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1226 News Found

USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review
Drug Approval | February 22, 2023

USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review

This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency


Dalton ramp ups sterile manufacturing capacity
News | February 20, 2023

Dalton ramp ups sterile manufacturing capacity

The new sterile filling line meets cGMP aseptic filling regulatory requirements


Merck and AstraZeneca present final results from Phase 3 PROpel Trial
Drug Approval | February 18, 2023

Merck and AstraZeneca present final results from Phase 3 PROpel Trial

Data build on previously reported results from the primary endpoint of investigator-assessed radiographic progression-free survival


Pfizer announces Talzenna and Xtandi combination data from phase 3 study
News | February 18, 2023

Pfizer announces Talzenna and Xtandi combination data from phase 3 study

Data show 37% reduction in risk of disease progression or death in men with metastatic castration-resistant prostate cancer treated with TALZENNA plus XTANDI


Aurobindo Pharma gets VAI classification from USFDA for Telangana plant
News | February 16, 2023

Aurobindo Pharma gets VAI classification from USFDA for Telangana plant

Company's Unit - IX, an API intermediate facility situated at Sangareddy District, Telangana, has now been classified as Voluntary Action Indicated


Sun Pharma Announces USFDA Approval for Generic Lenalidomide Capsules
News | February 11, 2023

Sun Pharma Announces USFDA Approval for Generic Lenalidomide Capsules

The respective product approval is based on Revlimid Capsules, 5mg, 10mg, 15mg, 25mg and 2.5mg, 20mg as a reference product


Janssen and Eli Lilly collaboration to address lack of pediatric therapies could rescue mirikizumab program, says GlobalData
News | February 06, 2023

Janssen and Eli Lilly collaboration to address lack of pediatric therapies could rescue mirikizumab program, says GlobalData

The agreement between Eli Lilly and Janssen was established to allow the two companies to share resources for the goal of accelerating the evaluation of the respective companies’ assets, mirikizumab and Tremfya (guselkumab).


CHMP recommends Bayer’s darolutamide for the treatment of metastatic hormone-sensitive prostate cancer
Drug Approval | January 31, 2023

CHMP recommends Bayer’s darolutamide for the treatment of metastatic hormone-sensitive prostate cancer

CHMP recommendation is based on Phase III data, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5%


NIB is playing a vital role in ensuring that quality biological products reach the health system: Dr. Mandaviya
Policy | January 29, 2023

NIB is playing a vital role in ensuring that quality biological products reach the health system: Dr. Mandaviya

It will help upgrade the infrastructure and technologies of the country's biopharmaceuticals and in-vitro diagnostic industry


Syngene Q3FY23 revenue reaches Rs. 803 Cr; PAT reaches Rs. 110 Cr
News | January 24, 2023

Syngene Q3FY23 revenue reaches Rs. 803 Cr; PAT reaches Rs. 110 Cr

The company is pleased to report positive performances from all divisions this quarter. Growth in our research divisions, Discovery Services and the Dedicated Centres was solid