Coronavirus Notebook: Bivalent Spikevax OKd For Filing In Australia, Pfizer & Moderna Under Growing Pressure To Share mRNA Knowhow

The World Health Organization and UNICEF say that disruptions caused by COVID-19 and actions taken to tackle the pandemic have left many children without protection against measles and other diseases. Austria’s Apeiron has given an update on the development of its candidate therapeutic, APN01.

New Coronavirus variant outbreak and covid-19 virus cell mutation spread
Moderna's bivalent vaccine targets the Omicron variant • Source: Alamy

The Australian regulator, the Therapeutic Goods Administration, has given Moderna the go-ahead to seek marketing approval of Spikevax Bivalent Zero/Omicron, a bivalent version of its COVID-19 vaccine Spikevax.

The new version, which is also known as mRNA-1273.211 and is not yet authorized anywhere, includes the mRNA sequence encoding...

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While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.

EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

 

Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.