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AI-assisted robots could reduce surgery complications by 5 times

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3:34 a.m. Today - 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.
3:00 a.m. Today - By MarketWatch
AI-assisted robots could reduce surgery complications by 5 timesAbout 100,000 people die annually due to medical errors, according to the National Center for Biotechnology Information. Here's how AI-assisted robots could improve surgical outcomes.
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.
10:30 a.m. Sept. 15, 2021 - By Victor Reklaitis
Biden to announce deal with U.K., Australia on sharing defense technology: reportsPresident Joe Biden on Wednesday will announce a new effort with the U.K. and Australia to share advanced defense technologies in a bid to counter China, according to reports from and . The White House said Biden is due to speak at 5 p.m. Eastern on a "national security initiative," and he will be joined virtually by U.K. Prime Minister Boris Johnson and Australian Prime Minister Scott Morrison.
8:50 a.m. Sept. 15, 2021 - By Tomi Kilgore
Indaptus Therapeutics stock nearly triples on heavy volume after allowance for patent of platform technology Shares of Indaptus Therapeutics Inc. nearly tripled on massive volume in midday trading, to bounce off the previous session's record closing low, after the developer of treatments for hepatitis and HIV announced the allowance of a patent for its platform technology. The stock was up as much as 307.8% at a six-month high of $28.83 before paring gains to be up 184.3%. Trading volume exploded to 119.2 million shares, compared with the full-day average of just 227,600 shares. The stock was the biggest gainer and third-most active on major U.S. exchanges. The company said before the open that its patent titled "Methods of Treatment of Infections Using Bacteria," provides broad protection for the application of the company's platform technology alone and in combination with standards of care for the treatment and inhibition of hepatitus B virus and human immunodeficiency virus (HIV) infections. "This notice of allowance gives us the optionality to confidently pursue our technology in viral diseases and/or to partner it for further development," said Chief Executive Jeffrey Meckler. The stock has now gained 45.7% year to date, while the iShares Biotechnology ETF has tacked on 13.2% and the S&P 500 has advanced 19.0%.
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%.
2:34 a.m. Sept. 15, 2021 - By Tomi Kilgore
Procept BioRobotics upsized IPO prices above the expected range, valuing company at $1 billionProcept BioRobotics Corp. is set to go public Wednesday, as the California-based surgical robotics company's upsized initial public offering priced above the expected range at $25.00 per share. The company sold 6.56 million shares in the IPO to raise $163.9 million. Procept had previously expected to offer 5.5 million shares in the IPO, which was projected to price between $22 and $24 per share. The stock is expected to begin trading Wednesday on the Nasdaq under the ticker symbol "PRCT." With 41.21 million shares outstanding after the IPO, the pricing values Procept at $1.03 billion. BofA Securities and Goldman Sachs are the joint lead bookrunning managers. The company had recorded a net loss of $27.4 million on revenue of $15.7 million in the six months ended June 30, after a loss of $25.7 million on revenue of $2.4 million in the same period a year ago. The company is going public at a time that the Renaissance IPO ETF has gained 7.4% over the past three months while the S&P 500 has tacked on 4.6%.
11:05 a.m. Sept. 14, 2021 - By Tomi Kilgore
Globalstar's stock takes a dive after Apple didn't say its new iPhone supports satellite communicationsShares of Globalstar Inc. took an afternoon dive Tuesday, as investors expressed disappointment that Apple Inc. did not say its new iPhone 13s would support satellite communications. The mobile satellite services company's stock sank 19.4%, after being down 5.3% just before the start of . The , after the that Apple would work with Globalstar as it added satellite communications to its next iPhone. The stock had climbed another 14.5% from Aug. 30 to the five-year closing high of $2.69 on Sept. 8, before pulling back. The stock has still rocketed 442.9% year to date, while the S&P 500 has advanced 18.3%.
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%.
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%.
