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Food and Drug Administration

2:15 a.m. Oct. 25, 2021 - By Ciara Linnane
Merck and Ridgeback Biotherapeutics announce start of rolling review of COVID antiviral in EuropeMerck and partner Ridgeback Biotherapeutics said Monday the European Medicines Agency has started a rolling review of molnupiravir, its oral antiviral treatment for COVID-19 in adults. "Merck plans to work with the EMA's Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process to facilitate initiating the formal review of the Marketing Authorization Application," the company said in a statement. The partner have already submitted an application for emergency use authorization for the treatment with the U.S. Food and Drug Administration and has said it would seek the same from other regulatory agencies around the world. If molnupiravir is granted marketing authorization in the EU, it would become the first oral medicine for the coronavirus-borne illness in the trading bloc. Merck and Ridgeback already that showed it reduced the risk of hospitalization or death in adults at risk from severe COVID-19 by 50%. While several effective vaccines have been developed against the illness, far fewer treatments have emerged, and those that have require infusions and must be administered in a clinical setting. Molnupiravir is a pill administered orally in capsule form every 12 hours for five days, according to clinicaltrials.gov. Through Day 29 in the Phase 3 trial, no patients given molnupiravir died, compared with the eight patients who died on the placebo. Merck expects to produce 10 million courses of the treatment by the end of the year. Merck shares were slightly higher premarket and have gained 4% in the year to date, while the Dow Jones Industrial Average has gained 17%.
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%.
4:47 a.m. Aug. 9, 2021 - By Jaimy Lee
Bluebird's stock falls 21% as it says it will focus on U.S. market for gene therapies, citing 'European payers'Shares of Bluebird Bio Inc. were down 21.6% in premarket trading on Monday after the company announced several setbacks to its business as part of its second-quarter earnings announcement. Bluebird plans to wind down its gene therapy operations in Europe, citing "European payers," which are primarily governments there. "European payers have not yet evolved their approach to gene therapy in a way that can recognize the innovation and the expected life-long benefit of these products," Bluebird executive Andrew Obenshain said in a news release. The company said it may license its three investigational gene therapies to a European company. Bluebird also said the Food and Drug Administration had placed a hold on its experimental Eli-cel product after a possible adverse event from a Phase 3 clinical study. Bluebird plans to complete its submission to the U.S. regulator sometime this year when the hold is lifted. Eli-cel, or elivaldogene autotemce, is a treatment for cerebral adrenoleukodystrophy, a rare disease that affects young boys. Bluebird's stock is down 42.1% for the year, while the broader S&P 50 is up 18.2%.
2:46 a.m. July 16, 2021 - By Tomi Kilgore
AstraZeneca says FDA advisory committee won't support CKD treatment for approval, partner FibroGen stock plunges AstraZeneca PLC has disclosed Friday that a U.S. Food and Drug Administration advisory committee has voted 13 to 1 not to support approval of roxadustat for the treatment of anaemia in chronic kidney disease (CKD) in non-dialysis dependent adult patients. Shares of FibroGen Inc. , which was AstraZeneca's partner in developing roxadustat, plummeted 34.1% in premarket trading, while AstraZeneca's U.S.-listed shares edged up 0.4%. The Cardiovascular and Renal Drugs Advisory Committee also voted 12 to 2 that the benefit-risk profile of roxadustat didn't support approval for the treatment of anaemia in CKD in dialysis-dependent adult patients. "Although we are disappointed by today's outcome, we will work closely with our partner FibroGen and the FDA to determine the path forward for roxadustat," said Mene Pangalos, executive vice president of BioPharmaceuticals R&D at AstraZeneca. The company noted that roxadustat is approved in China, Japan, Chile and South Korea for the treatment of CKD, and is under regulatory review in the European Union. FibroGen's stock has tumbled 33.0% year to date through Thursday and AstraZeneca shares have gained 13.9%, while the S&P 500 has tacked on 16.1%.
