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FDA Panel Endorses Moderna’s Covid-19 Vaccine for Broad Use

  • 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
    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
5:35 a.m. Oct. 15, 2021 - By Jaimy Lee
FDA: Abbott is recalling two lab-based COVID-19 tests due to the possibility of false positive resultsShares of Abbott Laboratories were up 0.6% in premarket trading on Friday, the day after the Food and Drug Administration the company is recalling two laboratory COVID-19 test kits because of concerns about false positives. The tests are the Alinity m SARS-CoV-2 AMP Kits and Alinity m Resp-4-Plex AMP Kits. The FDA previously issued a warning about the potential for false positives with these tests in September. Abbott's stock is up 7.8% for the year, while the broader S&P 500 has gained 18.1%.
3:42 a.m. Oct. 15, 2021 - By Jaimy Lee
FDA to hold advisory committee for Merck's experimental COVID-19 pillShares of Merck & Co. Inc. were down 0.1% in premarket trading on Friday, the day after the Food and Drug Administration said it plans to convene an advisory committee on Nov. 30 to discuss the company's experimental COVID-19 pill, molnupiravir. Merck is developing the antiviral with the privately held Ridgeback Biotherapeutics; it recently applied for emergency authorization. The FDA requested advisory committee meetings for each of the authorized COVID-19 vaccines but it did not convene one ahead of the authorizations of the monoclonal antibodies or Gilead Sciences Inc.'s remdesivir, an antiviral used to treat severely ill COVID-19 patients that is now fully approved. "We believe that, in this instance, a public discussion of these data with the agency's advisory committee will help ensure clear understanding of the scientific data and information that the FDA is evaluating to make a decision about whether to authorize this treatment for emergency use," Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said in a statement. Merck's stock is up 0.4% for the year, while the S&P 500 has gained 18.1%.
2:16 a.m. Oct. 15, 2021 - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 head toward 240 million and FDA panel endorses Moderna boosters for someThe global tally for the coronavirus-borne illness climbed above 239.6 million on Friday, while the death toll edged above 4.88 million, according to . The U.S. continues to lead the world with a total of 44.8 million cases and 721,567 deaths. The U.S. is averaging more than 1,800 deaths a day, , although new cases and hospitalizations are declining. A Food and Drug Administration advisory committee said Thursday that some Americans who received Moderna COVID-19 vaccine at least six months ago should get a half-dose booster to rev up protection against the coronavirus. The panel of outside advisers to the Food and Drug Administration voted unanimously to recommend a booster shot for seniors, as well as younger adults with other health problems, jobs or living situations that put them at increased risk from COVID-19.The committee will reconvene on Friday to discuss boosters for the Johnson & Johnson shot. India is second by cases after the U.S. at 34 million and has suffered 451,814 deaths. Brazil has second highest death toll at 602,099 and 21.6 million cases. In Europe, Russia has most fatalities at 216,402, followed by the U.K. at 138,647.
2:16 a.m. Oct. 14, 2021 - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 top 239 million as FDA panel meets on Moderna boosterThe global tally for the coronavirus-borne illness climbed above 239 million on Thursday, while the death toll edged above 4.87 million, according to . The U.S. continues to lead the world with a total of 44.7 million cases and 719,530 deaths. The U.S. is averaging close to 1,900 deaths a day, , although new cases and hospitalizations are declining. a Food and Drug Administration advisory committee will meet later Thursday to discuss and take a vote on whether to authorize a booster dose for people vaccinated with the Moderna vaccine. The committee will reconvene on Friday to discuss boosters for the Johnson & Johnson shot. India is second by cases after the U.S. at 34 million and has suffered 451,435 deaths. Brazil has second highest death toll at 601,574 and 21.6 million cases. In Europe, Russia has most fatalities at 215,438, followed by the U.K. at 138,487.
