submit phase I and phase II data for Crohn's disease: CDSCO Panel tells Roche Products India on RO7790121 study Dr. Divya Colin22 March 2025 6:00 PM ISTNew Delhi: Reviewing Phase III clinical study protocol of the monoclonal antibody RO7790121, the Subject Expert Committee (SEC) functional under the...
Conduct Phase III CT in Indian population: CDSCO Panel tells Roche Products India on Baloxavir marboxil Dr. Divya Colin6 March 2025 6:00 PM ISTNew Delhi: Noting that the Indian patient’s clinical data is not sufficient and acute uncomplicated influenza is not an unmet medical need, the...
CDSCO Panel Rejects Roche Products India local Phase III CT waiver proposal for Atezolizumab injection SC route Dr. Divya Colin18 Jun 2024 6:00 PM ISTNew Delhi: Recommending to conduct a phase III study in the Indian population to establish the safety and efficacy, the Subject Expert Committee (SEC)...
Roche gets CDSCO panel Nod To study safety, and efficacy of Faricimab Intravitreal injection Dr. Divya Colin29 Oct 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...
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...
Submit Phase IV CT protocol for Entrectinib: CDSCO panel tells Roche India Dr. Divya Colin2 Jan 2023 5:45 PM ISTNew Delhi: Rejecting the drug major Roche's alternative proposal to the Phase IV clinical trial of anti-cancer Entrectinib capsules of 100 mg and 200...
Roche India Atezolizumab marketing approval to be revoked for two indications: CDSCO panel Susmita Roy10 March 2022 6:50 PM ISTNew Delhi: In a major setback to Roche Products (India), the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO)...
Roche antibody cocktail for post-exposure prophylaxis of Covid-19 for adults gets CDSCO panel okay Medical Dialogues Team21 Sept 2021 5:05 PM ISTNew Delhi: With the aim of reducing the spread of the Covid-19 epidemic, the Subject Expert Committee (SEC), functional under the Central Drug...
First: Roche- CIPLA Antibody Cocktail of Casirivimab and Imdevimab for mild to moderate COVID-19 now available in India Ruchika Sharma24 May 2021 2:44 PM ISTThe antibody cocktail (Casirivimab and Imdevimab) is to be administered for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in...
Hold meeting with Roche to ensure immediate supply of Tocilizumab: Delhi HC to DoP Ruchika Sharma8 May 2021 2:45 PM ISTThe Delhi High Court passed the order after Roche told the court that it has no confirmed orders from the central government and was not aware of the...
Roche India gets CDSCO nod to COVID antibody cocktail of Casirivimab, Imdevimab Ruchika Sharma6 May 2021 2:00 PM ISTThe drug will be available through leading hospitals and COVID treatment centres, Roche India said.
