RepliCel Life Sciences Inc (TSXV:RP)
RepliCel is a regenerative medicine company developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function.
Bristol Myers Squibb (BMY -1.3%) announces that the European Commission (EC) has granted full Marketing Authorization for Inrebic (fedratinib) for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in certain patients with Myelofibrosis, a serious and often debilitating bone marrow disorder.
The approval allows the use of Inrebic in adult patients with primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis, who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.
Inrebic is the first, once-daily oral therapy to significantly reduce spleen volume and symptom burden for patients with myelofibrosis where treatment with ruxolitinib has failed, who are intolerant to ruxolitinib or who are JAK inhibitor naïve.
The approval of Inrebic was based on results from the JAKARTA and JAKARTA2 studies, which included patients from 14 countries in the EU, the company said.
The FDA approved Bristol Myers’ Breyanzi (lisocabtagene maraleucel; liso-cel) for patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment, the company had said earlier this month.
The European Union has reached an agreement with Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) for 300M doses of the COVID-19 vaccine co-developed by the two companies.
“The Commission has adopted the new contract today,” a European Commission spokesman has told Reuters on Monday.
The first 200M doses are to be delivered this year, and the negotiations are ongoing for the remainder, according to an official involved in talks with Pfizer.
“Discussions with the European Commission are ongoing,” a spokesman for Pfizer has told Reuters while a BioNTech declined to comment.
The new deal that follows a preliminary agreement reached in early January for 300M doses will double Pfizer/BioNTech COVID-19 vaccine supply to the region after the initial deal for 300M doses in November.
Roche announces FDA EUA filing for sars-cov-2 rapid antigen test
Roche (OTCQX:RHHBY -0.4%) announces that it has submitted an Emergency Use Authorization (EUA) filing to the U.S. FDA for a SARS-CoV-2 Rapid Antigen Test that is designed for use by healthcare professionals in point-of-care settings with patients experiencing symptoms of COVID-19.
Roche hopes to launch the test in partnership with SD Biosensor with whom Roche has a global distribution agreement, and expects to have tens of millions of SARS-CoV-2 Rapid Antigen Tests available per month in the United States at launch.
Roche had announced a partnership with Moderna (MRNA +6.2%) to utilise its Elecsys Anti-SARS-CoV-2 S antibody test in Moderna’s mRNA-1273 vaccine research trials, in December last year.
