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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
12:17 p.m. Today - MarketWatch.com
U.S. confident it has enough COVID-19 vaccines for boosters, kids' shotsWith more than 40 million doses of coronavirus vaccines available, U.S. health authorities said they're confident there will be enough for both qualified older Americans seeking booster shots and the young children for whom initial vaccines are expected to be approved in the not-too-distant future.
4:29 p.m. Sept. 24, 2021 - Barrons.com
Medicine’s Golden Age Is Dawning. 10 Picks to Play the Latest Innovations. Our 2021 healthcare roundtable highlights the technologies and treatments changing the face of medicine, and the companies that could benefit.
4:11 p.m. Sept. 24, 2021 - Barrons.com
PLx Pharma Aims to Fix What Ails Aspirin PLx hopes to upset the aspirin market with Vazalore, which reduces aspirin’s tendency to irritate the stomach for people who use aspirin regularly.
1:00 p.m. Sept. 24, 2021 - Barrons.com
Clearwater Analytics, Cue Health Soar in Debuts, Capping a Busy Week for IPOs Clearwater Analytics raised $540 million after selling 30 million shares at $18, above its expected range. Cue Health sold 12.5 million shares at $16, the midpoint of its range.
10:15 a.m. Sept. 24, 2021 - By Ciara Linnane
CDC head overrules advisers to allow COVID-19 boosters for at-risk workers, and Biden urges those eligible to act fastIn an unusual move, the head of the Centers for Disease Control and Prevention overruled a panel of advisers' recommendation that booster doses of a COVID-19 vaccine be offered only to people over 65 and those with weakened immune systems, allowing them to also be offered to front line workers, including in health care, schools and supermarkets.
9:16 a.m. Sept. 24, 2021 - By Jaimy Lee
CDC: We are not changing the definition of 'fully vaccinated' now that COVID-19 boosters are available The Centers for Disease Control and Prevention does not plan to change the definition of what it means to be "fully vaccinated" right now that BioNTech SE and Pfizer Inc.'s COVID-19 booster shots are available for a large group of the U.S. population. During a White House briefing on Friday, CDC director Rochelle Walensky said "we need to have more experience with our third shot and have more people eligible or recommended to receive it, before we change that definition." The Food and Drug Administration on Wednesday authorized a third booster dose of Pfizer's two-dose vaccine, making it the first vaccine to receive regulatory authorization for a booster. Moderna Inc.'s application for a booster shot for its two-dose vaccine is currently under review at the FDA.
7:47 a.m. Sept. 24, 2021 - Barrons.com
Biogen's Aduhelm Struggles Don't Hurt Lilly's Outlook, Says Analyst Lilly's experimental Alzheimer's therapy, donanemab, still has a “transformational growth opportunity,” despite Biogen's embattled rollout of Aduhelm, says J.P. Morgan Christ Schott.
5:46 a.m. Sept. 24, 2021 - Barrons.com
Vaccine Boosters Approved as CDC Head Overrules Panel. What to Know. Dr. Rochelle Walensky's decision aligns her institution with the Food and Drug Administration, which had earlier endorsed a broad use of Covid-19 booster shots.
2:48 a.m. Sept. 24, 2021 - Barrons.com
It May Be Time to Start Worrying About Bond Yields Again The yield on the 10-year Treasury note posted its biggest one-day jump since March on Thursday, climbing above 1.4%.
1:51 p.m. Sept. 23, 2021 - Barrons.com
CDC Panel Backs Boosters for Older Americans but Not High-Risk Workers An advisory committee to the agency rejected a recommendation for boosters for people aged 18 to 64 in an occupational or institutional setting where the risk of transmission is high.
1:05 p.m. Sept. 23, 2021 - MarketWatch.com
CDC panel backs Pfizer's COVID-19 booster for seniors, high-risk adultsThe U.S. vaccination drive against COVID-19 stands on the verge of a major new phase: Government advisers on Thursday recommended booster doses of Pfizer’s vaccine for millions of Americans.
12:32 p.m. Sept. 23, 2021 - Barrons.com
Stocks Are Past the September Doldrums—for Now, at Least Investors took comfort from the Chinese central bank's injection of more cash into the banking system and a Federal Reserve meeting that met expectations.
9:58 a.m. Sept. 23, 2021 - By Ciara Linnane
CDC to meet on boosters just hours after FDA authorized their use for seniors and high-risk individuals, as Africa slams U.K.'s travel rulesA team of advisers to the Centers for Disease Control and Prevention is expected to wrap up a two-day meeting Thursday on booster shots of the COVID-19 vaccine, just hours after the Food and Drug Administration authorized their use for senior citizens and those at risk of severe disease.