2:28 a.m. Sept. 10, 2021 - By Tomi Kilgore
Coronavirus tally: Daily average of new COVID-19 cases dips, but deaths rise to 6-month highThe global tally for the coronavirus-borne illness climbed to 223.23 million as of early Friday, while the death toll rose to 4,606,927, according to . The U.S. continues to lead the world with a total of 40.60 million cases and 654,598 deaths. The daily average of new cases over the past seven days was 147,816 as of Thursday, down from a recent peak of 166,105 on Sept. 1 and 5% less than what it was two weeks ago, according to . The daily average for deaths kept rising to 1,579, up 28% in two weeks and the most since March 9. The daily average for hospitalizations of 100,610 was down from a peak of 102,621 on Sept. 3 but up 1% from two weeks ago. The number of people that have been fully vaccinated grew to 177.43 million, or 53.4% of the total U.S. population, according to , while the number of people who have received at least one dose of a vaccine rose to 208.31 million, or 62.7% of the total population. In a speech from the White House late Thursday, President Joe Biden rolled out a " " to fight COVID-19, including new vaccine mandates, as he warned the country about a "tough stretch" in the fight against the delta variant.
3:21 a.m. Sept. 3, 2021 - By Tomi Kilgore
Forte Biosciences stock plunges more than 80% after 'disappointing' trial results of atopic dermatitis treatmentShares of Forte Biosciences Inc. plummeted 81.2% on heavy volume toward a record low in premarket trading Friday, after the biopharmaceutical company said it will no longer advance its lead product candidate FB-401, a treatment for atopic dermatitis. Trading volume spiked to 2.8 million shares ahead of the open, compared with the full-day average of about 754,000 shares. The company said late Thursday that a Phase 2 trial of FB-401 failed to meet statistical significance for the primary endpoint of the proportion of patients with at least 50% improvement in atopic dermatitis disease severity. The company said the primary endpoint was achieved by 58% of subjects on FB-401, compared with 60% of subjects on placebo. "The topline data is disappointing and we will continue to analyze the data; however, given this readout we will not continue to advance FB-401," said Chief Executive Paul Wagner. "We expect to provide investors with an update on the future plans for the company over the next several months." The stock, on track to open below the Dec. 19, 2019 record low close of $6.65, has dropped 25.0% over the past three months through Thursday, while the iShares Biotechnology ETF has climbed 16.7% and the S&P 500 has gained 8.2%.
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%.
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%
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%.
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.
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.
10:29 a.m. Aug. 24, 2021 - By Tomi Kilgore
Disney Cruise Line to require proof of vaccinations for passengers on cruises to The Bahamas from FloridaWalt Disney Co.'s Disney Cruise Line said Tuesday it will require all passengers at 12 years old on cruise ships departing from Port Canaveral, Florida for the Bahamas for COVID-19 before boarding. The requirement comes after the government of The Bahamas required that for sailings from Sept. 3 through Nov. 1 that all passengers eligible for COVID-19 vaccines be fully vaccinated before entering any of its cruise ports, including private islands such as Disney Castaway Cay. "Guests who choose not to provide proof of vaccination to meet the requirements of The Bahamas will not be permitted to board the ship," Disney Cruise Line said in a statement. Disney's announcement comes roughly two weeks after Norwegian Cruise Line Holdings Ltd. said paved the way for its cruises sailing from Florida ports to require confirmation of vaccination before boarding, after Florida's government had initially prohibited the company to require vaccine documentation. Also on Tuesday, representing workers at Disney World in Florida that will require workers to show proof of COVID-19 vaccinations. Disney's stock, which rose 0.6% in afternoon trading Tuesday, has slipped 1.3% year to date, while the Dow Jones Industrial Average has gained 15.7%.
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.
7:10 a.m. Aug. 17, 2021 - By Jon Swartz
CES will require proof of vaccination to attend in January 2022The biggest of U.S. tech shows on Tuesday announced that proof of vaccination is necessary for in-person attendance. CES, the Super Bowl of tech confabs that takes place in Las Vegas in early January, is planning a hybrid version. The weeklong event, last held with people in 2020, usually draws more than 100,000. "Based on today's science, we understand vaccines offer us the best hope for stopping the spread of COVID-19," Gary Shapiro, chief executive of Consumer Technology Association, which puts on the show, said in a statement. "We all play a part in ending the pandemic through encouraging vaccinations and implementing the right safety protocols. We are taking on our responsibility by requiring proof of vaccination to attend CES 2022 in Las Vegas."
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%.
