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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%.
3:24 a.m. Oct. 14, 2021 - By Jaimy Lee
NRx shares jump 39% on new clinical data testing its experimental COVID-19 drug in the critically illShares of NRx Pharmaceuticals Inc. soared 39.9% in premarket trading on Thursday after the company said new published in the Journal of Infectious Diseases and Treatment showed that its experimental COVID-19 therapy improved survival in critically ill patients. The data came from an open-label trial assessing respiratory failure in 21 patients who were too sick to participate in the company's Phase 2b/3 trial evaluating the drug, aviptadil, in COVID-19 patients with respiratory failure. NRx said there were no adverse events, though low blood pressure was reported and managed in two patients. NRx's stock is down 61.3% so far this year, while the broader S&P 500 is up 16.1%.
12:24 p.m. Oct. 13, 2021 - By Jaimy Lee
'Mixing' COVID-19 vaccines triggers a stronger immune response, preliminary NIH study saysGiving people a different COVID-19 booster than the vaccine series that they originally received is safe and generates an immune response that is stronger, according to a conducted by the National Institutes of Health. (At this time, only BioNTech and Pfizer Inc.'s COVID-19 booster has been authorized for people who were previously vaccinated with that vaccine series.) The preprint, which was published Wednesday in advance of a public presentation set for Friday afternoon, evaluates all three authorized or approved COVID-19 vaccines in the U.S. in 458 participants as part of a "mix-and-match" clinical trial. With the exception of the people who were exclusively vaccinated and boosted with Johnson & Johnson's shots, all participants reported efficacy rates of at least 90.7%. "These data strongly suggest that homologous and heterologous booster vaccine will increase protective efficacy against symptomatic SARS-CoV-2 infection," the authors wrote. There are, however, some limitations to the research. The study is not randomized, and it also only assessed data available 29 days after the participants received their boosters.
5:17 a.m. Oct. 12, 2021 - By Tomi Kilgore
Moderna to deliver additional 176.5 million COVID-19 vaccine doses for Covax after options exercisedShares of Moderna Inc. rallied 1.9% in premarket trading Tuesday, after the biotechnology company said Gavi, the Vaccine Alliance, has exercised its option to buy an additional 176.5 million COVID-19 vaccine doses for the Covax program. Of the additional doses, 116.5 million doses are expected to be delivered in the first quarter of 2022, while 60 million doses are expected to be delivered in the second quarter of 2022. Covax still has the option to buy an additional 116.5 million COVID-19 vaccine doses for delivery in the third quarter of 2022, and an additional 116.5 million doses in the fourth quarter. Moderna's stock has soared 192.1% year to date through Monday, while the S&P 500 has gained 16.1%.
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%.
9:38 a.m. Oct. 6, 2021 - By Jaimy Lee
WHO widely recommends GSK's malaria vaccineGlaxoSmithKline said Wednesday that the World Health Organization has widely recommended use of its malaria vaccine in children in sub-Saharan Africa and other regions with moderate or high rates of malaria transmission. A combination of malaria antivirals and the vaccine can cut the risk of episodes, hospital admissions, and death by about 70%, compared to using only the antivirals. GSK, which began developing the vaccine 30 years ago, will donate 10 million doses for pilot programs in Ghana, Kenya, and Malawi, and it plans to produce 15 million doses per year. GSK's stock is up 3.0% so far this year, while the broader S&P 500 has gained 15.7%.
3:32 a.m. Oct. 6, 2021 - By Tomi Kilgore
Voyager Therapeutics stock rockets after license option deal with Pfizer that could be valued at $630 millionShares of Voyager Therapeutics Inc. rocketed 38.9% in premarket trading Wednesday, after closing at a record low in the previous session, after the gene therapy company announced a license option agreement with Pfizer Inc. that could valued at more than $600 million. Trading volume spiked up to 3.9 million shares ahead of the open, which compares with the full-day average of about 173,000 shares. The agreement allows Pfizer to exercise options to license novel capsids generated from Voyager's RNA-driven screener technology, which would be used by Pfizer to develop, make and commercialize gene therapies. As part of the agreement, Voyager will receive an upfront payment of $30 million, and is entitled to receive up to $20 million in exercise fees. Voyager will also be eligible to receive up to $580 million in milestone payments, and will be eligible to receive "mid- to high-single-digit tiered royalties" based on sales of Pfizer products using the licensed capsids. The stock, which closed at a record low of $2.47 on Tuesday, has tumbled 36.5% over the past three months while the S&P 500 has inched up 0.1%.
