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etelcalcetide

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J&J halts manufacturing of COVID-19 at US plant after FDA warning

Inspection report found facility was “not maintained in a clean and sanitary condition”

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UPDATE: US pauses rollout of J&J’s COVID-19 vaccine amid reports of rare blood clots

An advisory committee to the CDC recommended extending the pause in the US to review additional data

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Amgen plans acquisition of Rodeo Therapeutics

Deal could be worth over $700m including potential future milestone payments

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J&J’s MS drug ponesimod receives approval in the US

US regulator has approved the drug – now named Ponvory – for relapsing forms of MS

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FDA accepts BMS’ investigational cardiovascular drug mavacamten for review

BMS gained the rights to mavacamten as part of its acquisition of MyoKardia

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Amgen adds to oncology pipeline with $1.9bn Five Prime Therapeutics acquisition

Five Prime's pipeline includes potentially first-in-class anti-FGFR2b antibody bemarituzumab

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Novavax seeks FDA emergency approval for COVID-19 vaccine by May

Company is hoping FDA will review data from a UK-based trial

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AZ, Amgen’s tezepelumab reduces asthma exacerbations in broad patient population

Detailed results from the NAVIGATOR trial presented at virtual AAAAI meeting

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J&J’s one-dose COVID-19 vaccine granted emergency use approval by FDA

Company has already started shipping doses of the vaccine to the US

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FDA authorises flexible storage for Pfizer/BioNTech COVID-19 vaccine

Vaccine can be transported/stored at standard pharmaceutical freezer temperatures

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FDA briefing document backs J&J’s one-dose COVID-19 vaccine

Company is seeking an emergency use authorisation in the US

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FDA updates guidance for COVID-19 vaccine makers addressing new variants

FDA said that it expects manufacturing information for modified vaccines to remain generally the same

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