7:32 a.m. Oct. 13, 2021 - By Jaimy Lee
White House says an estimated 7 million people have received a COVID-19 boosterThe number of people in the U.S who are eligible to get a COVID-19 but have not been vaccinated has decreased to 66 million individuals, compared with 97 million people who met these criteria back in late July, according to White House officials. "There's stronger evidence that vaccination requirements are working," Jeff Zients, the White House's COVID-19 response coordinator, said Wednesday during a press briefing. "They're driving up vaccination rates." He also said that an estimated 7 million people in the U.S. have gotten a COVID-19 booster shot; 3 million of those shots were administered in the last week. The only COVID-19 shot that is currently authorized is the one developed by BioNTech SE and Pfizer Inc. . A Food and Drug Administration advisory committee is scheduled to meet Thursday and Friday to discuss whether the regulator should authorize Moderna Inc.'s and Johnson & Johnson's booster shots.
2:29 a.m. Oct. 11, 2021 - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 near 238 million as Merck sees FDA approval for antiviralThe global tally for the coronavirus-borne illness climbed above 237.9 million on Monday, while the death toll rose above 4.85 million, according to . The U.S. continues to lead the world with a total of 44.3 million cases and 713,350 deaths. The U.S. is again averaging 2,000 deaths a day, , although new cases and hospitalizations are declining. Merck & Co. Inc. submitted an application for Emergency Use Authorization (EUA) with the Food and Drug Administration for molnupiravir, their oral antiviral medicine for the treatment of mild-to-moderate COVID-19 in adults. The company had disclosed that data from a Phase 3 trial found the treatment reduced the risk of of hospitalization or death in adults at risk for progressing to severe COVID-19 by 50%. India is second by cases after the U.S. at 33.9 million and has suffered 450,782 deaths. Brazil has second highest death toll at 601,011 and 21.6 million cases. In Europe, Russia has most fatalities at 213,522, followed by the U.K. at 138,139.
2:12 a.m. Oct. 11, 2021 - By Tomi Kilgore
Merck, Ridgeback submit EUA application for their pill to treat COVID-19 Merck & Co. Inc. and Ridgeback Biotherapeutics said Monday that Merck has submitted an application for Emergency Use Authorization (EUA) with the Food and Drug Administration for molnupiravir, their oral antiviral medicine for the treatment of mild-to-moderate COVID-19 in adults. The companies said the application followed positive results from a Phase 3 trial which showed that with adults at risk for progressing to severe COVID-19, molnupiravir reduced the risk of hospitalization or death by 50%. The companies said 7.3% (28 of 385) of those who received molnupiravir were hospitalized and there were not deaths after 29 days, while 14.1% of patients treated with a placebo (53 of 377) were hospitalized and there were eight deaths. "The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data," said Merck Chief Executive Robert Davis. Merck's stock, which fell 1.2% in premarket trading, has gained 3.4% year to date, while the Dow Jones Industrial Average has advanced 13.5%.
6:38 a.m. Oct. 8, 2021 - By Jaimy Lee
Giving Moderna's COVID-19 booster at the same time as Sanofi's flu is safe and effectiveU.S.-listed shares of Sanofi gained 0.4% in trading on Friday after it announced that co-administering a flu shot with Moderna Inc.'s experimental COVID-19 booster in seniors is safe and effective. Moderna's stock was down 2.7%. The interim findings came from a study of about 300 participants, and they showed a similar immune response and safety signal when giving the shots at the same time compared with giving the shots separately. Sanofi's flu shot, Fluzone High-Dose Quadrivalent, is approved in the U.S. for people who are 65 years old and older. Moderna's booster candidate is currently under review for emergency authorization at the Food and Drug Administration. So far this year, Sanofi's stock has gained 0.5% and Moderna shares have soared 187.8%, while the broader S&P 500 is up 16.1%.
4:08 a.m. Oct. 8, 2021 - By Jaimy Lee
AstraZeneca's experimental asthma gets an orphan drug designation for another diseaseU.S.-listed shares of AstraZeneca gained 0.3% in premarket trading on Friday after the company said an experimental asthma drug it is developing with Amgen has been given an orphan drug designation as a treatment for eosinophilic esophagitis, a rare inflammatory disease. The Food and Drug Administration is expected to decide whether to approve the investigational therapy, tezepelumab, for asthma in the first three months of 2022. AstraZeneca's stock is up 20.7% for the year, while the S&P 500 has gained 16.1%.
