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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
2:42 p.m. March 5, 2021 - Barrons.com
Vaccines Put Some Pep in the Step of Travel Stocks Stocks of airlines and cruise lines have been among the biggest victims of the pandemic. But as hopes for a recovery rise, these company have been raising funds and watching their shares take off.
5:57 a.m. March 5, 2021 - By Ciara Linnane
U.S. COVID-19 death toll tops 520,000 as Dr. Fauci cautions against reopening too soonThe U.S. death toll from the coronavirus-borne illness COVID-19 climbed above 520,000 on Friday, as Dr. Anthony Fauci became the latest health expert to slam state officials for prematurely dropping restrictions on movement at a time when their case numbers remain high and their vaccine programs are making slow progress.
4:41 a.m. March 5, 2021 - By Andrew Keshner
'I’ve been ready for this since this was declared a pandemic': J&J's one-shot COVID-19 vaccine is enticing for people who hate needles‘Trypanophobia’ is an extreme fear of needles. Approximately 16% of adult patients skipped flu shots because of their needle fears, one study said
4:18 a.m. March 5, 2021 - By Jaimy Lee
JAMA study: Ivermectin doesn't speed up recovery for patients with mild COVID-19New research indicates that ivermectin, a type of treatment for parasitic worms, does not help patients with mild COVID-19 recover any faster. The peer-reviewed , published Thursday in JAMA, examined the findings of a double-blind, randomized trial conducted in Cali, Colombia, in roughly 475 people with mild symptoms of COVID-19. Researchers concluded "the findings do not support the use of ivermectin for treatment of mild COVID-19, although larger trials may be needed to understand the effects of ivermectin on other clinically relevant outcomes." The drug first caught the attention of clinicians in the early days of the pandemic after an said the drug can inhibit replication of SARS-CoV-2, the virus that causes COVID-19. However, the Food and Drug Administration and others [l:cautioned back in April|https://www.fda.gov/animal-veterinary/product-safety-information/fda-letter-stakeholders-do-not-use-ivermectin-intended-animals-treatment-covid-19-humans%7CNEW] that trials needed to be conducted before the drug should be prescribed to COVID-19 patients.
4:10 a.m. March 5, 2021 - Barrons.com
Eli Lilly Will Unveil Alzheimer's Drug Data Next Week. What to Watch. Eli Lilly executives are confident that data from its monoclonal antibody called donanemab will impress.
2:00 a.m. March 5, 2021 - Barrons.com
Vertex Stock Fell After a Setback on a New Drug. It’s an Opportunity for Investors. The biotech’s cystic fibrosis franchise remains strong, and its pipeline looks promising
1:27 p.m. March 4, 2021 - Barrons.com
Amgen Acquires a Cancer Drug. Expect More Deals. The biotech firm is building its pipeline by adding an experimental drug that could compete against Bristol Myers Squibb in treating deadly stomach cancers.
10:03 a.m. March 4, 2021 - By Jaimy Lee
NIH to study three experimental COVID-19 treatmentsThe National Institutes of Health said Thursday that it is putting three more investigational COVID-19 treatments into Phase 2/3 clinical trials. The experimental therapies are: an inhalable beta interferon developed by Synairgen's ; AstraZeneca's monoclonal antibody combination, which will be tested as an infusion and also as an injection; and Sagent Pharmaceuticals Inc.'s oral serine protease inhibitor. Sagent is privately held. The NIH said it is trying to identify and study therapies aimed at treating people who develop mild or moderate forms of COVID-19. So far during the pandemic, there are few therapies available that effectively treat patients with COVID-19. Only one, Gilead Sciences Inc.'s Veklury, has received full approval from the Food and Drug Administration, though several other companies, including Eli Lilly & Co. and Regeneron Pharmaceuticals Inc. have received emergency authorization for their antibody treatments. Over the past year, Synairgen's stock has soared 763.1%, while U.S.-listed shares of AstraZeneca are up 0.4%. The broader S&P 500 is up 27.2%.
9:35 a.m. March 4, 2021 - By Ciara Linnane
U.S. COVID death toll above 518,000 as Biden adds voice to outrage at Texas and Mississippi for reopeningThe U.S. death toll from the coronavirus-borne illness COVID-19 climbed above 518,000 on Thursday, as President Joe Biden added his voice to a chorus of outrage over Texas and Mississippi's decision to reopen their states for business, just as declining case numbers are stalling and public health experts are urging Americans to stick with safety measures.