3:55 a.m. June 16, 2021 - By Jaimy Lee
Regeneron says its COVID-19 antibody treatment cuts the risk of death among hospitalized patientsShares of Regeneron Pharmaceuticals Inc. gained 0.1% in premarket trading on Wednesday after the company said its COVID-19 antibody therapy cut the risk of death in patients who have been hospitalized by 20%. This is the first time clinical research has demonstrated that Regeneron's antibody treatment has improved survival for hospitalized patients. The study, which is being conducted in the U.K. in patients who have not yet developed antibodies, follows other research that showed the company's antibody treatment can improve recovery times among people with mild or moderate forms of the disease. Regeneron said it is planning to ask the Food and Drug Administration to expand the emergency-use authorization in the U.S. to include these types of patients. Regeneron's stock is up 9.2% so far this year, while the broader S&P 500 has gained 13.0%.
3:55 a.m. June 11, 2021 - By Tomi Kilgore
Orphazyme stock losing half its value premarket, after rocketing fourfold the day beforeShares of Orphazyme A/S plunged 50.2% in active premarket trading Friday, , after the Denmark-based biopharmaceutical company said overnight that wasn't aware of any reason for the recent "extreme volatility." Trading volume was already up to 4.1 million shares before Friday's open, compared with the full-day average over the past 30 days of about 286,000 shares, according to FactSet On Thursday, the stock had soared as much 1,387% intraday before closing up 301.5% on volume of 7.9 million shares, and was halted a total of 22 times for volatility during the day. "The company is not aware of any material change in its clinical development programs, financial condition or results of operations that would explain such price volatility or trading volume that has occurred since June 10, 2021," the company said in a statement. "Investors who purchase the company's ADS or shares may lose a significant portion of their investments if the price of such securities subsequently declines." The company's applications for arimoclomol for Niemann-Pick disease type C are under priority review with the U.S. Food and Drug Administration, with an expected action date of June 17. Even with the previous day's surge, the stock has gained 62.9% over the past three months through Thursday, while the S&P 500 has gained 7.6%.
3:11 a.m. June 4, 2021 - By Barbara Kollmeyer
Pfizer-BioNTech Covid-19 vaccine approved for 12 to 15-year-olds in the U.K.The COVID-19 vaccine developed jointly by Pfizer and BioNTech has been approved for 12 to 15-year-olds in the U.K, the Medicines and Healthcare products Regulatory Agency (MHRA) . More than 2,000 children were involved in the clinical trial to determine the safety of the Pfizer-BioNTech vaccine, the chairman of the Commission on Human Medicines said. The MHRA said it would now be up to the U.K.'s Joint Committee on Vaccination and Immunisation (JCVI) to decide whether to vaccinate this age group as part of the country's inoculation program. The European Medicines Agency approved the Pfizer-BioNTech shot for use in 12 to 15-year olds last week, while the U.S. Food and Drug Administration d the Pfizer-BioNTech vaccine for 12-to-15 year-olds on May 10.
12:12 p.m. April 13, 2021 - By Mark DeCambre
S&P 500 books record high and Nasdaq rallies 1.1% as stock market reacts to Johnson & Johnson pause, hot CPI report The S&P 500 finished at a record and technology shares closed in the green Tuesday as long-term government bond yields retreated despite data showing a surge in consumer prices in March. Investors were hit with early negative headlines after the Food and Drug Administration and the Centers for Disease Control and Prevention requested the immediate halt in the use of Johnson & Johnson's one-shot COVID vaccine out of "an abundance of caution" due to extremely rare blood-clotting issues in women. That report was followed by a highly anticipated reading of March that showed U.S. consumer prices rising on the month for the fourth month in a row, with the pace of inflation hitting the highest level in 21/2 years. The rate of inflation over the past year shot up to 2.6% from 1.7% in the prior month, marking the highest level since the fall of 2018. The S&P 500 closed at a record at around 4,141, about 0.3% higher, while the Nasdaq Composite Index closed up 1.1% as technology shares scored a bounce off reteating bond yields. The 10-year Treasury note yielded 1.62% , with the decline following the CPI report, which some traders said wasn't as hot as expected, helping support some bids for long-dated bonds and relieving some of the pressure of higher borrowing costs on investments viewed as speculative like tech and tech-related shares. The Dow Jones Industrial Average , however, closed off 0.2% at aroound 33,677.