4:46 a.m. Oct. 7, 2021 - By Jaimy Lee
Pfizer, BioNTech file for FDA authorization for their COVID-19 vaccine in children Shares of Pfizer Inc. were up 0.1% in premarket trading on Thursday after the company and BioNTech SE announced they submitted an application for emergency use authorization for their COVID-19 vaccine in children between the ages of 5 and 11 years old. The Food and Drug Administration will review the safety and efficacy of the vaccine before deciding whether to authorize the shot for this age group. Pfizer's stock is up 14.1% so far this year, while the broader S&P 500 has gained 15.7%.
2:42 a.m. Oct. 5, 2021 - By Ciara Linnane
J&J amends FDA EUA submission for COVID-19 booster with data showing 94% protection against moderate to severe illnessJohnson & Johnson said Tuesday it has submitted an amendment to the emergency use authorization it's seeking from the U.S. Food and Drug Administration for a booster shot of its COVID-19 vaccine with additional data showing it increased protection to 94% against moderate to severe or critical COVID-19 in the U.S. The submission includes recent data from a Phase 3 trial that found the booster given 56 days after primary dose provided 94% protection against symptomatic illness in moderate to severe/critical COVID-19 and 100% protection against severe/critical COVID-19, at least 14 days post-booster vaccination. The submission further includes Phase 1/2 data that shows a booster given six months after the single shot vaccine increases antibody levels nine-fold a week after the booster that climbs to 12-fold higher four weeks after the booster. J&J is planning to submit the data to other regulators, to the World Health Organization and National Immunization Technical Advisory Groups. Shares were up 0.5% premarket and have gained 1.2% in the year through Monday, while the Dow Jones Industrial Average has gained 11%.
2:19 a.m. Oct. 5, 2021 - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 top 235 million and AstraZeneca seeks FDA EUA for antibodyThe global tally for the coronavirus-borne illness climbed above 235.4 million on Tuesday, while the death toll rose above 4.8 million, according to . The U.S. continues to lead the world with a total of 43.8 million cases and 703,285 deaths, after passing 700,000 late Friday. The U.S. is now averaging almost 2,000 deaths a day, , a slight improvement over recent trends and new cases and hospitalizations are declining. AstraZeneca has requested an Emergency Use Authorization to the U.S. Food and Drug Administration for its Covid-19 prophylaxis AZD7442, If granted, AZD7442 would be the first long-acting antibody to receive an EUA for Covid-19 prevention. Data from a Phase 3 trial showed a 77% reduction in the risk of developing symptomatic Covid-19 with long-acting antibody combination, the drug company said. India is second by cases after the U.S. at 33.8 million and has suffered 449,260 deaths. Brazil has second highest death toll at 598,152 and 21.5 million cases. In Europe, Russia has most fatalities at 207,932, followed by the U.K. at 137,378.
3:46 a.m. Oct. 4, 2021 - By Tomi Kilgore
OpGen stock rockets after upbeat revenue updateShares of OpGen Inc. rocketed 31.9% in active premarket trading Monday, after the precision medicine company provided a revenue update following the recent Food and Drug Administration clearance of its Acuitas AMR Gene Panel to aid in the diagnosis of severe infections. Trading volume spiked to 5.1 million shares ahead of the open, compared with the full-day average of about 1.8 million shares. The company said preliminary third-quarter revenue was approximately $1.2 million, compared with the FactSet consensus of $800,000. The stock has rallied 35.3% year to date through Friday, while the S&P 500 has gained 16.0%.
2:16 a.m. Oct. 1, 2021 - By Ciara Linnane
Merck shares jump 3.5% premarket after it reveals positive data in trial of COVID-19 antiviralMerck shares jumped 3.5% in premarket trade Friday, after the company said the oral antiviral it developed as a treatment for COVID-19 with partner Ridgeback Biotherapeutics reduced the risk of hospitalization or death in at risk adult patients with mild-to-moderate COVID by about 50% in an interim analysis of data from a Phase 3 trial. Some 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization, compared with 14.1% of patients given a placebo. Through Day 29, no patients given molnupiravir died, compared with eight patients who died on placebo. The company is now planning to submit an application for an emergency use authorization for the treatment from the Food and Drug Administration and will also seek it from other regulatory bodies around the world. The interim analysis looked at data from 775 patients enrolled in the trial on or prior to Aug. 5. Merck is planning to produce 10 million courses of treatment by year-end with more to come in 2022. Shares have fallen 3.7% in the year to date, while the S&P 500 has gained 14.7%.
