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.
The FDA approves a subcutaneous formulation of Johnson & Johnson’s (JNJ -1.9%) multiple myeloma med Darzalex (daratumumab). Originally, the CD38-directed cytolytic antibody was administered via intravenous infusion.
The formulation is based on Halozyme’s (HALO +0.6%) Enhanze drug delivery technology.
J&J in-licensed exclusive global rights to the product from Genmab A/S (GMAB +2.6%) in August 2012.
The European Medicine Agency’s advisory group CHMP has adopted a positive opinion backing the expanded use of Gilead Sciences’ (NASDAQ:GILD) HCV med Harvoni (ledispavir/sofosbuvir) to include patients as young as three years old (previous limit was 12 years old).
A final decision from the European Commission usually takes ~60 days.
Shares down 3% after its Q1 earnings released yesterday as investors wait for clarity on remdesivir.
NY Governor Cuomo, in his daily briefing confirmed the schools for the remainder of the academic year would be closed statewide, with a notice on summer schedule to be decided by the end of May.
With regards to support for frontline workers, he said he asked insurers to waive copays, deductibles for essential workers who seek mental health services due to the difficult circumstances in which they’ve been asked to work.
XBiotech (XBIT +3.4%) announces that it has identified human immune donors that can support the development of a True Human antibody therapy for COVID-19.
The donors, screened at South Texas Blood & Tissue Center, have high titers of COVID-19 antibodies and do not have a history of serious illness from the coronavirus.
The company is now receiving the blood samples and has begun the discovery process to isolate the genetic information responsible for producing the strong antibody responses.
The European Medicines Agency’s advisory group CHMP has adopted a positive opinion backing approval of Eli Lilly’s (NYSE:LLY) Taltz (ixekizumab) for the treatment of radiographic and non-radiographic axial spondyloarthritis (arthritis that affects the spine).
The interleukin-17A antagonist is currently approved in the EU for plaque psoriasis and psoriatic arthritis.
A final decision from the European Commission usually takes ~60 days.