6:06 a.m. April 13, 2021 - By Tomi Kilgore
Moderna, BioNTech stocks surge after regulators halt use of J&J vaccine Shares of Moderna Inc. shot up 8.6% in morning trading, BioNTech SE ran up 5.7% toward a 4-month high and Pfizer Inc. climbed 1.1% toward a 3-month high, after U.S. health regulators paused the use of Johnson & Johnson's COVID-19 vaccine . Meanwhile, J&J shares shed $2.98, or 1.8%, to shave about 20 points of the Dow Jones Industrial Average's price, as the Dow dropped 132 points, or 0.4%. Moderna's two-dose COVID-19 vaccine, and the two-dose vaccine from Pfizer and partner BioNTech are mRNA vaccines while J&J's one-dose vaccine is an adenovirus vaccine. The Centers for Disease Control and Prevention and the Food and Drug Administration said there have been six cases of blood clotting out of the roughly six million people who have received the J&J vaccine, all of who were women between the ages of 18 and 48.
3:27 a.m. April 13, 2021 - By Mark DeCambre
Dow futures turn south Tuesday after FDA and CDC call for pause of Johnson & Johnson COVID vaccineFutures for the Dow Jones Industrial Average and the S&P 500 pivoted lower Tuesday morning after said that the U.S. will seek a pause of the Johnson & Johnson vaccine due to blood-clotting issues. "We are recommending a pause in the use of this vaccine out of an abundance of caution," the Food and Drug Administration, said jointly with the Centers for Disease Control and Prevention. The New York Times, citing officials briefed on the decision, said a rare clotting issue has cropped up in six women within about two weeks of vaccination. Futures for the Dow fell 127 points or 0.4% and those for the S&P 500 were trading 0.3% lower at 4,107. Shares of J&J were down 3% in pre-market action on Tuesday. The FDA and the CDC are requesting that the J&J vaccine not be used at federal sites and is urging states to also follow suit.
4:40 a.m. March 11, 2021 - By Tomi Kilgore
Johnson & Johnson COVID-19 vaccine recommended for use in the EUJohnson & Johnson said Thursday that its single-shot COVID-19 vaccine candidate has received a "positive opinion" from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). That means the CHMP recommends conditional marketing authorization (CMA) for the vaccine candidate developed by J&J's Janssen Pharmaceutical Companies. If CMA is granted, the vaccine will become available in the European Union. "The European Medicines Agency's recommendation is a landmark moment for Johnson & Johnson and for the world," said J&J Chief Scientific Officer Paul Stoffels. "Now, as we await a decision on the use of our single-dose COVID-19 vaccine in the European Union, we remain confident that the Johnson & Johnson vaccine will prove a critical tool for fighting this pandemic." The U.S. Food and Drug Administration had granted the J&J vaccine on Feb. 27. J&J's stock, which rose 0.6% in premarket trading, has gained 4.1% over the past three months while the Dow Jones Industrial Average has gained 7.5%.
6:45 a.m. March 9, 2021 - By Tomi Kilgore
Second Sight Medical stock soars nearly 1,000% in 3 daysShares of Second Sight Medical Products Inc. shot up 30.7% to $15.38 on volume of 56.6 million shares in morning trading Tuesday, bringing its three-day gain to 975.5%, in the wake of the company's announcement that for the treatment of retinitis pigmentosa. The stock skyrocketed a record 304.9% on record volume of 739.7 million shares on March 5 after the announcement, then 103.3% on volume of 320.4 million shares on Monday, before Tuesday's gain. The stock had closed at a near 3-month low of $1.43 prior to the rally. On Tuesday, the stock had been up as much as 69.9% at an intraday high of $20.00, the highest price seen since February 2018, before paring gains. Separately, Paris-based Pixium Vision S.A. saying the business combination with Second Sight announced on Jan. 6 continues. At that time, an agreement with the developer of bionic vision systems in which Second sight will raise at least $25 million in working capital, Pixium will contribute to Second Sight certain assets in exchange for newly issued Second Sight common stock and Second Sight will transfer its Orion Assets to a newly formed subsidiary, which will be partially spun off to Second Sight shareholders. Second Sight's stock has advanced 339.4% over the past 12 months, while the S&P 500 has gained 41.6%.