5:19 a.m. Sept. 27, 2021 - By Jaimy Lee
Intra-Cellular says clinical study shows its schizophrenia drug helps patients with bipolar disorderShares of Intra-Cellular Therapies Inc. gained 1.5% in premarket trading on Monday after the company said clinical data showed that its experimental treatment for bipolar disorder reduced depressive symptoms. The Phase 3 study evaluated Caplyta, which is already approved as a treatment for schizophrenia, in 381 people with bipolar I or bipolar II disorder who were experiencing a depressive episode. There were no significant weight changes in the group of people who took the drug compared with those who got the placebo. The most common side effects were sleepiness and nausea. The drug is currently under review at the Food and Drug Administration as a bipolar therapy, and the regulator is expected to make a decision by Dec. 17. Intra-Cellular's stock has gained 15.5% so far this year, and the S&P 500 is up 18.6% for the year.
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.
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.
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.
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%.
2:34 a.m. Sept. 17, 2021 - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 top 227 million as FDA advisory committee meets on boostersThe global tally for the coronavirus-borne illness climbed above 227 million on Friday, while the death toll rose to 4.67 million, according to . The U.S. continues to lead the world with a total of 41.8 million cases and 670,009 deaths. Almost 2,000 deaths are being recorded daily, the most since Winter, and are almost entirely unvaccinated people. A Food and Drug Administration advisory committee will convene later Friday to review data and take a vote on whether booster vaccine doses are needed, but many experts say they are not and that the vaccines are still effective in preventing severe illness and death. New cases and hospitalizations have started to fall in some places recently, but the number of Americans that are fully vaccinated has stalled at 54.2%, India is second by cases after the U.S. at 33.4 million and has suffered 444,248 deaths. Brazil has second highest death toll at 589,246 and 21 million cases. In Europe, Russia has most fatalities at 193,111, followed by the U.K. at 135,134.
1:20 p.m. Sept. 15, 2021 - By Jaimy Lee
FDA says COVID-19 vaccines continue to protect people in the U.S. from severe diseaseThe Food and Drug Administration said Wednesday that observational studies have had mixed findings assessing whether the efficacy for BioNTech SE and Pfizer Inc.'s COVID-19 vaccine is declining as a result of time or the delta variant but in general the vaccines available in the U.S. continue to protect people against severe disease and death. The FDA's was published Wednesday in advance of an advisory committee meeting set for Friday; at that meeting, a group of independent experts will discuss and then vote on whether they think the FDA should approve a COVID-19 booster dose for people who are at least 16 years old or older. The FDA is not required to follow the advice of the committee but often does. Pfizer's document for the meeting was also published on Wednesday; it cited the need to look at the when it comes to making a regulatory decision about a third dose of its vaccine. The FDA's document, on the other hand, said it has not independently verified all potentially relevant studies.
5:29 a.m. Sept. 15, 2021 - By Jaimy Lee
Pfizer cites 'totality' of clinical data in bid for COVID-19 booster approvalShares of Pfizer Inc. gained 0.1% in premarket trading on Wednesday after the drug maker said the "totality" of clinical data indicates that people who are at least 16 years old and were vaccinated with the COVID-19 shot that it developed with BioNTech SE should get a booster after six months. In a published Wednesday morning by the Food and Drug Administration in advance of an advisory committee meeting set for Friday, Pfizer said its Phase 3 substudy examined 306 people between the ages of 18 and 55 years old who got a third dose. It found that an extra dose is considered safe and increased neutralizing antibody titers against the original strain of the virus as well as the beta and delta variants to a higher rate than what was reported after two doses in the clinical trials last year. Younger participants were more likely to report systemic events after the second and third doses than the first dose; fever was more common after the third dose. No adverse events were reported in the first month after the third dose. Pfizer also cited research conducted by Israel, the Centers for Disease Control and Prevention, and the hospital system Kaiser Permanente in the document, saying that data from Israel "suggest reduced effectiveness against severe disease could eventually follow observed reductions in effectiveness against SARS-CoV-2 infections." Pfizer's stock is up 21.4% this year, while the S&P 500 has gained 18.9%.
