The companies also announced regulatory submission for FF/VI as asthma therapy in the European Union. FF/VI, which also includes the investigational LAMA/LABA combination umeclidinium bromide/vilanterol,VI monotherapy and MABA,
The collaboration focuses on late-phase research, recruiting for and monitoring of clinical trials, and post-market surveillance. The partnership aims at developing products that overcome obstructions in clinical research,
The randomized, double-blind, global studies will compare CB-315 (250 mg BID) with the active comparator oral vancomycin (125 mg QID). Each study is likely to enroll 608 eligible
The move follows the agency’s warning to the company over the repeated violations of cGMPs (current good manufacturing practices) and the Federal Food, Drug and Cosmetic Act. In
The Preventing Abuse of Cough Treatments (PACT) Act of 2012 is expected to prohibit the sale of over-the-counter (OTC) cough medicines containing dextromethorphan (DXM) to teens below the
Under the agreement, Vertellus will include its worldwide operations across Europe and Asia encompassing India and China . Vertellus Specialties global supply chain corporate director Hugh Mitchell said
The double-blind, multi-center, placebo-controlled, parallel-group trial has enrolled 500 patients suffering with psoriatic arthritis, and were randomized 1:1:1 to receive either apremilast, 20 mg BID, 30 mg BID,
Under the agreement, Ascletis gained an exclusive license from Alnylam to develop and commercialise ALN-VSP in China including Hong Kong, Macau and Taiwan, while Alnylam retains all rights
Relday is based on a combination of its DosePro needle-free, subcutaneous drug delivery system with a proprietary, subcutaneous once-monthly formulation of risperidone for treating schizophrenia. The company expects
Omontys (peginesatide) injection is a synthetic, pegylated, peptide-based erythropoiesis-stimulating agent (ESA) indicated to treat anemia in patients with chronic kidney disease (CKD). According to the agreement, which ends
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