6:33 a.m. March 4, 2021 - By Tomi Kilgore
Moderna, IBM explore blockchain tech, AI to support 'smarter' management of COVID-19 vaccinesModerna Inc. and International Business Machines Corp. announced Thursday plans to work together to find technologies to support "smarter COVID-19 vaccine management." The technologies the companies will explore include artificial intelligence, blockchain and hybrid cloud, the companies said. "Moderna is committed to working with a coalition of partners to increase education and awareness of the importance of vaccination to help defeat COVID-19," said Michael Mullette, a managing director of North America commercial operations at Moderna. "We look forward to working with IBM to apply digital innovations to build connections between organizations, governments, and individuals to instill confidence in COVID-19 vaccines." Moderna's stock rose 1.6% in midday trading and IBM shares fell 0.7%, while the Dow Jones Industrial Average gained 118 points, or 0.4%. Moderna currently has one of three COVID-19 vaccines granted emergency use authorization by the Food and Drug Administration, the others being from Pfizer Inc. and BioNTech SE and Johnson & Johnson .
5:17 a.m. March 4, 2021 - Barrons.com
Novartis Will Help Manufacture CureVac's Covid-19 Vaccine The European drug giant Novartis said Thursday that it would manufacture doses of CureVac’s experimental Covid-19 vaccine beginning this summer.
3:29 a.m. March 4, 2021 - By Jaimy Lee
NIH tells Vir that experimental COVID-19 therapy may not benefit patientsShares of Vir Biotechnology Inc. tumbled 5.4% in premarket trading on Thursday, the day after the company said the experimental COVID-19 treatment that it's developing with GlaxoSmithKline may not benefit patients. U.S.-listed shares of GSK were up 0.6% in trading before the market opened on Thursday. The investigational monoclonal antibody therapy was being tested in hospitalized COVID-19 patients in a Phase 3 clinical trial conducted by the National Institutes of Health until an independent safety board recommended that the trial investigators close the study to enrollment at this time, Vir said. "While we are disappointed with the recommendation ... we are encouraged by the safety profile of VIR-7831 and by the possibility of a benefit on top of remdesivir and corticosteroids in this advanced cohort of patients," Vir CEO George Scangos said in a news release. (Remdesivir, which is also called Veklury, was developed by Gilead Sciences Inc. and is the only COVID-19 treatment to have a full Food and Drug Administration approval.) Vir's stock is down 6.9% over the past 12 months, while the broader S&P 500 has gained 27.2%.
9:57 a.m. March 3, 2021 - Barrons.com
Vir Shares Plummeted Today. What to Know. The company announced that a data and safety monitoring board had recommended ending a trial of its experimental antibody therapy in hospitalized Covid-19 patients.
3:11 a.m. March 3, 2021 - MarketWatch.com
Money pressures from COVID-19 may finally push hospitals to stop wasting billions of dollarsRecycle or reuse some supplies that now are being thrown away, and plan better for what supplies are is actually needed.
9:36 a.m. March 2, 2021 - By Ciara Linnane
U.S. COVID vaccine supply to be boosted by Merck helping make J&J vaccineThe U.S. COVID-19 vaccine program got a welcome jolt on Tuesday in the news that one of the biggest vaccine makers in the world will help make Johnson & Johnson's one-dose jab, potentially doubling the supply from what J&J could achieve on its own.
5:58 a.m. March 2, 2021 - Barrons.com
Merck Will Help J&J Make Vaccines, Report Says Merck has a well developed vaccine-production system, but its effort to develop a Covid-19 vaccine of its own failed in January.
4:09 a.m. March 2, 2021 - By Ciara Linnane
President Biden to announce later Tuesday that Merck will help make J&J vaccine: Washington PostPresident Joe Biden will announce later Tuesday that Merck & Co. will help make Johnson & Johnson's one-shot COVID-19 vaccine in an unusual agreement between two competitors that could lead to a significant boost in supply, citing unnamed senior administration officials. The deal was brokered by the government as it works to expand manufacturing of the vaccine, which was granted emergency use authorization by the U.S. Food and Drug Administration on Saturday. Merck is one of the world's biggest vaccine makers and its own effort to develop an effective COVID vaccine failed. Merck will dedicate two facilities in the U.S. to the effort with one providing "fill-finish" services, putting vaccine in vials for distribution, while the other will make the vaccine itself, said the paper. That could double the supply compared with what J&J can achieve on its own, it said. The U.S. vaccine program has been hampered by a shortage of supply of vaccines. J&J shares were slightly higher premarket, but have gained 14% in the last 12 months, while the S&P 500 has gained 26%. Merck shares were up 0.4%, and have fallen 11% in the last 12 months.
3:57 a.m. March 2, 2021 - Barrons.com
Sarepta Therapeutics Drops on Earnings. Why Analysts Remain Hopeful. Sarepta Therapeutics stock fell as markets digested its bigger-than-expected quarterly loss. But analysts say the setup for the stock remains positive.
