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On 14 August 2024, Celltrion received FDA approval for its global phase 3 clinical trial of CT-P55, biosimilar to Novartis’ Cosentyx® (secukinumab).

Celltrion reports that global market sales for Cosentyx® reached US $4.98 billion in 2023, and that Novartis’ “materia...

AstraZeneca has announced that its Imfinzi® (durvalumab) and Lynparza® (olaparib) combination has been approved in the EU as treatment for certain patients with primary advanced or recurrent endometrial cancer.  This approval follows the recommendation by the EMA’s Committe...

On 13 August, AstraZeneca announced that the National Medical Products Administration (NMPA) in China has given conditional approval for the use of Enhertu (trastuzumab deruxtecan) as a monotherapy treatment for patients with locally advanced or metastatic HER2-positive gas...

A representative from Novo Nordisk has recently announced that the company is planning to submit regulatory approval applications for its insulin icodec and semaglutide combination (IcoSema) in jurisdictions outside the US.  The decision to file the applications reportedly ...

India’s Medical Dialogues reports that Intas Pharmaceuticals has received the Central Drug Standard Control Organisation’s (CDSCO) approval to conduct a Phase III clinical study to compare the efficacy, safety, immunogenicity and pharmacokinetics of its proposed vedolizumab...

Formycon has announced its half-year financial results, reporting Group revenue of €26.9 million and a 2024 revenue forecast remaining between €55-€65 million, driven by its biosimilar pipeline and projects.

This includes the “strong performance” of FYB201, biosimila...

Eisai and Biogen have announced that Leqembi® (lecanemab) has been approved for the treatment of Alzheimer’s disease in the United Arab Emirates. The approval is based on results from the global Phase III Clarity study and will allow treatment of patients with mild cognitiv...

On 12 August 2024, Amgen filed a lawsuit with the US District Court for the District of New Jersey against Samsung Bioepis and Samsung Biologics asserting infringement of 36 patents relating to denosumab.  The BPCIA litigation reportedly follows the filing by Samsung Bioepi...