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Nov 13, 2024
On 13 November 2024, Alvotech announced its financial results for the first 9 months of 2024, reporting an increase in total revenues of US $300 million and an over four-fold increase in product revenue, year on year. Product development highlights for the year to...
Nov 13, 2024
On 13 November 2024, BioNTech announced that it has entered a definitive agreement to acquire Biotheus together with global rights to Biotheus’ late-stage clinical asset, BNT327/PM8002, an investigational bispecific antibody targeting PD-L1 and VEGF-A. Under the...
Nov 11, 2024
On 11 November 2024, Johnson & Johnson (J&J) announced that the US FDA has granted nipocalimab Breakthrough Therapy designation (BTD) for the treatment of adults living with moderate-to-severe Sjögren’s disease (SjD). This makes nipocalimab the only...
Nov 8, 2024
On 8 November 2024, Johnson & Johnson (J&J) announced that it has submitted applications to the US FDA and European Medicines Agency (EMA) for approval of a new indication for Darzalex Faspro® (daratumumab and hyaluronidase-fihj) in the US and Darzalex®...
Nov 8, 2024
On 8 November 2024, Korea Biomedical Review reported that Alteogen has signed an exclusive licence agreement with Daiichi Sankyo for the development and commercialisation of a subcutaneous (SC) injection form of Enhertu® (trastuzumab deruxtecan). The agreement...
Nov 8, 2024
On 8 November 2024, Celltrion announced that it has achieved accumulated sales for Q3 2024 of KRW 2.4 trillion, surpassing its 2023 annual sales. Its quarterly sales are the highest it has ever reported, up 31.2% year on year. Celltrion attributes its sales growth to...
Nov 7, 2024
On 7 November 2024, the Galien Foundation awarded Daiichi Sankyo and AstraZeneca the Prix Galien USA Award for Best Biotechnology Product in relation to Enhertu® (fam-trastuzumab deruxtecan-nxki), a drug used in the treatment of metastatic breast cancer. The award,...
Nov 6, 2024
On 6 November 2024, Regeneron and Sanofi announced that the EC, as recommended by CHMP, has approved Dupixent® (dupilumab) to treat eosinophilic esophagitis (EoE) in children aged 1 to 11 years who weigh at least 15 kg and who are inadequately controlled by,...
Nov 6, 2024
India’s Subject Expert Committee (SEC) has recommended the approval of an additional indication for BMS’ Opdivo® (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial...
Nov 6, 2024
Novo Nordisk has reported strong financial performance for the first nine months of 2024. According to a 6 November 2024 media release, company sales rose by 23% (in Danish kroner) and 24% at constant exchange rates (CER), reaching DKK 204.7 billion. Operating...
Nov 6, 2024
On 6 November 2024, Celltrion announced that it participated in the World ADC 2024 conference where it unveiled preclinical study results of two new antibody-drug conjugate (ADC) candidates – CT-P70 and CT-P71. CT-P70 and CT-P71 are ADC treatments designed to target...
Nov 5, 2024
On 5 November 2024, the Australian Register of Therapeutic Goods (ARTG), published 5 approvals of new brands for Amgen’s denosumab, confirming Amgen’s belief that biosimilar competition is imminent. This news follows Australian approval of Sandoz’s denosumab...
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