July 5, 2023

FDA approval of Rystiggo for the treatment of adults with generalized myasthenia gravis – UCB

UCB announced Rystiggo (rozanolixizumab-noli) has been approved by the FDA for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. Rozanolixizumab-noli injection for subcutaneous infusion is a humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor (FcRN), resulting in the reduction of circulating IgG..It is […]

admin Health 0 3 min read
July 4, 2023

Xigduo XR approved in China for adults with type-2 diabetes – AstraZeneca

AstraZeneca’s Xigduo XR (dapagliflozin and metformin hydrochloride extended-release), a once-daily fixed-dose combination, has been approved by China’s National Medical Products Administration (NMPA) for the treatment of adults with type-2 diabetes (T2D) as an adjunct to diet and exercise to improve glycaemic control. Xigduo XR combines two anti-hyperglycaemic agents with complementary mechanisms of action: dapagliflozin (trade name, Forxiga), a sodium-glucose cotransporter […]

admin Health 0 1 min read
July 3, 2023

New topline Olinvyk data highlighting reduced cost per admission from ARTEMIS real-world outcomes study – Trevena Inc

Trevena, Inc. announced new topline Olinvyk data from the ARTEMIS study. The ARTEMIS study was an electronic medical records (EMR) based assessment focused on clinical and health resource utilization outcomes at Cleveland Clinic and Wake Forest Baptist Health. The study reviewed Olinvyk-treated patients in the ~200 patient VOLITION study with comparable surgical patients (matched patients) treated with other IV opioids, […]

admin Health 0 3 min read
July 2, 2023

CHMP positive for Mircera to treat paediatric patients with anaemia associated with CKD – Roche

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Mircera (methoxypolyethylene glycolepoetin beta). The marketing authorisation holder for this medicinal product is Roche Registration GmbH. The CHMP adopted an extension to an existing indication for use in paediatric patients. For information, the […]

admin Health 0 32 sec read
July 1, 2023

MAA submitted to the European Medicines Agency for dasiglucagon for treatment of severe hypoglycemia in diabetes – Novo Nordisk + Zealand Pharma

Zealand Pharma A/S a biotechnology company focused on the discovery and development of innovative peptide-based medicines, announced it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for dasiglucagon injection for the treatment of severe hypoglycemia in adults, adolescents, and children aged 6 years and over with diabetes mellitus. Dasiglucagon injection was approved by the FDA […]

admin Health 0 41 sec read
June 30, 2023

CHMP extends the indication of Refixia to prophylaxis of bleeding in patients 12 years and above with haemophilia B – Novo Nordisk

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admin Health 0 17 sec read
June 29, 2023

Positive CHMP opinion for atogepant for the preventive treatment of adults with migraine – AbbVie

AbbVie announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of atogepant for the prophylaxis of migraine in adults who have four or more migraine days per month. If approved, AbbVie will be the only company to offer a once daily oral calcitonin gene-related peptide (CGRP) […]

admin Health 0 54 sec read
June 28, 2023

FDA approval for SurVeil drug-coated balloon for percutaneous transluminal angioplasty – Abbott

Surmodics, Inc. announced the receipt of FDA approval for the SurVeil drug-coated balloon (DCB). The SurVeil DCB may now be marketed and sold in the U.S. to physicians for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo or restenotic lesions (less than 180 mm in length) in femoral and popliteal arteries having reference vessel diameters of 4 mm […]

admin Health 0 36 sec read
June 27, 2023

FDA approves Jardiance for the treatment of type 2 diabetes in children 10 years and older – Boehringer Ingelheim + Eli Lilly

The FDA has approved Jardiance (empagliflozin) 10 mg and 25 mg tablets to lower blood sugar along with diet and exercise in children 10 years and older with type 2 diabetes, Boehringer Ingelheim and Eli Lilly and Company announced Jardiance is not recommended in patients with type 1 diabetes. It may increase the risk of diabetic ketoacidosis in these patients. […]

admin Health 0 1 min read
June 26, 2023

Health Canada approves Xcopri to treat partial offset seizures – Paladin Labs

SK Biopharmaceuticals said that Health Canada granted a Notice of Compliance for Xcopri (ingredient: cenobamate), its epilepsy drug, approving its application for marketing authorization in Canada. Paladin Labs, a local pharmaceutical company, will be in charge of commercializing the product in Canada. Xcopri is the first locally-developed epilepsy drug to score FDA approval, with the entire drug development process from […]

admin Health 0 42 sec read

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