8:30 a.m. Sept. 3, 2021 - By Ciara Linnane
Government health officials tell White House to scale back booster plan: reportGovernment health officials have advised the White House to scale back President Joe Biden's promise to offer boosters to vaccinated Americans beginning later this month, because available data are insufficient to determine they are necessary, citing unnamed people described as familiar with the discussion. Dr. Janet Woodcock, the acting commissioner of the Food and Drug Administration, and Dr. Rochelle P. Walensky, director of the Centers for Disease Control and Prevention, told the White House that they will only be able to determine in the coming weeks whether boosters are necessary for people who received the vaccine developed by Pfizer Inc. and German partner BioNTech SE , and, even then, they may only be needed by certain individuals. Biden said the government would only act with the approval of the FDA. But health experts were concerned that the Biden government was getting ahead of itself and ahead of its own regulatory agencies. The FDA is also awaiting data from Israel, which is already administering boosters to people 12 and older amid concerns that the vaccine's potency wanes over time. The FDA wants to see the underlying data on which that decision was based.
11:46 a.m. Sept. 2, 2021 - By Jaimy Lee
FDA committee to discuss COVID-19 booster shotsAn influential Food and Drug Administration advisory committee plans to meet Sept. 17 to discuss extra doses of the COVID-19 vaccines, including the application filed by BioNTech SE and Pfizer Inc. for a third dose of their COVID-19 shot. Moderna Inc. on Wednesday also submitted its application for a booster dose of its COVID-19 vaccine. The FDA's Vaccines and Related Biological Products Advisory Committee traditionally recommends whether the FDA should authorize or approve a vaccine or drug. The regulator is not required to follow the advice of the committee but it often does. The Biden administration previously said that COVID-19 booster shots will be available to adults starting Sept. 20, though from the FDA and the Centers for Disease Control and Prevention. "The FDA will review the supplemental application as expeditiously as possible, while still doing so in a thorough and science-based manner," Dr. Peter Marks, the director of the FDA's Center for Biologics Research and Evaluation, said in a on Wednesday.
1:03 p.m. Sept. 1, 2021 - By Claudia Assis
Moderna asks FDA to evaluate COVID-19 vaccine booster candidateModerna Inc. said late Wednesday it is submitting documents to the U.S. Food and Drug Administration (FDA) for the evaluation of a booster dose of its COVID-19 vaccine as a 50-microgram dose. The biotech company said it expects to submit data to European authorities and others around the world in the coming days. Data supported that the 50-microgram dose "shows robust antibody responses against the delta variant," the company said. Moderna's COVID-19 vaccination entails two shots of 100 micrograms each. has intensified in the past two months with both Moderna and Pfizer Inc. promoting their booster candidates, with support from the White House. Shares of Moderna rose 0.7% in the extended session after ending the regular trading day up 3.5%.
10:37 a.m. Aug. 26, 2021 - By Jaimy Lee
CDC: Overdoses of ivermectin are risingThere has been a "rapid increase" in prescriptions of ivermectin among people looking to treat or prevent COVID-19 cases, according to a issued Thursday by the Centers for Disease Control and Prevention. Ivermectin is an approved treatment for parasitic worms in animals and some rare conditions in humans, but not COVID-19 infections. "Adverse effects associated with ivermectin misuse and overdose are increasing, as shown by a rise in calls to poison control centers reporting overdoses and more people experiencing adverse effects," the CDC said Thursday. The Food and Drug Administration earlier this week , which is not proven to treat COVID-19. "You are not a horse," the regulator said in a tweet that has since gone viral. The drug is one of several therapies that are but have become a worrisome issue for public-health experts as people seek alternative ways to address COVID-19 infections.
