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Pfizer, BioNTech temporarily slow down shipments of COVID-19 vaccine to EU

'Temporary' reduction comes as companies bolster production capacity for the year

New dosing option for AZ’s Imfinzi approved in the EU and UK

Additional option extends dosing from two weeks to four weeks

Bayer’s finerenone scores FDA priority review for chronic kidney disease

FDA priority review is based on data from the phase 3 FIDELIO-DKD trial

J&J could launch its single-dose COVID-19 vaccine in March

Chief scientific officer Paul Stoffels said J&J is aiming for one billion doses in 2021

Merck wins speedy FDA review for 15-valent pneumococcal vaccine

Pfizer's rival 20-valent candidate was granted priority review in December 2020

AZ seeks EU approval for its Oxford University-partnered COVID-19 vaccine

CHMP could reach a decision on opinion by 29 January

Roche’s flu pill Xofluza gains EU approval

EU approval is based on results from three phase 3 studies

UK approves Moderna’s COVID-19 vaccine, secures another 10 million doses

Total number of doses secured by UK now totals 17 million

EMA recommends authorisation of Moderna’s COVID-19 vaccine

European Commission likely to formally approve the vaccine soon

‘Post-Brexit landscape for EU-wide IP Rights: The Story So Far’

Brexit means pharma must review its intellectual property rights across Europe

Moving times

Continuity and stability are vital when it comes to the EMA's relocation when it leaves London
SMC gives green light for Amgen’s Kyprolis

The committee also gives verdict on three other products

More regulatory features

Moderna wins EU authorisation for COVID-19 vaccine

EU Commission approval comes on the same day as positive CHMP opinion
AZ/Oxford University COVID-19 vaccine wins emergency approval in India

In June 2020, AZ signed a licensing deal with the Serum Institute for the vaccine
Roche’s tiragolumab plus Tecentriq combo wins FDA breakthrough therapy designation

Swiss pharma is aiming for approval in first-line NSCLC
New intramuscular administration for Biogen’s MS therapy Plegridy approved in the EU

New administration offers same efficacy as subcutaneous injection
FDA will not alter dosing schedules for authorised COVID-19 vaccines

Time period between first and second vaccines has been extended in the UK
Sinopharm’s COVID-19 vaccine scores approval in China

Vaccine found to be 79% effective in top-line results
Roche gets EU approval for fixed-dose Herceptin/Perjeta combination

Treatment can be administered as an injection instead of an intravenous infusion

More regulatory news

Latest regulatory appointments

ABPI appoints industry veteran Richard Torbett as new chief executive

Torbett initially joined the pharma association in March 2016
Professor Carole Longson moves from NICE to the ABPI

She joins the UK pharma body as its chief scientific officer
MedTech Europe appoints new board of directors

Chair of the board Michelle Brennan is among those newly elected
Greg Perry joins IFPMA as assistant director general

Will move to the global industry body from the Medicines Patent Pool
AVEO appoints Nikhil Mehta as its senior VP, regulatory and quality assurance

He joins the biopharma from Tang Capital Management

More appointments

COVID-19 Updates and Daily News

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OncoSec is a clinical-stage biotechnology company focused on developing cytokine-based intratumoral immunotherapies to stimulate the body's immune system to target...

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