Submit Current Safety Data of Indians: CDSCO Panel Tells Glenmark on anti-cancer drug ISB1442 Written By Dr. Divya Colin26 March 2024 6:00 PM ISTNew Delhi: Reviewing the Phase I/II clinical study protocol of the anti-cancer drug ISB1442 presented by the drug major Glenmark, the Subject Expert...
Recalculate sample size based on serious adverse event: CDSCO Panel Tells Roche on Polatuzumab vedotin study Written By Dr. Divya Colin25 March 2024 6:00 PM ISTNew Delhi: In line with the Phase IV clinical trial protocol of Polatuzumab Vedotin for Injection, 30mg/vial and 140 mg/vial, the Subject Expert...
Modify CT Protocol: CDSCO Panel Tells GSK on Respiratory Syncytial Virus(RSV) Vaccine Written By Dr. Divya Colin24 March 2024 6:00 PM ISTNew Delhi: Reviewing the Phase III clinical trial protocol presented by the drug major GSK for the Respiratory Syncytial Virus (RSV) vaccine...
Conduct bioequivalence study: CDSCO Panel Tells Emcure Pharmaceutical on Ferric Maltol Capsules Written By Dr. Divya Colin23 March 2024 6:00 PM ISTNew Delhi: Citing there is an unmet medical need, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation...
Submit Periodic Safety Update Report In Indian Population: CDSCO Panel Tells Intas on rHumanErythropoeitinalfa injection Written By Dr. Divya Colin22 March 2024 6:00 PM ISTNew Delhi: Reviewing the proposal presented by the drug major Intas Pharmaceuticals for the revision in package insertion of rh-EPO (r Human...
Pfizer Gets CDSCO Panel Nod to Study Anti-cancer Drug PF-07220060 Written By Dr. Divya Colin21 March 2024 6:00 PM ISTNew Delhi: The drug major Pfizer has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Submit Interim Safety, Efficacy Data: CDSCO Panel Tells Novartis on Crizanlizumab Written By Dr. Divya Colin20 March 2024 6:00 PM ISTNew Delhi: Reviewing the status of the ongoing studies of Crizanlizumab concentrate for solution for infusion 10mg/mL (100mg/10mL), the Subject Expert...
Pfizer Gets CDSCO Panel Nod To study Osivelotor in sickle cell disease Written By Dr. Divya Colin19 March 2024 5:30 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to drug...
CDSCO Panel Rejects Akum Pharma's Clonazepam-Duloxetine Combination Drug Written By Dr. Divya Colin18 March 2024 6:00 PM ISTNew Delhi: Reviewing the justification provided by the drug major Akum Pharmaceutical concerning the fixed-dose combination (FDC) Clonazepam plus...
AstraZeneca Gets CDSCO Panel Nod to Study anticancer drug Volrustomig Written By Dr. Divya Colin17 March 2024 6:00 PM ISTNew Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
UCPMP 2024: 5 major takeaways for Indian Pharma Marketers Meghna A Singhania16 March 2024 1:50 PM ISTNew Delhi: With the Government of India announcing the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024, it serves as a first...
Conduct Randomized Control Phase III CT in Indian Population: CDSCO Panel Tells Pfizer on Rimegepant Written By Dr. Divya Colin15 March 2024 6:00 PM ISTNew Delhi: Rejecting the proposal for local Phase III clinical trial waivers, the Subject Expert Committee (SEC) functional under the Central Drug...
