As Vietnam’s industrial capabilities have developed rapidly in recent decades, government officials have recognized the importance of helping to secure the nation’s supply of medicines. In an important milestone addressing this need, the Vietnamese Pharmacopoeia Commission (VPC) has signed a memorandum of understanding (MOU) with the U.S. Pharmacopeial (USP) Convention.
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Potential new drugs: 970 million and still counting Like astronomers counting stars in the familiar universe of outer space, chemists in Switzerland are reporting the latest results of a survey of chemical space - the so-called chemical universe where tomorrow’s miracle drugs may reside. The scientists conclude, based on this phase of the ongoing count, that there are 970 million chemicals suitable for study as new drugs.
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Yaupon Therapeutics, a privately held specialty pharmaceutical company, has announced it has completed enrollment for a pivotal Phase 2 clinical trial for Clearazide for the treatment of early-stage cutaneous T-cell lymphoma (CTCL - stages 1-2a). The study, which is being conducted under a Special Protocol Assessment (SPA) with the FDA, has enrolled 260 patients in 13 of the top cancer centers in the US.
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A discovery by scientists at deCODE genetics (Nasdaq: DCGN) and academic colleagues from Iceland, the Netherlands and Denmark has pointed to a common biological mechanism contributing to both kidney stones and decreased bone mineral density (BMD). About 60% of the population carry two copies of a single-letter variation in the human genome (SNP) on chromosome 21, putting them at roughly 65% greater likelihood of developing kidney stones than those who carry no copies.
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AcelRx Pharmaceuticals, Inc. announced positive results from the second Phase 2 clinical study evaluating the safety and efficacy of its ARX-01 Sufentanil NanoTabs(TM) for the management of acute post-operative pain in patients requiring opioid analgesia during hospitalization.
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Vantia Therapeutics, an emerging pharmaceutical company developing novel, small molecule drugs targeting large, underserved medical markets, announces positive results from a Phase IIa clinical trial of its lead development compound VA106483 for nocturia. The trial showed that oral VA106483 was successful in producing a predictable and sustained anti-diuretic effect in patients, as determined by increased osmolality and decreased urine output.
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Sosei Group Corporation (”Sosei”; TSE Mothers Index: 4565) and Vectura Group plc (”Vectura”; LSE: VEC) announce the commencement of a Phase III clinical study by Novartis, with NVA237, a once-daily, long-acting muscarinic antagonist (LAMA) for the treatment of chronic obstructive pulmonary disease (COPD). NVA237 is a dry powder formulation for oral inhalation of glycopyrronium bromide, a LAMA with a rapid onset of activity. The study has now appeared on clinicaltrials.
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Takeda Pharmaceutical Company Limited (”Takeda”) announced that Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary received on June 26 (U.S. time) a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the Company’s New Drug Application (NDA) for alogliptin, a selective dipeptidyl peptidase IV (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise.
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AlphaRx Inc. (OTCBB: ALRX) and Gaia BioPharma Limited reported positive pre-clinical results on GAI-122 injectable nanoemulsion in multiple in vitro and in vivo studies of memory impairment after prolonged anesthesia. Delirium is a common mental disorder with serious adverse outcomes in post-operative hospitalized patients.
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Sinovac Biotech Ltd.
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