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Rare disease UK

Effects of the Pandemic on Evidence Generation & Scientific Exchange

Farah Husein, Director, Evidence Generation, Canadian Centre of Excellence, at Takeda, discusses all things evidence generation, including the impact of the COVID-19 pandemic on HEOR, RWE, epidemiology, and PRO studies and...

Impetus Digital

- PMLiVE

FDA briefing document paves the way for Pfizer/BioNTech COVID-19 vaccine approval

Advisory Committee is set to meet today to discuss vaccine's safety and efficacy data

- PMLiVE

Novavax moves closer toward launch of US phase 3 COVID-19 vaccine trial

Company also completes enrolment in UK-based phase 3 trial

- PMLiVE

Joint COVID-19 trial begins testing drugs from Amgen, UCB and Takeda

Trial will test therapeutic candidates in hospitalised COVID-19 patients

Roche Basel Switzerland

Roche’s Xofluza pill wins FDA approval for post-exposure flu prevention

First single-dose flu medication approved for post-exposure prophylaxis

- PMLiVE

FDA sets 10 December date for Pfizer’s COVID-19 vaccine meeting

Independent experts will discuss EUA submission for mRNA-based vaccine

regeneron headquarters

Regeneron’s COVID-19 antibody cocktail scores FDA emergency approval

Drug approved to treat high-risk patients with mild to moderate COVID-19

- 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

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

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

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

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