5:26 a.m. Sept. 23, 2021 - By Elisabeth Buchwald
‘I decided I’d jump the gun': What to consider before getting a third shot if you’re not eligible yetAn FDA panel voted against recommending third shots of Pfizer for the general public, but recommended them for people who are at least 65 and at high-risk for severe disease.
4:16 a.m. Sept. 23, 2021 - Barrons.com
FDA Authorizes Booster for Some Americans. Call on Rollout Could Come Today. The authorization allows a booster dose administered six months after the second shot of the Pfizer vaccine for people 65 and older, or in high-risk groups.
2:45 a.m. Sept. 23, 2021 - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 top 230 million and FDA backs boosters for seniors and those at high riskThe global tally for the coronavirus-borne illness climbed above 230 million on Thursday, while the death toll rose to 4.72 million, according to . The U.S. continues to lead the world with a total of 42.5 million cases and 681,199 deaths. The U.S. is averaging more than 2,000 deaths a day, the most since late February. The U.S. moved a step closer Wednesday to offering booster doses of Pfizer's COVID-19 vaccine to senior citizens and others at high risk from the virus as the Food and Drug Administration signed off on the targeted use of the extra shots, The FDA authorized booster doses for Americans who are 65 and older, younger adults with underlying health conditions and those in jobs that put them at high-risk for COVID-19. The CDC started a two-day meeting on Wednesday to make their own recommendations on who should get boosters. India is second by cases after the U.S. at 33.6 million and has suffered 446,050 deaths. Brazil has second highest death toll at 592,316 and 21.3 million cases. In Europe, Russia has most fatalities at 197,834, followed by the U.K. at 135,961.
2:31 a.m. Sept. 23, 2021 - Barrons.com
Markets Defy Fed’s Hawkish Shift. Here’s Why. Evergrande faces deadline for $83.5 million payment, Biden doubles U.S. vaccine donations to 1.1 billion doses, former Treasury officials urge Congress to act on debt limit, and other news to start your day.
4:21 p.m. Sept. 22, 2021 - MarketWatch.com
FDA backs Pfizer COVID-19 boosters for seniors and those at high riskThe U.S. has moved a step closer to offering booster doses of Pfizer’s COVID-19 vaccine to seniors and others at high risk from the virus.
10:48 a.m. Sept. 22, 2021 - By Ciara Linnane
Global tally of COVID-19 cases nears 230 million, as Biden convenes virtual pandemic summit and doubles U.S. purchase of Pfizer vaccineThe global tally of confirmed cases of the coronavirus-borne illness COVID-19 was heading close to 230 million on Wednesday, as President Joe Biden prepared to host a virtual summit on the pandemic with world leaders gathered in New York for the United Nations General Assembly.
8:02 a.m. Sept. 22, 2021 - Barrons.com
4 Midsize Biotech Stocks That Have Breakout Potential It’s been a tough year for small- and mid-cap biotech stocks. We looked at four names in the mid-cap biotech space that analysts love.
6:04 a.m. Sept. 22, 2021 - Barrons.com
Biogen Stock Is Down on a Report That Few Have Received Its New Alzheimer's Therapy Biogen stock is falling on a report that only around 100 patients have received its approved Alzheimer's treatment Aduhelm as of Sept. 11.
5:09 a.m. Sept. 22, 2021 - Barrons.com
CDC Advisory Panel to Consider Pfizer Booster. What to Know. A committee that advises the Centers for Disease Control and Prevention begins a two-day meeting that likely will end with detailed recommendations on how the U.S. should roll out booster doses of Pfizer's vaccine.
4:59 a.m. Sept. 22, 2021 - By Jaimy Lee
Incyte gets FDA approval for atopic dermatitis drugShares of Incyte Corp. were down 4.0% in premarket trading on Wednesday, the day after the company announced that the Food and Drug Administration had approved Opzelura as a treatment for some patients with mild to moderate atopic dermatitis. The FDA approval for the topical drug came with a warning for serious adverse events - also referred to a black-box warning - that is consistent with oral JAK inhibitors, according to Mizuho Americas analysts. "Bigger picture, this marks yet another approval for INCY as the company attempts to diversify away from a prevailing over-reliance on Jakafi," J.P. Morgan analysts told investors on Wednesday morning. Information about the drug's price is expected to be disclosed at an investor call on Wednesday. Incyte's stock is down 12.5% for the year, while the broader S&P 500 is up 15.9%.