5:36 a.m. Feb. 24, 2021 - By Mark DeCambre
Stock-index futures skid south Wednesday morning as 10-year Treasury breaches 1.4%U.S. stock-index futures turned south as bond yields Tuesday morning took a leg higher, weighing on interest-rate sensitive assets. The move for bond yields, with the 10-year Treasury note breaching a rate at 1.4%, came as investors appeared to digest a report from the Food and Drug Administration, which said that Johnson & Johnson's single-dose COVID-19 vaccine candidate has no unexpected safety concerns, in a step that moves the experimental vaccine one step closer to emergency authorization. Futures for the Dow Jones Industrial Average declined 0.3% to 31,422, the S&P 500 index futures fell 0.3% at 3,867, while Nasdaq-100 futures declined 0.8% to 13,085, with the technology-laden index the most sensitive to yield moves. On Tuesday, the Dow , the S&P 500 index and the Nasdaq Composite Index stagewd a dramatic turnaround on the heels of comments from Federal Reserve Chairman Jerome Powell, who said accommodative policy would be in place for the foreseeable future.
3:48 a.m. Feb. 19, 2021 - By Jaimy Lee
J&J submits application for its COVID-19 vaccine to the WHOShares of Johnson & Johnson gained 0.4% in premarket trading on Friday after the company said it had submitted an application for its experimental single-dose COVID-19 vaccine to the World Health Organization for emergency authorization. Obtaining an emergency-use listing from the WHO allows J&J's vaccine candidate to be made available through Covax, a global consortium supplying COVID-19 vaccines to lower-income countries. J&J's vaccine, which has not yet been authorized for use in the U.S., is set to be reviewed by a group of vaccine experts next week as part of the Food and Drug Administration's regulatory process. The company also submitted a regulatory application for its coronavirus vaccine in the European Union on Feb. 15. J&J's stock is up 11.3% over the past year, while the S&P 500 is up 16.3%.
11:04 a.m. Feb. 1, 2021 - By Jaimy Lee
Bank of America downgrades Moderna stock over concerns about valuationShares of Moderna Inc. tumbled 8.2% in trading on Monday after Bank of America analysts downgraded the company's stock to underperform from neutral, citing valuation concerns. Until December, Moderna was a clinical-stage company that had yet to bring to market a single therapy, but it now has one of two authorized COVID-19 vaccines in the U.S. The company's stock is up 52.7% so far this year and has soared 677.6% over the past 12 months. Moderna "shares continue to run...attaining levels that are increasingly difficult to justify on a fundamental basis," the Bank of America analysts wrote in a Feb. 1 note to investors. They estimate that Moderna's COVID-19 vaccine will have about 14% of the COVID-19 vaccine market in the U.S. and Europe, and it will generate peak sales of $12.8 billion in 2022, a sales figure that is expected to decline to less than $1 billion by 2027. The emergence of two other viable COVID-19 vaccine candidates, which are being developed by Johnson & Johnson and Novavax Inc. , also cut into analyst expectations, though neither experimental vaccine has received emergency use authorization from the Food and Drug Administration or has so far reported efficacy rates as high as Moderna or BioNTech SE /Pfizer Inc.'s vaccines. "The number of vaccine options with compelling characteristics (single injection, lower cost, clean safety) could begin to weigh on Moderna's margins and market share longer-term," Bank of America analysts concluded. The S&P 500 is up 13.5% over the last 12 months.
