Drug Research
Sterling announces strategic investment in ADC Biotechnology
Global contract development and manufacturing organisation (CDMO), Sterling Pharma Solutions (Sterling), has announced a new strategic partnership with ADC Biotechnology (ADC Bio), a UK based biotechnology company specialising in antibody drug conjugates.
The partnership will see Sterling make a significant...
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FDA Grants Fast Track Designation for Remestemcel-L in the Treatment of Acute Respiratory Distress Syndrome Due to COVID-19
Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, announced that the United States FDA has granted Fast Track designation for remestemcel-L in the treatment of acute respiratory distress syndrome (ARDS) due to COVID-19 infection. Fast Track...
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Janssen Inc Announces the Initiation of a Rolling Submission for its Single-dose Janssen COVID-19 Vaccine Candidate with Health Canada
Janssen Inc. the pharmaceutical companies of Johnson & Johnson, has initiated a rolling submission with Health Canada for its investigational single-dose vaccine candidate for the prevention of COVID-19.
Health Canada announced a rolling review of the investigational single-dose Janssen COVID-19...
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EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2
EMA has received an application for conditional marketing authorisation (CMA) for BNT162b2, a COVID?19 mRNA vaccine developed by BioNTech and Pfizer. The assessment of BNT162b2 will proceed under an accelerated timeline. An opinion on the marketing authorisation could be...
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Biogen partners with Sage Therapeutics on depression, movement disorder drugs
Biogen entered into an agreement to jointly develop and commercialise Sage Therapeutics' zuranolone for major depressive disorder (MDD) and postpartum depression (PDD), as well as SAGE-324 for essential tremor, the companies announced Friday. Under the deal, Biogen will pay...
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AstraZeneca Says Forxiga Approved In Japan For Heart Failure
AstraZeneca’s Forxiga (dapagliflozin) has been approved in Japan for the treatment of patients with chronic heart failure (HF) who are receiving standard of care.
HF is a life-threatening chronic disease that prevents the heart from pumping sufficient levels of blood...
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Lonza invests to expand manufacturing capabilities at Oregon site
Lonza AG has announced a significant investment to expand its particle engineering and drug product capabilities to meet increased market demand at its Bend, Oregon site. New suites for the development and clinical manufacture of drug product intermediates and...
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