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- 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

- PMLiVE

Pfizer announces positive phase 3 results of RSV vaccine candidate in older adults

It is estimated that RSV infections in older adults account for 177,000 hospitalisations and 14,000 deaths each year in the US alone

- PMLiVE

Study found Pfizer’s Paxlovid only helped over 65s avoid hospitalisation and death

Researchers studied data from 109,000 patients – nearly all of whom had been vaccinated against COVID-19, been previously infected, or both

- PMLiVE

Moderna seeks FDA Emergency Use Authorisation for BA.4/BA.5 COVID-19 booster

The application is 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

Merck granted fast track designation by FDA for end-stage renal disease therapy

MK-2060 is currently being investigated in a phase 2 study to evaluate the efficacy and safety of two different doses

- PMLiVE

Pfizer and BioNTech seek FDA Emergency Use Authorisation for BA.4/BA.5 COVID-19 booster

The companies have rapidly increased production of the newly developed vaccine and are ready to deliver doses from September

- PMLiVE

Pfizer told by FDA to test additional Paxlovid course in patients with COVID-19 rebound

The company must produce the initial results of a randomised controlled trial by 30 September next year

- PMLiVE

GSK’s application for momelotinib in myelofibrosis with anaemia accepted by FDA

40% of myelofibrosis patients are already anaemic at the time of diagnosis and nearly all patients are estimated to develop anaemia eventually

- PMLiVE

Novartis reports death of two patients treated with Zolgensma

The company has notified health authorities in markets where the drug is sold and has informed relevant healthcare professionals

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