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- PMLiVE

Pfizer CEO says COVID-19 vaccine efficacy data could come ‘soon’

Data monitoring committee has not yet conducted any interim efficacy analysis of the shot

- 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

- PMLiVE

Novartis scores CHMP backing for cholesterol drug Leqvio

Potential first-in-class treatment moves closer to EU approval

- PMLiVE

Pfizer CEO pushes back COVID-19 vaccine submission to November

Company previously said it would seek approval by October

- PMLiVE

Pfizer and BioNTech’s COVID-19 vaccine begins EMA evaluation

Vaccine is the second to undergo EMA's 'rolling review' process after AstraZeneca/Oxford Uni's candidate

- PMLiVE

EMA begins rolling review of AZ’s COVID-19 vaccine candidate

Agency has started evaluating data from non-clinical laboratory studies

- PMLiVE

EMA accepts application for bluebird bio’s Lenti-D in CALD

Gene therapy could become a potentially transformative treatment for cerebral adrenoleukodystrophy

- PMLiVE

Researchers call on Pfizer to delay COVID-19 vaccine application

Reports that the company could seek regulatory approval in October have raised safety concerns

- PMLiVE

FDA sets January decision date for Xalkori in ALK-positive lymphoma

FDA submission is based on results from ADVL0912 and A8081013 studies

- PMLiVE

Pfizer’s ALK inhibitor Lorbrena hits the mark in head-to-head lung cancer trial

Results showing that the drug is an improvement on Xalkori were released at ESMO 2020 virtual congress

- PMLiVE

BioNTech bolsters COVID-19 vaccine capacity with Novartis deal

Deal will expand production capacity for BNT162b2 candidate

- PMLiVE

Novavax CEO anticipates filing COVID-19 vaccine for approval in December

Pfizer also announces over 50% enrolment in COVID-19 vaccine trial

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