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- PMLiVE

AveXis

- PMLiVE

Pfizer, BioNTech to submit emergency use request for COVID-19 vaccine to FDA today

Shot could be available for high-risk populations in the US by middle of December

- PMLiVE

FDA delays BMS’ liso-cel decision, citing COVID-19 travel restrictions

Inspection of third-party manufacturing plant delayed due to COVID-19

- PMLiVE

Novartis and smartpatient launch app experience for wet AMD patients

Wet AMD is the leading cause of severe vision loss and legal blindness in people over the age of 65

- PMLiVE

FDA set to publish reviews of data relating to COVID-19 vaccine EUAs

Agency set to publish data as part of 'transparency' efforts

- PMLiVE

FDA advisory committee overwhelmingly votes no on Biogen’s aducanumab

Path to approval looks increasingly difficult for potential Alzheimer’s treatment

- PMLiVE

Novartis’ canakinumab failed to improve survival in COVID-19 study

Swiss pharma company had been studying drug in hospitalised COVID-19 patients

- PMLiVE

EMA will assess potential COVID-19 vaccine on ‘case by case’ basis

Agency will not specify a minimum level of efficacy, according to Reuters

- PMLiVE

FDA briefing documents back Biogen’s Alzheimer’s drug aducanumab

Documents show the efficacy data for the drug as being ‘exceptionally persuasive’

- PMLiVE

The Unknown Unknowns

Patient insights are fundamental to ensuring we understand the reality of living with a condition. We need to consciously  challenge our approach and ensure we are unearthing authentic patient insights that...

Bedrock Healthcare Communications

- PMLiVE

COVID-19 vaccine developers won’t face pre-approval FDA inspections for EUAs

Companies typically face inspections before gaining approval from the FDA

- PMLiVE

Novartis weathers the COVID-19 storm in Q3, lifts outlook

Core operating income increased by 11%, profits from net income drop

- PMLiVE

Vaccine developers call on FDA to offer clarity on COVID-19 trials

Comments from J&J and Pfizer made before FDA advisory committee meeting yesterday

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