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J&J Single-Dose Covid-19 Vaccine One Step Closer to Emergency Use

  • J&J Single-Dose Covid-19 Vaccine One Step Closer to Emergency Use J&J Single-Dose Covid-19 Vaccine One Step Closer to Emergency Use 2:37
    Moderna Delivers Covid-19 Shots, Boosts Vaccination Campaign Moderna Delivers Covid-19 Shots, Boosts Vaccination Campaign 1:52
    FDA Panel Endorses Moderna’s Covid-19 Vaccine for Broad Use FDA Panel Endorses Moderna’s Covid-19 Vaccine for Broad Use 3:23
    Hospitals Face Hurdles With Covid-19 Vaccine Rollout Hospitals Face Hurdles With Covid-19 Vaccine Rollout 3:40
9:31 a.m. Today - By Jaimy Lee
FDA committee to hold meeting about COVID-19 vaccines for children in JuneThe Food and Drug Administration advisory committee plans to hold a on June 10 to discuss authorizing COVID-19 vaccines for use in pediatric populations. Pfizer Inc.'s is the only authorized vaccine that is available to 16 and 17-year-olds at this time. The company is currently about whether it will authorize the same vaccine for 12 to 15-year-olds, which would make it the first vaccine authorized for use in this group of teens. During the meeting, FDA officials are also expected to share details about what they expect to see in applications to authorize and approve these vaccines for use in children. The advisory committee will not discuss specific vaccines, the regulator said.
9:28 a.m. Today - By Jack Denton
BioNTech shares soar 7% as COVID-19 vaccines help revenues smash estimatesShares in BioNTech surged 7% on Monday, after the German biotech’s first-quarter earnings revealed a windfall of revenue and profit amid the global push to vaccinate against COVID-19.
7:10 a.m. Today - Barrons.com
Novavax's Covid-19 Vaccine Could Still Be Months Off Investors' eyes are now on this evening's quarterly earnings call.
5:19 a.m. Today - By Andrew Keshner
Will full FDA approval for Pfizer-BioNTech's vaccine move the needle on vaccine hesitancy?'This will be one less arrow in the concern quiver.'
4:28 a.m. Today - By Jaimy Lee
Inovio's stock is up after it shares new data from Phase 2 clinical trial for its COVID-19 vaccine candidateShares of Inovio Pharmaceuticals Inc. gained 8.0% in premarket trading on Monday after the company said its experimental COVID-19 vaccine was safe and also triggered antibody titers in 400 or so adult participants in a Phase 2 clinical trial. The were published Friday as a preprint. Inovio has largely struggled to move its two-dose, DNA-based COVID-19 vaccine candidate forward. A Phase 3 clinical study is still on hold, due to "remaining questions" from the Food and Drug Administration about a device used for administering the shots. Inovio said in April that the Department of Defense stopped funding development of its COVID-19 vaccine, and the Phase 3 clinical trial for the still-investigational shots will largely be conducted outside of the U.S. Inovio's stock is down 22.6% for the year, while the S&P 500 is up 12.7%.
4:26 a.m. Today - Barrons.com
Copper and Other Metals Are the New Bitcoin. Here’s Why. Colonial Pipeline shutdown could cause gasoline prices to hit $3 a gallon even sooner, Covid-19 vaccines could be approved for adolescents, AstraZeneca chief’s pay package contested, and other news to start your day.
3:48 a.m. Today - By Jaimy Lee
Four COVID-19 vaccines are being tested in children and teens. Here's when different age groups could become eligible for shots.The Food and Drug Administration is expected to grant emergency authorization to Pfizer's COVID-19 vaccine for 12- to 15-year-olds within the week. If that occurs, it will be the first shot authorized for this group of younger teens.
2:57 a.m. Today - By Jaimy Lee
The U.S. prepares to begin giving COVID-19 shots to 12- to 15-year-olds as Pfizer's vaccine nears expanded authorization Now that the U.S. is getting close to authorizing the first COVID-19 vaccine for younger teens, it will pave the way for immunizations to begin to reach a broader group of Americans at a time when the pace of vaccinations is slowing.
2:29 p.m. May 9, 2021 - Barrons.com
The Number of U.S. Covid-19 Deaths Are 'No Doubt' an Undercount, Dr. Fauci Says Here's what you need to know to navigate the markets today.
8:23 a.m. May 9, 2021 - By Andrew Keshner
Can you be fired for refusing to get a COVID-19 vaccine? America is about to find outA court date on an early test is coming up later in May, and that's just one of several lawsuits making their way through the system.
