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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
    First U.S. Covid-19 Vaccines Roll Out First U.S. Covid-19 Vaccines Roll Out 4:33
    FDA Authorizes Pfizer-BioNTech Covid-19 Vaccine for U.S. Use FDA Authorizes Pfizer-BioNTech Covid-19 Vaccine for U.S. Use 2:59
    Emergency Use of Covid-19 Vaccine One Step Closer After FDA Panel Vote Emergency Use of Covid-19 Vaccine One Step Closer After FDA Panel Vote 3:33
3:33 a.m. Today - By Jaimy Lee
Cerecor's investigational COVID-19 therapy gets Fast Track designation from the FDAShares of Cerecor Inc. gained 17.3% in premarket trading on Tuesday after the company said its experimental COVID-19 drug had received a Fast Track designation from the Food and Drug Administration. The treatment candidate is a monoclonal antibody being targeted at people with COVID-19 who are sick enough to be hospitalized. Cerecor's stock is down 3.8% for the year, while the S&P 500 is up 11.5%.
2:23 a.m. Today - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 near 159 million and death toll above 3.3 millionThe global tally for the coronavirus-borne illness edged close to 159 million on Tuesday, according to , while the death toll rose above 3.3 million. The U.S. continues to lead the world in cases and deaths by wide margins, with 32.7 million cases and 582,162 deaths, or about a fifth of the worldwide tallies. India is second to the U.S. by cases at 22.7 million and third by fatalities at 246,116. The crisis in India continues a day after the World Health Organization said the double-mutant variant that first emerged there is a "variant of concern" and is likely far more transmissible than the original virus. Called the B.1.627 variant, it has two spike proteins instead of one. There was good news on the vaccine front when the U.S. Food and Drug Administration granted to the vaccine developed by Pfizer Inc. and German partner BioNTech SE for use in 12- to 15-year-olds. Brazil is third with 15.2 million cases and second by fatalities at 423,229. Mexico has the fourth-highest death toll at 219,098 and 2.4 million cases, or 15th highest tally. The U.K. has 4.5 million cases and 127,870 deaths, the fifth-highest in the world and highest in Europe.
1:24 p.m. May 10, 2021 - By Claudia Assis
FDA authorizes emergency use of Pfizer, BioNTech COVID vaccine to kids 12-15The U.S. Food and Drug Administration late Monday authorized the emergency use of Pfizer Inc. and BioNTech SE COVID-19 vacccine for children between the ages of 12 and 15. Acting FDA commissioner Janet Woodcock called the expansion of the emergency use a "significant step in the fight against the COVID-19 pandemic." The FDA had granted the vaccine emergency use for people 16 and older. "Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations," she said. From March 2020 through April 2021, about 1.5 million COVID-19 cases in kids 11 to 17 years of age have been reported to the Centers for Disease Control and Prevention, the FDA said.
9:31 a.m. May 10, 2021 - 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.
4:28 a.m. May 10, 2021 - 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%.
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%.
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%.
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%.
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%.
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.
9:22 a.m. April 28, 2021 - By Ciara Linnane
Biden administration to seek ban on menthol cigarettes: WSJPresident Joe Biden's administration is planning to seek a ban on menthol cigarettes, the Wall Street Journal reported Wednesday, citing people familiar with the matter. The move, which is expected to be unveiled this week, could eliminate more than a third of all cigarettes sold in the U.S., the paper said. It stems from a U.S. Food and Drug Administration finding in 2013 that menthols are harder to quit than regular cigarettes and likely pose a higher health risk. They are also deemed more attractive to young people because the menthol masks the harsh quality of cigarette smoke. A nationwide menthol ban would take years to implement, and industry leaders have signaled that they might fight a ban in court. Tobacco stocks were mixed on the news with Phillip Morris International Inc. down 0.4% and British American Tobacco ADR's down 0.8%, while Altria Group Inc. was up 0.1%.
