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- PMLiVE

Legend Biotech

- PMLiVE

FDA priority review granted for J&J, Legend Biotech’s myeloma CAR T therapy

CAR T therapy demonstrated an overall response rate of 97% in relapsed/refractory multiple myeloma patients after 12.4 months

Roche Basel Switzerland

EC approves Venclyxto-based combinations for newly diagnosed AML

The treatment is approved for newly diagnosed acute myeloid leukaemia patients who can’t receive intensive chemotherapy

- PMLiVE

EU asks AZ to deliver 120 million COVID-19 vaccines by the end of June

The EU has launched a new lawsuit against the drugmaker which could result in financial sanctions

- PMLiVE

EU moves forward with legal action against AZ over vaccine supply issues

Legal proceeding launched on the basis of 'breaches of the advanced purchase agreement'

- PMLiVE

J&J resumes US rollout of single-dose COVID-19 vaccine

CDC and FDA recommended pause be lifted after ‘rigorous review’ of very rare blood clots

- PMLiVE

EU may seek legal action against AstraZeneca following vaccine supply cuts

EU supply issues for the AZ vaccine started in January 2021

- 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

EMA finds overall benefit-risk ‘remains positive’ for J&J COVID-19 vaccine

Safety committee finds possible link to ‘very rare cases’ of unusual blood blots with low blood platelets

- PMLiVE

Janssen will not seek regulatory approval for Erleada plus Zytiga in prostate cancer

Decision follows mixed results from the phase 3 ACIS study

- PMLiVE

Second Sarclisa combination regimen for multiple myeloma approved in EU

Second indication for Sarclisa covers drug’s use in combination with another standard myeloma treatment

- PMLiVE

European Commission approves Opdivo plus Cambometyx for advanced kidney cancer

Checkpoint inhibitor plus tyrosine kinase inhibitor approved for the first-line treatment of advanced renal cell carcinoma

- PMLiVE

J&J delays EU COVID-19 vaccine rollout following pause in the US

FDA and CDC recommended pausing rollout in US after reported cases of rare blood clots in vaccinated individuals

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