.
Regulatory Affairs > News
Regulatory Affairs > News
VitalMax develops new immune support formula
Vitalmax Vitamins has developed VitaGreens, a new antioxidant supplement which is able to deliver super immune-boosting and toxic cleansing health benefits.
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Progenra deploys Dotmatics drug research platform
Progenra, a biotechnology company, has selected Dotmatics' suite of scientific informatics solutions to enhance its drug research and development process.
Automation > IT & Software > News
Automation > IT & Software > News
Aegis wins US patent for octreotide formulations
Aegis Therapeutics has received US patent covering pharmaceutical composition of octreotide.
Drug Research > Drug Delivery > News
Drug Research > Drug Delivery > News
Actavis wins FDA approval for Ropinirole extended-release tablets
Actavis Group, a generic pharmaceuticals company, has gained FDA approval for Ropinirole extended-release tablets, 2mg, 4mg, 6mg, 8mg and 12mg.
Regulatory Affairs > News
Regulatory Affairs > News
ArQule, Daiichi complete patient recruitment in Phase III NSCLC trial
ArQule and Daiichi Sankyo have announced the completion of patient recruitment in Phase III clinical trial of Tivantinib in advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC) patients.
Contract Research & Services > Clinical Trials > News
Contract Research & Services > Clinical Trials > News
DCI wins FDA approval for Pertzye NDA
Digestive Care (DCI) has gained FDA approval for its new drug application (NDA) for Pertzye, a pancreatic enzyme product containing bicarbonate-buffered enteric-coated microspheres.
Regulatory Affairs > News
Regulatory Affairs > News
FDA approves Perrigo ANDA for Lansoprazole capsules
The FDA has approved Perrigo Company's abbreviated new drug application (ANDA) for Lansoprazole capsules of strength 15mg.
Production & Manufacturing > OTC > News
Production & Manufacturing > OTC > News
German regulatory authority approves Helix trial of topical Interferon Alpha-2b
The Federal Institute for Drugs and Medical Devices, the German regulatory authority, has approved Helix BioPharma's clinical trial application for a European Phase III efficacy trial of Topical Interferon Alpha-2b in patients with low-grade cervical lesions.
Regulatory Affairs > News
Regulatory Affairs > News
Dr Reddy's introduces generic version of Plavix in US
Dr Reddy's Laboratories has introduced bioequivalent generic version of Plavix, Clopidogrel Tablets, USP 75mg and 300mg, in the US.
Drug Research > Drug Discovery & Development > News
Drug Research > Drug Discovery & Development > News
Pfizer outlines Systems-based Pharmaceutics vision in London
Pfizer has outlined systems-based Pharmaceutics vision to increase drug performance at the Advanced Process Modelling Forum in London.
Production & Manufacturing > Process & Production > News
Production & Manufacturing > Process & Production > News
Spectrum begins Phase II NHL study with Zevalin
Spectrum Pharmaceuticals has begun Phase II study of Zevalin in combination with the redox modulating agent motexafin gadolinium (MGd) in patients with rituximab-refractory low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL).
Contract Research & Services > Clinical Trials > News
Contract Research & Services > Clinical Trials > News