3:01 a.m. Aug. 26, 2021 - By Tomi Kilgore
Pfizer, BioNTech sign LOI with Brazil's Eurofarma to make COVID-19 vaccines for use in Latin AmericaPfizer Inc. and BioNTech SE said Thursday that they have signed a letter of intent (LOI) with Brazil-based biopharmaceutical company Eurofarma Laboratórios SA to make COVID-19 vaccines for distribution in Latin America. Eurofarma will receive drug product from the U.S., and will perform manufacturing activities, with distribution expected to start in 2022. The annual production is expected to be more than 100 million doses. Pfizer and BioNTech said it will now have 20 manufacturing facilities in four continents. The companies have shipped 1.3 billion COVID-19 vaccine doses to more than 120 countries to date, and aim to provide 2 billion doses to low and middle income countries through 2022. The Pfizer-BioNTech vaccine has been by the U.S. Food and Drug Administration, and the companies have initiated an application for approval of a third dose as a booster. Shares of Pfizer are up 0.3% in premarket trading, while BioNTech's stock is down 0.8% and futures for the S&P 500 are slipping 0.1%.
8:49 a.m. Aug. 25, 2021 - By Jaimy Lee
BioNTech, Pfizer initiate application for approval of a third dose of their COVID-19 vaccineBioNTech SE and Pfizer Inc. said Wednesday that they initiated an application to U.S. regulators for a third dose of Comirnaty, their COVID-19 vaccine. BioNTech's stock was down 0.2% in trading on Wednesday, while Pfizer's stock fell 1.8%. The companies said they plan to complete the submission of a third dose for Americans who are at least 16 years old sometime this week. The supplemental application comes about two week after the Biden administration announced that adults who received the mRNA vaccines developed by BioNTech/Pfizer and Moderna Inc. will likely be allowed to get a third dose starting Sept. 20. The two-shot vaccine received full approval from the Food and Drug Administration on Monday. So far this year, BioNTech's stock has soared 353.2%, shares of Pfizer have gained 29.0%, and the S&P 500 is up 19.4%.
5:58 a.m. Aug. 25, 2021 - By Tomi Kilgore
Moderna completes BLA submission for full approval of COVID-19 vaccineShares of Moderna Inc. rallied 4.0% in morning trading Wednesday after the biotechnology company said it has completed the submission to the Food and Drug Administration for its Biologics License Application (BLA) for the "full licensure" of its COVID-19 vaccine, for people 18 years old and older. "This BLA submission for our COVID-19 vaccine, which we began in June, is an important milestone in our battle against COVID-19 and for Moderna, as this is the first BLA submission in our company's history," said Chief Executive Stéphane Bancel. "We are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through six months after dose 2." The announcement comes two days after the COVID-19 vaccine developed by Pfizer Inc. and partner BioNTech SE , while Moderna's vaccine is currently granted emergency use authorization, as is Johnson & Johnson's vaccine. Moderna's stock has soared 293.1% year to date, while shares of Pfizer have climbed 28.5% and J&J have gained 10.7%. The S&P 500 has advanced 19.5% this year.
2:22 a.m. Aug. 24, 2021 - By Tomi Kilgore
Coronavirus tally: Daily average for new cases, deaths and hospitalizations keep climbing to multi-month highsThe global tally for the coronavirus-borne illness climbed to above 212.61 million as of early Tuesday, while death toll rose to 4,442,545, according to . The U.S. led the world with a total of 37.94 million cases and 629,411 deaths. The daily average of new cases over the past seven days rose to 150,625 as of Monday, up 29% from two weeks ago, and the highest count since Jan. 30, according to . The daily average for deaths increased to 1,057, up 91 in two weeks and the most since March 24. The daily average for hospitalizations of 93,318 was up 39% from two weeks ago and the most since Feb. 6. The number of people that have been fully vaccinated rose to 171.1 million, or 51.5% of the total U.S. population, according to , while the number of people who have received at least one dose of a vaccine edged up to 201.7 million, or 60.8% of the total population. Hopes that vaccination rates would increase were boosted by the Food and Drug Administration's developed by Pfizer Inc. and BioNTech SE on Monday for people at least 16 years old.
