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Sandoz’s biosimilar medicine application accepted by FDA

If approved, the higher concentration formulation could decrease the number of injections required for patients currently receiving a lower dose of Hyrimoz

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FDA approves Incyte’s Opzelura for vitiligo

It is the first and only FDA-approved product for repigmentation in patients with nonsegmental vitiligo

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Roche’s diagnostic test for Alzheimer’s receives FDA Breakthrough Device Designation

Alzheimer's affects more than 55 million people globally and is the most common form of dementia

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Sanofi and Regeneron announce positive phase 3 trial results for eosinophilic oesophagi in children under 12

There are currently no approved treatments for children with eosinophilic oesophagi under the age of 12

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FDA grants Novavax’s COVID-19 vaccine emergency use authorisation for adults

The decision was based on data from a phase 3 trial which showed the vaccine was 90.4% effective in preventing mild, moderate or severe COVID-19

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Sanofi and Sobi announce positive phase 3 trial results for severe haemophilia A

Results from the study showed once-weekly efanesoctocog alfa doses provided ‘clinically meaningful’ bleed protection for patients with severe haemophilia A

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Roche’s Lunsumio granted Priority Review by FDA for people with relapsed or refractory follicular lymphoma

If approved, this could be the first such antibody approved by the FDA for the treatment of any type of non-Hodgkin lymphoma

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Pfizer’s Paxlovid given FDA permission to be prescribed by US pharmacists

Under the Emergency Use Authorisation revision, pharmacists will be able to prescribe the COVID-19 treatment to patients, providing they meet certain conditions

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FDA grants Priority Review for Biogen and Eisai’s lecanemab for early Alzheimer’s disease

Lecanmab is being evaluated in the ongoing phase 3 Clarity Alzheimer's clinical trial

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Sanofi Global Health unveils new nonprofit Impact brand

The brand will enable 30 Sanofi medicines to be distributed to 40 low-income countries

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Pfizer and BioNTech sign $3.2bn COVID-19 vaccine supply agreement with US government

The companies will supply 105 million doses, which may include adult Omicron-adapted COVID-19 vaccines, subject to FDA authorisation

Cannes Lion 2022

Our Top 5 Pharma Picks From Cannes Lions

Here are five of Art's top five pharma and healthcare picks from Cannes Lions 2022.

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