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- PMLiVE

CALD gene therapy

- PMLiVE

GSK wins approval for anti-PD-1 antibody Jemperli in endometrial cancer

AnaptysBio earns a $20m milestone payment on approval after originally developing the drug

- PMLiVE

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”

- PMLiVE

bluebird bio anticipates lift of clinical holds on LentiGlobin in mid-2021

Previously reported case of MDS in phase 1/2 study has been re-classified as transfusion-dependent anaemia

- PMLiVE

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

- PMLiVE

BMS and bluebird bio gain FDA approval for multiple myeloma therapy

Abecma is a CAR T cell therapy approved for pre-treated myeloma patients

- PMLiVE

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

- PMLiVE

FDA accepts BMS’ investigational cardiovascular drug mavacamten for review

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

- PMLiVE

bluebird bio reveals long-term data for Lenti-D gene therapy in CALD

At 24 months of follow-up, 90% of patients were free of major functional disabilities

- PMLiVE

bluebird bio says AML case “very unlikely” to be related to gene therapy LentiGlobin

bluebird bio's gene therapy LentiGlobin is used to treat sickle cell disease

- PMLiVE

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

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

- PMLiVE

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

- PMLiVE

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

Vaccine can be transported/stored at standard pharmaceutical freezer temperatures

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