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136-150 of 47526 results
GSK closes North Carolina plant after Legionella bacteria found in cooling tower
By PBR Staff Writer
UK drugmaker GlaxoSmithKline (GSK) has closed its Zebulon drug manufacturing plant in North Carolina, US, after the discovery of bacteria related to Legionnaires' disease, a potentially fatal form of pneumonia.
Production & Manufacturing > Manufacturing > News
Gliknik licensee Pfizer gets FDA orphan drug status for GL-2045 to treat rare neurological disorder
By PBR Staff Writer
Gliknik has announced that its licensee Pfizer has received orphan drug designation from the US Food and Drug Administration (FDA) for its autoimmune candidate drug GL-2045 for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), a rare neurological disorder.
Contract Research & Services > Contract Services > News
Taro’s Keveyis get FDA approval to treat primary hyperkalemic and hypokalemic periodic paralysis
By PBR Staff Writer
Taro Pharmaceutical Industries has received approval from the US Food and Drug Administration (FDA) for Keveyis (dichlorphenamide) 50mg tablets to treat primary hyperkalemic and hypokalemic periodic paralysis.
Regulatory Affairs > News
Fresenius Kabi launches Cisatracurium Besylate Injection in US
By PBR Staff Writer
German health care firm Fresenius Kabi has launched Cisatracurium Besylate Injection, a new specialty injectable product, in three presentations in the US.
Drug Research > Drug Delivery > News
Vitae starts Phase I multiple ascending dose trial of VTP-43742 to treat autoimmune disorders
By PBR Staff Writer
US-based Vitae Pharmaceuticals has started a Phase I multiple ascending dose clinical trial of its wholly owned and first-in-class RORγt inhibitor product candidate, VTP-43742, to treat autoimmune disorders.
Drug Research > Drug Discovery & Development > News
BioClin begins Phase II trial of B-701 to treat urothelial cell carcinoma
By PBR Staff Writer
US-based BioClin Therapeutics has started a Phase II clinical study of B-701, an anti-FGFR3 antibody, being investigated to treat locally advanced or metastatic urothelial cell carcinoma, also called bladder cancer.
Drug Research > Drug Discovery & Development > News
MedImmune, Inovio enter into strategic cancer vaccine collaboration
By PBR Staff Writer
MedImmune, a global biologics R&D arm of AstraZeneca, has entered into a license agreement and collaboration with Inovio Pharmaceuticals, a biotechnology firm that develops DNA-based immunotherapies for cancer and infectious diseases.
Contract Research & Services > Contract Services > News
Aduro completes patient enrollment in Phase Ib trial of CRS-207 to treat mesothelioma
Aduro Biotech (ADRO) announced that it has completed enrollment in the Phase Ib clinical trial of its novel immunotherapy, CRS-207, in combination with standard-of-care chemotherapy in patients with unresectable malignant pleural mesothelioma (MPM).
Contract Research & Services > Clinical Trials > News
ARIAD doses first patient in Phase II dose-ranging optic trial of Iclusig
ARIAD Pharmaceuticals (ARIA) announced that the first patient has been treated in its OPTIC (Optimizing Ponatinib Treatment In CML) trial of Iclusig (ponatinib).
Contract Research & Services > Contract Research > News
Immune Design, Merck to evaluate two immunotherapies with Keytruda to treat NHL and melanoma
By PBR Staff Writer
Immune Design has entered into partnership with the subsidiaries of Merck to evaluate the safety and efficacy of its oncology investigative agents, G100 and LV305 in combination with Merck's Keytruda (pembrolizumab) to treat patients with non-Hodgkin's lymphoma (NHL) and melanoma, respectively.
Drug Research > Drug Delivery > News
SomaLogic, Otsuka extend research collaboration for Therapeutic SOMAmer development
SomaLogic announced that Otsuka Pharmaceutical has extended its initial collaboration agreement with SomaLogic to continue the development of several SOMAmer therapeutics. Specific projects and financial terms in the extended agreement were not disclosed.
Contract Research & Services > Contract Research > News
Turing acquires US marketing rights to Daraprim from Impax Laboratories
Turing Pharmaceuticals announced that it has acquired the exclusive rights to market Daraprim (pyrimethamine) in the US from Impax Laboratories.
Contract Research & Services > Contract Services > News
Upsher-Smith gets FDA approval For generic Namenda tablets
Upsher-Smith Laboratories (Upsher-Smith) announced that it has received US Food and Drug Administration (FDA) approval of an abbreviated new drug application (ANDA) for Memantine Hydrochloride Tablets in 5mg and 10mg strengths.
Production & Manufacturing > OTC > News
Symbiomix reports positive trial results for SYM-1219 for bacterial vaginosis
Positive results of Symbiomix Therapeutics' first pivotal trial for lead drug candidate SYM-1219, a single-dose, oral product candidate for the treatment of bacterial vaginosis (BV), were presented today at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting in Portland, Oregon.
Drug Research > Drug Discovery & Development > News
FDA advisory committee to review Collegium's Xtampza ER for chronic pain
Collegium Pharmaceutical (COLL) announced that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the US Food and Drug Administration (FDA) is scheduled to review the Company's New Drug Application (NDA) for Xtampza(TM) ER (oxycodone extended-release capsules) on September 11, 2015.
Production & Manufacturing > Process & Production > News
136-150 of 47526 results