9:17 a.m. April 28, 2021 - By Ciara Linnane
Biden administration to seek ban on menthol cigarettes: WSJPresident Joe Biden's administration is planning to seek a ban on menthol cigarettes, the Wall Street Journal reported Wednesday, citing people familiar with the matter. The move, which is expected to be unveiled this week, could eliminate more than a third of all cigarettes sold in the U.S., the paper said. It stems from a U.S. Food and Drug Administration finding in 2013 that menthols are harder to quit than regulator cigarettes and likely pose a higher health risk. They are also deemed more attractive to young people because the menthol masks the harsh quality of cigarette smoke. A nationwide menthol ban would take years to implement, and industry leaders have signaled that they might fight a ban in court. Tobacco stocks were mixed on the news with Phillip Morris International Inc. down 0.4% and British American Tobacco ADR's down 0.8%, while Altria Group Inc. was up 0.1%.
8:03 a.m. April 26, 2021 - By Jaimy Lee
UniQure stock is up after FDA lifts clinical hold on experimental gene therapy Shares of UniQure gained 9.1% in trading on Monday after the company said the Food and Drug Administration had lifted a clinical hold on the hemophilia B program for its experimental gene therapy. UniQure said it now expects to share top-line data from the clinical trial sometime this quarter. The regulator had implemented the hold in December after a patient in the trial was diagnosed with hepatocellular carcinoma, though later study of the individual found that the patient may have been predisposed to this type of carcinoma. All participants in the trial will continue to receive abdominal ultrasounds for at least six months. "We still view the official clearance from the agency as an important de-risking event for QURE shares," Raymond James analyst Danielle Brill wrote in an investor note on Monday. UniQure's stock is down 3.2% for the year, while the broader S&P 500 is up 11.3%.
4:13 a.m. April 26, 2021 - By Jaimy Lee
FDA to discuss whether immuno-oncology drugs with 'accelerated' approval should remain on the marketThe Food and Drug Administration advisory committee plans to hold a three-day this week to evaluate a type of quicker approval used primarily for immuno-oncology drugs that are thought to help address unmet treatment needs among people with cancer. The FDA's "accelerated approval" process requires drug makers to conduct what are called confirmatory trials to back up the limited data used to inform the initial regulatory ok. The meeting will focus on Roche Holding AG's Tecentriq; Merck & Co Inc.'s top-selling drug Keytruda, which brought in $14.3 billion in 2020; and Bristol Myers Squibb Co.'s Opdivo, which generated $6.9 billion last year. The FDA said in documents that these drugs received additional accelerated approvals to treat different types of cancers "but subsequent confirmatory trial(s) have not verified clinical benefit ... The FDA is seeking the committee's advice on next steps for each product including whether the indications should remain on the market while additional trial(s) are conducted." The meeting is scheduled for April 27 to 29.
11:36 a.m. April 22, 2021 - By Jaimy Lee
FDA approves GSK's endometrial cancer therapyU.S.-listed shares of GlaxoSmithKline were down 1.4% in trading on Thursday after the Food and Drug Administration said it had granted accelerated approval to the company's endometrial cancer treatment. The immunotherapy, which was called dostarlimab and is now named Jemperli, is approved to treat patients with severe forms of this kind of cancer who have a genetic feature known as dMMR. About one-quarter of patients with this kind of cancer have dMMR tumors, the FDA said in a statement. A clinical trial with 71 participants found that Jemperli got rid of or reduced dMMR tumors in 42% of the patients. The regulator also said that additional trials are needed to back up the clinical data -- the approval is an "accelerated" decision based on unmet need -- and those studies are already underway. A GSK spokesperson did not immediately respond to a request for Jemperli's price. GSK's stock has gained 2.4% so far this year, while the S&P 500 is up 10.2%.
