New five-year breast cancer survival data from Greenwich Lifesciences Inc. ignited its stock for a wild ride that climbed nearly 1,000% upward Dec. 9, marking one of the biotech sector’s biggest single-day gains in 2020.
The independent data monitoring committee overseeing Cortexyme Inc.’s phase II/III trial of atuzaginstat (COR-388), a gingipain inhibitor for patients with Alzheimer’s disease, has recommended the study continue to its one-year endpoint.
The phase III study of Zepzelca (lurbinectedin) as combination therapy from Jazz Pharmaceuticals plc and Pharmamar SA was a stumble, but the companies said they found plenty of encouraging data prompting them to continue development.
Despite challenges tossed at the phase III study of mitapivat from Agios Pharmaceuticals Inc. by COVID-19, top-line data showed the oral therapy hit its primary endpoint in treating adults with pyruvate kinase (PK) deficiency who don’t receive regular transfusions.
Genesis Therapeutics Inc. CEO and co-founder Evan Feinberg likens the collaboration of his company’s team of chemists, biologists and software developers to that of a jazz band. Everyone has to be familiar with everyone else’s roles and responsibilities in order to do their job, or play a solo, when it’s their turn.
Moderna Inc. and Covaxx Inc. are readying for delivery more than 220 million doses of their respective COVID-19 vaccines to Europe and emerging countries in newly cut deals. Moderna, of Cambridge, Mass., said it granted an option to the European Commission to buy up to 80 million additional doses of mRNA-1273 and is set to manufacture 500 million to 1 billion doses globally in 2021. The company said the vaccine, if approved, will ship to the EU beginning in December. The company’s shares (NASDAQ:MRNA) had a solid day Nov. 25, with shares closing 10.78% upward at $109.18.
Moderna Inc. and Covaxx Inc. are readying for delivery more than 220 million doses of their respective COVID-19 vaccines to Europe and emerging countries in newly cut deals. Moderna, of Cambridge, Mass., said it granted an option to the European Commission to buy up to 80 million additional doses of mRNA-1273 and is set to manufacture 500 million to 1 billion doses globally in 2021. The company said the vaccine, if approved, will ship to the EU beginning in December. The company’s shares (NASDAQ:MRNA) had a solid day Nov. 25, with shares closing 10.78% upward at $109.18.
Four days after receiving European approval, the FDA has followed suit for Alnylam Pharmaceuticals Inc.’s Oxlumo (lumasiran), the first treatment for primary hyperoxaluria type 1, an ultra-rare genetic disorder that contributes to kidney stones and deposits.
With its acquisition of privately held Oncoimmune Ltd. for an up-front $425 million in cash, Merck & Co. Inc. ups its COVID-19 game with CD24Fc, a recombinant fusion protein targeting the innate immune system that is faring well in treating pandemic patients.
In what the FDA calls “an incremental step” in treating hospitalized COVID-19 patients, the agency has issued an emergency use authorization (EUA) for Eli Lilly and Co.’s baricitinib in combination with remdesivir.
