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4738 News Found

Sage Therapeutics and Biogen initiate rolling submission of New Drug Application for Zuranolone
Biotech | May 02, 2022

Sage Therapeutics and Biogen initiate rolling submission of New Drug Application for Zuranolone

The companies expect to complete the submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression is anticipated in the first half of 2023


AstraZeneca’s new R&D Centre and Alexion HQ in Cambridge, Massachusetts
News | May 01, 2022

AstraZeneca’s new R&D Centre and Alexion HQ in Cambridge, Massachusetts

Move brings together AstraZeneca and Alexion colleagues in a purpose-built facility in Kendall Square, Cambridge, MA, a world-leading life sciences hub


Inmagene receives USFDA's IND clearance for ox40 antagonist
Biotech | May 01, 2022

Inmagene receives USFDA's IND clearance for ox40 antagonist

The planned Phase 1 study is a double-blind, randomized, placebo-controlled dose-escalation study in healthy adult subjects and AD patients


BeiGene to open new site at Princeton, New Jersey
Biotech | May 01, 2022

BeiGene to open new site at Princeton, New Jersey

Flagship U.S. facility will include biologic manufacturing and late stage research and clinical development of innovative cancer medicines


Camzyos is the first and only USFDA-approved cardiac myosin inhibitor
Biotech | April 29, 2022

Camzyos is the first and only USFDA-approved cardiac myosin inhibitor

Approval based on groundbreaking Phase 3 EXPLORER-HCM trial demonstrating benefit in patients receiving Camzyos versus placebo


Ami Organics earmarks Rs 190 cr to expand API production in Ankleshwar
News | April 29, 2022

Ami Organics earmarks Rs 190 cr to expand API production in Ankleshwar

The plant is expected to start commercial operations from Q4FY24


Kapruvia approved by European Commission for hemodialysis patients
Drug Approval | April 28, 2022

Kapruvia approved by European Commission for hemodialysis patients

First approved therapy in Europe for the treatment of chronic kidney disease (CKD)-associated pruritus in hemodialysis patients


Lupin and Yabao announce strategic partnership in China
News | April 27, 2022

Lupin and Yabao announce strategic partnership in China

The demand for high-quality paediatric medicines has been growing rapidly in China as a result of the government’s support and policy measures


Lupin appoints Diana Amador-Toro as Senior Vice President, Global Compliance
People | April 27, 2022

Lupin appoints Diana Amador-Toro as Senior Vice President, Global Compliance

Diana is a senior leader with more than 38 years of field experience in U.S. FDA’s Office of Regulatory Affairs (ORA)


Syngene full-year revenue from operations up 19% to Rs. 2604 crore
News | April 27, 2022

Syngene full-year revenue from operations up 19% to Rs. 2604 crore

Revenue from operations up 15% to Rs. 758 crore in fourth quarter