12:00 a.m. March 2, 2021 - Barrons.com
Podcast: Apple’s iPhone 13 Order Rumored to Hit 100 Million Berkshire Hathaway spends $24.7 billion on share buybacks. Apple’s iPhone 13 order could hit 100 million. And airline stocks are riding high amid increased vaccine optimism.
2:17 p.m. March 1, 2021 - Barrons.com
Novavax Hopes to Start Supplying Covid Shots This Spring The vaccine developer aims to supply 2 billion doses a year.
12:26 p.m. March 1, 2021 - Barrons.com
The Dow Soared 600 Points Because Stocks Set Sail on Calmer Rates Interest rates settled into a range, and indications of a continued economic recovery bolstered stocks on Monday. All three major U.S. stock indexes rallied.
11:40 a.m. March 1, 2021 - By Mark DeCambre
S&P 500 scores best day gain in about 9 months, as March kicks off with brighter economic outlookU.S. stock-market benchmarks closed sharply higher Monday, with some strategists attributing the enthusiasm to a cool-down of last week's rapid rise in bond yields that had unsettled the bullish mood on Wall Street.
11:38 a.m. March 1, 2021 - By Jaimy Lee
FDA authorizes the first single-dose COVID-19 vaccine The Food and Drug Administration on Saturday granted emergency authorization to Johnson & Johnson's COVID-19 vaccine, making it the third vaccine to become available to Americans during the pandemic and the first to only require one dose.
10:45 a.m. March 1, 2021 - By Nicole Lyn Pesce
'Andrew Cuomo is a colossal a—hole': John Oliver dissects the New York governor's recent scandalsThe 'Last Week Tonight' host addressed the Cuomo administration's underreported COVID-19 deaths, sexual misconduct allegations and fake philosophical quotes
9:44 a.m. March 1, 2021 - By Tomi Kilgore
Athenex stock plunges to pace all decliners after disappointing FDA response to breast cancer treatment NDAShares of Athenex Inc. plummeted 54.6% on very active afternoon trading Monday, enough to be the biggest decliner listed on major U.S. exchanges, after the Food and Drug Administration said the biopharmaceutical company's New Drug Application (NDA) for its metastatic breast cancer treatment, oral paclitaxel plus encequidar, is not ready for approval in its present form. Trading volume spiked to 40.1 million shares, compared with the full-day average of about 1.1 million shares. The company said earlier that the FDA issued a complete response letter (CRL) expressing concerns of a safety risk to patients, and recommended a new clinical trial be conducted. Separately, the company reported a fourth-quarter net loss that widened to $49.5 million, or 53 cents a share, from $21.7 million, or 28 cents a share, in the year-ago period, wider than the FactSet consensus for a per-share loss of 44 cents. Revenue fell 36.5% to $21.8 million, topping the FactSet consensus of $20.7 million. The stock has lost 55.1% over the past 12 months, while the iShares Nasdaq Biotechnology ETF has climbed 40.2% and the S&P 500 has advanced 32.4%.
9:28 a.m. March 1, 2021 - By Myra P. Saefong
Gold prices stretch losing streak to 5 sessions Gold futures give up early Monday gains to stretch losses into a fifth straight session despite a pause in the run up for the 10-year U.S. Treasury note yields.
9:19 a.m. March 1, 2021 - By Ciara Linnane
J&J CEO says Americans should start getting single-dose COVID vaccine within 48 hoursThe head of Johnson & Johnson said Americans should start receiving the company's COVID-19 vaccine within 48 hours, adding further ammunition to the effort to get jabs into arms and contain the pandemic that has killed more than half a million people.
6:26 a.m. March 1, 2021 - By Mark DeCambre
As rising Treasury yields spook stock investors, March looms like a lionAfter a frenetic February, investors are probably hoping that March holds true to its proverb: In like a lion out like a lamb.
6:06 a.m. March 1, 2021 - Barrons.com
Airline Stocks Are Flying Again Because Vaccines Keep Coming Airline stocks were rallying Monday on more positive vaccine news and hopes for a monumental travel recovery as the pandemic winds down.
3:21 a.m. March 1, 2021 - Barrons.com
J&J's Vaccine Is Authorized. Here's What It Means for the Stock. Analysts say the vaccine's success highlights the company's underappreciated scientific prowess, and that revenues could be higher than expected.
3:09 a.m. March 1, 2021 - By Quentin Fottrell
Dr. Fauci on J&J’s COVID-19 vaccine: ‘I would have no hesitancy whatsoever to take it’ Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said, ‘People need to get vaccinated as quickly, and as expeditiously, possible’Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said, ‘People need to get vaccinated as quickly, and as expeditiously, possible.’
