PHARMAP 2023 to focus on pharmaceutical challenges and strategies

The Congress gathers the whole value chain of the pharmaceutical industry on June, 12-13, 2023 in Switzerland

Zydus receives final and tentative approval from USFDA for Tofacitinib Tablets

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

The audit is a pre-approval inspection for three products filed from the facility

Lupin receives approval from USFDA for Brexpiprazole Tablets

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

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

Serum Institute of India likely front-runner to win supply of HPV vaccines for UIP, says GlobalData

The Indian government will float a global tender in April 2023 to procure HPV vaccines.

Patritumab Deruxtecan shows better clinical activity in patient with lung and breast cancer

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

The antiviral is efficacious in non-human primates, and is safe and well-tolerated in humans

Bliss GVS Pharma gets 3 minor observations from USFDA for Palghar unit

The observations are procedural in nature