Bulletin
Investor Alert

Topics

Food and Drug Administration

Video

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
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.
3:50 a.m. Oct. 14, 2021 - By Jaimy Lee
Regeneron is seeking full FDA approval for its monoclonal antibody for two types of COVID-19 patientsShares of Regeneron Pharmaceuticals Inc. gained 2.7% in premarket trading on Thursday after the company said the Food and Drug Administration accepted its application for approval of its monoclonal antibody treatment for non-hospitalized COVID-19 patients and as a prophylaxis for some people who have been exposed to the virus. The FDA said it will decide whether to approve the therapy by April 13 based on the priority review designation it granted to the application. It plans to hold an advisory committee meeting in advance of the decision. Regeneron said it plans to submit its monoclonal antibody treatment for FDA approval for hospitalized COVID-19 patients later this year. The treatment, Regen-Cov, has received emergency authorization for all three of these indications in the U.S. Regeneron's stock is up 13.2% this year, while the broader S&P 500 has gained 16.2%.
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.
4:11 a.m. Oct. 11, 2021 - By Jaimy Lee
Protagonist Therapeutics shares soar after FDA lifts clinical hold on its experimental cancer drugShares of Protagonist Therapeutics Inc. soared 87.0% in premarket trading on Monday after the company said the Food and Drug Administration had lifted a clinical hold on clinical trials of rusfertide, its experimental blood cancer treatment. The hold was put into place over concerns of skin tumors from animal research and a deeper examination of four new cancer cases that emerged during a clinical trial. No safety concerns were identified during the hold. The investigational treatment is expected to move forward into a Phase 3 clinical trial for polycythemia vera in the first quarter of next year. SVB Leerink analyst Joseph Schwartz told investors that lifting the clinical hold is a "very welcomed surprise, given the hold was disclosed less than a month ago, and it was unclear how long it would last." Protagonist's stock is down 9.5% so far this year, while the broader S&P 500 is up 16.9%.
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%.
4:24 a.m. Oct. 8, 2021 - By Jaimy Lee
ChemoCentryx's stock jumps 80% after receiving FDA approval for vasculitis drugShares of ChemoCentryx Inc. soared 80.3% in premarket trading on Friday after the company said that it had received approval from the Food and Drug Administration for its ANCA-associated vasculitis therapy. The company said this is the first new drug to treat the rare autoimmune disease in a decade. ChemoCentryx's stock slipped 68.3% this year, 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%.
2:19 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%.
4:26 a.m. Sept. 30, 2021 - By Jaimy Lee
Mirim's treatment for a rare liver disorder gets FDA approvalShares of Mirim Pharmaceuticals Inc. gained 2.3% in premarket trading on Thursday, the day after the company announced that the Food and Drug Administration had approved Livmarli as a treatment for cholestatic pruritus in people with the genetic disorder Alagille syndrome. It's the first and only drug for the 2,000 to 2,500 children in the U.S. who have this rare liver disorder. Livmarli is priced at about $391,000 per year, according to Raymond James analyst Steven Seedhouse, who estimates a $300 million market for this therapy. "We expect this drug to be widely adopted amongst children with ALGS," he wrote in a note on Wednesday. "Thus, the market's relatively muted reaction to approval despite overly discounting for regulatory risk heading into approval in our view provides an opportunity to buy now." Mirim's stock is up 6.9% so far this year, while the broader S&P 500 has gained 15.5%.
2:55 a.m. Sept. 28, 2021 - By Ciara Linnane
Pfizer and BioNTech submit initial data to FDA from trial of COVID-19 vaccine in children aged 5 to 12 Pfizer Inc. and German partner BioNTech SE said Tuesday they have submitted initial data from the late-stage trial of their COVID-19 vaccine in children aged 5 to 12 to the U.S. Food and Drug Administration, and are seeking an emergency-use authorization to add that patient group to the program. The news comes after the companies released initial data from the trial last week, saying the vaccine had proved safe and effective. The companies used two doses of just 10 mg in a trial involving 2,268 participants. "Topline immunogenicity and safety readouts for the other two age cohorts from the trial -- children 2 to <5 years of age and children 6 months to <2 years of age -- are expected as soon as the fourth quarter of this year," the companies said in a statement. They are also planning to submit data from the full Phase 3 trial for scientific peer-reviewed publication. Pfizer shares were down 0.6% premarket, while BioNTech was down 3%.
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.
4:13 a.m. Sept. 17, 2021 - By Steve Gelsi
