Coronavirus: FDA approves first COVID-19 treatment for children younger than 12
WASHINGTON — The U.S. Food and Drug Administration has expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include children who have tested positive and who are either hospitalized or at high risk from the disease. Veklury, administered via injection, is the first approved COVID-19 treatment for children under 12 years of age. Today we expanded approval of the #COVID19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms. This marks the first approved #COVID19 treatment for children younger than 12. Previously, Veklury was only approved for children 12 under an emergency use authorization.wftv.com
Coronavirus: Gilead recalls vials of COVID-19 drug remdesivir due to glass particles
( Nic Coury/Bloomberg via Getty Images, File)Officials with Gilead Sciences Inc. on Friday announced a voluntary recall of two lots of its COVID-19 drug, remdesivir, after finding glass particles in some of the vials. >> Read more trending newsThe recall was announced after the company received a complaint from a customer about the glass, officials said. >> Related: Coronavirus: FDA approves remdesivir as treatment for COVID-19 virusGilead spokesman Chris Ridley told Bloomberg News that 55,000 vials of the drug were being recalled Friday, enough to treat 11,000 patients. >> Related: WHO does not recommend remdesivir as COVID-19 treatment, doesn’t fully rule it outHospitals using remdesivir were advised to stop using the lots under recall immediately. Company officials said consumers who have experienced problems that they think might be related to the recalled drug should contact their physician or healthcare provider.wftv.com
Everything You Need to Know About Merck’s Game-Changing Covid Pill
Molnupiravir, an antiviral pill being developed by Merck & Co., has been touted as a potential game changer in the fight against Covid-19. The experimental medication was shown to reduce the risk of hospitalization or death by about half in a late-stage study of adults with mild-to-moderate cases. The promise of a drug that patients can easily get and take at home has prompted some governments to order supplies even before regulators have decided whether to approve its use.washingtonpost.com
The Latest: Hawaii imposes new COVID-19 travel restrictions
There were 1,225 new confirmed COVID-19 cases increasing the state total to 60,873. ___WASHINGTON -- Pharmaceutical companies Pfizer and BioNTech will seek emergency government approval for their coronavirus vaccine, as the U.S. aims to begin administering doses by the end of the year. ___LOUISVILLE, Kentucky — Kentucky reported a new daily record of 3,649 coronavirus cases Thursday amid warnings by Gov. He and public health experts are warily watching the number of patients hospitalized with the COVID-19 disease caused by the coronavirus. ___WASHINGTON — Infection disease expert Dr. Anthony Fauci says he “wants to settle” concerns about a coronavirus vaccine as he returns to the White House podium for the first time in months.
Remdesivir has ‘little or no effect’ in reducing coronavirus deaths, WHO says
A study coordinated by the World Health Organization has indicated that remdesivir, along with three other potential drug treatments for the coronavirus, has "little or no effect" on death rates among hospitalized patients. The interim results from the WHO's Solidarity Therapeutics Trial, said to be the world's largest randomized control trial of coronavirus treatments, were published Thursday. The results indicated that the remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon drug treatment regimens "appeared to have little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients." "No study drug definitely reduced mortality (in unventilated patients or any other subgroup of entry characteristics), initiation of ventilation or hospitalisation duration," the authors of the study wrote. The WHO's findings come a week after drugmaker Gilead Sciences published the final data on its own large-scale trial of remdesivir.cnbc.com
Asia Today: India cases approach 7 million amid slower pace
Indias total coronavirus positive cases near 7 million with another 73,272 infections reported in the past 24 hours. The Health Ministry on Saturday put the total positive caseload at 6.97 million, second to 7.66 million infections registered in the worst-hit United States. (AP Photo/Yirmiyan Arthur)NEW DELHI – India’s confirmed coronavirus cases are nearing 7 million with another 73,272 reported in the past 24 hours. India is seeing a slower pace of coronavirus spread since mid-September, when the daily infections touched a record of 97,894 cases. “We have to work aggressively to make sure that during winter months and during the festive season coronavirus cases don’t rise dramatically,” said Dr. Randeep Guleria, a government health expert.