6:23 a.m. April 21, 2021 - By Jaimy Lee
FDA inspection of Emergent's COVID-19 vaccine plant identifies 'potential quality issues' Shares of Emergent BioSolutions Inc. were up 1.3% in trading on Wednesday after the Food and Drug Administration said it inspected a plant in Baltimore that had been scheduled to begin producing Johnson & Johnson's COVID-19 vaccine after reports emerged of cross-contamination in vaccine production there. J&J confirmed several weeks ago that quality standards had not been met at the Emergent facility. The FDA said that none of the vaccines produced at the facility in question have been distributed, and Emergent is working to address the regulator's concerns. "At the agency's request, Emergent BioSolutions has agreed to pause new production while it works with the FDA to resolve potential quality issues," the FDA said in a statement. The agency's so-called identified a number of problems at the plant, including a lack of "thorough review" of how workers move throughout the facility and poor decontamination practices. Emergent is the U.S. manufacturing partner for the J&J shot in the U.S. Emergent's stock is down 25.8% for the year, while the broader S&P 500 has gained 10.1%.
9:33 p.m. April 18, 2021 - By Quentin Fottrell
What determines when Americans reclaim their ‘liberty’? Here is Dr. Fauci’s answer Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, appeared Thursday before a House subcommittee on the coronavirus pandemicAnthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, was appearing before a House Select Subcommittee on the Coronavirus Crisis.
9:28 p.m. April 18, 2021 - By Quentin Fottrell
The public’s expectation of perfection: Risk of blood clot from Johnson & Johnson COVID-19 vaccine is 0.00009% ‘It’s the same perceptual problem when we blindly drive to the airport texting, yet worry about the airplane’‘It’s the same perceptual problem when we blindly drive to the airport texting, yet worry about the airplane.’
11:48 a.m. April 15, 2021 - By Jaimy Lee
Merck scraps two treatments for hospitalized COVID-19 patients, will focus on antiviral for non-hospitalized patientsShares of Merck & Co. were up 0.1% in premarket trading on Thursday after the drug company said the oral antiviral COVID-19 treatment it is developing with Ridgeback Biotherapeutics did not help hospitalized patients in a mid-stage clinical trial. The companies now plan to test molnupiravir in non-hospitalized COVID-19 patients in a Phase 3 trial, with plans to file for emergency authorization in the second half of the year. They are also planning to see if the experimental therapy works for post-exposure prophylaxis. In a separate news release, Merck said it is discontinuing MK-7110 as a treatment for patients hospitalized with COVID-19, saying that the Food and Drug Administration's request for additional clinical information would push the launch into 2022. "Merck is now focusing its efforts on advancing molnupiravir, which, as an oral medicine for outpatient use, represents a promising potential new approach, and on accelerating production of Johnson & Johnson's COVID-19 vaccine," Dr. Roy Baynes, chief medical officer for Merck Research Laboratories, said in the release. Merck's stock has gained 6.6% since the start of the year, while the broader S&P 500 is up 9.8%.
10:10 a.m. April 13, 2021 - By Jaimy Lee
CDC committee to hold emergency meeting for J&J's COVID-19 shot on Wednesday afternoonThe Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices is scheduled to hold an on Wednesday, starting at 1:30 p.m. Eastern Time, in response to a federal recommendation made Tuesday to temporarily halt immunizations using Johnson & Johnson's COVID-19 vaccine. The recommendation was made after six people who received the J&J shot were diagnosed with severe blood clots in combination with low levels of blood platelets. About 6.8 million people in the U.S. in total have been administered the J&J vaccine. The meeting, which will be publicly webcast, is expected to conclude with a vote about whether the vaccine should continue to be used, how it should be used going forward, or how people who develop blood clots as a result of the vaccine should be treated. The ACIP after the Food and Drug Administration granted the emergency authorization.
10:10 a.m. April 13, 2021 - By Jaimy Lee
CDC committee to hold emergency meeting for J&J's COVID-19 shot on Wednesday afternoonThe Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices is scheduled to hold an on Wednesday, starting at 1:30 p.m. Eastern Time, in response to a federal recommendation made Tuesday to temporarily halt immunizations using Johnson & Johnson's COVID-19 vaccine. The recommendation was made after six people who received the J&J shot were diagnosed with severe blood clots in combination with low levels of blood platelets. About 6.8 million people in the U.S. in total have been administered the J&J vaccine. The meeting, which will be publicly webcast, is expected to conclude with a vote about whether the vaccine should continue to be used, how it should be used going forward, or how people who develop blood clots as a result of the vaccine should be treated. The ACIP after the Food and Drug Administration granted the emergency authorization.
