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FDA places partial clinical hold on three Gilead phase 3 trials for MDS and AML treatments

The company confirmed that six other phase 2 trials would go ahead as previously planned

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Pfizer and BioNTech start clinical trial for Omicron-based COVID-19 vaccine

The clinical trial involves adults aged 18 to 55 who received an Omicron-based vaccine candidate as part of a two-dose primary series, as well as a booster

- PMLiVE

FDA restricts use of certain antibody treatments for COVID-19

The restrictions reflect recent data that shows these antibodies are not effective against the Omicron variant

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FDA grants priority review for Roche’s Evrysdi for spinal muscular atrophy in babies

The review of Evrysdi has been developed for pre-symptomatic babies under two months old with spinal muscular atrophy

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Gilead’s Veklury receives FDA approval for non-hospitalised high-risk patients to treat COVID-19

The FDA also issued an EUA for the treatment to include non-hospitalised paediatric patients 12 years and under who are at high risk of disease progression

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AstraZeneca’s Enhertu receives FDA grant for priority review

The approval is based on results from the DESTINY-Breast03 trial which showed a significant risk reduction of unresectable or metastatic HER-2 positive breast cancer progression

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Pfizer’s Cibinqo granted FDA approval for adults with moderate-to-severe atopic dermatitis

The FDA based its approval on results from a clinical trial programme involving over 1,600 patients

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BMS and Century Therapeutics agree on deal potentially worth over $3bn

The collaboration unites Century’s iPSC-derived allogeneic cell therapy line with BMS’s record in developing oncology drugs and cell therapies

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Pfizer expands access to lipid nanoparticle technology in new agreement with Acuitas Therapeutics

Acuitas’ LNP technology is already used in the Pfizer/BioNTech COVID-19 vaccine, Comirnaty

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Amgen’s Lumykras receives conditional marketing authorisation from EC

The drug is the first targeted therapy for patients diagnosed with advanced NSCLC with the KRAS G12C mutation

- PMLiVE

Pfizer/BioNTech confirm new global collaboration to develop first mRNA-based shingles vaccine

The companies plan to begin clinical trials of the new vaccine in the second half of 2022

- PMLiVE

Pfizer/BioNTech receives expanded authorisation from the FDA for its COVID-19 booster

The booster dose of the companies’ COVID-19 vaccine is now authorised to include individuals aged 12 years and older

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