Novavax’s updated version of its Covid-19 vaccine is now FDA authorized for use in the U.S., joining the approved shots from Moderna and partners Pfizer and BioNTech. Novavax said its protein-based vaccine will be available in coming days.
Arcellx attributes the death to limitations of the treatments that patients receive while their cell therapies are being manufactured. The company is working to expand these so-called bridging therapy options for patients.
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Vector BioMed has developed a technology platform for designing and manufacturing the lentiviruses used to deliver cell and gene therapies. The startup is launching as the field continues to experience shortages of these viral vectors.
In partnering with clinical-stage Arcellx, Gilead Sciences gains the opportunity to develop a cell therapy for multiple myeloma that could offer advantages over currently available therapies for the blood cancer. The deal announced Friday came as Arcellx reported additional data during the annual meeting of the American Society of Hematology that showed continued durability of the cell therapy.
Novavax’s Covid-19 vaccine is now authorized as a booster shot for adults. The regulatory decision, which comes three months after the shot was first granted FDA emergency authorization, introduces a booster shot alternative to messenger RNA vaccines.
Sanofi is collaborating with startup miRecule to develop an RNA therapy for facioscapulohumeral muscular dystrophy. The pharmaceutical giant gets global rights to miRecule’s therapy for this type of muscular dystrophy, which has no FDA-approved treatments.
The TSX Venture Exchange has a strong history of helping early-stage health and life sciences companies raise patient capital for research and development.
Clinical-stage Arcellx raised $123.8 million from its IPO, which the company will use to advance to a pivotal test for its lead program, a CAR T-cell therapy for multiple myeloma. Though Arcellx trails its large pharmaceutical rivals, the biotech contends its technology produces cell therapies with key advantages.
Novavax reported that its Covid-19 vaccine was 100% effective at protecting against moderate and severe disease and 90.4% effective overall. The vaccine is seen as an important alternative to messenger RNA vaccines because of its storage and distribution advantages.
Novavax says it’s building up its manufacturing capacity now to be ready to ship Covid-19 vaccine globally as emergency authorizations are granted in coming months. The company expects to seek FDA authorization in the second quarter.
The company, which also published Phase I data from its Phase I/II study earlier this month, is enrolling 10,000 volunteers aged 18 to 84 for the placebo-controlled trial of the vaccine against SARS-CoV-2, NVX-COV2373.
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The company is running a Phase I/II study that started in May in Australia and plans to open a Phase III study of its vaccine candidate, NVX-CoV2373, that will enroll up to 30,000 participants starting in the fall.
The company is developing phage-based therapies designed to target specific bacteria strains, as contrasted with antibiotics, which target multiple types of bacteria.
The firm announced that it closed a $22 million Series C2 round, following a $25 million Series C1 round that it had closed last June, led by Asian investors.
Firm raises funding for RNAi therapy's clinical development from group of Chinese funds.