Turning Point Brands shares fall on FDA denial orderTobacco and accessories company Turning Point Brands Inc.'s shares fell 5% Friday after it said it's considering a formal appeal and potential legal relief as a result of a market denial order (MDO) from the U.S. Food and Drug Administration for some of its vapor products. "TPB will continue to engage with the FDA and other stakeholders as we consider options moving forward," the company said. The FDA denial order came in response to a Premarket Tobacco Product Application by Turning Point Brands. The company said the application "established that the products' continued marketing would be 'appropriate for the protection of public health', the standard established by the Family Smoking Prevention and Tobacco Control Act of 2009. "These products are crucial to improving public health by helping adult smokers migrate to less harmful products," the company said. Shares of the company are up 8.8% so far this year compared to a gain of 19.1% by the S&P 500 .
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%.
4:00 a.m. Sept. 10, 2021 - By Tomi Kilgore
Apellis Pharmaceuticals stock plunges after disappointing result from GA treatment studies Shares of Apellis Pharmaceuticals Inc. plunged 31.6% toward a 10-month low to pace all premarket losers Friday, after one of the Phase 3 studies of the biopharmaceutical company's eye disease treatment failed to meet its primary endpoint. The company said late Thursday that the OAKS study for pegcetacoplan met the primary endpoint, as it significantly reduced geographic atrophy (GA) lesion growth, while the DERBY study missed its primary endpoint of GA lesion growth reduction. The company said it plans to submit a New Drug Application (NDA) for pegcetacoplan for GA to the U.S. Food and Drug Administration in the first half of 2022. Wedbush downgraded Apellis to neutral from outperform, saying the previous upgraded was predicated on both studies holding a "high probability of success," but the readout ended up in the "mixed bag" scenario. J.P. Morgan slashed its stock price target to $57 from $101, but kept its overweight rating, saying "patience required" but pegcetacoplan "likely gets across the goal line" eventually. Apellis' stock has shed 2.8% year to date through Thursday, while the iShares Biotechnology ETF has advanced 14.8% and the S&P 500 has gained 19.6%.
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%.
4:58 a.m. Aug. 27, 2021 - By Tomi Kilgore
Cassava's stock tumbles again, after Quanterix said it 'did not' prepare data charts presented by Cassava, that are under disputeQuanterix Corp. said that while it was previously engaged by Cassava Sciences Inc. to perform sample testing, the digitized biomarker analysis company said it, or its employees, "did not interpret the test results or prepare the data charts" presented by Cassava to the Alzheimer's Association International Conference (AAIC) in July, or otherwise. Earlier this week, to a request the Food and Drug Administration halt clinical studies of Cassava's Alzheimer's treatment because of , Cassava had said that data from Alzheimer's patients were generated by Quanterix. The news of the halt request had sent Cassava's stock plunging 39.9% in two days through Thursday. Quanterix's stock dropped 9.2% on Thursday, after losing 1.5% on Wednesday. In Friday's statement, Quanterix said it is "widely recognized for its commitment to business integrity and to upholding the highest standards of quality." Quanterix's stock rose 4.5% in premarket trading, while Cassava shares tumbled 21.2%
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.
2:37 a.m. Aug. 25, 2021 - By Tomi Kilgore
Cassava Sciences stock tumbles, and company responds to allegations disputing trial dataCassava Sciences Inc. responded Wednesday to allegations posted overnight regarding the "accuracy and integrity" of trial data for its treatment of Alzheimer's disease, saying it believed the claims are "false and misleading." Cassava's stock had rallied 1.9% on Tuesday, and 16.4% over the past three days, with the company saying early Tuesday that it reached agreement with the Food and Drug Administration under a Special Protocol Assessment (SPA) for its Phase 3 studies of oral simufilam for the treatment of Alzheimer's patients. The stock then tumbled after the bell -- it was down 17.8% in Wednesday's premarket -- after requesting the FDA halt the current clinical studies of simufilam, disputing the validity of clinical biomarker data, the integrity of western blot analyses and the integrity of analyses involving human brain tissue. "As a science company, we champion facts that can be evaluated and verified," said Chief Executive Remi Barbier. "This helps people make informed choices. It is important for stakeholders to separate fact from fiction, which is why we wish to address allegations head-on." Cassava with the "fact" that data from Alzheimer's patients were generated by an independent company, Quanterix Corp., and said western blot analysis is "foundational," and a standard lab technique used to detect a protein of interest. The stock has rocketed 1,627.7% year to date through Tuesday, while the S&P 500 has gained 19.4%.
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.
7:09 a.m. Aug. 23, 2021 - By Tomi Kilgore
Cruise stocks rally after FDA approval of Pfizer COVID-19 vaccineShares of cruise operators rallied Monday, as the Food and Drug Administration's full approval of the COVID-19 vaccine developed by Pfizer Inc. and partner BioNTech SE boosted hopes for increased vaccination rates. Carnival Corp.'s stock ran up 2.6%, Norwegian Cruise Line Holdings Ltd. shares climbed 3.0% and Royal Caribbean Group tacked on 1.1%. In comparison, the S&P 500 advanced 0.9%. The companies have required its staff and guests on most of their cruises to be vaccinated. Acting FDA Commissioner Janet Woodcock said the FDA approval of the Pfizer-BioNTech vaccine " ."
Browse topics:

Filter results by

Location

Us (353)

Europe (45)

Eu (34)

Asia Pacific (30)

China (24)

Canada (7)

Link to MarketWatch's Slice.