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osteoporosis

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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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Sandoz to invest €50m in Austrian manufacturing facility to meet global antibiotic demand

Amoxicillin and other vital penicillin products will benefit from the investment

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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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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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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

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Novartis to separate generic drugs division Sandoz to create standalone company

The spin-off will allow shareholders to participate fully in the potential future upside of both companies

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Sandoz’s application for MS biosimilar accepted by FDA

The proposed ‘first-of-a-kind’ biosimilar matched the reference medicine, Biogen’s Tysabri, in terms of efficacy, safety and immunogenicity

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Sandoz’s biosimilar medicine application accepted by FDA

If approved, the higher concentration formulation could decrease the number of injections required for patients currently receiving a lower dose of Hyrimoz

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