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- PMLiVE

GSK’s anaemia drug gets FDA advisory committee support for patients on dialysis

A final decision for daprodustat by the FDA is expected by 1 February 2023

- PMLiVE

Janssen’s Tecvayli granted FDA approval for multiple myeloma

A phase 2 study demonstrated an overall response rate of 61.8% in Tecvayli-treated patients

- PMLiVE

Merck to donate Sudan Ebola virus vaccine to International AIDS Vaccine Initiative

Around 50,000 doses are expected to be provided for further clinical research use

- PMLiVE

AstraZeneca’s Imjudo/Imfinzi combination approved by FDA for unresectable liver cancer

Phase 3 trial results demonstrated a 22% reduction in risk of death versus sorafenib

- PMLiVE

Merck’s Prevymis shows promise in phase 3 cytomegalovirus disease prevention trial

The drug demonstrated non-inferior efficacy compared to standard of care valganciclovir

- PMLiVE

Novavax’s COVID-19 vaccine candidate approved for emergency use by FDA as a booster

The authorisation is for those unable to receive an FDA-authorised mRNA bivalent booster

- PMLiVE

FDA awards over $38m for advancement of rare disease treatments

Grants will support clinical trials, natural history studies and regulatory science tools

- PMLiVE

Merck and Bill & Melinda Gates Institute sign licensing agreement for tuberculosis candidates

The non-profit will determine their potential for inclusion in new affordable treatment regimens

Biomarin

BioMarin’s application for haemophilia A gene therapy accepted by FDA

If approved, the treatment would be the first gene therapy in the US for this indication

- PMLiVE

Merck and Moderna to jointly develop personalised cancer vaccine in $250m deal

The vaccine is currently being evaluated as a treatment for high-risk melanoma patients

- PMLiVE

Pfizer/BioNTech BA.4/BA.5 COVID-19 booster approved for emergency use by FDA in children five to 11 years

The doses will be shipped immediately, pending recommendation from the CDC

- PMLiVE

Genentech shares positive two-year data for Evrysdi in spinal muscular atrophy study

The study enrolled the ‘broadest and most diverse’ patient population ever studied in an SMA trial

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