According to Johns Hopkins Case Tracker, global confirmed COVID-19 cases are 1,076,017, up 7.8% from yesterday. Deaths are up 13.0% to 58,004. Leaders:
U.S.: 261,438 (+26,976)/6,699 (+1,092)
Italy: 119,827 (+4,585)/14,681 (+766).
Spain:117,710 (+7,472)/10,935 (+839).
Germany: 89,838 (+5,574)/1,230 (+156).
China: 82,509 (+77)/3,326 (+4).
A bit of encouraging news is that the growth rates have peaked in Italy and Spain. The curve in the U.S. remains on a steep upslope (Data Center section).
Aimed at facilitating nationwide access to antibody-rich blood products for COVID-19 patients, the FDA has instituted an emergency investigational new drug application (eIND) process for convalescent plasma, with its SARS-CoV-2 antibodies, collected from people who have recovered from the infection.
Based on prior history with respiratory viruses and data from China, convalescent plasma and its more refined relative, hyperimmune globulin (concentrated SARS-CoV-2 antibodies), may shorten the recovery time for severely ill patients.
The agency says it has provided information to healthcare providers on how to submit applications for clinical studies at academic institutions.
The Mayo Clinic will serve as lead institution while the American Red Cross will help with plasma collection and distribution.
Selected tickers: Emergent BioSolutions (EBS +1.4%), ADMA Biologics (ADMA +8.5%), Kamada Ltd. (KMDA), XBiotech (XBIT +5.0%)
The European Medicines Agency (EMA) is recommending the use of Gilead Sciences’ (GILD +1.4%) remdesivir for treating COVID-19 in compassionate use programs.
EMA advisory group CHMP is encouraging the company to make the antiviral available in a “fair and transparent” way to member states wishing to participate in international clinical trials or treating patients under compassionate use.
CytoDyn (OTCQB:CYDY) has filed a request with the FDA for a preliminary meeting to discuss new clinical data which supports its objective to obtain Breakthrough Therapy designation (BTD) for leronlimab in the treatment of metastatic triple-negative breast cancer (mTNBC).
The FDA had previously recommended such a meeting to provide preliminary advice prior to resubmission of a BTD request.
The company is also conducting a Phase 2 trial with leronlimab for 22 solid cancer tumors simultaneously.
Incyte (NASDAQ:INCY) is working with the FDA to initiate a Phase 3 clinical trial, RUXCOVID, to evaluate the efficacy and safety of ruxolitinib (Jakafi) plus standard-of-care (SoC), compared to SoC therapy alone, in patients with COVID-19 associated cytokine storm.
Additionally, the company intends to launch a separate Expanded Access Program in the U.S. to allow eligible patients with COVID-19 associated cytokine storm to receive ruxolitinib.