3:34 a.m. Sept. 22, 2021 - By Jaimy Lee
CDC committee to meet today and Thursday to again discuss BioNTech and Pfizer's COVID-19 boosterA Centers for Disease Control and Prevention committee is Wednesday and Thursday to again discuss the science and possible administration plan for BioNTech SE and Pfizer Inc.'s COVID-19 booster shot. The CDC's Advisory Committee on Immunization Practices sets out the guidelines for how vaccines should be used in the U.S. The Food and Drug Administration has not approved or authorized an extra dose of the BioNTech and Pfizer vaccine except in people who are immuno-compromised, and an influential FDA committee last week recommended that boosters to older people and those who are at higher risk of severe disease. Some experts have suggested that the FDA decision is coming this week.
2:30 a.m. Sept. 22, 2021 - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 top 229.5 million and CDC advisers to meet to discuss boostersThe global tally for the coronavirus-borne illness climbed above 229.5 million on Wednesday, while the death toll rose to 4.71 million, according to . The U.S. continues to lead the world with a total of 42.4 million cases and 678,503 deaths. A team of advisers to the Centers for Disease Control and Prevention are scheduled to meet later Wednesday to decide on booster shots of the Pfizer/BioNTech COVID vaccine, The meeting comes after of a committee of advisers to the Food and Drug Administration, who rejected a proposal to offer boosters to everyone above the age of 16, but in favor of offering them to people older than 65 or with weakened immune systems. The CDC must now decide which patient groups might need boosters. The U.S. is now averaging 2,046 deaths a day, , the most since March 1, and are almost entirely unvaccinated people. India is second by cases after the U.S. at 33.5 million and has suffered 445,768 deaths. Brazil has second highest death toll at 591,440 and 21.2 million cases. Brazil's health minister Marcelo Queiroga tested positive for COVID on Tuesday in New York, where he was attending the U.N.'s General Assembly. In Europe, Russia has most fatalities at 196,235, followed by the U.K. at 135,793.
7:42 a.m. Sept. 21, 2021 - By Andrew Keshner
‘I’m a firm believer in science, but I'd still like to wait’: Pfizer's vaccine results for kids might not lead to quick vaccinations4 in 10 parents of children ages 5 to 11 say they’ll take a 'wait and see' approach before they have their kids vaccinated, according to a survey from the Kaiser Family Foundation.
6:09 a.m. Sept. 21, 2021 - Barrons.com
J&J: Booster Shot Works, but First Doses Are Effective A dose two months after the first shot of its vaccine offered 75% protection against moderate to severe Covid-19 globally, and 94% protection in the U.S.
2:42 a.m. Sept. 21, 2021 - By Ciara Linnane
Johnson & Johnson says Phase 3 trial data confirms 'strong and long-lasting' protection from COVID-19 vaccine Johnson & Johnson said Tuesday data from a Phase 3 trial and real-world evidence confirm that its single-shot COVID-19 vaccine offers strong and long-lasting protection against hospitalization and death. The company said further data shows that a booster shot offers increased protection. Data shows 94% protection in the U.S. with a booster given at two months, a four-fold increase in antibodies when given at two months and a 12-fold increase when given at six months. "The safety profile of the vaccine remained consistent and was generally well-tolerated when administered as a booster," the company said in a statement. The company has submitted data from the trial to the U.S. Food and Drug Administration and other regulators, the World Health Organization and National Immunization Technical Advisory Groups (NITAGs) worldwide. The Phase 3 trial included 390,000 people who got the J&J one-shot vaccine versus about 1.52 million unvaccinated people matched on age, sex, time, three-digit zip code and comorbidities and predictors for COVID-19 infection severity. The trial was conducted from March to late July 2021. Shares rose 1.1% premarket and have gained 4% in the year through Monday's close, while the Dow Jones Industrial Average has gained 11% and the S&P 500 has gained 16%.
1:46 p.m. Sept. 20, 2021 - Barrons.com
Pfizer and BioNTech Say Vaccine Has Positive Results in Kids The study, which tested a smaller dose than is used in the jabs given to people aged 12 and older, found that the vaccine was safe and well-tolerated.
1:44 p.m. Sept. 20, 2021 - Barrons.com
Stocks Notch Worst Day in Months on Evergrande Fears The highly indebted Chinese property giant has debt obligations due this week it can't pay. Investors worried about spillover into the wider market.
