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1375 News Found

Zydus Announces New Data Presentations at The Liver Meeting 2022
News | November 04, 2022

Zydus Announces New Data Presentations at The Liver Meeting 2022

Saroglitazar Mg is an investigational compound in the USA/EU, undergoing Phase 2b/3 clinical trials in patients with Primary Biliary Cholangitis and Phase 2b in patients with Non- alcoholic Steatohepatitis


GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA
Drug Approval | November 03, 2022

GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA

This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan


Lonza and Singzyme to accelerate development of Bioconjugates
News | November 01, 2022

Lonza and Singzyme to accelerate development of Bioconjugates

Through the collaboration, Lonza will gain access to Singzyme’s enzymatic conjugation platform enabling the site-specific binding of payloads with peptidic linkers to proteins of interest


Aptar Pharma completes Phase I global injectables expansion program
News | November 01, 2022

Aptar Pharma completes Phase I global injectables expansion program

The expansion program includes investments in France and the U.S., adding an additional 23,000+ m² of manufacturing footprint.


USFDA approves Imjudo in combination with Imfinzi for liver cancer
Drug Approval | October 26, 2022

USFDA approves Imjudo in combination with Imfinzi for liver cancer

Approval based on HIMALAYA Phase III trial results which showed single priming dose of Imjudo added to Imfinzi reduced risk of death by 22% vs. sorafenib


CEPI and SK bioscience partner to advance mRNA vaccine technology
News | October 26, 2022

CEPI and SK bioscience partner to advance mRNA vaccine technology

CEPI will provide up to US$40 million in initial funding to support the development of mRNA-vaccine candidates against Lassa Fever virus


Quizartinib granted priority review in the U.S.
Drug Approval | October 26, 2022

Quizartinib granted priority review in the U.S.

Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone


Merck’s PREVYMIS effective for prevention of cytomegalovirus disease in adults post kidney transplantation
Clinical Trials | October 23, 2022

Merck’s PREVYMIS effective for prevention of cytomegalovirus disease in adults post kidney transplantation

Separate Phase 3 study evaluating 200 days of therapy with PREVYMIS in HSCT recipients at high risk of late clinically significant CMV infection recently completed, meeting its primary endpoint


IHL Launches Heart Health Calculator
Healthcare | October 23, 2022

IHL Launches Heart Health Calculator

Tech-driven calculator, which serves as a preventive tool that helps in heart risk assessment using several factors


Zydus receives tentative approval from USFDA for Roflumilast tablets
Drug Approval | October 18, 2022

Zydus receives tentative approval from USFDA for Roflumilast tablets

Roflumilast Tablets had annual sales of US $248 million in the United States according to IQVIA data