IPP Bureau
Zydus receives final and tentative approval from USFDA for Tofacitinib Tablets
By IPP Bureau - March 22, 2023
Tofacitinib Tablets, 5 mg and 10 mg had annual sales of US $900 million in the United States (IQVIA MAT December 2022)
Granules Consumer Health concludes FDA audit with zero observations
By IPP Bureau - March 22, 2023
The audit is a pre-approval inspection for three products filed from the facility
Lupin receives approval from USFDA for Brexpiprazole Tablets
By IPP Bureau - March 22, 2023
Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, (RLD Rexulti) had estimated annual sales of US $1,575 million in the US (IQVIA MAT December 2022)
Zydus granted Orphan Drug Designation by USFDA for ZYIL1
By IPP Bureau - March 22, 2023
ZYIL1 is a novel oral small molecule NLRP3 inhibitor which has demonstrated CSF penetration in non-human primates
CTSI appoints Harish Trivedi as CEO, South Asia
By IPP Bureau - March 22, 2023
PHARMAP 2023 to focus on pharmaceutical challenges and strategies
By IPP Bureau - March 22, 2023
The Congress gathers the whole value chain of the pharmaceutical industry on June, 12-13, 2023 in Switzerland
Glenmark receives ANDA approval for Prochlorperazine Maleate Tablets
By IPP Bureau - March 21, 2023
According to IQVIA sales data for the 12-month period ending January 2023, the Compazine Tablets, 5 mg and 10 mg market achieved annual sales of approximately US $26.9 million
Caplin receives USFDA approval for Rocuronium Bromide Injection
By IPP Bureau - March 21, 2023
Rocuronium Bromide Injection had an annual sale of approximately US $53 million in the US (IQVIA MAT December 2022)
Serum Institute of India likely front-runner to win supply of HPV vaccines for UIP, says GlobalData
By IPP Bureau - March 21, 2023
The Indian government will float a global tender in April 2023 to procure HPV vaccines.
Novartis shares Zolgensma long-term data demonstrating sustained durability up to 7.5 years post-dosing
By IPP Bureau - March 21, 2023
All children (100%) in the presymptomatic intravenous cohort of LT-002 maintained or achieved all assessed motor milestones, including independent walking
AI platforms market for healthcare industry to reach $4.3 billion in 2024: GlobalData
By IPP Bureau - March 21, 2023
Various healthcare companies are already implementing high-tech solutions into existing healthcare systems.
Patritumab Deruxtecan shows better clinical activity in patient with lung and breast cancer
By IPP Bureau - March 20, 2023
Subgroup analysis by HER2 expression from phase 1/2 trial of patients with HER3 expressing metastatic breast cancer highlighted in a second Presidential Session
Janssen announces novel dengue antiviral demonstrates efficacy in pre-clinical data
By IPP Bureau - March 20, 2023
The antiviral is efficacious in non-human primates, and is safe and well-tolerated in humans
Phase 3 data show Deuruxolitinib significantly improve scalp hair regrowth in Alopecia Areata
By IPP Bureau - March 20, 2023
The Phase 3 data presented at AAD include a comprehensive review of the THRIVE-AA2 results and further elaborate the topline data reported in August 2022
Bliss GVS Pharma gets 3 minor observations from USFDA for Palghar unit
By IPP Bureau - March 19, 2023
The observations are procedural in nature
