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5636 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


Moderna finalizes plan for long-term strategic partnership with Canada
Biotech | May 01, 2022

Moderna finalizes plan for long-term strategic partnership with Canada

Onshore manufacturing facility is expected to be based in Quebec and produce up to 100 million mRNA respiratory vaccine doses annually


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


Once-weekly icodec demonstrates superior reduction in HbA1c vs degludec
Biotech | April 29, 2022

Once-weekly icodec demonstrates superior reduction in HbA1c vs degludec

In the trial, there was no statistical difference in estimated hypoglycaemia rates, and no severe hypoglycaemia events were observed for people treated with insulin icodec


Ultomiris approved in the US for adults with generalised myasthenia gravis
Drug Approval | April 29, 2022

Ultomiris approved in the US for adults with generalised myasthenia gravis

Ultomiris showed early effect and lasting improvement in activities of daily living and has potential to reduce treatment burden with dosing every 8 weeks


Moderna files for authorization of its Covid-19 vaccine in young children six months to six years
Biotech | April 29, 2022

Moderna files for authorization of its Covid-19 vaccine in young children six months to six years

Submission to regulators globally is based on phase 2/3 studies of mRNA-1273 in young children


Philips and Prisma Health sign multi-year, long-term strategic partnership
Digitisation | April 29, 2022

Philips and Prisma Health sign multi-year, long-term strategic partnership

South Carolina’s largest health system adopts Philips software solutions for patient monitoring and enterprise imaging, helping to drive interoperability and data analytics, and deliver on Quadruple Aim


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