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Shares of vaccine makers fell on Thursday as President-elect Donald Trump nominated Robert F. Kennedy Jr., a prominent vaccine skeptic, to lead the Department of Health and Human Services. Moderna’s stock closed more than 5% lower on Thursday, shares of Novavax fell more than 7% and Pfizer’s stock ended more than 2% lower. Shares of BioNTech, the German drugmaker that helped develop a Covid vaccine with Pfizer, closed more than 6% lower. Shares of those companies dipped further in extended trading as Trump confirmed his pick in a post on his platform Truth Social. Kennedy’s track record as a vaccine skeptic is extensive.
Persons: Donald Trump, Robert F, Kennedy Jr, Trump, Kennedy Organizations: Department of Health, Human Services, Pfizer, GSK, Health, Trump, Moderna, Health Defense Locations: Novavax, British, U.S
Whereas cases of the STI in newborns increased by 30% annually in recent years — greatly alarming public health experts — the upward trend has decelerated. San Francisco’s Public Health Department was the first to recommend doxyPEP for gay and bisexual men and trans women, in October 2022. That helped trigger a long decline in condom use among gay and bisexual men in particular. The protocol, called doxyPrEP, demonstrated generally comparable efficacy at preventing STIs compared with doxyPEP studies among gay men. Public health experts have attributed this century’s surge in STIs, at least in part, to a steady defunding of state and local public-health clinics.
Persons: STIs, gonorrhea, Chlamydia, , Laura Bachmann, Julie Dombrowski, Pfizer’s, doxyPEP, MISTR, Jeffrey Klausner, Trump, ” Klausner, Organizations: Centers for Disease Control, Blacks, NBC News, MediaNews, Getty, University of Washington, Public Health Department, CDC, PrEP, Food and Drug Administration, HIV, University of Southern Locations: Seattle, gonorrhea, Chicago, New York, Africa, Puerto Rico, , Munich, Canada, Japan, University of Southern California
In October, the Centers for Disease Control and Prevention recommended that high-risk adults get a second updated Covid vaccine to bolster their protection against the virus. No other vaccines are given at such a high frequency, but experts say there’s no reason to believe that the vaccines — and in particular, the mRNA vaccines from Pfizer and Moderna — aren’t effective. Pfizer’s and Moderna’s vaccines were the first to use mRNA technology to induce immunity to a virus, an approach that proved critical in the early days of the pandemic because mRNA vaccines can be developed much faster than traditional vaccines. Despite the CDC recommending an additional shot, there’s no evidence that the mRNA vaccines aren’t working as expected, said Akiko Iwasaki, a professor of immunology at the Yale School of Medicine. In a perfect world, the Covid vaccines would be able to be updated much faster to match the strains in circulation.
Persons: Akiko Iwasaki, Iwasaki, , , Ashish Jha, ” Jha, , Jha, I’ve, “ Topping, John Wherry, ” Wherry, Anna Durbin, ” Durkin, we’ll Organizations: Centers for Disease Control, Pfizer, Moderna, CDC, Yale School of Medicine, Emory University, Brown University School of Public Health, White, University of Pennsylvania, Johns Hopkins University School of Medicine
The Food and Drug Administration on Friday approved Pfizer 's treatment for a rare genetic bleeding disorder, making it the company's first-ever gene therapy to win clearance in the U.S. The agency greenlit the drug, which will be marketed as Beqvez, for adults with moderate to severe hemophilia B who meet certain requirements. Without that protein, called factor IX, patients with hemophilia B bruise easily and bleed more frequently and for longer periods of time. The gene therapy will compete with Australia-based CSL Behring's Hemgenix, a similar treatment that won FDA approval for hemophilia B in 2022. The company is also developing a gene therapy for Duchenne muscular dystrophy, a genetic disorder that causes muscles to weaken gradually.
Persons: IX, hemophilia, Adam Cuker, Cuker Organizations: Drug Administration, Pfizer, U.S, Penn's, Spark Therapeutics, hemophilia Locations: U.S, Australia
The New York drugmaker also said Tuesday it's reaffirming its forecast for 2024, a month after surprising Wall Street with an initial outlook that missed consensus. In the fourth quarter, Pfizer said it booked 8% operational revenue growth outside its market-leading COVID vaccine, Comirnaty, and treatment, Paxlovid. Comirnaty sales tumbled 53% in the quarter to $5.4 billion, and Pfizer took a $3.1 billion hit from Paxlovid for a revenue reversal. It included sales expectations for its COVID-19 products that fell more than $5 billion short of expectations. The company had previously scaled back its sales expectations for 2023, which sent Pfizer shares plunging and contributed to a rough year for the stock.