11:02 a.m. Jan. 15, 2021 - By Ciara Linnane
Global deaths from COVID-19 top 2 million as U.S. suffers most weekly fatalities since start of the pandemic Weekly deaths exceed CDC’s estimate for flu-related deaths for entire 2019-2020 season The global case tally for the coronavirus-borne illness COVID-19 climbed above 93 million on Friday and the death toll climbed above 2 million, with the U.S. leading all nations by cases and fatalities.
10:21 a.m. Jan. 13, 2021 - By Ciara Linnane
U.S. sees record one-day death toll and experts worry new variant may make activities like plane travel more risky Vaccine program must speed up to avoid reaching 640,000 deaths by spring, equal to lives lost in the 1918 flu pandemicThe U.S. set another grim milestone in the coronavirus pandemic on Tuesday, when more than 4,400 COVID-19 patients died, the most in a single day since the start of the outbreak, and experts said that with cases continuing to accelerate, the worst is still to come.
10:19 a.m. Jan. 5, 2021 - By Ciara Linnane
January will be worst month for U.S. pandemic so far with post-holiday travel cases seen surging U.S. sets fresh record for hospitalizations and Los Angeles County says a COVID-19 patient is dying every 15 minuteshe number of global cases of the coronavirus-borne illness COVID-19 edged toward 86 million on Tuesday and the U.S. set yet another record for hospitalizations, as experts warned that January will likely be the worst month of the pandemic so far due to a surge in new infections after holiday travel.
10:56 a.m. Jan. 4, 2021 - By Ciara Linnane
U.S. heads toward 21 million COVID-19 cases and 353,000 deaths as vaccine program continues to lag all targets ‘Last mile’ vaccine distribution has been far slower than required, ‘with millions of doses still sitting on the shelves,’ says Raymond James analystThe global case tally for the coronavirus-borne illness COIVID-19 climbed above 85 million on Monday, as the U.S. headed toward 21 million cases and 353,000 deaths, as the vaccine program continued to advance with fits and starts and to lag all early targets.
3:39 a.m. Dec. 21, 2020 - By Jaimy Lee
Agio's shares jump 20% after announcing plans to sell cancer portfolioShares of Agios Pharmaceuticals Inc. soared 20.6% in premarket trading on Monday after the company said it is selling its oncology portfolio to Servier, a privately held French pharmaceutical company. Servier will pay $1.8 billion in cash upfront and $200 million in potential future milestone payments for vorasidenib as well as a small percentage of royalties for U.S. net sales of acute myeloid leukemia treatment Tibsovo and U.S. net sales of vorasidenib, if the experimental therapy is approved by the Food and Drug Administration. The deal is expected to close in the second quarter of next year. Shares of Agios have tumbled 30.0% this year, while the S&P 500 is up 14.8%.
4:17 a.m. Dec. 18, 2020 - By Jaimy Lee
E.U. to buy an additional 80 million doses of Moderna's coronavirus vaccineShares of Moderna Inc. were down 0.1% in premarket trading on Friday after the company said the European Commission now plans to purchase an additional 80 million doses of its COVID-19 vaccine candidate. The commission had previously made a deal for 80 million doses. Moderna's still investigational vaccine requires two doses for each person, spaced one month apart. It has not yet been approved or authorized in any country; however, . European Union health officials are expected to decide whether to grant a conditional marketing authorization for the vaccine on Jan. 6. Moderna's stock has soared 636.2% so far this year, while the S&P 500 is up 15.2%.
3:42 a.m. Dec. 17, 2020 - By Jaimy Lee
Allergic reaction to COVID-19 vaccine reported in AlaskaHealth officials in Alaska said Wednesday that a health care worker who had received one dose of BioNTech and Pfizer Inc.'s COVID-19 vaccine had a "presumed allergic reaction." The individual, who did not have a history of allergies, reported flushing and shortness of breath within 10 minutes of receiving the vaccine and is currently hospitalized. U.K. officials last week said there had been two among the first group of people to start receiving the shots there. Hospitals in Alaska began administering doses of the BioNTech/Pfizer vaccine on Tuesday, four days after the Food and Drug Administration granted emergency authorization to the vaccine, making it the first coronavirus vaccine to be made available to people in the U.S. "We expected that a side effect like this could occur," Dr. Anne Zink, chief medical officer for the state, said in a news release. "All sites that are approved to provide vaccinations in Alaska must have medications on hand to deal with an allergic reaction."