12:35 p.m. Sept. 20, 2021 - By Ciara Linnane
Upbeat result of COVID-19 vaccine trial in 5- to 11-year-olds tempered as U.S. daily death rate tops 2,000 for first time since March 1Positive results from a trial of the COVID-19 vaccine developed by Pfizer and German partner BioNTech in children 5 to 11 years old was tempered Monday by a rising average death rate, with the U.S. now seeing more than 2,000 fatalities a day for the first time since March 1.
9:23 a.m. Sept. 20, 2021 - Barrons.com
The Stock Market Is Tanking. These 5 Stocks Are Not. A few companies shrug off the general malaise on Monday and stand out as beacons of hope.
9:01 a.m. Sept. 20, 2021 - Barrons.com
Toast, Freshworks Boost IPO Price Ranges Ahead of Listing More than a dozen companies are listing their shares this week including Toast, Freshworks, Remitly, Clearwater Analytics and Cue Health.
5:48 a.m. Sept. 20, 2021 - Barrons.com
FDA Panel Is a Win for Pfizer, Despite Mixed Result, Analyst Says SVB Leerink analyst Geoffrey Porges sees a silver lining from Pfizer's bumpy ride at a Food and Drug Administration advisory committee meeting about Covid-19 vaccine boosters.
3:51 a.m. Sept. 20, 2021 - Barrons.com
Pills to Battle Covid Are Coming. These Firms Stand to Gain. Merck, Pfizer, and the Atea Pharmaceuticals each expect Phase 3 data on an oral Covid-19 antiviral in the coming months.
3:50 a.m. Sept. 20, 2021 - By Mike Murphy
Fauci OK with FDA panel's COVID booster decision, tries to clear up confusionDr. Anthony Fauci on Sunday said he was not disappointed by an FDA's panel's rejection last week of a plan to start giving widespread COVID-19 vaccine boosters, and tried to clear up some of the public's confusion over boosters.
3:47 a.m. Sept. 20, 2021 - By Jaimy Lee
FDA panel recommends Pfizer’s COVID-19 booster for 65 and older, but not for the general publicA group of advisors to the Food and Drug Administration on Friday reframed a proposed approval of BioNTech and Pfizer's COVID-19 booster for the general population, and it instead recommended authorization of an additional dose of the vaccine to people at least 65 years old and those at high risk for severe disease.
3:15 a.m. Sept. 20, 2021 - By Ciara Linnane
Pfizer and BioNTech say COVID-19 vaccine safe and effective in children aged 5 to 11Pfizer Inc. and German partner BioNTech SE on Monday announced positive results in a Phase 2/3 trial of their COVID-19 vaccine in children aged 5 to 11, and said the vaccine was safe, well tolerated and produced "robust" neutralizing antibody response. The companies said participants in the trial were given a two-dose regimen of 10 ug administered 21 days apart, a smaller dose than the 30 ug given to people aged 12 and older. "The antibody responses in the participants given 10 ug doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 ug doses," the companies said in a joint statement. "The 10 ug dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age. These are the first results from a pivotal trial of a COVID-19 vaccine in this age group." The companies are planning to submit the data to the Food and Drug Administration and the European Medicines Agency, as well as to other regulators around the world as soon as possible. Results from a trial involving children younger than 5 are expected "as soon as later this year," said the statement. "Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. -- underscoring the public health need for vaccination," said Pfizer CEO Albert Bourla in the statement. There were 2,268 participants in the trial. Shares of both companies were lower premarket, caught up in a broad market rout sparked by fears of a default by Chinese property developer China Evergrande. Pfizer shares have gained 19% in the year to date, while BioNTech has gained 341%. The SPDR S&P Biotech ETF has fallen 6% and the S&P 500 has gained 18%.
2:39 a.m. Sept. 20, 2021 - Barrons.com
It’s Crunchtime for Evergrande. The Market Is Worried. SpaceX’s successful civilian mission opens doors to future flights, Tesla software upgrade isn’t ready for drive time, says head of NTSB, debt ceiling resolution heads to a standoff in Congress, and other news to start your day.
2:35 p.m. Sept. 19, 2021 - Barrons.com
FDA's Final Decision on Boosters Expected Later This Week, Fauci Says President Joe Biden wanted booster shots to be ready as soon as this week, pending FDA approval, because “we wanted to be ready," Fauci said.
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