FDA authorizes remdesivir drug as emergency treatment for COVID-19
WASHINGTON (Reuters) - The U.S. Food and Drug Administration (FDA) has granted authorization to Gilead Sciences Inc (GILD.O) for emergency use of its experimental antiviral drug remdesivir to treat patients with COVID-19, the agency and President Donald Trump said on Friday. FILE PHOTO: Vials of investigational coronavirus disease (COVID-19) treatment drug remdesivir are capped at a Gilead Sciences facility in La Verne, California, U.S. March 18, 2020. We want to make sure nothing gets in the way of these patients getting the medicine, so we made a decision to donate about 1.5 million vials, he said. Gilead has defended prospects for remdesivir in helping fight the coronavirus pandemic against signs that it may not provide a significant benefit. Vice President Mike Pence said the 1.5 million vials would start being distributed to hospitals on Monday.feeds.reuters.com
Jim Cramer on Wednesday's rally: 'Remdesivir is just what the doctor ordered'
CNBC's Jim Cramer on Wednesday grew more optimistic about America's ability to safely resume business activity after hearing welcoming news about an antiviral's potential to fight coronavirus from Gilead Sciences. Preliminary results of a clinical trial studying the effects of remdesivir on Covid-19 returned positive data in helping patients recover from the contagion. "Remdesivir is just what the doctor ordered," Cramer said. The U.S. government has taken drastic measures to slow the spread of the deadly virus to prevent medical centers from becoming overwhelmed with Covid-19 patients. "That's why the market roared higher today, and make no mistake, this move was all about remdesivir," Cramer said of Wednesday's rally.cnbc.com
Investors should be cautious on the potential for Gilead's drug Remdesivir, analysts say
A new report from STAT News on Gilead's experimental drug Remdesivir serves as an encouraging update on the drug's potential to fight Covid-19, however analysts argue it's largely anecdotal and should be interpreted with caution. Remdesivir was one of the first medicines identified as a contender to treat Covid-19 given it showed promise in the past in treating SARS and MERS, both caused by coronaviruses. A statement from the University of Chicago Medicine said that "drawing any conclusions at this point is premature and scientifically unsound." The report from the Chicago hospital comes amid mounting anecdotal evidence supporting the drug's potential effectiveness in treating the virus. As CNBC's Meg Tirrell has highlighted, this is not controlled clinical trial data it is a glimpse into what one of the sites that is running the trial is seeing.cnbc.com
Gilead stock pops 8% after report says coronavirus drug trial shows encouraging early results
Gilead Sciences shares popped by more than 8% on Friday after details leaked of a closely watched clinical trial of the company's antiviral drug Remdesivir, showing what appears to be promising results in treating Covid-19. The University of Chicago's phase 3 drug trial found that most of its patients had "rapid recoveries in fever and respiratory symptoms" and were discharged in less than a week, health-care publication STAT News reported Thursday. "The best news is that most of our patients have already been discharged, which is great. We've only had two patients perish," University of Chicago infectious disease specialist Kathleen Mullane said, according to STAT News, which obtained a video of her remarks. Gilead shares jumped as much as 16% in after-hours trading Thursday immediately after the report published.cnbc.com
Watch live: World Health Organization holds press conference on the coronavirus outbreak
World Health Organization officials are holding a press conference to update the public on the coronavirus outbreak, which has infected more than 737,000 people across the globe, according to data compiled by Johns Hopkins University. However, WHO Director-General Tedros Adhanom Ghebreyesus said at press conference Friday that a vaccine is likely 12 to 18 months away. Biotech company Moderna began the first human trial testing for a potential vaccine to prevent COVID-19 last week. There are no proven therapies for the coronavirus, which has killed at least 35,000 people across the globe. Read CNBC's live updates to see the latest news on the COVID-19 outbreak.cnbc.com
Trump presses FDA to fast-track potential coronavirus drugs
WASHINGTON (Reuters) - U.S. President Donald Trump on Thursday called on U.S. health regulators to expedite potential therapies aimed at treating COVID-19 amid the fast-spreading coronavirus outbreak, saying it could lead to a breakthrough while a vaccine is still under development. Trials on potential coronavirus therapies are already in the works, and it was unclear how Trumps call for faster experimental testing process could further expedite an effective treatment. It could be a game changer or maybe not, Trump told reporters. FDA Commissioner Stephen Hahn said his agency was working quickly to examine all possibilities. In the short term, were looking at drugs that are already approved for other indications, Hahn said.feeds.reuters.com