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- PMLiVE

Sanofi and Regeneron’s Dupixent approved by FDA for prurigo nodularis

The two phase 3 trials showed a meaningful reduction in itching

- PMLiVE

Pfizer and BioNTech seek FDA authorisation for COVID-19 booster for children

An application will also be submitted to the European Medicines Agency to extend the marketing authorisation for this age group

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Pfizer and Sangamo Therapeutics reopen recruitment for haemophilia A gene therapy trial

The trial was voluntarily paused by the two partners last year and later placed on hold by the FDA

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Pfizer to supply 6 million Paxlovid treatments to low- and middle-income countries

Eligible countries will be offered treatment courses according to Pfizer’s tiered pricing approach

- PMLiVE

Lilly’s Retevmo approved by FDA for RET fusion+ advanced/metastatic solid tumours

Results demonstrated an overall response rate of 44% across multiple tumour types

- PMLiVE

bluebird bio’s Skysona approved by FDA to treat cerebral adrenoleukodystrophy

The gene therapy was shown to slow the progression of neurologic dysfunction

- PMLiVE

Pfizer’s investigational meningococcal vaccine shows promise in phase 3 trial

There is currently no single vaccine available in the US to help protect against the main five serogroups

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FDA and NIHR launch public-private partnership for rare neurodegenerative diseases

The announcement follows President Biden signing the Accelerating Access to Critical Therapies for ALS Act in December 2021

- PMLiVE

Pfizer doses first patients with mRNA-based influenza vaccine

Available vaccine strains that match circulating influenza viruses offer only 40%-60% protection

- PMLiVE

Pfizer/BioNTech BA.1 COVID-19 booster receives CHMP recommendation

If an authorisation is granted, doses of the bivalent booster will be available to all 27 EU member states

- PMLiVE

Moderna granted FDA authorisation for emergency use of BA.4/BA.5-targeting bivalent COVID-19 booster

The application was based on preclinical data and clinical trial data available from a phase 2/3 study evaluation of the company's BA.1 Omicron-targeting bivalent booster candidate

- PMLiVE

Sanofi and Sobi’s efanesoctocog alfa granted FDA priority review for haemophilia A

Phase 3 results showed once-weekly doses provided clinically meaningful bleed protection for patients with haemophilia A

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