2:51 a.m. Aug. 23, 2021 - By Tomi Kilgore
Coronavirus tally: Average daily U.S. death toll tops 1,000 for first time in 5 months, FDA set to approve Pfizer vaccineThe global tally for the coronavirus-borne illness climbed to 211.9 million as of early Monday, while death toll rose to 4,432,694, according to . The U.S. led the world with a total of 37.71 million cases and 628,503 deaths. The daily average of new cases over the past seven days rose to 149,675 as of Sunday, up 36% from two weeks ago, but down from 150,138 on Saturday, according to . The daily average for deaths increased to 1,008, topping the 1,000 mark for a second-straight day, and up 95% in two weeks, and the most since March 25. Hospitalizations of 92,482 was up 43% from two weeks ago and the most since Feb. 6. The number of people that have been fully vaccinated rose to 170.82 million, or 51.5% of the total U.S. population, according to . The Food and Drug Administration is Pfizer Inc.'s and partner BioNTech SE's COVID-19 vaccine as early as Monday.
2:54 p.m. Aug. 20, 2021 - By Wallace Witkowski
Pfizer and BioNTech shares rise on report FDA could fully approve COVID-19 vaccine next weekPfizer Inc. and U.S.-listed shares of BioNTech SE rose in the extended session Friday following a report that the drug makers will likely get full Food and Drug Administration approval for their COVID-19 vaccine sometime next week. Pfizer shares rose more than 2% after hours, following a 0.2% decline to close at $48.72, and German-based BioNTech's ADRs rallied more than 5%, following a 5.1% gain to close at $348.68. Late Friday, that the FDA could approve the vaccine, which up until now has been distributed on an emergency basis, as early as Monday but could possibly go past that if regulators need more time to review data. The Department of Health and Human Services recently announced that to those who already received their first two shots. Back in July, Pfizer and BioNTech reported targeting the delta variant of the virus.
6:33 a.m. Aug. 18, 2021 - By Tomi Kilgore
Virpax's stock rockets nearly 5-fold in 2 days after upbeat FDA response to its SARS-CoV-2 inhibitorShares of Virpax Pharmaceuticals Inc. rocketed for a second straight day on heavy volume, after the company announced an upbeat pre-investigational new drug response from the Food and Drug Administration on its product to inhibit SARS-CoV-2 and the flu. The stock shot up 53.6% in morning trading, after soaring 265.5% on Tuesday, to mark a two-day gain of 461.4%. Trading volume was 28.0 million shares early Wednesday, after a record total of 165.9 million shares on Tuesday, compared with the full-day average over the past 30 days of 9.7 million shares. Before Tuesday's open, Virpax said the FDA indicated it may pursue a New Drug Application (NDA) for MMS019, as a once daily intranasal treatment. MMS019 is Virpax's "high-density molecular masking spray under development for the use as an anti-viral barrier product." The company said MMS019 has shown to inhibit viral replication of SARS-CoV-2 and flue in animals, even at much higher ranges that what is encountered in humans in the nasal passages, with no adverse effects. The stock, which started trading in February, as now run up 484.2% over the past three months, while the S&P 500 has gained 7.8%.
7:49 a.m. Aug. 16, 2021 - By Tomi Kilgore
Pfizer, BioNTech submit trial data on COVID-19 booster shot to FDAPfizer Inc. and partner BioNTech SE announced Monday that data from a Phase 1 study has been submitted to the U.S. Food and Drug Administration, for the evaluation of a third, booster dose of their COVID-19 vaccine. The companies said they will also submit the data to the European Union's version of the FDA, the European Medicines Agency, as well as other regulatory authorities, in the coming weeks. In the U.S., Pfizer-BioNTech plan to seek licensure of a third dose in people at least 16 years old. Last week, for some people with compromised immune systems. "This initial data indicate that we may preserve and even exceed the high levels of protection against the wild-type virus and relevant variants using a third dose of our vaccine," said BioNTech Chief Executive Ugur Sahin. "A booster vaccine could help reduce infection and disease rates in people who have previously been vaccinated and better control the spread of virus variants during the coming season." Shares of Pfizer slipped 0.6% in midday trading and BioNTech's stock dropped 10.6%, while the S&P 500 eased 0.4%.
