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- PMLiVE

Pfizer-BioNTech booster offers 95.6% efficacy against COVID-19

Results from the world’s first randomised, controlled COVID-19 vaccine booster trial show a third dose of Pfizer-BioNTech’s Comirnaty offers near-total protection from infection

- PMLiVE

US COVID-19 booster programme expanded

The FDA and CDC have given the green light to an expansion of the US COVID-19 booster programme to include another shot of the Moderna and J&J vaccines as well...

- PMLiVE

Biosimilars boosted by FDA’s landmark ruling for Boehringer’s Cyltezo

The FDA has approved Boehringer’s Cyltezo (adalimumab-adbm) as ‘interchangeable’ with Humira (adalimumab) in a landmark ruling

regeneron headquarters

FDA accepts Regeneron’s REGEN-COV for priority review for treatment of COVID-19

In Europe, the EMA will review a Marketing Authorisation Application for the antibody cocktail

- PMLiVE

FDA approves Eli Lilly’s Verzenio in high risk early breast cancer

Verzenio is the first addition to adjuvant endocrine therapy approved by the FDA in nearly two decades for the treatment of HR+ HER2- early breast cancer

- PMLiVE

AstraZeneca requests Emergency Use Authorization from FDA for COVID-19 antibody

Phase 3 data shows the long-acting antibody combination produces a 77% reduction in the risk of developing symptomatic COVID-19

- PMLiVE

Positive data for Lyme disease booster vaccine

A booster shot of Valneva/Pfizer’s VLA15 vaccine candidate against tick-borne Lyme disease demonstrates a strong immune response

Biogen Idec building

Rocky start for Biogen’s Alzheimer’s drug Aduhelm

Controversial Alzheimer’s treatment Aduhelm is struggling to realise its potential, with only 100 patients receiving the therapy so far in the US

- PMLiVE

COVID-19 Pfizer/BioNTech booster approved by FDA and CDC

The plan to offer Americans a third, booster shot of the Pfizer/BioNTech COVID-19 vaccine has finally been waved through by the FDA and CDC

- PMLiVE

FDA approves Seagen/Genmab’s antibody-drug conjugate Tivdak for women with advanced cervical cancer

The drug has been granted accelerated approval, and the companies have also released positive data on first-line treatment

- PMLiVE

UK announces COVID boosters for a “bumpy winter” ahead

A single shot of Pfizer’s COVID-19 vaccine will be offered to 30 million people in the UK including those 50 or over and frontline health and social care workers

- PMLiVE

Sanofi boosts transplant portfolio with newly approved Rezurock

Sanofi’s acquisition of Kadmon Holdings adds Rezurock to its transplant portfolio in a deal worth $1.9bn.

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