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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

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

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

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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

Biotech Innovation in the Time of COVID-19

Chris Garabedian, CEO of Xontogeny, dives into biotech and digital health innovation, current industry gaps and obstacles, how to encourage biotech entrepreneurs, AI & machine learning, and much more!

Impetus Digital

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NICE rejects AstraZeneca and MSD’s Lynparza as NHS prostate cancer treatment

The drug will not be available as a treatment option for men with prostate cancer in England and Wales

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Qureight announces world’s first digital biomarker for lung fibrosis will ‘transform’ clinical trials

The AI-based Lung8 imaging software picked up differences in response between patients who had an experimental drug compared with those who took a placebo

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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

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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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MIT researchers develop AI model to detect Parkinson’s from breathing patterns

The tool uses a series of connected algorithms that can assess if someone has PD from their nocturnal breathing

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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

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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

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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

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