4:23 p.m. May 7, 2021 - By Mark DeCambre
Dow, S&P 500 both log new records despite weak April jobs report The Dow Jones Industrial Average and the S&P 500 index on Friday both finish at new records on the same day for the first time in about three weeks while the Nasdaq outperformed as technology stocks led the charge.
9:00 a.m. May 7, 2021 - By Ciara Linnane
India sets grim record of more than 414,000 new COVID cases a single day as pressure builds on Modi for nationwide lockdown The global tally of confirmed cases of the coronavirus-borne illness COVID-19 climbed above 156 million on Friday, and India set another record with 414,188 new cases in a 24-hour period, as Pfizer Inc. and BioNTech SE started the process of applying for full regulatory approval of their vaccine.
6:14 a.m. May 7, 2021 - By Jaimy Lee
FDA advisory committee votes 10-8 in favor of ChemoCentryx's experimental drug; stock is downShares of ChemoCentryx Inc. tumbled 61.7% in trading on Friday, the day after a Food and Drug Administration advisory committee voted 10-8 that the benefits of the company's experimental autoimmune drug, avacopan, outweigh the risks. The mixed response from committee members followed critical words from the FDA earlier this week . The company's stock this week was downgraded by Raymond James and Stifel Nicolaus, among others. Raymond James analyst Steven Seedhouse told investors that while he downgraded the stock to outperform, from strong buy, he still predicts a FDA approval by July 7 and a future blockbuster in avacopan, which is being evaluated as a treatment for anti-neutrophil cytoplasmic auto-antibody-associated vasculitis. "We're actually not changing our unadjusted avacopan estimates (~$1.9B peak unadjusted U.S. sales), only our probability of success (now at 50% vs. 100% prior)," he wrote. "Yes, we're calling this a pure coin flip between now and July 7." ChemoCentryx's stock is down 54.4% for the year, while the broader S&P 500 is up 11.8%.
5:20 a.m. May 7, 2021 - Barrons.com
Pfizer, BioNTech Ask FDA for Full Approval of Covid-19 Vaccine Pfizer and BioNTech have begun submitting an application to the U.S. Food and Drug Administration for full approval of their Covid-19 vaccine.
4:44 a.m. May 7, 2021 - By Jaimy Lee
SVB Leerink upgrades Epizyme, citing sales potential for lymphoma drugShares of Epizyme Inc. were up 11.0% in premarket trading on Friday after SVB Leerink upgraded the company's stock to outperform, from market perform, citing Tazverik's potential opportunity in the follicular lymphoma market. Analyst Andrew Berens told investors that the drug's potential as a "maintenance" therapy could represent a "significant upside to current valuation." (Maintenance treatments can be used to prevent relapses of some cancers.) Berens said he had previously estimated the drug could generate $252 million in sales in 2030; now he sees the potential for $854 million in sales, including sales from both treatment and maintenance prescriptions. The Food and Drug Administration as a therapy for relapsed or refractory follicular lymphoma in June of last year. Epizyme's stock is down 37.3% for the year, while the S&P 500 is up 11.8%.
2:56 a.m. May 7, 2021 - By Ciara Linnane
Pfizer and BioNTech start process of seeking full FDA approval of their COVID-19 vaccinePfizer Inc. and German partner BioNTech SE said Friday they have initiated rolling submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration for full approval of their COVID-19 vaccine in individuals 16 years of age and older. The vaccine was already granted emergency use authorization last December, a measure used by the FDA in emergency situations. "Data to support the BLA will be submitted by the Companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review," the companies said in a joint statement. Since the vaccine was granted an EUA on Dec. 11, the companies have delivered more than 170 million doses across the U.S. Pfizer and BioNTech has also submitted an application to expand the EUA to include individuals aged 12-to-15 years-old, and plan to submit a supplemental BLA to support licensure of the vaccine in that age group once the required 6 months of data after a second dose are available. Pfizer shares rose 0.6% premarket, while BioNTech shares rose 4.3%. Those shares have climbed 106% in the year to date, while the SPDR S&P Biotech ETF has fallen 11% and the S&P 500 has gained 11.9%.
6:42 p.m. May 6, 2021 - By Mike Murphy
Is it time to start easing indoor mask mandates? Ex-FDA chief Scott Gottlieb thinks soIn an interview Thursday night with CNBC's Shepard Smith, Gottlieb, who led the Food and Drug Administration from 2017-'19, said easing rules now will strengthen the CDC's credibility later
1:34 p.m. May 6, 2021 - By Michael Brush
Investing in the Covid-19 vaccine companies? Here's the great divide in the groupSome have a robust pipeline of drugs that uses new technology. And others may be left behind.
