CHMP recommends Roche’s Evrysdi for babies under two months old with spinal muscular atrophy (SMA)
July 21, 2023 09:30 ET
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F. Hoffmann-La Roche Ltd
Positive recommendation is based on interim data from ongoing RAINBOWFISH trial which showed majority of Evrysdi-treated babies were able to stand and walk within timeframes typical of healthy babies...
New clinical and real-world data for Roche’s Vabysmo at ASRS reveal improved outcomes for people with two leading causes of vision loss
July 20, 2023 01:00 ET
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F. Hoffmann-La Roche Ltd
Late-breaking post-hoc data indicate Vabysmo leads to less fibrosis, which may negatively impact vision, than aflibercept in people with diabetic macular edema (DME)Real-world data reinforce that...
Positive Phase III results for Roche’s OCREVUS (ocrelizumab) twice a year, 10-minute subcutaneous injection in patients with multiple sclerosis
July 13, 2023 01:00 ET
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F. Hoffmann-La Roche Ltd
Phase III OCARINA II trial met primary and secondary endpoints OCREVUS twice a year, 10-minute injection has the potential to further improve the treatment experience and expand OCREVUS usage in MS...
European Commission approves Roche’s fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma
July 11, 2023 01:00 ET
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F. Hoffmann-La Roche Ltd
Columvi is the first CD20xCD3 T-cell-engaging bispecific antibody available in Europe to treat the most common and aggressive form of lymphoma Approval is based on results from the phase I/II...
Four-year follow up data for Roche’s Evrysdi show continued increase in number of children with a severe form of spinal muscular atrophy (SMA) able to sit, stand and walk
June 30, 2023 11:50 ET
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F. Hoffmann-La Roche Ltd
Data from ongoing FIREFISH study confirm long-term efficacy and safety profile of Evrysdi in children with Type 1 SMANinety-one percent of children were alive at month 48More than 95% maintained the...
FDA approves Roche’s Columvi, the first and only bispecific antibody with a fixed-duration treatment for people with relapsed or refractory diffuse large B-cell lymphoma
June 16, 2023 01:00 ET
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F. Hoffmann-La Roche Ltd
Pivotal study showed durable responses, with a 56% overall response rate, a 43% complete response (remission) rate and a median duration of response of 1.5 years (18.4 months)1Given over a fixed...
Roche awarded WHO prequalification for the cobas® HPV test, increasing access to cervical cancer screening tools in low and lower-middle income countries
June 13, 2023 01:00 ET
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F. Hoffmann-La Roche Ltd
Every year, over 600,000 women worldwide are diagnosed with cervical cancer and over 340,000 die from this preventable disease, caused by infection with human papillomavirus (HPV). Nine out of 10...
New data show Roche’s subcutaneously administered crovalimab achieved disease control and was well-tolerated in people with paroxysmal nocturnal haemoglobinuria (PNH)
June 09, 2023 08:45 ET
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F. Hoffmann-La Roche Ltd
The COMMODORE 2 study demonstrated that subcutaneous crovalimab every four weeks was non-inferior to intravenous eculizumab every two weeks, with comparable safety, in people new to C5...
Roche’s BTK inhibitor fenebrutinib significantly reduced brain lesions in people with relapsing forms of multiple sclerosis
May 17, 2023 01:00 ET
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F. Hoffmann-La Roche Ltd
Fenebrutinib is an investigational, potent and highly selective oral Bruton’s tyrosine kinase (BTK) inhibitor, the only reversible BTK inhibitor currently in Phase III multiple sclerosis (MS)...
FDA accepts application for Roche’s Vabysmo for the treatment of retinal vein occlusion (RVO)
May 09, 2023 01:00 ET
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F. Hoffmann-La Roche Ltd
Acceptance based on two phase III studies that demonstrated early and sustained vision improvement with Vabysmo, meeting primary endpoint of non-inferiority compared to afliberceptApplication was...