Entries by aaron

CDSCO Panel Approves AstraZeneca’s Protocol Amendment Proposal to Study Capivasertib Plus Abiraterone

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major AstraZeneca’s proposal for amendment of protocol for the clinical study ” A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib+Abiraterone Versus Placebo+Abiraterone as Treatment for Patients with DeNovo Metastatic […]

CDSCO Panel grants Sanofi’s Updated Prescribing Information for FDC Ibuprofen plus Paracetamol

New Delhi: The drug major Sanofi has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to update prescribing information for the fixed-dose combination (FDC) Ibuprofen 100mg plus Paracetamol 162.5mg suspension and Ibuprofen 400mg plus Paracetamol 325mg tablet. This came after the firm presented the proposal for […]

CDSCO Panel Rejects Dr Reddy’s Proposal to Study FDC of Ketorolac plus Serratiopeptidase Capsules

New Delhi: Citing there is no rationality of the combination and significant benefits, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has rejected the drug major Dr. Reddys Laboratories’ proposal to conduct a clinical trial of fixed-dose combination (FDC) Ketorolac Tromethamine 10mg plus Serratiopeptidase 15mg Capsules. This came after […]

FDA approves first treatment for reactions to multiple foods after accidental exposure

The FDA has approved omalizumab (Xolair) injection as first medication to help reduce allergic reactions to multiple foods after accidental exposure. Omalizumab is a monoclonal antibody that helps reduce certain allergic reactions including anaphylaxis in adults and children 1 year and older. Patients who take Xolair must continue to avoid foods they are allergic to. […]

Supply of Sub-Standard Items: 26 Delhi Hospitals under scanner of Anti Corruption Branch

New Delhi: Amid the ongoing issue of using sub-standard medical items, as many as 26 government hospitals have been asked to share details with the Anti-Corruption Branch (ACB) of their approval and purchase committee.   This development comes after the ACB arrested 10 people for allegedly being involved in the supply of sub-standard items to […]

Telangana drug regulator becomes eligible to observe USFDA inspections

Hyderabad: The US Food and Drug Administration (USFDA) has announced that drug inspectors of the Drugs Control Administration, Telangana are eligible to observe USFDA inspections conducted in Telangana as part of collaboration. Telangana has become the fourth state in India to become eligible to observe the inspections, joining Gujarat, Karnataka, and Goa. The US drug […]

Cancer Care: Over 600,000 International patients travel to India every year

New Delhi: Patient Herbert from Tanzania, suffering from non-Hodgkin lymphoma (A type of blood cancer), came to India for treatment last year. Now, After two months, with proper diagnosis of the disease and three cycles of Immunotherapy Chemo treatment in India, he is going back to his country with the chemo protocol and plans to […]

Sanofi Dupixent gets Japenese nod for chronic spontaneous urticaria

Paris: Sanofi has announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in people aged 12 years and older whose disease is not adequately controlled with existing therapy. Japan is the first country to approve Dupixent for […]

26-year-old pregnant woman with uncontrolled diabetes underwent real-time Continuous Glucose Monitoring at Kauvery Hospital

Chennai: Kauvery Hospital Alwarpet, announced a significant milestone in maternal healthcare with successful integration of real time CGMS (Continuous Glucose Monitoring Study) Sensor Monitoring.  This has yielded remarkable results for patients such as the 26-yr old woman with documented history of seisure disorder and learning disability. Initially diagnosed as a pre-diabetic, her condition evolved into […]