6:06 a.m. April 13, 2021 - By Tomi Kilgore
Moderna, BioNTech stocks surge after regulators halt use of J&J vaccine Shares of Moderna Inc. shot up 8.6% in morning trading, BioNTech SE ran up 5.7% toward a 4-month high and Pfizer Inc. climbed 1.1% toward a 3-month high, after U.S. health regulators paused the use of Johnson & Johnson's COVID-19 vaccine . Meanwhile, J&J shares shed $2.98, or 1.8%, to shave about 20 points of the Dow Jones Industrial Average's price, as the Dow dropped 132 points, or 0.4%. Moderna's two-dose COVID-19 vaccine, and the two-dose vaccine from Pfizer and partner BioNTech are mRNA vaccines while J&J's one-dose vaccine is an adenovirus vaccine. The Centers for Disease Control and Prevention and the Food and Drug Administration said there have been six cases of blood clotting out of the roughly six million people who have received the J&J vaccine, all of who were women between the ages of 18 and 48.
4:34 a.m. April 13, 2021 - By Tomi Kilgore
Novocure's stock rockets into record territory after upbeat DMC review of lung cancer treatment trialShares of Novocure Ltd. skyrocketed 80.7% toward a record high in premarket trading Tuesday, after the tumor treatment company said an independent data monitoring committee (DMC) said the interim analysis of a Phase 3 trial would be accelerated. The trial is of Novocure's Tumor Treating Fields, which are electric fields that disrupt cancer cell division, in stage 4 non-small cell lung cancer. The DMC concluded that the trail should continue with no evidence of increased systemic toxicity. Novocure plans to submit an Investigational Device Exemption (IDE) to the Food and Drug Administration. "The accelerated interim analysis with an encouraging outcome adds to the accumulating evidence of Tumor Treating Fields' broad potential across a range of hard-to-treat cancers," said Novocure Executive Chairman William Doyle. Novocure's stock, which is on track to open well above its Feb. 19 record close of $190.17, has dropped 25.5% over the past three months through Monday while the S&P 500 has gained 8.4%.
3:24 a.m. April 13, 2021 - By Ciara Linnane
UPDATE: FDA and CDC call for pause in use of J&J vaccine over blood clotting disorderThe two leading federal public health agencies called for an immediate pause in the use of the Johnson & Johnson COVID-19 vaccine on Tuesday, after six recipients in the U.S. developed a rare disorder involving blood clots within six to 13 days after being vaccinated. The news was first reported by the New York Times, citing officials briefed on the decision. The U.S. Food and Drug Administration and Centers for Disease Control and Prevention said all six were women aged between 18 and 48 and emphasized that the adverse events appear to be "extremely rare." "In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia)," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research and Dr. Anne Schuchat, Principal Deputy Director of the CDC said in a statement. So far, nearly 7 million Americans have received J&J shots, and about 9 million more have been delivered to states, CDC data shows. Scientists from the FDA and CDC will jointly investigate possible links between the vaccine and the clotting disorder and determine whether it should continue to be used or be limited. An emergency meeting of the CDC's outside advisory committee has been scheduled for Wednesday. "Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution," said the statement. Regulators in Europe are concerned about a similar issue with another coronavirus vaccine, developed by AstraZeneca PLC and Oxford University researchers. J&J shares slid 3.3% premarket, but are up 2.7% in the year to date through Monday, while the Dow Jones Industrial Average has gained 10.3%.