9:04 a.m. Oct. 4, 2021 - By Jaimy Lee
J&J to test experimental RSV vaccine in 23,000 people in Phase 3 clinical studyJohnson & Johnson experimental respiratory syncytial virus (RSV) vaccine had an 80% efficacy rate against the virus, which can lead to bronchitis and pneumonia, according to new clinical data shared Saturday. It had a slightly lower efficacy rate of 70% when it comes to preventing symptomatic respiratory infections caused by the virus. The Phase 2b clinical trial is evaluating the vaccine candidate in 5,782 people 65 years old and older in the U.S. J&J said it launched the Phase 3 study and now plans to test the investigational RSV vaccine in 23,000 people who are 60 years old and older. J&J's stock has gained 1.2% so far this year, while the broader S&P 500 is up 14.7%.
4:48 a.m. Oct. 4, 2021 - By Jaimy Lee
RedHill's stock is up 7.0% as it shares new data about experimental COVID-19 drugShares of Redhill Biopharma Ltd. gained 7.0% in premarket trading on Monday after the company said it had new data from a Phase 2/3 clinical study evaluating its experimental oral antiviral opaganib in severely ill, hospitalized COVID-19 patients. Redhill said the treatment candidate reduced mortality by 62% when evaluating 251 of the 475 patients enrolled in the study. Several companies developing COVID-19 drugs have shared new data since Friday, when Merck & Co. Inc. said its . The news sent Merck's shares soaring and created widespread excitement among clinicians. RedHill's stock is down 45.9% for the year, while the broader S&P 500 [S: spx] is up 14.7%.
4:57 a.m. Sept. 29, 2021 - By Jaimy Lee
Pfizer says administering pneumococcal and flu shots at the same time is safe and effectiveShares of Pfizer Inc. gained 0.3% in premarket trading on Wednesday after the drugmaker said its combination pneumococcal and flu vaccine is safe and effective when administered at the same time. The Phase 3 study is evaluating Prevnar 20 and a flu shot in about 1,700 people 65 years old and older, testing responses from participants who got both shots at the same time and participants who got their shots a month apart. "Vaccination rates decline when someone needs to make multiple appointments to receive these vaccines," Luis Jodar, chief medical officer for Pfizer Vaccines, said in a news release. Pfizer is also testing a combination of Prevnar 20 and the COVID-19 vaccine it developed with BioNTech SE in a Phase 3 clinical trial. Pfizer's stock is up 16.9% for the year, while the broader S&P 500 has gained 15.9%.
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.
3:30 a.m. Sept. 24, 2021 - By Jaimy Lee
WHO recommends Regeneron's monoclonal antibody treatment for COVID-19Shares of Regeneron Pharmaceuticals Inc. were down 0.1% in premarket trading on Friday after the World Health Organization recommended its monoclonal antibody as a treatment for COVID-19. The global body says the combination treatment can be used in COVID-19 patients who are at high risk of severe disease as well as in severe and critically ill COVID-19 patients who have not yet developed antibodies. The therapy has generated $3.5 billion in revenue in the first half of 2021. "WHO also calls for the sharing of technology to allow for the manufacturing of biosimilar versions so all patients who may need this treatment have access to it," it said in a statement on Friday. So far this year, Regeneron's stock is up 33.8%, while the broader S&P 500 has gained 18.4%.
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.
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%.
