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FDA Authorizes Merck's Covid-19 Pill: Here's How It Works

  • FDA Authorizes Merck's Covid-19 Pill: Here's How It Works FDA Authorizes Merck's Covid-19 Pill: Here's How It Works 5:55
    Pfizer's Fight Vs. Covid & Cancer Pfizer's Fight Vs. Covid & Cancer 2:07
2:20 a.m. Nov. 16, 2021 - By Ciara Linnane
UPDATE: Pfizer to allow generics companies to make its COVID-19 oral antiviral treatment, expand access to poorer countriesPfizer Inc. said Tuesday it has signed a voluntary license agreement with United Nations-backed public health organization the Medicines Patent Pool that will allow generics makers to manufacture its COVID-19 oral antiviral treatment. The move will help expand access to the drug to low and middle-income countries. Under the terms of the main license agreement, qualified generic medicine manufacturers worldwide that are granted sub-licenses "will be able to supply PF-07321332 in combination with ritonavir to 95 countries, covering up to approximately 53% of the world's population," the company said in a statement. "This includes all low- and lower-middle-income countries and some upper-middle-income countries in Sub-Saharan Africa as well as countries that have transitioned from lower-middle to upper-middle-income status in the past five years. " Pfizer will not receive royalties on sales in those countries and will also waive royalties on sales in all countries covered by the agreement as long as COVID remains classified as a Public Health Emergency of International Concern by the World Health Organization. Pfizer said last week it would seek an emergency-use authorization for the treatment "as soon as possible." The company released data from a double-blind Phase 2/3 clinical trial in 1,219 unvaccinated adults with COVID-19 who were at high risk of severe disease and found it reduced the risk of dying or ending up in the hospital by 89%. Less than 1% of the patients who took the drug were hospitalized by the 28-day mark, compared with the 7% who received the placebo and were hospitalized or died. Participants took two pills a day for five days. Antivirals are expected to become a game changer in the pandemic, as they can be taken at home, while the current treatments are done by infusion in a clinical setting. Pfizer shares were down 0.7% premarket but have gained 35% in the year to date, while the Dow Jones Industrial Average has gained 18% and the S&P 500 has gained 25%.
2:41 a.m. Nov. 8, 2021 - By Jaimy Lee
Regeneron says its COVID-19 antibody cocktail can prevent COVID-19 infections for months Shares of Regeneron Pharmaceuticals Inc. gained 3.7% in premarket trading on Monday after the company said four subcutaneous injections of its monoclonal antibody treatment protected unvaccinated people from contracting COVID-19 by 81.6% for up to eight months. Four infusions of the treatment are considered one dose. "These results demonstrate that REGEN-COV has the potential to provide long-lasting immunity from SARS-CoV-2 infection, a result particularly important to those who do not respond to COVID-19 vaccines including people who are immunocompromised," Dr. Myron Cohen, a physician in charge of the National Institutes of Health's work on monoclonal antibodies, said in a news release. Regeneron has already shared similar data in a published in the New England Journal of Medicine but this is a new analysis of that data, which came from a trial assessing giving the treatment to one household member if another was sick to see if it could prevent testing positive for the virus. The results came from 1,684 people who participated in the Phase 3, randomized, placebo-controlled trial. Regeneron's therapy is currently authorized as a treatment for people who are at high risk of severe disease and post-exposure prophylaxis for high-risk people who have been exposed to the virus. Regeneron's stock is up 26.6% so far this year, while the broader S&P 500 has gained 25.1%.
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%.
10:03 a.m. Aug. 17, 2021 - By Jaimy Lee
Roche says arthritis drug authorized to treat hospitalized COVID-19 patients is in short supply Roche Holding AG said Monday that Actemra, its rheumatoid arthritis drug that recently received authorization in the U.S. as a COVID-19 treatment for hospitalized patients, is in short supply and will be so for weeks or months. The drug "has been widely used to treat hospitalized patients with severe or critical COVID-19 around the world, and demand for this medicine has increased to unprecedented levels globally," the company said. Demand for Actemra in the U.S., where the delta variant is behind the recent surge in cases and hospitalizations, is "well beyond 400% of pre-COVID levels over the last two weeks alone," according to Roche, which cited manufacturing limits, supply constraints, and the labor-intensive process of developing biologic drugs as reasons for the shortage. Roche's stock is up 15.6% so far this year, while the broader S&P 500 has gained 19.2%.
