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The European Ccommission approves Avzivi, a biosimilar referencing bevacizumab – Bio Thera Solutions

Written by | 9 Sep 2024

The European Medicines Agency (EMA) has approved Avzivi (BAT 1706), a biosimilar referencing bevacizumab (Avastin), according to an announcement from Bio-Thera Solutions. Avzivi is intended for the treatment… read more.

Finerenone showed statistically significant improvement in cardiovascular outcomes in adults with common form of heart failure with high unmet medical need – Bayer

Written by | 8 Sep 2024

Detailed results from the Phase III study FINEARTS-HF demonstrate that compared to placebo, finerenone (Kerendia/ Firialta) showed a statistically significant improvement in cardiovascular outcomes in patients with heart… read more.

European Commission approves EUR Neffy (epinephrine nasal spray) for emergency treatment of severe allergic reactions in adults and children – ARS Pharma

Written by | 7 Sep 2024

ARS Pharmaceuticals, Inc. announced the European Commission’s approval of EURneffy for emergency treatment of severe allergic reactions in adults and children weighing at least 30 kilograms. This approval… read more.

Nucala (mepolizumab) approved in Japan for treatment of adults with chronic rhinosinusitis with nasal polyps – GSK

Written by | 6 Sep 2024

GSK plc announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), for the treatment of chronic… read more.

FDA clears Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for use by people with type 2 diabetes – Insulet Corporation

Written by | 5 Sep 2024

Insulet Corporation , the global leader in tubeless insulin pump technology with its Omnipod brand of products, announced its groundbreaking Omnipod 5 Automated Insulin Delivery System (Omnipod 5)… read more.

Ordspono (odronextamab) approved in the European Union for the treatment of relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma – Regeneron Pharma

Written by | 3 Sep 2024

Regeneron Pharmaceuticals, Inc. announced that the European Commission (EC) has approved Ordspono (odronextamab) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse… read more.

UCB to accelerate innovation and strategic partnerships, divesting mature product portfolio in China to CBC Group.

Written by | 2 Sep 2024

UCB, a global biopharmaceutical company, announced a strategic divestment deal in China, underscoring its strategic shift towards innovation and partnership in one of the world’s fastest-growing pharmaceutical markets…. read more.

FDA clearance of the HYDROS Robotic System, the next-generation, AI-powered platform for aquablation therapy – PROCEPT BioRobotics Corporation

Written by | 1 Sep 2024

PROCEPT BioRobotics Corporation announced FDA 510(k) clearance of its next-generation platform, the HYDROS Robotic System. Leveraging insights from over 50,000 procedures, HYDROS features FirstAssist AI treatment planning, advanced… read more.

Leqembi (lecanemab) authorized for early alzheimer’s disease in Great Britain – Eisai + Biogen

Written by | 31 Aug 2024

Eisai Co., Ltd. and Biogen Inc. announced that the humanized amyloid-beta (Abeta monoclonal antibody “Leqembi” (brand name, generic name: lecanemab) has been granted a Marketing Authorization by the… read more.

FDA approval & authorization for Omicron KP.2-adapted COVID-19 Vaccine – BioNTech SE + Pfizer

Written by | 30 Aug 2024

Pfizer Inc. and BioNTech SE announced that the FDA has approved the supplemental Biologics License Application for individuals 12 years of age and older (COMIRNATY (COVID-19 Vaccine, mRNA),… read more.

Update on cannabidiol oral solution phase III trial in Japan in treatment-resistant epilepsies – Jazz Pharma

Written by | 29 Aug 2024

Jazz Pharmaceuticals plc announced top-line results from the Phase III open-label, single-arm trial in Japan evaluating the safety and efficacy of cannabidiol oral solution (marketed as Epidiolex/Epidyolex globally)… read more.

First real-world analysis of Ebola vaccine reveals 84% effectiveness during Democratic Republic Congo outbreak – Merck Inc

Written by | 28 Aug 2024

When a deadly outbreak of the Ebola virus spread through the Democratic Republic of Congo in 2018, Merck’s then-unapproved vaccine (Ervebo) was quickly deployed to help address the… read more.

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