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1848 News Found

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


Briefs: Biocon, Laurus Labs and Smruthi Organics
Drug Approval | February 13, 2023

Briefs: Biocon, Laurus Labs and Smruthi Organics

Laurus Labs has announced that the USFDA completed inspection of the formulations manufacturing facility Unit-2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.


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


Pharma companies developing vaccines with efficacy against Omicron variants will gain competitive advantage in China, says GlobalData
News | January 27, 2023

Pharma companies developing vaccines with efficacy against Omicron variants will gain competitive advantage in China, says GlobalData

The WHO has urged China to increase adoption of mRNA vaccines, given their high efficacy against variant strains.


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


Astellas announces hold lifted by FDA on Fortis clinical trial of AT845
Drug Approval | January 23, 2023

Astellas announces hold lifted by FDA on Fortis clinical trial of AT845

Astellas stands on the forefront of healthcare change to turn innovative science into value for patients


SK bioscience appoints new executives
People | January 23, 2023

SK bioscience appoints new executives

Two biopharmaceutical experts join SK bioscience to strengthen the future strategies