IPP Bureau

Zydus receives final and tentative approval from USFDA for Tofacitinib Tablets
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
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
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
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
CTSI appoints Harish Trivedi as CEO, South Asia

By IPP Bureau - March 22, 2023

PHARMAP 2023 to focus on pharmaceutical challenges and strategies
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
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
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
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
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
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
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
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
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
Bliss GVS Pharma gets 3 minor observations from USFDA for Palghar unit

By IPP Bureau - March 19, 2023

The observations are procedural in nature

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