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Biosimilars
The Food and Drug Administration (FDA) has granted an expanded interchangeable designation for Yuflyma (adalimumab-aaty), now including prefilled syringe (40mg) and autoinjectors (40mg and 80mg) presentations. 26 May 2025
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An American biotech company developing solutions that treat urothelial and specialty cancers.
Latest News & Features of interest to CellTrion
Biotechnology
US healthcare group Abbott has signed a wide-ranging agreement with health authorities in Abu Dhabi to localize pharmaceutical manufacturing, develop biosimilars, and accelerate digital transformation, as the emirate deepens its bid to become a regional powerhouse in the global life sciences sector. 20 June 2025
Biotechnology
Danish vaccine specialist Bavarian Nordic is set to collect $160 million from the sale of a US priority review voucher (PRV) earned through the approval of its chikungunya vaccine, Vimkunya (chikungunya vaccine), marking one of the highest prices paid for a PRV in recent years. 20 June 2025
Pharmaceutical
Japan’s Ministry of Health, Labor and Welfare (MHLW) has accepted UK pharma major GSK’s regulatory application to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to include adults aged 18 to 49 years at increased risk of severe RSV disease. 20 June 2025
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended five novel medicines for approval at its June 2025 meeting. 20 June 2025
Biotechnology
Further expanding the indications for French pharma major Sanofi’s mega-blockbuster Dupixent (dupilumab), the US Food and Drug Administration (FDA) has approved the drug for the treatment of adult patients with bullous pemphigoid (BP). 20 June 2025
Pharmaceutical
A reshaped agenda for the Centers for Disease Control and Prevention’s vaccine advisory committee meeting on June 25–26 signals a departure from the initial vaccine slate. New appointees named by Health and Human Services Secretary Robert F. Kennedy Jr dismantled the previous committee structure two days after dismissing all 17 members. 20 June 2025
Biotechnology
Sanofi has signed a strategic agreement with health authorities in Abu Dhabi to accelerate vaccine development and manufacturing in the United Arab Emirates. 19 June 2025
Biotechnology
The US Food and Drug Administration has approved US biotech Incyte’s Monjuvi (tafasitamab-cxix) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL). 19 June 2025
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has announced that Japanese drugmaker Eisai and US biotech Biogen Leqembi (lecanemab) has not been recommended for use in the National Health Service (NHS) in England. 19 June 2025
Pharmaceutical
US biotech Actio Biosciences has raised $66 million in a series B round topport its pipeline of genetically targeted therapies, with new funding led by Regeneron Ventures and repeat backing from Deerfield Management. 19 June 2025
Latest In Brief for CellTrion
Biotechnology
The benefits from Eli Lilly’s Kisluna (donanemab) remain too small to justify the additional cost to the National Health Service (NHS), said the UK health technology assessor the National Institute for Health and Care Excellence (NICE), which also rejected Japanese drugmaker Eisai and US biotech Biogen Leqembi (lecanemab) for the same reason. 19 June 2025
Latest Relevant Ones To Watch News
Supernus Pharmaceuticals is to buy Sage Therapeutics for total consideration of around $795 million. 16 June 2025
12 June 2025
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