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Sotorasib

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AstraZeneca’s Tezspire receives MHRA approval as add-on treatment for severe asthma

Tezspire demonstrated reduced annualised rate of asthma exacerbations

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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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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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AstraZeneca’s Tezspire receives EC approval as severe asthma add-on treatment

Tezspire demonstrated superiority across every primary and key secondary endpoint compared to placebo

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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

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Amgen announces positive results for Lumakras colorectal cancer combination treatment

Results demonstrated a confirmed objective response rate of 30% and median progression free survival of 5.7 months

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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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Amgen’s Lumakras shows promising results for patients with non-small cell lung cancer

Results from the phase 3 trial demonstrated superiority over standard of care Docetaxel chemotherapy in KRAS G12C-mutated non-small cell lung cancer

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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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Amgen announces positive results for Solaris biosimilar for paroxysmal nocturnal haemoglobinuria

ABP 959 demonstrated no ‘clinically meaningful’ difference to the reference product in the phase 3 study

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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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