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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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A global biotech developing of novel antibody-based drugs with innovative technologies.
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Pharmaceutical
Data presented on the EURneffy/neffy adrenaline (epinephrine) nasal spray at the European Academy of Allergy & Clinical Immunology Congress last month highlights a comparable clinical pharmacological response to intramuscular adrenaline injection, despite congestion associated with allergic rhinitis. 12 July 2025
Pharmaceutical
CSL Seqirus, a subsidiary of Australia’s CSL Limited, said it has commenced shipping its differentiated portfolio of influenza vaccines for the 2025/26 US season. 11 July 2025
Pharmaceutical
At its July meeting, the European Medicines Agency’s pharmacovigilance committee (PRAC) completed its review of French specialty vaccine maker Valneva Ixchiq (chikungunya virus vaccine, a live attenuated chikungunya vaccine, following reports of serious side effects. 11 July 2025
Biotechnology
The National Institute for Health and Care Excellence (NICE) has published final guidance recommending Eli Lilly’s Omvoh (mirikizumab) for use on the National Health Service (NHS) in England and Wales as an option for moderately to severely active Crohn’s disease in adults. 11 July 2025
Pharmaceutical
Nuclidium, a radiopharma company developing a proprietary copper-based theranostic platform, has announced the successful closing of its Series B financing round, raising 79 million Swiss francs ($99 million). 11 July 2025
Biotechnology
Chinese cell therapy developer NK CellTech has raised nearly 100 million renminbi ($14 million) in an extended series A+++ round to support the clinical development of its flagship NK cell therapies and broaden its pipeline. 11 July 2025
Biotechnology
Sino-American biopharma Ascentage Pharma announced that its proprietary novel Bcl-2 selective inhibitor lisaftoclax (APG-2575) has been approved by China’s National Medical Products Administration (NMPA). 11 July 2025
Pharmaceutical
Lewy body dementia (LBD) remains one of the most overlooked and complex neurodegenerative conditions, but momentum is building around a small group of experimental therapies, according to new research from DelveInsight. 11 July 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved US mRNA specialist Moderna supplemental Biologics License Application (sBLA) for Spikevax, the company's COVID-19 vaccine, in children six months through 11 years of age who are at increased risk for COVID-19 disease. 11 July 2025
Biotechnology
French biotech Osivax has published results from a Phase IIa trial showing that its lead candidate OVX836, a broad-spectrum influenza vaccine, demonstrated a strong safety profile and immune response when administered alongside a conventional flu shot. 10 July 2025
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Pharmaceutical
Ireland-based biopharma Jazz Pharmaceuticals has been called out for a couple of indiscretions by The Prescription Medicines Code of Practice Authority (PMCPA), which was established by the Association of the British Pharmaceutical Industry (ABPI) to operate the ABPI Code of Practice for the Pharmaceutical Industry. 11 July 2025
Latest Relevant Ones To Watch News
US CAR-T focused biotech CARGO Therapeutics today announced that it has entered into a definitive merger agreement with Concentra Biosciences, initially worth roughly $200 million. The news sent CARGO’s stock up as much as 9.6% to $4.81 in pre-market activity. 8 July 2025
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