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Novavax Pins COVID-19 Hopes On Ex-US, Booster Markets

Delay In FDA Filing Until Q4

 
• By Alaric DeArment

The company is planning to file with regulators in the UK, EU, Canada, Australia and New Zealand, with an emphasis on booster shots in developed markets.

COVID-19 vaccine
Novavax plans a flurry of ex-US filings for its COVID-19 vaccine amid another delay in its EUA filing in the US • Source: Shutterstock

Although Novavax, Inc. is late to the COVID-19 vaccine party, the company is expressing confidence in the potential role in the market for its NVX-CoV2373, potentially as a booster shot, with new data showing strong activity against variants of concern. It is also looking ahead as it tests combinations of NVX-CoV2373 with its flu vaccine.

The Gaithersburg, MD-based vaccine maker announced its second quarter earnings on 5 August, reporting revenues of $298m, compared with $35.5m in second quarter 2020

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Takeda Plans US Investment But Sees Little Impact From Tariffs

 
• By Alaric DeArment

The Japanese drug maker is on track for three pivotal Phase III readouts and two regulatory submissions in 2025.

Q1 S&E In Brief: Tracking New Launches And Catalysts In Biopharma

 
• By Jessica Merrill and Joseph Haas

Neurocrine, Madrigal and Vanda updated investors on new drug launches, while Cytokinetics talked to investors about an FDA extension for aficamten.

Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By Joseph Haas

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.

Sarepta Slammed By Double Blow: Elevidys Sales Miss, Prasad’s CBER Appointment

 
• By Mandy Jackson

Sarepta’s stock price was battered after Vinay Prasad was appointed to lead the US FDA’s CBER, then the company’s shares were bruised when Q1 Elevidys sales came in below consensus.

More from Business

Building Up US Biopharma Manufacturing Will Require Investments In Talent

 
• By Jessica Merrill

Workforce development will be essential to meeting president Trump’s goal to return biopharma manufacturing to the US.

Finance Watch: Deerfield Closes $600m-Plus VC Fund; Gates Speeds Up Health Investments

 
• By Mandy Jackson

Private Company Edition: Deerfield’s third innovations fund will back therapeutics and other opportunities, the Gates Foundation – a sometimes funder of biotech firms – will spend $200bn over the next 20 years, and NewLimit raised a $130m series B round, among other financings.

Pharma Left Hanging After US/UK Trade Pact

 
• By Kevin Grogan

An ‘historic economic prosperity deal’ does not include the sector.