10:55 a.m. Dec. 11, 2020 - By Ciara Linnane
U.S. suffers its worst week of cases, deaths and hospitalizations since the start of the pandemic CDC head warns U.S. will see more deaths every day for next few months than died on Sept. 11, 2001, or in the attack on Pearl HarborThe U.S. suffered its worst week for cases, deaths and hospitalizations with the coronavirus illness COVID-19, as the Food and Drug Administration said it would grant emergency use authorization to the vaccine developed by Pfizer Inc. and its Germany partner BioNTech SE.
10:22 a.m. Dec. 10, 2020 - By Ciara Linnane
U.S. sets record one-day death toll from coronavirus as FDA committee meets to review Pfizer–BioNTech vaccine FDA head says initial assessment is ‘this is a vaccine that does meet our criteria. ... But we do want to hear from the vaccine advisory committee.’The U.S. set fresh records for single-day fatalities from the coronavirus illness COVID-19 and hospitalizations, as a U.S. regulatory advisory committee gathered to offer its verdict on the vaccine developed by Pfizer Inc. and its German partner BioNTech SE.
10:26 a.m. Dec. 9, 2020 - By Ciara Linnane
U.S. coronavirus case tally climbs to 15 million from 14 million in just five days U.S. sets fresh record for COVID-19 hospitalizations; Angela Merkel pleads with Germans to limit gatherings during holidaysThe global case tally for the coronavirus illness COVID-19 climbed above 68 million on Wednesday and the U.S. tally rose above 15 million as the virus continued to race across the nation, filling hospitals with record numbers of patients
4:36 p.m. Dec. 8, 2020 - By Ciara Linnane
U.S. suffers deadliest week from coronavirus since pandemic broke out A group of doctors and scientists urge leaders to follow the science and stop the misinformation that has undermined the U.S. response to the crisisThe U.S. has set another grim milestone in the coronavirus pandemic, averaging the most deaths from COVID-19 in a week since the start of the outbreak, as cases continue to rise across the country and hospitals fill with patients
9:49 a.m. Dec. 7, 2020 - By Ciara Linnane
More than 101,000 COVID-19 patients are now in U.S. hospitals, and Dakotas lead nation in cases per capita ‘The vaccine’s critical. But it’s not going to save us from this current surge. Only we can save us from this current surge,’ says Dr. BirxThe U.S. set another record for hospitalizations with the coronavirus illness COVID-19 on Sunday, while case numbers and fatalities remained high, and the nation braced for what is expected to be a very dark winter.
11:00 a.m. Dec. 4, 2020 - By Ciara Linnane
CDC forecasts up to 19,500 deaths from COVID-19 in week ending Dec. 26 ‘People were less willing to change their behavior than any other day during the pandemic,’ data analyst says of Thanksgiving DayThe U.S. set yet another record for new cases and fatalities in a single day from the coronavirus illness COVID-19 and the nation’s leading public health agency said there could be up to 19,500 deaths in the week ended Dec. 26.
8:46 a.m. Dec. 4, 2020 - By Ciara Linnane
What we still don’t know about COVID vaccines after the U.K.’s emergency-use authorization of the Pfizer-BioNTech candidate Logistics, supply capacity and an accelerated timeline all represent ongoing challengesThe U.K. government granted emergency use authorization to the COVID-19 vaccine being developed by Pfizer Inc. and German partner BioNTech SE with some fanfare on Wednesday, but experts cautioned that the news does not mean the pandemic is close to being over.