8:19 a.m. May 6, 2021 - Barrons.com
Federal Judge Overturns National Ban on Evictions Here's what you need to know to navigate the markets today.
4:23 a.m. May 6, 2021 - By Jaimy Lee
Pfizer's next play: A vaccine maker and pandemic 'partner' to governmentsPfizer Inc.’s COVID-19 vaccine is on track to generate a whopping $26 billion in sales this year, making it the drug maker’s top-selling drug and forging a new path into infectious diseases for the legacy drug maker.
3:28 a.m. May 6, 2021 - By Jaimy Lee
Moderna reports $1.7 billion in COVID-19 vaccine sales, posts first profit everModerna Inc. brought in $1.7 billion in sales of its COVID-19 vaccine in the first quarter of 2021, marking the company's first significant billion-dollar revenue haul this year and also the first time it's ever reported a GAAP profit. Moderna had earnings of $1.2 billion, or $2.84 per share, in the first quarter of 2021. This is compared to a loss of $124 million, or 35 cents per share, in the first quarter a year ago. The FactSet consensus was $2.39. Moderna had revenue of $1.9 billion for the quarter, up from $8 million in the same quarter a year ago. The FactSet consensus for revenue was $2.0 billion. This quarter marked the first time that the company has generated product revenue during the first three months of the year. About $1.7 billion of that came from sales of its COVID-19 vaccine. (Before receiving authorization from the Food and Drug Administration, it generated grant and collaboration revenue.) Moderna's stock is up 55.8% for the year, while the S&P 500 has gained 10.9%.
6:14 a.m. May 5, 2021 - Barrons.com
Altria Stock Is Sliding. Mounting Woes Cost the Tobacco Giant a Bull. Argus analyst Kristina Ruggeri downgraded tobacco giant Altria to Hold from Buy. She cited the declining value of the company’s investments outside of traditional tobacco, and the risk of more cigarette regulation.
4:25 a.m. May 5, 2021 - Barrons.com
General Motors Is Doing Just Fine Yellen walks back comments on interest rate hike, Goldman Sachs asks U.S. workers to return to the office this summer, Biden sets new vaccination goal, and other news to start your day.
3:26 a.m. May 5, 2021 - By Tonya Garcia
CVS banks on future gains from pediatric vaccines as hesitant adults drive recent COVID vaccination declineCVS Health Corp. said it has recently seen a decline in the number of adults coming in for COVID-19 vaccine shots, but its outlook for the rest of the year assumes gains from the administration of pediatric vaccines.
1:03 p.m. May 4, 2021 - By Mark DeCambre
What happened in the stock market today? Tech sees worst day since March, Dow ekes out gainStocks end mostly lower Tuesday, but come sharply off their lows as investors sift through comments from U.S. Treasury Secretary Janet Yellen who said interest rates could rise a bit if the economy overheats.
11:15 a.m. May 4, 2021 - By Barbara Kollmeyer
Sweating over stock picks? Get rid of the losers and watch your portfolio fly, says this index manager Investors could learn a thing or two from our call of the day, which is all about the stocks your portfolio is begging you to get rid of.
10:41 a.m. May 4, 2021 - By Ciara Linnane
India's COVID-19 case tally tops 20 million after nearly doubling in three monthsThe global tally of confirmed cases of the coronavirus-borne illness COVID-19 climbed above 153.5 million on Tuesday, and India's case tally rose above 20 million, after nearly doubling in three months.
8:03 a.m. May 4, 2021 - By Jaimy Lee
ChemoCentryx's stock dives after critique from the FDA about experimental treatment for rare autoimmune diseaseShares of ChemoCentryx Inc. plunged 44.8% in trading on Tuesday after the Food and Drug Administration questioned the rationale behind some of the clinical data for avacopan, an experimental treatment for a rare autoimmune disease. The document was released in advance of a FDA advisory committee scheduled for Thursday. ChemoCentryx is seeking approval for avacopan as a treatment for anti-neutrophil cytoplasmic auto-antibody-associated vasculitis. Joseph Schwartz, an analyst for SVB Leerink, told investors that the "FDA briefing documents are surprisingly critical and suggest that CCXI has an uphill battle," noting that the regulator's stance in the briefing document was a surprise. Raymond James analyst Steven Seedhouse also described his surprise at the FDA's decision to question the investigational therapy's safety and efficacy; however, he still expects a positive decision from the committee. ChemoCentryx's stock is down 56.6% for the year, while the broader S&P 500 is up 11.6%.
7:39 a.m. May 4, 2021 - Barrons.com
Pfizer's Covid-19 Vaccine Could Be Approved for 12- to 15-Year-Olds By Next Week Here's what you need to know to navigate the markets today.
