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.
Johnson & Johnson (NYSE:JNJ) is up 4% premarket on light volume in reaction to its announcement that it has selected a lead COVID-19 vaccine candidate.
A Phase 1 clinical trial should launch in September. The first batches of product could be available for emergency use in early 2021.
It plans to establish new U.S. vaccine manufacturing capabilities and additional capacity ex-U.S.
On the heels of the U.S. Department of Health and Human Services acceptance of 30M doses of hydroxychloroquine from Novartis (NYSE:NVS) and 1M doses of chloroquine from Bayer (OTCPK:BAYRY), the FDA has signed off on Emergency Use Authorization of the meds to treat COVID-19.
Amarin (NASDAQ:AMRN) has lost its patent battle against generics.
Shares are down 68% in after hours action.
Developing …
Update: The court found that the generic firms’ marketing applications will infringe on the asserted claims of the Amarin patent but added that the asserted claims are invalid as obvious.
Clinical trials of rheumatoid arthritis drug Kevzara – as a coronavirus treatment – has been expanded by Sanofi (NASDAQ:SNY) and Regeneron (NASDAQ:REGN) to patients outside the U.S.
The trial, expected to enroll about 300 patients, will recruit hospitalized patients from several countries who are severely or critically ill with COVID-19.
Hopes are that the drug that can suppress a so-called cytokine storm, which happens when the immune system overreacts and attacks the body’s organs.
More than 1M Americans have been tested for coronavirus, President Trump said at the White House coronavirus task force briefing.
No other country has conducted that many tests, he said.
More than 100K tests per day are being conducted, said Alex Azar, Secretary of Health and Human Services.
Update at 5:20 PM ET: FDA Commissioner Dr. Stephen Hahn said Abbott Laboratories (NYSE:ABT) will be delivering tomorrow its new coronavirus test that can produce a positive diagnosis in as little as five minutes.
5:30 PM: FEMA is sending ventilators to New Jersey, Michigan, Illinois, and Louisiana, Trump said.
5:35 PM: Honeywell (NYSE:HON) says it’s already doubled its production of N95 masks and is working on doubling it again soon; eventually it will boost production to five times what it is today.
5:41 PM: United Technologies (NYSE:UTX) has started manufacturing face shield and expects to 10K shields in the next four weeks, said UTX Chairman and CEO Greg Hayes at the briefing.
5:49 PM: Trump says the social distancing guidelines may be “toughened up a little bit.” Yesterday he extended the guidelines, originally planned to last 15 days, to the end of April.
Travel restrictions will stay in place and more may e added he said, referring to restrictions on travel from EU, Canada, and Mexico.
5:56 PM: “We’ve talked about” a national stay-at-home order, Trump said, but added that it’s “pretty unlikely” he’ll call for one. The travel advisory is working well, he said.
6:00 PM: Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he expects the virus to become a seasonal occurrence, but points out that the U.S. will be better prepared for the next time.
The U.S. now has much better testing capacity and is better able to trace contacts among people. Furthermore, several clinical trials for treatments are being conducted, Fauci said.
6:07 PM: Trump expects to build up the economy quickly once the virus subsides. “I think we’ll be stronger for it.”
6:10 PM: Briefing ends.
In the U.S., 159,184 cases of Covid-19 have been confirmed and 2,945 people have died from the virus, according to the Johns Hopkins University coronavirus tracker.