1:32 a.m. March 1, 2021 - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 top 114 million and U.S. death toll above 513,000The global tally for confirmed cases of the coronavirus that causes COVID-19 climbed above 114 million on Monday, while the death toll rose above 2.53 million. The U.S. has the highest case tally in the world at 28.6 million and the highest death toll at 513,092. The U.S. added 50,925 new cases on Sunday, according to a New York Times tracker, and at least 1,129 people died. The U.S. has averaged 67,868 cases a day in the past week, down 26% from two weeks ago. The U.S. Food and Drug Administration on Saturday to the vaccine developed by Johnson & Johnson, that has the advantage of being a one-dose regimen that does not require the refrigeration required by the existing vaccines. The move has bolstered hopes that vaccination can now speed up. Brazil has the second highest death toll at 254,942 and is third by cases at 10.6 million. India is second worldwide in cases with 11.1 million, and now fourth in deaths at 157,157. Mexico has the third highest death toll at 185,715 and 13th highest case tally at 2.1 million. The U.K. has 4.2 million cases and 123,083 deaths, the highest in Europe and fifth highest in the world.
7:00 a.m. Feb. 28, 2021 - By MarketWatch
As rising Treasury yields spook stock investors, March looms like a lionAfter a frenetic February, investors are probably hoping that March holds true to its proverb: In like a lion out like a lamb.
4:00 a.m. Feb. 28, 2021 - By MarketWatch
As rising Treasury yields spook stock investors, March looms like a lionAfter a frenetic February, investors are probably hoping that March holds true to its proverb: In like a lion out like a lamb.
3:30 p.m. Feb. 27, 2021 - Barrons.com
FDA Issues Emergency Use Authorization for J&J Covid-19 Vaccine The move paves the way for the rollout of the third Covid-19 vaccine authorized in the U.S.
1:46 p.m. Feb. 27, 2021 - MarketWatch.com
How does the Johnson & Johnson COVID-19 vaccine compare with the Pfizer and Moderna shots?Can I choose which one I get?
2:24 p.m. Feb. 26, 2021 - Barrons.com
The Pandemic Tested Healthcare R&D. Now the Future Looks Bright. Mass vaccinations are necessary to keep Covid-19 at bay. But there’s a lot more than just vaccines in pharma and biotech pipelines.
1:40 p.m. Feb. 26, 2021 - By Jaimy Lee
FDA tells J&J it's working on an emergency authorization for its COVID-19 vaccine Shares of Johnson & Johnson gained 1.3% in after-hours trading on Friday after the Food and Drug Administration said it has contacted the company to say it is "rapidly" working toward issuing an emergency use authorization for J&J's COVID-19 vaccine candidate. The FDA statement was sent out Friday evening about an hour after an advisory committee that the benefits of the experimental vaccine outweigh the risks. "The agency has also notified our federal partners involved in vaccine allocation and distribution so they can execute their plans for timely vaccine distribution," FDA officials said in the statement. J&J said earlier this week that it plans to deliver 20 million doses of its single-dose vaccine in the U.S. by the end of March. J&J's stock is up 10.7% over the past 12 months, while the broader S&P 500 has gained 22.4%.
12:54 p.m. Feb. 26, 2021 - Barrons.com
J&J Covid-19 Vaccine Endorsed for Use by FDA Panel Regulator could approve It as soon as Saturday, joining authorized vaccines from Pfizer and Moderna.
12:08 p.m. Feb. 26, 2021 - By Jaimy Lee
FDA committee votes unanimously, says benefits of J&J's COVID-19 vaccine outweigh the risksShares of Johnson & Johnson were up 1.3% in after-hours trading on Friday after a Food and Drug Administration advisory committee vote 22-0 in favor of the regulator authorizing the company's COVID-19 vaccine candidate. The FDA is not required to follow the advice of the committee but often does. The single-dose vaccine had an overall efficacy rate of about 66% in the Phase 3 clinical trial, and the U.S. arm of the trial showed an efficacy rate of about 72% and of 85% when protecting against severe or critical disease. The most common adverse events were pain at the injection site and fatigue. The trial was conducted in the U.S., South Africa, and several Central and South American countries. If the FDA moves forward with authorizing the experimental vaccine, it will be the third COVID-19 vaccine to be available in the U.S. - and the first to require only one dose. Both the Moderna Inc. and BioNTech SE and Pfizer Inc.'s vaccines, which were separately authorized in December, require two doses spaced several weeks apart. J&J's stock has gained 10.7% over the past 12 months, while the broader S&P 500 is up 22.4%
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