3:01 a.m. April 8, 2021 - By Ciara Linnane
Eli Lilly and Incyte say Phase 3 study of baricitinib in hospitalized COVID-19 patients failed to meet main goalEli Lilly & Co. and Incyte Corp. said Thursday a Phase 3 trial of rheumatoid arthritis treatment baricitinib plus standard of care (SoC) versus placebo plus SoC failed to meet its main goal. The trial's primary endpoint was defined as a difference in the number of patients needing non-invasive ventilation including high flow oxygen, or invasive mechanical ventilation or death by Day 28. Patients treated with baricitinib were 2.7% less likely than those receiving standard of care to progress to ventilation or death, a difference that was not statistically significant. The trial, involving 1,525 patients, showed 38% reduction in mortality by Day 28 in patients that were treated with baricitinib plus standard of care, including corticosteroids and remdesivir. Lilly said it will publish detailed data from the study in a peer-reviewed journal in the coming months. "Even though the study did not show a statistically-significant benefit on the primary endpoint, this trial showed the largest effect reported to date for reduction in mortality observed for this patient population with COVID-19," said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines. The U.S. Food and Drug Administration has granted emergency use authorization to baricitinib in combination with remdesivir in hospitalized patients with COVID-19 requiring supplemental oxygen, invasive mechanical ventilation or extracorporeal membrane oxygenation. Baricitinib, an oral JAK inhibitor, was discovered by Incyte. It is approved as Olumiant in the U.S. as a treatment for adults with moderate to severe rheumatoid arthritis and in the EU and Japan as a treatment for atopic dermatitis. Lilly shares were up 0.4% premarket, while Incyte was up 2%.
4:32 a.m. April 7, 2021 - By Tomi Kilgore
Anthem to provide employees with an incentive to be fully vaccinated against COVID-19Anthem Inc. said Wednesday it will provide an incentive to any of its employees who are fully vaccinated against COVID-19. The health insurer said the incentive will be in the form of a one-time credit toward medical premiums or a donation to the Anthem Cares Fund that helps support fellow employees in need, at the employees choice. "Anthem is committed to empowering our associates to live a healthy lifestyle, therefore it was important that we provided an incentive to those who receive the COVID-19 vaccination. I am impressed and grateful for everything our associates have done and continue to do for the customers and communities we serve," said Chief Human Resources Officer Leah Stark. There are currently three COVID-19 vaccines that have been granted emergency use authorization by the Food and Drug Administration, two-dose vaccines from Pfizer Inc. and partner BioNTech SE and Moderna Inc. , and Johnson & Johnson's one-dose vaccine. Anthem's stock, which was indicated down 0.4% in premarket trading, has rallied 9.7% year to date while the S&P 500 has gained 8.5%. (This replaces an earlier item that removes the dollar amount of the incentive provided by the company, after the company said the amount noted in a previous release resulted from a "publishing mistake.")
9:35 a.m. April 5, 2021 - By Tomi Kilgore
Chembio Diagnostics stock rockets on record volume after commercial launch of rapid COVID-19 testShares of Chembio Diagnostics Inc. skyrocketed 63.8% on record volume in afternoon trading Monday, to pace all gainers listed on major U.S. exchanges, in the wake of the point-of-care diagnostics company's announcement of the commercial launch of its rapid COVID-19/flu test. The stock was on track for the biggest one-day percentage gain since it doubled, on March 12, 2004. Trading volume ballooned to 206.6 million shares, compared with the full-day average of less than 1 million shares. The company said its test has been granted emergency use authorization by the Food and Drug Administration. Chembio said after Thursday's closing bell that the product, which produces results in 15 minutes, requires no instrumentation and simultaneously differentiates SARS-CoV-2 antigens and influenza Type A and Type B infections, is immediately available for shipment. "As COVID-19 converges with the flu, it is critical for physicians to be able to quickly differentiate between these viruses at the point-of-care, which present with nearly identical symptoms, in order to take appropriate clinical actions and maximize efficient use of healthcare resources," said Charles Caso, vice president of sales and marketing at Chembio. The stock has run up 21.4% year to date, while the S&P 500 has gained 8.6%.
