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On 16 August 2024, Bio-Thera announced that it has entered into a licensing and supply agreement with Pharmapark for BAT2306, biosimilar to Cosentyx® (secukinumab).  Under the agreement, Pharmapark will have exclusive rights to distribute and market BAT2306 in Russia and ot...

On 16 August 2024, AstraZeneca announced that the FDA has approved its Imfinzi® (durvalumab), in combination with chemotherapy, for resectable early stage non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinas...

On 15 August 2024, Alvotech and Advanz Pharma announced that European Medicines Agency (EMA) has accepted a Marketing Authorisation Application (MAA) for Alvotech-developed AVT06, biosimilar to Regeneron’s Eylea® (aflibercept).  The companies expect EMA marketing authorisat...

On 15 August 2024, Alvotech announced its financial results for the first half of 2024, reporting total revenues of US$236 million, a more than 10-fold increase compared to 1H 2023, and product revenues of US$66 million, up 190% from 1H 2023.  Its EBITDA was positive for th...

Incyte has announced positive results from a pivotal study of tafasitamab (Monjuvi®) in relapsed or refractory follicular lymphoma.

Based on these positive results, Incyte expects to file a supplemental Biologics License Application for tafasitamab for the treatment ...

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 ...