4:38 a.m. Sept. 14, 2021 - By Jaimy Lee
Merck CEO: Authorization of its experimental antiviral COVID-19 treatment could come by year endMerck & Co. Inc. said it expects the company's experimental oral antiviral treatment for COVID-19 could get emergency authorization by the end of the year. "We expect to be able to see clinical data here in the back half of the year and still have the potential for an interim analysis and potential for emergency use authorization before year end," Merck CEO Robert Davis told investors at the Morgan Stanley Global Healthcare Conference on Monday. Merck and Ridgeback Biotherapeutics Inc. have been testing the investigational therapy, molnupiravir, in a Phase 3 clinical trial. There are few authorized or approved new COVID-19 treatments beyond the monoclonal antibodies developed by Eli Lilly & Co. , GlaxoSmithKline and Vir Biotechnology Inc. , and Regeneron Pharmaceuticals Inc. and Gilead Sciences Inc.'s Veklury. The medical community has called for easy-to-take medications that can treat the disease caused by SARS-CoV-2. The U.S. has already purchased 1.7 million courses of molnupiravir, dependent on authorization from regulators. Merck's stock is down 7.0% for the year, while the broader S&P 500 is up 18.9%.
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.
2:58 a.m. Sept. 1, 2021 - By Tomi Kilgore
Merck, Ridgeback start Phase 3 trial of oral drug to prevent COVID-19Shares of Merck & Co. Inc. and Ridgeback Biotherapeutics said Wednesday that they have started a Phase 3 trial of molnupiravir, and oral antiviral therapeutics for the prevention of COVID-19 infection. Merck's stock gained 0.4% in premarket trading. The drug makers said the study is enrolling people at least 18 years old who live in the same house as someone who tested positive for SARS-CoV-2 and had symptoms. Primary endpoints include percentage of participants with COVID-19 through day 14, the percentage of those with an adverse event and the percentage of those who had to discontinue to the study because of an adverse event. ""As the pandemic continues to evolve and surges are being reported in many places around the world, it is important that we investigate new ways to protect individuals exposed to the virus from becoming infected with symptomatic disease," said Dr. Nick Kartsonis, senior vice president, vaccines and infectious diseases, clinical research, Merck Research Laboratories. "If successful, molnupiravir could provide an important additional option towards reducing the burden of COVID-19 on our communities." Merck's stock has slipped 2.2% year to date through Tuesday, while the SPDR Health Care Select Sector ETF has rallied 19.2% and the Dow Jones Industrial Average has advanced 15.5%.
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%.
6:03 a.m. Aug. 25, 2021 - By Jaimy Lee
J&J says new data indicates an extra dose of its COVID-19 vaccine can boost antibody levelsShares of Johnson & Johnson gained 0.8% in premarket trading on Wednesday after the company shared interim clinical data that indicates Americans who have received its single-dose COVID-19 vaccine could get a second dose. J&J said in a news release that two Phase 1/2a studies examining people who had received its shot found that a second dose boosted antibody levels. (The studies have not yet been published in a medical journal or on a preprint server.) The company said last month that people vaccinated with its shot still had strong immune responses eight months after vaccination. "We also see that a booster dose of the Johnson & Johnson COVID-19 vaccine further increases antibody responses among study participants who had previously received our vaccine," Dr. Mathai Mammen, global head of J&J's Janssen Research & Development business, said in a news release. Federal health officials last week said that Americans who have been vaccinated with the mRNA vaccines developed by BioNTech SE /Pfizer Inc. and Moderna Inc. . J&J's stock is up 11.4% so far this year, while the broader S&P 500 has gained 19.4%.
3:14 a.m. Aug. 25, 2021 - By Tomi Kilgore
Coronavirus tally: Daily average of COVID-19 cases rises to 7-month high, as J&J data supports booster shotsThe global tally for the coronavirus-borne illness climbed to 213.30 million as of early Wednesday, while the death toll rose to 4,454,812, according to . The U.S. led the world with a total of 38.08 million cases and 630,838 deaths. The daily average of new cases over the past seven days rose to 151,441 as of Tuesday, up 28% from two weeks ago, and the highest count since Jan. 29, according to . The daily average for deaths increased to 1,116, up 84% in two weeks and the most since March 19. The daily average for hospitalizations of rose to 94,082, up 35% from two weeks ago and the most since Feb. 6. The number of people that have been fully vaccinated grew to 171.4 million, or 51.6% 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 202.04 million, or 60.9% of the total population. Johnson & Johnson announced Wednesday data that supported the use of a COVID-19 vaccine booster shot, eight months after people previously received J&J's single-shot vaccine.
