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F. Hoffmann-La Roche Ltd: FDA grants Breakthrough Therapy Designation for Venclexta in combination with azacitidine for the treatment of patients with myelodysplastic syndromes need for new treatment options
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This is the 11th Breakthrough Therapy Designation for Roche s
haematology
Venclexta demonstrating its potential across multiple blood cancers
Basel, 21 July 2021 - Roche] study is a phase Ib, open-label, non-randomised, multicentre, dose-finding study evaluating Venclexta/Venclyxto (venetoclax) in combination with azacitidine in treatment-naïve patients with higher-risk myelodysplastic syndromes (MDS) comprising a dose-escalation portion and a safety expansion portion. The primary objectives of the study are to assess the safety profile and pharmacokinetics and determine the recommended phase II dose and dosing schedule of Venclexta/Venclyxto in combination with azacitidine. The response criteria specified in the M15-531 study are based on the modified Internatio
Costs of raw material for drugs rise by up to 140%
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API prices of certain drugs like fever and pain relief drug paracetamol and life-saving antibiotic Meropenem (also used for Covid), and anti-diabetic metformin, have more than doubled to as high as 139%, 127% and 124% respectively, putting the spotlight back on India’s near total-dependence on the Dragon.
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(This story originally appeared in on Jul 20, 2021)A steep rise in the cost of raw materials for essential drugs, called active pharmaceutical ingredients (API) in pharma circles, by up to 140% in certain cases since the pre-pandemic level, is pinching the industry hard. The overall increase, averaging nearly 50% in the wake of high-priced imports and supply disruptions from China, have raised doubts on the availability of drugs and could lead to shortages, particularly of those that are key in Covid therapy.
F. Hoffmann-La Roche Ltd: Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19
casirivimab
hospitalised patients
Basel, 20 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Japan s Ministry of Health, Labour and Welfare (MHLW) has approved Ronapreve(casirivimab and imdevimab), for the treatment of patients with mild to moderate COVID-19 via intravenous infusion. The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. Ronapreve has been shown to improve survival in high-risk, non-hospitalised COVID-19 patients by reducing the risk of hospitalisation and death. In addition, its ability to retain activity against emerging variants, including the Delta variant, has been demonstrated in preclinical studies, said Levi Garraway, M.D., Ph.D., Roche s Chief Medical Officer and Head of Global Product Development. Today s ap
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Hemlibra is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins involved in the natural coagulation cascade, and restore the blood clotting process for people with haemophilia A. Hemlibra is a prophylactic (preventative) treatment that can be administered by an injection of a ready-to-use solution under the skin (subcutaneously) once-weekly, every two weeks or every four weeks (after an initial once-weekly dose for the first four weeks). Hemlibra was created by Chugai Pharmaceutical Co., Ltd. and is being co-developed globally by Chugai, Roche and Genentech. It is marketed in the United States by Genentech as Hemlibra (emicizumab-kxwh), with kxwh as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.