IPP Bureau
USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review
By IPP Bureau - February 22, 2023
This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency
Merck updates on Phase 3 MOVe-AHEAD trial evaluating Lagevrio
By IPP Bureau - February 22, 2023
The safety profile of LAGEVRIO in this trial was generally consistent with that observed in previously reported clinical studies
Mandaviya focuses on high value pharmaceuticals and high-end medical devices to reduce the import dependency
By IPP Bureau - February 22, 2023
First release of Rs.166 crores incentives under PLI scheme for pharmaceuticals
Redcliffe Labs launches BD MAX MDR TB test for MDR-TB in a Single test
By IPP Bureau - February 21, 2023
Becomes the 1st diagnostics company in India to launch BD MAX MDR TB test
Bluestem Biosciences files 24 patent applications
By IPP Bureau - February 21, 2023
At commercial scale, Bluestem's patent pending technologies will reduce carbon emission by an estimated 75% or more and be cost-competitive with petroleum based chemicals
Teijin and Axcelead to establish drug discovery research JV
By IPP Bureau - February 21, 2023
The new company will utilize Teijin's drug discovery research technologies, facilities, equipment and personnel.
New data confirm survival benefits of darolutamide in patients with metastatic hormone-sensitive prostate cancer
By IPP Bureau - February 21, 2023
New subgroup analysis from Phase III ARASENS trial shows that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel increased overall survival (OS)
Astellas updates on Fezolinetant application in US
By IPP Bureau - February 21, 2023
Astellas stands on the forefront of healthcare change to turn innovative science into value for patients
Dalton ramp ups sterile manufacturing capacity
By IPP Bureau - February 20, 2023
The new sterile filling line meets cGMP aseptic filling regulatory requirements
Piramal Pharma starts production at new API facility in Riverview, Michigan
By IPP Bureau - February 20, 2023
New manufacturing facility dedicated to the production of active pharmaceutical ingredients (APIs) and high potency active pharmaceutical ingredients (HPAPIs)
Sun Pharmaceuticals to acquire minority stake in Agatsa Software and Remidio Innovative Solutions
By IPP Bureau - February 20, 2023
Agasta Software is engaged in research, development and commercialization of medical devices
Briefs: Neuland Laboratories, Cipla and Zydus
By IPP Bureau - February 20, 2023
Cipla has received 8 inspectional observations in Form 483
Zydus receives tentative approval from USFDA for Canagliflozin and Metformin Hydrochloride Tablets
By IPP Bureau - February 20, 2023
Canagliflozin and Metformin Hydrochloride Tablets had annual sales of US $49.4 million in the United States
India achieves 15,000+ transplants in a year
By IPP Bureau - February 20, 2023
There is a fast resurgence in the transplant activities post COVID
Fluor selected by Agilent for expansion of oligonucleotide manufacturing facility in Colorado
By IPP Bureau - February 19, 2023
Fluor is providing architectural and engineering services and procuring equipment for the new 275,000 square-foot manufacturing facility that will house two manufacturing lines to double manufacturing capability