2:31 a.m. April 5, 2021 - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 top 131.3 million and U.S. death toll above 555,000The global tally for the coronavirus-borne illness rose above 131.3 million on Monday, according to , while the death toll rose above 2.85 million. The U.S. continues to lead the world by cases, at 30.7 million, or about a quarter of the global tally, and fatalities, at 555,001. The U.S. added at least 36,670 new cases on Sunday, and at least 277 people died, although those numbers are likely under-reported given reduced staffing at hospitals at weekends. The U.S. has averaged 64,019 cases a day for the last week, up 18% from the average two weeks ago, as cases continue to rise despite the vaccination program, a trend experts say is due to states reopening and dropping restrictions on movement and overall pandemic fatigue. The U.S. is unlikely to face a "true" fourth wave of COVID-19 outbreaks, but the country should wait a few weeks longer before easing mitigation efforts, former Food and Drug Administration Commissioner Dr. Scott Gottlieb said Sunday. Speaking to CBS News' "Face the Nation," Gottlieb acknowledged that young people were driving new coronavirus outbreaks in many states, but that vaccination efforts should prevent another devastating surge of the virus. Outside of the U.S., Brazil is second globally in cases at 12.9 million and also second with a death toll at 331,433. India is third worldwide in cases with 12.6 million and fourth in deaths at 165,101. Mexico is third by deaths at 204,147 and 13th highest by cases at 2.3 million. The U.K. has 4.4 million cases and 127,078 deaths, the highest in Europe and fifth highest in the world.
3:02 a.m. April 1, 2021 - By Ciara Linnane
Pfizer, BioNTech say study of COVID-19 patients six months after second vaccine dose proved it is safe and effectivePfizer Inc. and German partner BioNTech SE said Thursday a study of COVID-19 patients six months after receiving a second dose of their vaccine BNT162b2 confirmed its high efficacy and lack of serious safety concerns. The companies said an analysis of 927 confirmed symptomatic cases of COVID-19 showed the vaccine had a 91.3% efficacy against the illness, measured seven days through up to six months after the second dose. The vaccine was 100% effective in preventing severe disease as defined by the U.S. Centers for Disease Control and Prevention and 95.3% effective in preventing severe disease as defined by the U.S. Food and Drug Administration. The vaccine also proved to be 100% effective in preventing COVID-19 cases when used against the South African variant, which is more infectious than the original virus. Experts have worried that new variants might prove more resistant to the vaccines that have won emergency use authorization from regulators. Pfizer and BioNTech said they have now evaluated vaccine safety in more than 44,000 participants 16 years of age and older, with more than 12,000 vaccinated participants having at least six months follow-up after a second dose. "These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the U.S. FDA," said Pfizer Chief Executive Albert Bourla. Prizer shares were up 0.2% premarket, while BioNTech shares were up 1.2%.
3:24 a.m. March 30, 2021 - By Jaimy Lee
BD gets FDA authorization for test that can detect COVID-19 and the fluBecton, Dickinson & Co. said it received emergency authorization from the Food and Drug Administration for a rapid, antigen test that can detect SARS-CoV-2 and two types of influenza. The test, which runs on the company's BD Veritor System, takes about 15 minutes to produce results and is expected to be available this summer. BD's stock has gained 10.9% over the past 12 months, while the broader S&P 500 is up 56.2%.
5:24 a.m. March 29, 2021 - By Ciara Linnane
Moderna says it's on track to deliver second 100 million doses to US. government by end MayModerna Inc. said Monday it has shipped the 100 millionth dose of its COVID-19 vaccine to the U.S. government and expects to meet its commitment dates for all current orders, including delivering a second 100 million doses by the end of May and a third 100 million by end-July. Since the vaccine was granted emergency use authorization by the U.S. Food and Drug Administration in December, Moderna shipped more than 16 million doses in January, 26 million in February and 44 million to date in March. "Looking forward, the company expects to ship 40-50 million doses per month to the U.S. Government to fulfill its commitments. All U.S. government supply comes from Moderna's dedicated supply chain in the U.S.," Moderna said in a statement. Shares were down 1.6% premarket, but have gained 28% in the year to date, while the SPDR S&P Biotech ETF has fallen 5.5% and the S&P 500 has gained 6%.