6:35 a.m. May 4, 2021 - MarketWatch.com
Pfizer COVID-19 vaccine expected to get FDA authorization for 12- to 15-year-olds next weekThe U.S. Food and Drug Administration is expected to authorize Pfizer's COVID-19 vaccine for youngsters ages 12 to 15 by next week, according to a federal official and a person familiar with the process, setting up shots for many before the beginning of the next school year.
6:24 a.m. May 4, 2021 - Barrons.com
Pfizer Expects $26B in Covid-19 Vaccine Sales This Year After a week of disappointing earnings reports from big biopharma firms, Pfizer bucked the trend, reporting first-quarter earnings and revenue that beat Wall Street expectations.
6:06 a.m. May 4, 2021 - Barrons.com
Why Strong Earnings Aren’t Enough Apple, Epic Games trial begins, Bill and Melinda Gates announce divorce, Biden lifts refugee cap, and other news to start your day.
4:07 a.m. May 4, 2021 - Barrons.com
Myriad Genetics Stock Is Jumping. Earnings Were Great. Revenues for the genetic testing company were higher than expected, and the per-share loss was smaller.
3:42 a.m. May 4, 2021 - By Ciara Linnane
UPDATE: Precipio shares soar 32% premarket after rapid COVID test becomes available on AmazonShares of microcap Precipio Inc. , a specialty diagnostics company, soared 32% in premarket trade Tuesday, adding to gains of more than 170% on Monday, after the company said its COVID-19 rapid antibody test is now available on Amazon.com's business platform. The 20-minute test, which was awarded emergency use authorization from the U.S. Food and Drug Administration in December, can only be purchased by qualified medical point-of-care providers. "Physicians and other medical facilities may now purchase these items directly from Amazon, and receive them within 2 business days," the company said in a statement on Monday. The test can identify the presence of antibodies that have been developed from exposure to the coronavirus-borne illness, or from vaccination and show an immune response. "Antibodies are the body's natural biological response to an infection or vaccination, and their development begins the body's process of building immunity to protect against future infections," Precipio said in the statement. The stock has gained 139% in the year to date, while the S&P 500 has gained 11.6%.
2:22 a.m. May 4, 2021 - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 top 153.5 million and India's death toll above 200,000The global tally for the coronavirus-borne illness rose above 153.5 million on Tuesday, according to , while the death toll rose to 3.2 million. The U.S. continues to lead the world in cases and deaths by wide margins, with 32.5 million cases and 577,523 deaths, or about a fifth of the worldwide tallies. There was positive vaccine news which said the U.S. Food and Drug Administration is expected to authorize Pfizer's COVID-19 vaccine for youngsters ages 12 to 15 by next week, citing a federal official and a person familiar with the process, setting up shots for many before the beginning of the next school year. The U.S. vaccine program has slowed as more older people have been fully vaccinated and experts say inoculating young people will go a long way toward expanding it. India is second to the U.S. by cases at 20.3 million and third by fatalities at 222,408. Indian hospitals are still overwhelmed by cases and lacking in supplies including oxygen. Brazil is third with 14.8 million cases and second by fatalities at 408,622. Mexico has the fourth-highest death toll at 217,345 and 2.3 million cases, or 15th highest tally. The U.K. has 4.4 million cases and 127,799 deaths, the fifth-highest in the world and highest in Europe.
10:21 p.m. May 3, 2021 - MarketWatch
AstraZeneca's Farxiga gets U.S. FDA approvalAstraZeneca PLC said Tuesday that the U.S. Food and Drug Administration approved Farxiga for the treatment of chronic kidney disease in patients at risk of progression with, and without, Type 2 diabetes.
12:23 p.m. May 3, 2021 - Barrons.com
A Small Forward Step for Sarepta's Muscular Dystrophy Treatments Encouraging data from a small study of the company's next drug for Duchenne muscular dystrophy lifted prospects for the "show-me" stock.
9:19 a.m. May 3, 2021 - Barrons.com
Pfizer's Earnings Are Tuesday. Here's What to Expect. The company says its Covid-19 vaccine provides the viability of a focus on developing and acquiring drugs.
5:24 a.m. May 3, 2021 - Barrons.com
How Shareholders Missed Out on a Potential $6 Billion in Bristol Myers’ Deal for Celgene An all-or-nothing bet on drug approvals highlights the risks investors take.
10:56 a.m. May 1, 2021 - By Elisabeth Buchwald
Do you still need to wear a mask if you're fully vaccinated? The CDC has new advice'Fully vaccinated people can still carry the virus, but are very unlikely to get sick from it,' said Dr. Victoria Ward, a clinical assistant professor at Stanford University and pediatrician
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