1:12 p.m. Dec. 3, 2020 - By Ciara Linnane
U.S. posts record one-day COVID death toll — before the predicted post-Thanksgiving surge December, January and February will be the ‘most difficult time in the public health history of this nation, largely because of the stress that it’s going to put on our health-care system,’ says CDC head Robert RedfieldThe U.S. hit some grim milestones in the coronavirus pandemic in a single day Wednesday, with a record number of fatalities and more than 100,000 COVID-19 patients in hospitals for the first time since the start of the outbreak, as a leading public health official warned of a cold, hard winter to come.
4:03 a.m. Dec. 3, 2020 - By Nicole Lyn Pesce
CDC director warns the next three months will be ‘the most difficult’ in public health history About 90% of U.S. hospitals are in ‘hot zones’ with high levels of coronavirus spread, Dr. Robert Redfield saysAbout 90% of U.S. hospitals are in ‘hot zones’ with high levels of coronavirus spread, Dr. Robert Redfield says
10:48 a.m. Dec. 2, 2020 - By Ciara Linnane
U.S. COVID-19 death toll tops 272,000 as CDC pushes ahead with plans for expected vaccine rollout U.K. grants emergency-use authorization to Pfizer and partner BioNTech’s vaccine candidate, but many hurdles remainThe U.S. set a fresh record for hospitalizations with the coronavirus illness COVID-19 on Wednesday and the death toll climbed above 272,000, as the nation’s main public health agency pushed ahead with planning for an expected vaccine rollout.
10:50 a.m. Dec. 1, 2020 - By Ciara Linnane
U.S. is heading for 100,000 COVID-19 patients in hospitals as experts worry about a coming Thanksgiving travel spike ‘What happened during Thanksgiving is a lot like a 100-mile-an-hour wind going into a forest fire,’ says epidemiologist Michael OsterholmThe U.S. set a record for hospitalizations with the coronavirus illness COVID-19 on Tuesday at almost 100,000 patients and health experts worried that the situation will worsen in the coming weeks after millions traveled across the country for the Thanksgiving holiday.
2:31 a.m. Dec. 1, 2020 - By Tomi Kilgore
Pfizer, BioNTech apply for CMA in Europe for COVID-19 vaccine candidateShares of Pfizer Inc. rallied 2.8% while Germany-based BioNTech SE dropped 2.5% in premarket trading Tuesday, after the company said they submitted their COVID-19 vaccine candidate BNT162b2 for Conditional Marketing Authorization (CMA) to the European Medicines Agency (EMA). If the EMA recommends granting a CMA, that could lead to use of BNT162b2 in Europe before the end of 2020. The companies had to the Food and Drug Administration on Nov. 20. On Monday, Moderna Inc. , and said it will apply for CMA with the EMA. Shares of Pfizer have gained 9.7% over the past three months and BioNTech's stock has rocketed 114.9%, while the S&P 500 has edged up 2.7%.
10:58 a.m. Nov. 23, 2020 - By Ciara Linnane
U.S. coronavirus case tally tops 12 million amid growing fears that Thanksgiving travel will spark another surge of infections ‘Four days before a holiday with potentially the most indoor and in-person gatherings of the year in the U.S., the virus is here and more prevalent than ever,’ says one analystThe global case tally for the coronavirus illness COVID-19 rose to 58.8 million on Monday and the U.S. tally rose above 12 million, with new daily infections heading toward 200,0000 a day amid growing fears that Thanksgiving travel will spark another surge.
7:32 a.m. Nov. 21, 2020 - By Ciara Linnane
U.S. moves closer to 200,000 daily COVID cases; Birx and Fauci urge Americans to follow safety measures over Thanksgiving Fauci at press briefing: ‘If you’re fighting a battle, and the cavalry is on the way, you don’t stop shooting. You keep going until the cavalry gets here.’The global case tally for the coronavirus illness COVID-19 climbed above 57 million on Friday, and the U.S. moved closer to 200,000 cases in a day and set a fresh record for hospitalizations as the virus continues to infect people in every state and region.
