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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...

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...

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...

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...

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...

Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing with U.S. FDA for EUA

Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases...

Moderna Announces Amendment to Current Supply Agreement with UK Government for an Additional 2 Million Doses of mRNA Vaccine Against COVID-19

Moderna, Inc. , a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced a supply agreement with the UK government for an additional 2 million doses of mRNA-1273,...

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