Roche Evrysdi gets European Commission nod for babies under two months old with spinal muscular atrophy Ruchika Sharma30 Aug 2023 3:00 PM ISTBasel: Roche has announced that the European Commission has approved the extension of the Evrysdi (risdiplam) European Union (EU) marketing...
Roche reports inadvertent disclosure in lung cancer immunotherapy study Ruchika Sharma23 Aug 2023 2:30 PM ISTBasel: Roche announced today that it has been made aware of an inadvertent disclosure of the second interim analysis of the Phase III SKYSCRAPER-01...
Roche gets CDSCO panel nod to study Crovalimab Dr. Divya Colin20 Aug 2023 6:00 PM ISTNew Delhi: The drug major Roche has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Patent infringement: Roche sues Novartis unit over generic lung disease drug Ruchika Sharma3 Aug 2023 1:30 PM ISTSwiss drugmaker Roche's Genentech subsidiary has accused a Novartis unit of infringing one of its patents by selling a generic version of its...
Roche Gets CDSCO Nod To Study Anticancer FDC Drug Dr. Divya Colin25 July 2023 6:00 PM ISTNew Delhi: In a significant development, the drug major Roche has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central...
Roche Evrysdi gets CHMP recommendation for babies under two months old with spinal muscular atrophy Ruchika Sharma24 July 2023 3:30 PM ISTEvrysdi is currently approved in the EU for the treatment of patients aged two months or older,
Roche, Alnylam collaborate for hypertension therapy Ruchika Sharma24 July 2023 12:29 PM ISTUnder the terms of the agreement, Alnylam will receive an upfront payment of USD 310m and is eligible to receive development, regulatory and...
Roche announces positive phase III results for Ocrevus twice a year, 10-minute subcutaneous injection in multiple sclerosis patients Ruchika Sharma16 July 2023 2:30 PM ISTBasel: Roche has announced that the Phase III OCARINA II trial evaluating OCREVUS (ocrelizumab) as a twice a year 10-minute subcutaneous injection met...
Roche gets European Commission nod for fixed duration Columvi for diffuse large B-cell lymphoma Ruchika Sharma11 July 2023 4:30 PM ISTColumvi is a CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells.
Revise CT Protocol: CDSCO Panel Tells Roche on Ophthalmic Drug RO7200220 Dr. Divya Colin10 July 2023 6:00 PM ISTNew Delhi: Responding to the drug major Roche's proposal to conduct a Phase III clinical trial of RO7200220, anti-interleukin-6 (IL-6), the Subject...
CDSCO Panel Approves Roche's Protocol Amendment Proposal to Study Polatuzumab Vedotin Dr. Divya Colin2 July 2023 5:15 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has approved the protocol amendment...
US FDA declines to approve Regeneron's higher dose Eylea Ruchika Sharma30 Jun 2023 11:00 AM ISTRegeneron was seeking approval for the drug to treat wet AMD, the leading cause of blindness among the elderly, and two eye diseases that are common...