4:04 a.m. July 1, 2021 - By Jaimy Lee
Novavax's experimental COVID-19 shot has 86.4% efficacy against the Alpha variantShares of Novavax Inc. were up 2.5% in premarket trading on Thursday, the day after The New England Journal of Medicine published a looking at how Novavax's COVID-19 vaccine candidate performed in a Phase 3 clinical trial conducted in 15,000 participants in the U.K. An earlier analysis of the data was previously published as a preprint. According to the new study, Novavax's experimental vaccine has an overall efficacy rate of 96.4% against the original strain of the virus and an 86.3% efficacy rate against the Alpha variant, which was first identified in the U.K. and has been the most dominant form of the virus in many countries since the start of the year. Novavax did not mention the Delta variant, which is now the most dominant form of the virus in the U.K., in this study. The company is conducting separate studies of its experimental shot in the U.S. Novavax's stock is up 90.4% for the year, while the broader S&P 500 has gained 14.4%.
11:57 a.m. June 25, 2021 - Barrons.com
Pfizer's Fight Vs. Covid & CancerAlbert Bourla, Pfizer's chairman & CEO, speaks with Jack Hough on the Streetwise podcast about the future of Covid booster shots as well as crucial cancer research and pursuing new breakthroughs in medicine.
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
2:01 a.m. May 4, 2021 - By Tomi Kilgore
Pfizer beats earnings expectations and lifts guidance, as COVID-19 revenue outlook increases 73%Shares of Pfizer Inc. jumped 1.6% toward a near five-month high in premarket trading Tuesday, after the drug giant beat earnings expectations and raised its full-year outlook, as revenue expectations for its COVID-19 vaccine jumped 73%. Net income rose to $4.88 billion, or 86 cents a share, from $3.36 billion, or 60 cents a share, in the year-ago period. Excluding nonrecurring items, adjusted earnings per share increased to 93 cents from 63 cents, and beat the FactSet consensus of 77 cents. Revenue grew 45% to $14.58 billion, above the FactSet consensus of $13.54 billion. Vaccine revenue tripled, to $4.89 billion from $1.61 billion, while oncology revenue rose 18% to $2.86 billion and internal medicine revenue grew 11% to $2.59 billion. For 2021, the company raised its guidance ranges for adjusted EPS to $3.55 to $3.65 from $3.10 to $3.20 and for revenue to $70.5 billion to $72.5 billion from $59.4 billion to $61.4 billion, as revenue expectations for the COVID-19 vaccine (BNT162b2) increased to $26 billion from $15 billion. The revenue projection for BNT162b2 includes guidance for 1.6 billion doses expected to be delivered this year. The stock, which is on track to open at the highest prices seen since mid-December, has gained 8.2% year to date through Monday, while the S&P 500 has advanced 11.6%.
6:13 a.m. May 3, 2021 - By Jaimy Lee
Pfizer says it submitted application for COVID-19 vaccine to Indian regulators 'months ago'Shares of Pfizer Inc. gained 2.2% in trading on Monday after the pharmaceutical company said it will donate $70 million in medicine to India, which is facing the worst surge in COVID-19 cases worldwide during the pandemic. The drugmaker also reiterated that the COVID-19 vaccine it developed with BioNTech SE has not yet been approved in India, though the application was "submitted months ago." "We are currently discussing with the Indian government an expedited approval pathway to make our Pfizer-BioNTech vaccine available for use in the country," Pfizer CEO Albert Bourla wrote in a letter on Monday. As part of the donation to India, Pfizer will provide common treatments for COVID-19, including steroids and anticoagulants, as well as antibiotics for secondary bacterial infections. It will also provide funding for ventilators and oxygen concentrators. Pfizer's stock is up 7.3% for the year, while the broader S&P 500 has gained 11.3%.
10:48 a.m. April 15, 2021 - By Jaimy Lee
Merck scraps two treatments for hospitalized COVID-19 patients, will focus on antiviral for non-hospitalized patientsShares of Merck & Co. were up 0.1% in premarket trading on Thursday after the drug company said the oral antiviral COVID-19 treatment it is developing with Ridgeback Biotherapeutics did not help hospitalized patients in a mid-stage clinical trial. The companies now plan to test molnupiravir in non-hospitalized COVID-19 patients in a Phase 3 trial, with plans to file for emergency authorization in the second half of the year. They are also planning to see if the experimental therapy works for post-exposure prophylaxis. In a separate news release, Merck said it is discontinuing MK-7110 as a treatment for patients hospitalized with COVID-19, saying that the Food and Drug Administration's request for additional clinical information would push the launch into 2022. "Merck is now focusing its efforts on advancing molnupiravir, which, as an oral medicine for outpatient use, represents a promising potential new approach, and on accelerating production of Johnson & Johnson's COVID-19 vaccine," Dr. Roy Baynes, chief medical officer for Merck Research Laboratories, said in the release. Merck's stock has gained 6.6% since the start of the year, while the broader S&P 500 is up 9.8%.
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%.
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.
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.
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