3:36 a.m. Aug. 16, 2021 - By Tomi Kilgore
Coronavirus tally: Global cases of COVID-19 top 207 million, as U.S.'s daily average rises to 6-month highThe global tally for the coronavirus-borne illness climbed above 207.2 million on Monday, while death toll rose to 4,364,409, according to . The U.S. continued to lead the world in cases with 36.68 million and in deaths with 621,635. On a daily basis, the seven-day average for new COVID-19 cases rose to 130,808 as of Sunday, , up 64% from two weeks ago, to mark the 11-straight day above 100,000 and the highest rate since Feb. 3. The 7-day average of deaths was 662 on Sunday, up 113% from two weeks ago and the highest since early May, while the number hospitalized has increased 65% to 76,088. The number of people fully vaccinated in the U.S. was 168.36 million, or 50.7% of the total population as of Sunday, according to , including 61.7% of the adult population. The number of adults receiving at least one dose grew to 185.88 million, or 72%. "We've got to get people vaccinated," said Dr. Anthony Fauci, chief medical adviser to President Biden, on CBS's "Face the Nation" on Sunday. "We have about 90 million people who are eligible to be vaccinated, who are not vaccinated. And that's very highly concentrated in the southern states, including Mississippi and other states in which you have, compared to the general average of vaccinations in the country, an under vaccinated group."
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%.
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%.
5:09 a.m. Aug. 4, 2021 - By Tomi Kilgore
BeyondSpring stock more than triples after lung cancer treatment meets endpoints in Phase 3 trialShares of BeyondSpring Inc. more than tripled -- up 242% -- on heavy volume in premarket trading Wednesday, after the New York-headquartered biopharmaceutical company said a Phase 3 trial of its lung cancer treatment met the primary and key secondary endpoints. The stock, which closed at a record low last week, was on track to open at the highest price seen during regular-session hours since April 2018. Trading volume spiked to 8.0 million shares, compared with the full-day average of about 196,000 shares. The company said plinabulin met the primary endpoint of increasing overall survival and met secondary endpoints, such as improving overall response rates, progression-free survival, 24- and 36-month overall survival rates and significant reduction in the incidence of Grade 4 neutropenia. Chief Medical Officer Ramon Mohanlal said the success of the study represents "proof-of-concept of plinabulin's immune-enhancing mechanism of action that is complimentary to that of checkpoint inhibitors, and which is the rationale for it to be combined as triple IO combinations in multiple tumor indications." The stock had dropped 21.1% year to date through Tuesday, while the iShares Biotechnology ETF has gained 11.8% and the S&P 500 has advanced 17.8%.
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%.
4:39 a.m. Aug. 2, 2021 - By Tomi Kilgore
Velodyne Lidar Chairman Joseph Culkin steps down from role for health reasonsVelodyne Lidar Inc. said Monday that Joseph Culkin will step down as chairman of the board for health reasons, but will remain an "active" director of the board. Culkin co-founded Velodyne Lidar's predecessor company, Velodyne Acoustics, and has been on Velodyne Lidar's board since September 2016. The company named board member Michael Dee as Chairman. Dee was Chief Financial Officer of Graf Industrial Corp., which was the special purpose acquisition company (SPAC) that Velodyne Lidar merged with in September 2020 to go public. Velodyne Lidar's stock, which rose 1.8% in premarket trading Monday, has plunged 64.9% year to date, while shares of competitor Luminar Technologies Inc. have plummeted 45.9% and the S&P 500 has gained 17.0%.
4:50 a.m. July 30, 2021 - By Tomi Kilgore
Erytech Pharma stock nearly doubles on heavy volume after ALL treatment granted Fast Track designationShares of Erytech Pharma SA rocketed 98.5% on heavy volume in premarket trading Friday, enough to make them the biggest gainer and most actively traded ahead of the open, after the France-based biopharmaceutical company said it's treatment for hypersensitive acute lymphocytic leukemia (ALL) patients was granted Fast Track designation by the Food and Drug Administration. Trading volume was 11.5 million shares in recent trading, compared with the full-day average of about 66,600 shares. "This is yet another significant milestone and meaningful inflection point in advancing our lead product candidate eryaspase, further supporting our recently announced intention to submit a [Biologics License Application] for eryaspase in hypersensitive ALL patients," said Chief Executive Gil Beyen. "We believe that the FDA's Fast Track designation for eryaspase underscores its potential to address this high unmet medical need." The stock, which closed Thursday at a 16-month low, has tumbled 42.8% over the past three months through Thursday, while the iShares Biotechnology ETF has gained 7.2% and the S&P 500 has tacked on 5.7%.
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%.
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