10:22 a.m. Nov. 10, 2020 - By Ciara Linnane
Coronavirus update: U.S. adds another 130,000 cases in a day: ‘This is what exponential math looks like,’ says expert Per capita new case numbers are highest in North Dakota, South Dakota, Iowa and Wisconsin, filling hospitals and raising concerns that systems will be overwhelmed The global tally of confirmed cases of the coronavirus illness COVID-19 climbed above 51 million on Tuesday with cases racing across the U.S. and Europe as more localities opted to impose restrictions on movement to curb the spread.
11:33 a.m. Nov. 9, 2020 - By Ciara Linnane
Coronavirus update: U.S. case tally tops 10 million and Biden warns vaccination is still months away despite positive Pfizer news There is now ‘light at the end of the tunnel’ with a return to ‘normalcy’ appearing likely in 2021, according to Raymond James analystThe U.S. tally of confirmed cases of the coronavirus illness COVID-19 rose above 10 million on Monday, and financial markets enjoyed a historic rally following positive news on a leading COVID-19 vaccine candidate.
3:53 a.m. Nov. 9, 2020 - By Tomi Kilgore
BioNTech, Pfizer stocks soar after COVID-19 vaccine candidate achieves 'success' in first analysisShares of Germany-based BioNTech SE shot up 23.4% and Pfizer Inc. jumped 11.5% in premarket trading Monday, after the company's said their COVID-19 vaccine candidate achieved "success" in the first interim analysis from a Phase 3 study. The companies said BNT162b2 vaccine candidate was found to be more than 90% effective in preventing COVID-19 in trial participants without previous evidence of SARS-CoV-2 infection. The companies said they are planning to submit for Emergency Use Authorization (EUA) to the Food and Drug Administration soon after the safety milestones are met, which is currently expected in the third week of November. "Today is a great day for science and humanity," said Pfizer Chief Executive Dr. Albert Bourla. "The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine's ability to prevent COVID-19." BioNTech shares have soared 171.6% year to date through Friday and Pfizer's stock has lost 7.1%, while the S&P 500 has gained 8.6%.
12:11 p.m. Nov. 4, 2020 - By Mark DeCambre
S&P 500, Nasdaq book best postelection rally in history as Biden-Trump presidential contest remains undecidedThe S&P 500 and the Nasdaq on Wednesday produced the best postelection gain on record, as investors focus on the possibility that the race for the White House between President Donald Trump and former Vice President Joe Biden might yield a split government. Biden was seen edging Trump for the presidency after Tuesday's Election Day results, which were still being tallied but the expectations for a Democratic sweep appeared dashed, making it more likely that Republicans and Democrats would lock horns over the next four years--viewed as the type of political gridlock that is felicitous for financial markets. Crucial battleground states like Georgia, Michigan and Pennsylvania continued to be counted, with Biden holding a 248 electoral college lead, compared against Trump's 214. A total of 270 votes are required to determine a winner for the White House. Technology-related stocks led the way on Wednesday on the belief that a Biden victory and a split Congress would make the Democratic challenger's hope of raising taxes and enacting stricter regulation on tech companies less likely. The Nasdaq Composite Index gained 430 points, or 3.9%, to reach 11,591, the S&P 500 index climbed 74.45 points, or 2.2%, to 3,443, with both indexes registering their best returns in the trading day after an election on record, according to Dow Jones Market Data. Meanwhile, the Dow Jones Industrial Average finished up 1.3% higher at 27,848, but finished the session well off its best levels at 28,302, which would have resulted in the best day for the benchmark since 1900. In corporate news, shares of Biogen surged after the U.S. Food and Drug Administration offered a positive assessment of the company's experimental Alzheimer's disease drug. Meanwhile, health-care shares [s; XLV] gained 4.5% on the day, leading the S&P 500's 11 sectors, perhaps, on the belief that a Biden presidency would maintain Obamacare. The focus on politics comes also as the Federal Reserve commenced its two-day policy meeting which will conclude on Thursday and could signal that the central bank will reiterate its support for financial markets amid the economic uncertainty wrought by the pandemic.
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