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.
2:45 a.m. Aug. 20, 2021 - By Tomi Kilgore
Coronavirus tally: U.S. daily average of COVID-19 cases, deaths and hospitalization rise to multi-month highsThe global tally for the coronavirus-borne illness climbed above 210 million as of early Friday, while death toll rose to 4,404,511, according to . The U.S. led the world with a total of 37.29 million cases and 625,166 deaths. The daily average of new cases over the past seven days rose to 143,827 as of Thursday, up 44% from two weeks ago and the most since Feb. 1, according to . The daily average for deaths increased to 911, up 108% in two weeks, and the most since March 31, while hospitalizations of 86,877 was up 53% from two weeks ago and the most since Feb. 9. The number of people that have been fully vaccinated rose to 169.59 million, or 51.1% of the total U.S. population, according to . AstraZeneca PLC said Friday that in a late stage trial. "There were no cases of severe Covid-19 or Covid-19-related deaths in those treated with AZD7442," the company said.
2:36 a.m. Aug. 19, 2021 - By Tomi Kilgore
Coronavirus tally: Global cases of COVID-19 tops 209 million, U.S. daily average of deaths rises to 4-month highThe global tally for the coronavirus-borne illness climbed above 209.3 million as of early Thursday, while death toll rose to 4,393,138, according to . The U.S. led the world with a total of 37.16 million cases and 624,253 deaths. The daily average of new cases over the past seven days ticked back above 140,000 on Wednesday, after a brief one-day dip below it on Tuesday, according to . At 140,893, the daily average is up 47% from two weeks ago, and up from 32,305 from a month ago. The daily average for deaths rose to 809, up 97% from two weeks ago and the highest seen since early April, while the daily average of hospitalizations of 85,118 is up 56% from two weeks ago and the highest since early February. The number of people that have been fully vaccinated rose to 169.19 million, or 51.0% of the total U.S. population, according to . Federal health officials said Wednesday that those who have received the vaccines from Moderna Inc. and from Pfizer Inc. and BioNTech SE will be , starting in September.
2:55 a.m. Aug. 18, 2021 - By Tomi Kilgore
Coronavirus tally: Daily average of new cases slips, to snap a 39-day streak of increases based on NYT dataThe global tally for the coronavirus-borne illness climbed above 208.6 million as of early Wednesday, while death toll rose to 4,383,333, according to . The U.S. remained the world leader with 37.02 million cases and 623,322 deaths. On a daily basis, the seven-day average for cases slipped to 139,872 on Tuesday from 142,414 on Monday, to snap a 39-day streak of increases. The daily average was still up 52% from two weeks ago, and 4.5 times the average of 31,138 a month ago, . The daily average of deaths slipped to 696 on Tuesday from 704 on Monday, while hospitalizations increased to 83,291 from 82,519 on Monday, the most since Feb. 11. The number of people that have been fully vaccinated rose to 168.90 million, or 50.9% of the total U.S. population, according to . The U.S. is expected to announce Wednesday that most vaccinated Americans eight months after being fully vaccinated.
2:27 a.m. Aug. 17, 2021 - By Tomi Kilgore
Coronavirus tally: Global cases of COVID-19 nears 208 million, as U.S. reportedly set to recommend boostersThe global tally for the coronavirus-borne illness climbed above 207.9 million as of early Tuesday, while death toll rose to 4,372,554, according to . In the U.S., cases reached 36.89 million while deaths increased to 622,322, with both leading the world. On a daily basis, the seven-day average for cases grew to 141,365 on Monday, more than four times the daily average of 30,901 a month ago, and the most since Feb. 2, according to . The seven-day average for deaths rose to 704, up from 273 a month ago and the most since May 4, while hospitalizations rose to 81,556, up from 23,432 a month ago and the most since Feb. 12. The number of people that have been fully vaccinated rose to 168.69 million, or 50.8% of the total U.S. population, according to . The U.S. is set to announce that most vaccinated Americans shot eight months after being fully vaccinated, according to late Monday.
