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Aug 15, 2024
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...
Aug 15, 2024
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...
Aug 14, 2024
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’ “material...
Aug 14, 2024
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...
Aug 14, 2024
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...
Aug 13, 2024
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...
Aug 13, 2024
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...
Aug 13, 2024
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, biosimilar...
Aug 13, 2024
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...
Aug 12, 2024
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...
Aug 12, 2024
On 12 August 2024, Sandoz formally announced the introduction of Jubbonti® and Wyost® in Canada via its Canadian website. We previously reported in July 2024 Sandoz’s (informal) announcement via Linkedin that the company had launched its denosumab biosimilar Wyost®...
Aug 12, 2024
On 12 August 2024, Celltrion announced that its high concentration, buffer free (100mg/ml) adalimumab, biosimilar to AbbVie’s Humira®, is now on the Costco member prescription program. The Celltrion buffer free product was FDA approved on 23 May 2023 and was launched...
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