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5:50 a.m. Oct. 13, 2021 - By Jaimy Lee
Progenity's stock is up 4.9% after securing four patents for ingestible technologiesShares of Progenity Inc. gained 4.9% in trading on Wednesday after the company said it received four patents from the U.S. Patent and Trademark Office related to its ingestible technologies that can be used to deliver medicine to the gastrointestinal tract. Progenity's stock has tumbled 56.0% so far this year, while the S&P 500 is up 15.8%.
1:12 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%.
9:34 a.m. July 16, 2021 - By Tomi Kilgore
Kadmon's graft-versus-host treatment gets FDA approvalKadmon Holdings Inc. said Friday that Rezurock, its treatment of chronic graft-versus-host disease (cGVHD) in adjusts and pediatric patients older than 12 was approved by the Food and Drug Administration. The biopharmaceutical company's stock, which has been halted for news until 2:45 p.m. Eastern, was up 7.6% in afternoon trading prior to the halt. Kadmon said it expects Rezurock to be available in the U.S. by late August 2021. "Patients receiving Rezurock reported significant improvements in cGVHD symptoms, showing that not only did treatment result in organ responses, but it also made people feel better," said Stephanie Lee, professor at the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine. "This is so important for a chronic disease with a high symptom burden." The stock has lost 8.0% year to date, while the S&P 500 has gained 15.5%.
4:12 a.m. July 16, 2021 - By Joseph Walker
Cleveland Clinic, Mount Sinai and Providence won’t give Biogen’s new Alzheimer’s drug The three hospital operators are holding off on administering Aduhelm amid a debate over its effectivenessThree large hospitals are declining to administer Biogen Inc.’s new Alzheimer’s treatment, Aduhelm, the latest rupture to emerge from the Food and Drug Administration’s controversial approval of the drug last month.
3:54 a.m. July 16, 2021 - By Joseph Walker
Cleveland Clinic, Mount Sinai and Providence won’t give Biogen’s new Alzheimer’s drug The three hospital operators are holding off on administering Aduhelm amid a debate over its effectivenessThree large hospitals are declining to administer Biogen Inc.’s new Alzheimer’s treatment, Aduhelm, the latest rupture to emerge from the Food and Drug Administration’s controversial approval of the drug last month.
3:40 a.m. June 22, 2021 - By Jaimy Lee
New research says Pfizer and Moderna's mRNA vaccines don't affect sperm parametersNew published in JAMA found there was no difference in sperm parameters in 45 men who received mRNA vaccines against COVID-19. The two authorized mRNA vaccines, which were developed by Pfizer Inc. and Moderna Inc. , are the most commonly utilized COVID-19 vaccines in the U.S. Researchers at the University of Miami Miller School of Medicine say they initiated the study after hearing concerns from some people that the vaccines could impact fertility. They noted the study has some limitations, given that the number of men enrolled in the study is a small sample size, and semen analysis is "an imperfect predictor of fertility potential." Back in April, concerns about fertility were cited as a top reason to avoid COVID-19 vaccination, , with 42% of adults between the ages of 18 and 29 saying they have heard the shots can cause infertility and 5% saying they believe this is true.
2:29 a.m. June 2, 2021 - By Jaimy Lee
Moderna signs deal to provide up to 466 million doses of its COVID-19 shot to UnicefShares of Moderna Inc. were down 0.2% in premarket trading on Wednesday after it announced a deal with Unicef to supply 34 million doses of its COVID-19 vaccine in the fourth quarter of 2021 and up to 466 million doses of its mRNA shot in 2022. Moderna's stock is up 76.7% for the year, while the broader S&P 500 has gained 11.8%. Results from the second interim analysis of the NIH-led Phase 1 study of the Moderna COVID-19 Vaccine in the 56-70 and 71+ age groups were published on September 29 in The New England Journal of Medicine. On November 30, 2020, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases. On November 30, 2020, the Company also announced that it filed for Emergency Use Authorization with the U.S.FDA and a Conditional Marketing Authorization (CMA) application with the European Medicines Agency. On December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older. Moderna has also received emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore, Qatar, Taiwan, the Philippines, Thailand, Brunei, Paraguay, Japan, South Korea and an Emergency Use Listing (EUL) from the World Health Organization (WHO). Initial data from Moderna's Phase 2 study in the U.S. showed that a single 50 µg dose of mRNA-1273 or mRNA-1273.351 given as a booster to previously vaccinated individuals increased neutralizing antibody titer responses against SARS-CoV-2 and two variants of concern, B.1.351 (first identified in South Africa) and P.1 (first identified in Brazil). A booster dose of mRNA-1273.351, the Company's strain-matched booster, achieved higher neutralizing antibody titers against the B.1.351 variant of concern than a booster dose of mRNA-1273. Safety and tolerability profiles following third dose booster injections of 50 µg of mRNA-1273 or mRNA-1273.351 were generally comparable to those observed after the second dose of mRNA-1273 in the previously reported Phase 2 and Phase 3 studies. A manuscript describing these preliminary results was submitted as a preprint to medRxiv and will be submitted for peer-reviewed publication upon completion of the multivalent mRNA-1273.211 booster arm. About Moderna
8:28 p.m. April 18, 2021 - By Quentin Fottrell
The public’s expectation of perfection: Risk of blood clot from Johnson & Johnson COVID-19 vaccine is 0.00009% ‘It’s the same perceptual problem when we blindly drive to the airport texting, yet worry about the airplane’‘It’s the same perceptual problem when we blindly drive to the airport texting, yet worry about the airplane.’