4:40 a.m. March 26, 2021 - By Ciara Linnane
GlaxoSmithKline and Vir Biotech seek FDA emergency authorization for COVID antibody treatmentGlaxoSmithKline PLC and Vir Biotechnology Inc. said Friday they have submitted to the U.S. Food and Drug Administration an application for emergency use authorization for their antibody treatment for mild-to-moderate COVID-19 in adults and adolescents aged 12 and older who are at risk of hospitalization or death. The companies said early data from a Phase 3 trial found the treatment showed an 85% reduction in hospitalization or death compared to placebo. There were 583 patients enrolled in the trial. Vir shares slid 0.8% premarket, but have gained 97% in the year to date, while the S&P 500 has gained 4%.
12:12 p.m. March 25, 2021 - By Claudia Assis
Pfizer, Eli Lilly say experimental arthritis drug tanezumab hits FDA snagPfizer Inc. and Eli Lilly and Co. said Thursday that a joint advisory committee of the U.S. Food and Drug Administration has voted against their investigational tanezumab drug for the treatment of certain types of arthritis in adults when use of other drugs aren't possible. "While we are disappointed with today's outcome, we continue to believe that tanezumab has a positive benefit-risk profile for patients with moderate-to-severe osteoarthritis pain for whom current treatments are ineffective or not appropriate," Ken Verburg, tanezumab development team leader at Pfizer, said in a statement. There was one voting question focused on whether the drug's benefits outweigh its risks, and the committee voted 19-1 against it, the companies said.
9:36 a.m. March 22, 2021 - By Tomi Kilgore
Odonate Therapeutics stock plummets toward record low after plan to 'wind down' operationsShares of Odonate Therapeutics Inc. plummeted 79.0% in active afternoon trading Monday, after the pharmaceutical company said it will wind down operations following disappointing data from its cancer treatment. The company said it determined, following feedback from the Food and Drug Administration in a pre-New Drug Application (pre-NDA) meeting, that tesetaxel, an orally administered chemotherapy agent, is unlikely to receive FDA approval. "Therefore, the company is discontinuing the development of tesetaxel and will wind down the operations of the company," the company said in a statement. Since going public in December 2017 at an initial public offering price of $24, the stock has traded in a closing price range of $11.78 (Dec. 27, 2018) to $45.63 (June 16, 2020); on Friday, the stock closed at $19.03. The stock has lost 73.9% over the past three months, while the S&P 500 has gained 7.0%.
5:40 a.m. March 19, 2021 - By Jaimy Lee
Incyte's Jakafi failed Phase 3 clinical trial as a treatment for some severely ill COVID-19 patientsShares of Incyte Corp. gained 1.6% in trading on Friday, the day after the company said its chemotherapy Jakafi did not meet the primary endpoint in a Phase 3 trial as a treatment for some severely ill COVID-19 patients. Incyte said it still plans to provide the drug on a compassionate-use basis pending approval from the Food and Drug Administration because Jakafi seems to improve mortality rates among these patients. The trial evaluated Jakafi in patients taking Gilead Sciences Inc.'s Veklury who were on mechanical ventilators and had also been diagnosed with acute respiratory distress syndrome. "There remains a significant unmet medical need for treatments that may potentially improve survival outcomes for patients suffering from severe COVID-19 related complications, specifically those requiring mechanical ventilation," Incyte CEO Steven Stein said in a news release. Incyte's shares have gained 21.2% over the past 12 months, while the broader S&P 500 is up 63.2%.