Persons: Pfizer, York drugmaker, it's Organizations: Pfizer, Pfizer Inc Locations: York
New York CNN —It was the year of artificial intelligence, and no Big Tech company leaned into the trend like Microsoft. That’s why CNN Business’ staff chose Nadella as the CEO of the Year, beating out other contenders including Chase CEO Jamie Dimon, OpenAI CEO Sam Altman and Nvidia CEO Jensen Huang. “There’s no question 2023 was the year of AI,” Nadella told CNN in an emailed response. OpenAI CEO Sam Altman and Nadella shared the stage at OpenAI’s first developer conference to discuss their partnership. Nadella told CNN he indeed remains “focused” on empowering both people and organizations to achieve more, as it continues to make and deploy new products.
Persons: Satya Nadella, Nadella, Jamie Dimon, Sam Altman, Jensen Huang, , ” Nadella, Pfizer’s Albert Bourla, Taylor Swift, Gil Luria, DA Davidson, , OpenAI —, Justin Sullivan, OpenAI’s Altman, Altman, “ It’s, OpenAI, ” OpenAI, ” Luria, Greg Brockman, Luria, Fred Havemeyer, “ Mr, Brad Barket, Stuart Carlaw, Nadella’s, he’s, ” Carlaw, hasn’t, ” Takeshi Numoto, — CNN’s Allison Morrow Organizations: New, New York CNN, Big Tech, Windows, CNN Business ’, Chase, Nvidia, CNN, Fortune, Microsoft, Ivy League, University of Wisconsin -, University of Chicago Booth School of Business, ChatGPT, Google, Macquarie, ABI Research Locations: New York, Silicon Valley, Seattle , Washington, Valley, India, University of Wisconsin - Milwaukee, Instacart, OpenAI
Competition will make obesity drugs successful
  + stars: | 2023-12-01 | by ( Robert Cyran | ) www.reuters.com   time to read: +3 min
In an interview with the Financial Times, he proposed spreading reimbursements over time if the medication proves to be successful. There’s some practical grounding in that solution, but the path of other similar drugs suggests that a competitive market is a better way to make it successful. Snag is, the drugs cost several thousand dollars per patient annually, even after discounts. Medicare, which covers 66 million seniors, can’t pay for weight loss drugs under current law. While it makes more sense for insurers or governments to pay over time if the drugs benefits last, schemes like the one that Jørgensen suggests can only do so much.
Persons: Lars Fruergaard Jørgensen, Jørgensen, , Lauren Silva Laughlin, Sharon Lam Organizations: Reuters, Novo Nordisk, Financial Times, Centers for Disease Control, Prevention, North Carolina, The New England, of Medicine, Employers, Thomson Locations: U.S, The, United States, Danish
[1/4] Employees work in the manufacturing of Pfizer’s new respiratory syncytial virus (RSV) vaccine Abrysvo, in this undated handout picture. Pfizer/Handout via REUTERS Acquire Licensing RightsWASHINGTON, Nov 28 (Reuters) - Senior Biden administration officials met with RSV vaccine makers this week to underscore the need for manufacturers such as Sanofi (SASY.PA) and AstraZeneca (AZN.L) to urgently meet demand as winter approaches, the White House said on Tuesday. At a meeting at the White House on Monday, officials and manufacturers also agreed to plan now to meet next year's demand for the vaccines targeting respiratory syncytial virus, which generally causes mild, cold-like symptoms but can develop into severe illness in infants and older adults. "Monday's meeting follows numerous in-person and virtual meetings to seek ways manufacturers can make more RSV immunizations available for infants," the White House said in a statement. Reporting by Susan Heavey and Ahmed Aboulenein; Additional reporting by Mike Erman; Editing by Katharine Jackson and Nick ZieminskiOur Standards: The Thomson Reuters Trust Principles.
Persons: Susan Heavey, Ahmed Aboulenein, Mike Erman, Katharine Jackson, Nick Zieminski Organizations: Pfizer, Handout, REUTERS Acquire, Rights, Biden, Sanofi, AstraZeneca, White, U.S . Centers for Disease Control, Prevention, CDC, Thomson Locations: U.S
CNN —With holiday season underway, you may be realizing that you forgot to get your Covid-19 and flu vaccines, and now you’ll be sitting across the table from your elderly relatives. Covid-19 vaccines were updated this year to target one strain of the coronavirus rather than two. “The flu vaccine might have been an adjuvant for the Covid vaccine,” she said. Moss led a recent study that compared neutralizing antibody responses of 53 Israeli health care workers who received their bivalent Covid-19 vaccines separately or with a flu shot. Blood samples from these health care workers were equally able to prevent Covid-19 and flu viruses from infecting cells, whether they got their vaccines together or separately.