4:58 a.m. April 11, 2021 - By Quentin Fottrell
Weary of #fakenews, more Americans are getting their COVID-related news from peer-reviewed medical journals Social media doesn’t help people differentiate what is real from what is fake, but this class of publications mightSocial media doesn’t help people differentiate what is real from what is fake, but this class of publications might.
8:14 a.m. April 6, 2021 - By Jaimy Lee
Research letter indicates that Moderna's COVID-19 vaccine has efficacy past 6 months Shares of Moderna Inc. gained 5.9% in trading on Tuesday after published in The New England Journal of Medicine indicates that the company's COVID-19 vaccine generated antibodies that extend at least six months after the second dose among a small group of study participants. This is based on tracking COVID-19 antibodies in 33 participants in the Phase 1 clinical trial, which is still ongoing. This is a to data recently released about immune response to BioNTech SE and Pfizer Inc.'s mRNA vaccine. "Our data show antibody persistence," the researchers wrote in the letter, which published Tuesday. At this time it is unknown how long the vaccines protect people who have been immunized. Shares of Moderna have gained 17.5% since the start of the year, while the broader S&P 500 is up 8.6%.
5:36 p.m. March 30, 2021 - MarketWatch
Germany restricts use of AstraZeneca vaccineBERLIN -- Germany's government said Tuesday it will restrict the use of the AstraZeneca PLC's Covid-19 vaccine for people younger than 60 following fresh blood-clotting incidents among recipients, potentially presenting the country's sputtering vaccine rollout with fresh delays.
2:25 p.m. March 15, 2021 - MarketWatch
AstraZeneca vaccine suspended in much of EuropeGermany, Italy, France and Spain joined the ranks of European countries that have temporarily halted use of the Covid-19 shot made by AstraZeneca PLC over blood-clot concerns, dealing another blow to the continent's sluggish vaccination rollout and threatening the credibility of the vaccine itself.
2:09 a.m. March 11, 2021 - MarketWatch
Denmark pauses AstraZeneca jabs after blood clots--Denmark pauses AstraZeneca vaccinations vaccine amid blood clot reports --Connections between the vaccines and this side effect yet to be investigated by EU --AstraZeneca confirmed the vaccine has generally been well tolerated in trials The Danish health authority said Thursday that it will pause vaccinations with AstraZeneca PLC's coronavirus vaccine for 14 days after reports of cases of blood clots in those vaccinated.
5:51 p.m. March 10, 2021 - MarketWatch
COVID-19 antibody drug effective, say Glaxo, VirA monoclonal-antibody drug reduced hospitalizations or death from Covid-19 by 85% compared with a placebo in a clinical trial, said Vir Biotechnology Inc. and GlaxoSmithKline PLC, the drug's developers.
7:50 a.m. Jan. 21, 2021 - By Ciara Linnane
Biden signs flurry of orders to tackle pandemic that has now cost more than 407,000 American lives Fauci addresses board of World Health Organization with promise that U.S. will join international response to crisisThe global case tally for the coronavirus-borne illness COVID-19 edged above 97 million on Thursday with the U.S. accounting for 24 million of those cases, as President Joe Biden wasted no time in implementing his plan to address a crisis that has caused the loss of more than 407,000 American lives.
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