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%.
7:15 a.m. Aug. 16, 2021 - By Tomi Kilgore
CureVac stock gains after upbeat preclinical data on COVID-19 vaccine candidate on primatesShares of CureVac N.V. gained 0.4% in morning trading Monday, but bucked the selloff in the biotechnology sector and the broader stock market, after the Germany-based company revealed upbeat preclinical data regarding its vaccine candidates against the coronavirus that causes COVID-19, in non-human primates. The stock's gain comes as the iShares Biotechnology ETF dropped 2.4% and the S&P 500 slid 0.7%. The first-generation vaccine candidate, CVnCoV, and second-generation vaccine candidate, CV2CoV, were developed in collaboration with U.K.-based drug maker GlaxoSmithKline PLC and is based on mRNA technology, the same in the COVID-19 vaccines developed by Moderna Inc. and Pfizer Inc. and BioNTech SE . GlaxoSmithKline's stock eased 0.1% in morning trading. The company said CV2CoV achieved better activation of immune responses, with higher antibody neutralizing capacity across all variants, including the delta variant. "The current study shows that the immune responses and resulting protection produced by our second-generation candidate, based on our mRNA technology featuring targeted optimizations, are substantially improved in non-human primates against both the original SARS-CoV-2 virus as well as the Beta and Delta Variants of Concern and the Lambda Variant of Interest," said CureVac Chief Scientific Officer Dr. Igor Splawski.
4:31 a.m. Aug. 16, 2021 - By Tomi Kilgore
Enlivex stock soars to lead premarket gainers after getting OK to start Phase 2b trial of COVID-19 treatmentShares of Enlivex Therapeutics Ltd. soared 21.4% toward a five-month high, enough to pace all premarket gainers early Monday, after the Israel-based immunotherapy company said it received the OK to start a Phase 2b clinical trial for its treatment of severe and critical COVID-19 patients with acute respiratory distressed syndrome (ARDS). The Israel Ministry of Health authorized the trial after reviewing Phase 2 trial data. The Phase 2b trial is expected to recruit up to 152 patients in Israel and certain European countries, and is designed to evaluate the safety and efficacy of Allocetra when administered in addition to standard care treatment. The stock has rallied 20.6% year to date through Friday, while the S&P 500 has gained 19.0%.
3:50 a.m. Aug. 12, 2021 - By Jaimy Lee
WHO to study whether three drugs, including J&J's Remicade, can help hospitalized COVID-19 patientsThe World Health Organization plans to test three new drugs as possible treatments for people who have been hospitalized for COVID-19. This includes Ipca Laboratories Ltd.'s malaria drug artesunate; Novartis AG's cancer medication Gleevec; and Johnson & Johnson's rheumatoid arthritis drug Remicade. All of the drugs are already in use for other reasons. There are still few therapies that effectively treat COVID-19 patients, especially those who have severe enough disease that they end up hospitalized. "Finding more effective and accessible therapeutics for COVID-19 patients remains a critical need," WHO director-general Tedros Adhanom Ghebreyesus said in a news release.
3:27 a.m. Aug. 5, 2021 - By Jaimy Lee
Moderna says its COVID-19 shot provides 93% immunity after six months Moderna Inc.'s said Thursday that its COVID-19 vaccine is 93% efficacious six months after the second dose as part of its . This is different than what Pfizer Inc. said last week about its COVID-19 shot, which is that % four to six months after getting the second shot. Both vaccines are two-dose mRNA shots that had an efficacy rate of about 95% in clinical trials. "We are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through six months," Moderna CEO Stéphane Bancel said in a statement. The figure came from a new analysis of the Phase 3 clinical trial it conducted in the U.S. At that time, Moderna said the vaccine had an efficacy rate of 94.1%. Moderna's stock is up 301.1% so far this year, while the broader S&P 500 has gained 17.2%.
