With the FDA’s required safety milestone notched in their phase III study of COVID-19 vaccine candidate BNT-162b2, Pfizer Inc. and Biontech SE said they will request emergency use authorization “within days.”

Nutcracker Therapeutics Inc., a startup developing a "push-button GMP-in-a-box" platform to manufacture mRNA therapeutics, has raised $60 million in series B financing led by Arch Venture Partners.

While its mRNA COVID-19 vaccination effort gets the most attention these days, Moderna Inc. is also moving in other directions as the company will lead mRNA discovery programs drawn from its early stage pipeline in new collaborations with Vertex Pharmaceuticals Inc. and Italy’s Chiesi Farmaceutici SpA. These two deals highlight the “huge opportunity for mRNA beyond SARS-CoV-2 and vaccines,” Piper Sandler analysts wrote Sept. 16.

The Astrazeneca plc and Oxford University phase III trial of their adenovirus-based coronavirus vaccine is back up and running in the U.K. after a week’s worth of study and decision-making. The company said it still plans to report data from the study by the end of this year.

DUBLIN – Translate Bio Inc. is the first beneficiary to gain from Sanofi SA’s massive $11.7 billion addition to its balance sheet, following its recent disposal of its holdings in long-time partner Regeneron Pharmaceuticals Inc. Lexington, Mass.-based Translate Bio is getting $300 million up front, another $125 million in equity investment and up to $1.9 billion in milestones under a major expansion of an existing agreement with Paris-based Sanofi to develop mRNA-based vaccines for infectious disease.

LONDON – A veteran of the European vaccines industry has brought together three companies in three countries, in what is described as an ultra-fast-track COVID-19 vaccine development program. From a standing start less than three months ago, the three biotechs, Reithera Srl in Rome, Leukocare AG in Munich, Germany, and Univercells SA in Brussels, Belgium, have advanced to GMP manufacturing, with first-in-human studies due to start in June.

The U.S. Biomedical Advanced Research and Development Authority (BARDA) commitment of up to $483 million to accelerate Moderna Inc.’s mRNA vaccine candidate, mRNA-1273, in efforts to fight coronavirus (SARS-CoV-2) would enable the company to supply millions of doses per month in 2020 and tens of millions per month in 2021 if the vaccine candidate is successful in the clinic.

DUBLIN – Ethris GmbH and Neurimmune AG have formed a collaboration to develop nebulized, mRNA-encoded monoclonal antibodies directed at SARS-CoV-2, which will be delivered directly to the lungs of patients with COVID-19.