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- PMLiVE

major thrombotic cardiovascular events

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

Merck and Ridgeback’s oral antiviral halves COVID-19 risk of hospitalisation or death

The phase 3 study shows the risk was halved compared to placebo for patients with mild or moderate COVID-19

- PMLiVE

Merck to acquire Acceleron in a deal worth around $11.5bn

The acquisition of the biopharmaceutical company will complement and strengthen Merck’s cardiovascular pipeline

- PMLiVE

Mysterious big pharma company eyes US biotech Acceleron

Speculation is running high that a major pharma company will make a move on Massachusetts-based pulmonary and haematology biotech Acceleron this week

- PMLiVE

Lynparza significantly delays disease progression as first-line treatment in prostate cancer

New data show AstraZeneca and Merck‘s PARP inhibitor, Lynparza, delayed disease progression as a first-line treatment in advanced prostate cancer

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

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.

Biomarin

FDA pauses BioMarin gene therapy trial

The study for BMN 307 in genetic disease phenylketonuria will be paused while malignancies in mice are explored

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