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

 
• By Ian Schofield

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 the spike protein of the Omicron variant and the same...

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Pfizer’s All-Comers CRPC Dream For Talzenna Quashed For Lack Of Biomarker-Negative Rigor

 
• By Bridget Silverman

The lack of a formal analysis of efficacy in castration-resistant prostate cancer patients without HRR mutations doomed Pfizer’s Talzenna at the US FDA's Oncologic Drugs Advisory Committee, as FDA oncology chief Richard Pazdur says chance cannot be ruled out.

Darzalex Faspro Gains US FDA AdComm Support For Smoldering Myeloma Claim

 
• By Bridget Silverman

The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.

STARGLO Dulled: Genentech’s Columvi Data Not Generalizable To US Patients, FDA Panel Says

 
• By Sue Sutter

The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

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UroGen’s Bladder Cancer Drug Draws Split Decision From US FDA Panel

 
• By Sue Sutter

The Oncologic Drugs Advisory Committee voted 5-4 that the overall benefit-risk of UGN-102 is not favorable in patients with recurrent low grade, intermediate-risk, non-muscle invasive bladder cancer and also divided on whether randomized trials should be required for future development programs.

US FDA Will Help States Apply To Import Cheaper Drugs From Canada

 
• By Cathy Kelly

The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.

Global Pandemic Deal Adopted As 124 Countries Say Yes; US Sits Out

 
• By Neena Brizmohun

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.