4:40 a.m. March 11, 2021 - By Tomi Kilgore
Johnson & Johnson COVID-19 vaccine recommended for use in the EUJohnson & Johnson said Thursday that its single-shot COVID-19 vaccine candidate has received a "positive opinion" from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). That means the CHMP recommends conditional marketing authorization (CMA) for the vaccine candidate developed by J&J's Janssen Pharmaceutical Companies. If CMA is granted, the vaccine will become available in the European Union. "The European Medicines Agency's recommendation is a landmark moment for Johnson & Johnson and for the world," said J&J Chief Scientific Officer Paul Stoffels. "Now, as we await a decision on the use of our single-dose COVID-19 vaccine in the European Union, we remain confident that the Johnson & Johnson vaccine will prove a critical tool for fighting this pandemic." The U.S. Food and Drug Administration had granted the J&J vaccine on Feb. 27. J&J's stock, which rose 0.6% in premarket trading, has gained 4.1% over the past three months while the Dow Jones Industrial Average has gained 7.5%.
9:04 a.m. March 10, 2021 - By Jaimy Lee
Vertex to begin Phase 1/2 trial of treatment for people with type 1 diabetesShares of Vertex Pharmaceuticals Inc. were down 0.2% in trading on Wednesday after the company said it started an early-stage clinical trial for its experimental treatment for people with type 1 diabetes. It also said the therapy received a fast-track designation from the Food and Drug Administration. The Phase 1/2, single-arm, open-label study will be conducted at multiple sites in the U.S. and aims to enroll 17 participants. Vertex gained access to the therapy through its roughly $1 billion acquisition of Semma Therapeutics Inc. in 2019. Vertex's stock is down 7.4% over the past year, while the S&P 500 has rallied 41.1%. The clinical trial is a Phase 1/2, single-arm, open-label study in patients who have T1D with impaired hypoglycemic awareness and severe hypoglycemia. This will be a sequential, multi-part clinical trial to evaluate the safety and efficacy of different doses of VX-880. Approximately 17 patients will be enrolled in the clinical trial. About Type 1 Diabetes T1D results from the autoimmune destruction of insulin-producing islet cells in the pancreas, leading to loss of insulin production and impairment of blood glucose control. The absence of insulin leads to abnormalities in how the body processes nutrients, leading to high blood glucose levels. High blood glucose can lead to diabetic ketoacidosis and over time, to complications such as kidney disease/failure, eye disease (including vision loss), heart disease, stroke, nerve damage and even death. Due to the limitations and complexities of insulin delivery systems, it can be difficult to achieve and maintain balance in glucose control in patients with T1D. Hypoglycemia often results because of the difficulty in balancing the different factors that impact glucose levels, including insulin, diet and exercise. Hypoglycemia remains a critical limiting factor in glycemic management, and severe hypoglycemia can cause loss of consciousness, coma, seizures, injury, and can be fatal. Over time, patients with T1D can develop impaired awareness of hypoglycemia, meaning they are no longer able to perceive the early signs of a hypoglycemic event, which can be dangerous and result in life threatening events. There are currently limited treatment options beyond insulin for the management of T1D.
8:49 a.m. March 10, 2021 - By Jaimy Lee
Bluebird's stock is up after saying illness reported in clinical trial wasn't likely caused by gene therapyShares of Bluebird Bio Inc. gained 6.9% in trading on Wednesday after the company said it was "unlikely" that the diagnosis of acute myeloid leukemia in a patient participating in an early-stage study can be attributed to its sickle cell disease treatment candidate. The experimental gene therapy is currently being tested in a Phase 1/2 clinical trial. "It is very unlikely our BB305 lentiviral vector played a role in this case and we have shared with the FDA that we believe these results support lifting the clinical holds on our β-thalassemia and sickle cell disease programs," Philip Gregory, Bluebird's chief scientific officer, said in a news release. The Food and Drug Administration had placed a clinical hold on the programs in February. "The findings, in our view, are pretty convincing that the vector is not responsible," Bernstein analysts told investors on Wednesday. Bluebird's stock is down 51.5% over the past 12 months, while the broader S&P 500 is up 41.1%.
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