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Moderna
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US mRNA specialist Moderna today announced Health Canada has approved mRESVIA (respiratory syncytial virus mRNA vaccine) for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. 8 November 2024
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A clinical-stage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies for the treatment of cancer and infectious
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USA-based Viatris said in a website posting that it has been informed by its partner, Israel-based Mapi Pharma, that it has received a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for GA Depot 40mg from the US Food and Drug Administration (FDA). 12 March 2024
Biotechnology
US immunology specialist Acelyrin came up with positive trial results for izokibep, which last year failed to meet a study endpoint for the treatment of moderate-to-severe hidradenitis suppurativa (HS). 12 March 2024
Pharmaceutical
Israel-based RedHill Biopharma has announced the issuance of a new US patent related to Talicia (omeprazole/amoxicillin/rifabutin). 11 March 2024
Pharmaceutical
The ACTION3 Phase III trial of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) was successful in the pre-specified interim analysis of the proteinuria (efficacy) endpoint from the trial’s first 72 randomized patients, Melbourne, Australia-based Dimerix Limited revealed today. 11 March 2024
Pharmaceutical
In a new report, The World Health Organization (WHO) has warned of growing resistance to certain HIV medications, while the overall picture on combating the disease remains positive. 11 March 2024
Pharmaceutical
Germany’s Bayer has entered into deal with USA-based BridgeBio Pharma to commercialize its cardiovascular candidate acoramidis worth $310 million in upfront and milestone payments. Research news last week included Denmark’s Novo Nordisk releasing positive new data on its semaglutide, showing it cut kidney-disease related events in diabetes patients by 24%. Also, Singapore-based TauRx Pharma released new data on its Alzheimer’s candidate hydromethylthionine mesylate (HMTM). US President Joe Biden is moving further with his intent to bring down drug prices in the USA, with plans not to limit Medicare negotiations to just 20 drugs a year. 10 March 2024
Pharmaceutical
In another win for Denmark’s Novo Nordisk, the US Food and Drug Administration approved a new indication for use for its Wegovy (semaglutide) injection to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight. 9 March 2024
Biotechnology
The US Food and Drug Administration (FDA) yesterday approved Opdivo (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer. 8 March 2024
Biotechnology
US precision genetic firm Solid Biosciences saw its shares gain 6.3% to $10.01 by late morning, on news of a licensing deal. 7 March 2024
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Rystiggo (rozanolixizumab), from Belgium’s largest drug maker UCB. 7 March 2024
Latest In Brief for Moderna
Biotechnology
GigaGen has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS). 4 October 2024
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BeiGene has announced plans to rebrand as BeOne Medicines, a move the cancer specialist says reflects its commitment to fighting cancer through collaboration. 15 November 2024
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