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Biogen and Eisai’s Alzheimer’s drug receives FDA accelerated approval

An application has also been submitted for US approval under the traditional pathway

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bluebird bio sells second FDA priority review voucher for $95m

The company sold its first voucher to Dutch biotech Argenx for $102m

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FDA approves first drug to delay onset of type 1 diabetes

Provention Bio’s Tzield delayed the average onset of type 1 diabetes by over four years

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FDA approves Seagen’s Adcetris combination for paediatric patients with Hodgkin lymphoma

Patients had a 59% reduction in the risk of disease progression or relapse, second cancer or death

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Sobi’s Kineret granted FDA Emergency Use Authorisation for COVID-19 related pneumonia

The IL-Ra1 inhibitor was found to reduce the risk of disease progression by 64%

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GSK to submit drug application for new antibiotic to US FDA

Gepotidacin could be the first new novel oral antibiotic treatment for uncomplicated urinary tract infections in over 20 years

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Johnson & Johnson to acquire Abiomed in deal worth $16.6bn

The agreement will broaden the company’s cardiovascular technologies portfolio

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Gilead’s Trodelvy granted FDA priority review for metastatic breast cancer

Phase 2 study results showed a 34% reduction in risk of disease progression or death

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GSK’s Boostrix approved by FDA for use during pregnancy to prevent whooping cough in infants

4.2% of the cases of pertussis reported in the US in 2021 were in infants younger than six months

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Merck’s sotatercept shows promise as pulmonary arterial hypertension add-on treatment in phase 3 trial

The study met its primary endpoint of a clinically meaningful improvement in six-minute walk distance

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FDA approves scPharmaceuticals’ on-body infusor for congestive heart failure

The at-home device delivers the equivalent of what a patient would receive by way of IV

Modern Medical Affairs: How to Leverage Tech and Data as an MSL

Dr. Luca Dezzani, VP of US Oncology Medical Affairs at Johnson & Johnson, explores innovation in Medical Affairs, new technologies for data dissemination and medical education, how to engage with...

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