11:33 a.m. Aug. 13, 2021 - By Tomi Kilgore
Sesen Bio's stock rocked on heavy volume after shock FDA decision on BLA for cancer treatmentShares of Sesen Bio Inc. was rocked for a more than 75.4% loss on massive volume in afternoon trading Friday, after the company focused on cancer treatments shocked investors by saying it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration. Trading volume spiked to 54.5 million shares, compared with the full-day average of about 6.5 millions shares. The CRL was regarding its Biologics License Application (BLA) for Vicineum for the treatment of unresponsive non-muscle invasive bladder cancer (NMIBC). The FDA determined that it can't approve the BLA for Vicineum in its present form. "We are deeply disappointed by this unexpected result, and it is an unfortunate day for patients suffering from BCG-unresponsive NMIBC," said Sesen Chief Executive Dr. Thomas Cannell. The company said it plans to request a meeting with the FDA "as soon as possible" to discuss the next steps needed for the BLA to be approved. The stock was trading around $5.92 just prior to a trading halt for news, to mark a 20.6% intraday gain, and a 51.0% rally since the Aug. 9 close. In its second-quarter earnings report before the Aug. 9 open, the company said in a July meeting with the FDA regarding the BLA for Vicineum, there was no Advisory Committee meeting planned at that time, and that no post-marketing requirements had been identified, and said an FDA decision on the BLA was expected by Aug. 18. The stock has now lost 10.4% year to date, while the iShares Biotechnology ETF has gained 11.8% and the S&P 500 has advanced 18.8%.
2:19 a.m. Aug. 13, 2021 - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 top 205.4 million as FDA authorizes vaccine booster for those with weak immune systemsThe global tally for the coronavirus-borne illness headed above 205.4 million on Friday, while the death toll climbed above 4.33 million according to . The U.S. leads the world with a total of 36.3 million cases and in deaths with 619,093 as the highly infectious delta variant continues to spread fast, especially in states with low vaccination rates. As expected, the U.S. Food and Drug Administration late Thursday for those with weakened immune systems in its first regulatory nod for a booster shot in the U.S. "The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease," acting FDA Commissioner Janet Woodcock said in a statement. "After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna vaccines." The FDA's announcement was made ahead of the CDC advisory committee's meeting, which is scheduled for Friday. The committee is expected to decide whether the CDC should recommend an extra shot for people who are immunocompromised. India is second by cases at 32.1 million and third by deaths at 430,254 according to its official numbers, which are expected to be undercounted. Brazil is second in deaths at 566,896, but is third in cases at 20.3 million. Mexico has fourth-highest death toll at 246,811 but has recorded just 3.0 million cases, according to its official numbers. In Europe, Russia continues to pull ahead of the U.K. by deaths at 165,996, while the U.K. has 1301,016, making Russia the country with the fifth-highest death toll in the world and highest in Europe.
3:23 a.m. Aug. 12, 2021 - By Jaimy Lee
CDC advisory committee to meet Friday, discuss COVID-19 booster shotsAn influential group of advisors to the Centers for Disease Control and Prevention is scheduled to meet Friday to discuss whether people who are immunocompromised should receive COVID-19 booster shots. This is the main item on the agenda for the CDC's Advisory Committee on Immunization Practices , which will be webcast. Media outlets, citing anonymous sources, that the Food and Drug Administration is expected to update the emergency-use authorizations for Pfizer Inc. and Moderna Inc.'s COVID-19 shots to allow them to be used as booster shots in people with weaker immune systems.
2:26 a.m. Aug. 12, 2021 - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 head toward 205 million and FDA reportedly read to authorize boosters for someThe global tally for the coronavirus-borne illness headed above 204.8 million on Thursday, while the death toll climbed above 4.32 million according to . The U.S. leads the world with a total of 36.2 million cases and in deaths with 618,479 as the highly infectious delta variant continues to spread fast, especially in states with low vaccination rates. The U.S. Food and Drug Administration is expected to authorize a third dose of the COVID-19 vaccine for those with weakened immune systems as soon as Thursday, The emergency-use authorization would apply to both the Pfizer-BioNTech and Moderna vaccines, which are based on the same mRNA technology. India is second by cases at 32 million and third by deaths at 429,669 according to its official numbers, which are expected to be undercounted. Brazil is second in deaths at 565,748, but is third in cases at 20.2 million. Mexico has fourth-highest death toll at 246,203 but has recorded just 2.9 million cases, according to its official numbers. In Europe, Russia continues to pull ahead of the U.K. by deaths at 165,201, while the U.K. has 130,021, making Russia the country with the fifth-highest death toll in the world and highest in Europe.
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