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- PMLiVE

FDA’s director and deputy director of its Office of Vaccines Research & Review resign

The departure of director Marion Gruber and deputy director Philip Krause is unexpected

- PMLiVE

GSK/SK bioscience COVID-19 vaccine to enter phase 3 trial

The study will be one of the first global phase 3 trials to compare two different COVID-19 vaccine candidates

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Therapy Watch COVID-19 tracker

Research Partnership

- PMLiVE

US demand for COVID-19 antibody treatments rising fast

With the ‘fourth wave’ of COVID-19 in the US, Regeneron and GSK report high demand for their monoclonal antibody treatments

- PMLiVE

AZ’s new rare disease unit wins in Wilson disease

Alexion purchase looks increasingly ‘copper-bottomed’ as AstraZeneca prepares to submit data for ALXN1840 in Wilson disease

AstraZeneca AZ

AstraZeneca’s Forxiga approved in Japan for the treatment of CKD

Approval was based on positive data from the phase 3 trial for chronic kidney disease

- PMLiVE

Pfizer/BioNTech file for FDA approval for COVID-19 booster jab

New data shows third dose boosts antibodies by more than three times

- PMLiVE

Protection against COVID-19 reduces over time in fully vaccinated, according to new real-world study

The Zoe COVID-19 Study shows protection could fall by up to 14%

- PMLiVE

FDA’s approval of Pfizer/BioNTech’s COVID-19 vaccine “is a milestone” says acting FDA commissioner Janet Woodcock

After more than a billion doses have been given worldwide, Comirnaty is now officially approved for people aged 16 and over in the US

- PMLiVE

AZ to seek approval for “long-acting” COVID-19 antibodies

AZD7442 significantly reduced the risk of developing symptomatic COVID-19 in phase 3 trial and is a one-dose treatment that can be given via an intramuscular injection

regeneron headquarters

UK approves Regeneron’s COVID-19 antibody cocktail

Ronapreve is the first monoclonal antibody therapy against COVID-19 approved in Europe

- PMLiVE

COVID-19 vaccine protection wanes over time, backing up the need for boosters

While both Pfizer/BioNTech and AstraZeneca’s vaccines offer good protection, a new UK study shows the protection reduces over time and the UK's booster campaign is likely to begin in September

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