4:15 a.m. Aug. 3, 2021 - By Jaimy Lee
Sanofi to buy mRNA developer for $3.2 billionShares of Translate Bio Inc. soared 29.8% in premarket trading on Tuesday after Sanofi said it will spend $3.2 billion to buy the developer of messenger RNA (mRNA) technologies. The U.S.-listed shares of Sanofi were down 0.1% in premarket trade. "A fully owned platform allows us to develop additional opportunities in the fast-evolving mRNA space," Sanofi CEO Paul Hudsons said in a statement. Investors are paying much closer attention to mRNA developments since the mRNA COVID-19 vaccines developed by Moderna Inc. and BioNTech SE /Pfizer Inc. have been authorized. Sanofi and Translate are also developing a mRNA COVID-19 vaccine; the experimental shot is currently in a Phase 1/2 clinical study. "Given the early stage of TBIO's platform, and the company's recent pivot into vaccines, the deal terms strike us as favorable for SNY and fair for TBIO," SVB Leerink's Geoffrey Porges told investors on Tuesday. So far this year, Translate's stock has gained 58.1% and Sanofi is up 5.5%. The S&P 500 has gained 17.0%.
4:12 a.m. July 29, 2021 - By Jaimy Lee
Viatris gets FDA approval of first biosimilar version of Sanofi's insulin LantusShares of Viatris Inc. gained 3.3% in premarket trading on Thursday, the day after the Food and Drug Administration approved the first biosimilar verson of insulin glargine from Viatris and Biocon Biologics Ltd. Biocon is a privately held biopharma company based in India. The newly approved treatment, Semglee, is a biosimilar and interchangeable version of Lantus, Sanofi's once-blockbuster long-actin insulin. Semglee will be sold exclusively by the companies for 12 months before the FDA can approve another biosimilar version of Lantus. Biosimilar drugs are copies of complex biologic drugs; this is somewhat similar to how generic drugs compare to brand-name prescription medications, in that that biosimilars and generic drugs are less expensive than the brand-name alternatives. Viatris shares are down 24.0% so far this year, while the broader S&P 500 is up 17.1%.
4:01 a.m. July 28, 2021 - By Jaimy Lee
Pfizer shares limited data about its COVID-19 booster candidate, says it ups protection against the delta variantPfizer Inc. said Wednesday that a third dose of its COVID-19 vaccine likely provides further protection against the delta variant, which is more infectious and thought to be driving the recent surge in cases, hospitalizations, and deaths in the U.S. The drug maker announced the news as part of its , saying that an additional dose of its two-dose COVID-19 vaccine series produced neutralizing antibody titers against delta that are 5 times higher than getting two doses in younger people and 11 times higher than getting two doses in older people. Pfizer did not provide any additional information at this time. Pfizer's stock is up 14.3% so far this year, while the broader S&P 500 has gained 17.2%.
3:53 a.m. July 27, 2021 - By Jaimy Lee
Regeneron, AstraZeneca to develop obesity treatmentShares of Regeneron Pharmaceuticals Inc. were down 0.1% in premarket trading on Tuesday after the company announced a deal with AstraZeneca to develop and commercialize obesity treatments that target a specific gene, GPR75. The companies will split development costs and profits if the drug is successful. Regeneron's stock is up 19.6% so far this year, while the S&P 500 has gained 17.7%.
4:06 a.m. July 22, 2021 - By Jaimy Lee
Pfizer to pay at least $1 billion to develop, commercialize Arvinas' investigational breast-cancer therapyShares of Arvinas Inc. were up 6.0% in premarket trading on Thursday after the company announced a billion-dollar deal with Pfizer Inc. to develop and commercialize its experimental breast-cancer treatment. Pfizer will make a $650 million upfront payment to Arvinas, in addition to a $350 million equity investment. Separately, there are up to $1.4 billion in potential milestone payments. The therapy, ARV-471, is expected to move into Phase 3 clinical trials sometime next year. Arvinas' stock is down 8.7% for the year, while the S&P 500 is up 15.1%.
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