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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 investigational...

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® (daratummab)...

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 includes an ...

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 t...

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, present...

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, intolerant to, ...

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 carcinoma.  T...

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 profit incr...

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 ...