Persons: Mandy Cohen, ” Cohen, , , Susanna Barouch, Barouch, they’re, Stephen Moss, Moss, ” Moss, Dr, Sanjay Gupta, William Schaffner Organizations: CNN, US Centers for Disease Control, CDC, US Food and Drug Administration, University of Michigan, Pfizer, CNN Health, Vanderbilt University Locations: Boston, Cambridge , Massachusetts, Netherlands
The Covid Vaccine Windfall Turns for Pfizer and Moderna
  + stars: | 2023-11-19 | by ( Allysia Finley | ) www.wsj.com   time to read: 1 min
Journal Editorial Report: The week’s best and worst from Kim Strassel, Kyle Peterson, Mary O'Grady and Dan Henninger. Images: AP/AFP/Getty Images/Reuters/Zuma Press Composite: Mark KellyThe U.S. was in a fit of Covid panic during Thanksgiving week two years ago. Share prices in Pfizer and Moderna surged. By month’s end, Pfizer’s stock-market value had surpassed $300 billion, up 50% from the start of the pandemic. In 2022 Pfizer became the first pharmaceutical company to book more than $100 billion in annual sales owing to government purchases of its vaccines and antiviral pill.
Persons: Kim Strassel, Kyle Peterson, Mary O'Grady, Dan Henninger, Mark Kelly The Organizations: Getty, Zuma, Pfizer, Moderna Locations: Mark Kelly The U.S
Pfizer can recover from its post-Covid fatigue
  + stars: | 2023-10-31 | by ( ) www.reuters.com   time to read: +2 min
Pfizer reported plummeting demand for its Covid vaccines and treatments, with an overall revenue decline of over 40% compared to last year, and a $2.4 billion loss that included a $5.6 billion charge for Covid inventory write-offs. Pfizer now thinks 2023 revenue from shots and pills for the disease will total about $12.5 billion, over a 75% decrease from last year. Peers trade at around 5 times sales, and if Pfizer did too its enterprise value would be about $235 billion. Instead it’s almost 20% less, and the stock is worth one-fifth less than it was at the end of 2019. They do not reflect the views of Reuters News, which, under the Trust Principles, is committed to integrity, independence, and freedom from bias.
Persons: Ivan Alvarado, It’s, Peers, it’s, What’s, Robert Cyran, John Foley, Aditya Sriwatsav Organizations: Pfizer, REUTERS, Reuters, Covid, X, Vodafone, Thomson Locations: Santiago , Chile, Spain
The Nobel Prize in Medicine was awarded Monday to two scientists whose work led to the mRNA vaccines against COVID-19. As countries prepared to roll out those shots, The Associated Press took a look at how the vaccines were developed so quickly. ___How could scientists race out COVID-19 vaccines so fast without cutting corners? A head start helped -- over a decade of behind-the-scenes research that had new vaccine technology poised for a challenge just as the coronavirus erupted. Both shots — one made by Pfizer and BioNTech, the other by Moderna and the National Institutes of Health — are so-called messenger RNA, or mRNA, vaccines, a brand-new technology.
Persons: Dr, Anthony Fauci, Buddy Creech, ” Creech, Tal Zaks, , Drew Weissman, Weissman, Katalin, Philip Dormitzer, Barney Graham’s, ” Fauci, Graham, Jason McLellan, hadn't, , ” Graham, Germany’s, Pfizer’s Dormitzer, Ugur Sahin Organizations: Medicine, COVID, Associated Press, Vanderbilt University, Infectious Diseases Society of America, Pfizer, BioNTech, Moderna, National Institutes of Health, NIH, University of Pennsylvania, Penn, NIH’s Vaccine Research Center, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Department of Science Education, AP Locations: U.S, Massachusetts, BioNTech, New York, China
WASHINGTON (AP) — Updated COVID-19 vaccines are coming soon, just in time to pair them with flu shots. Approval of updated COVID-19 shots is expected within days. Political Cartoons View All 1148 ImagesHere is what you need to know about fall vaccinations:WHY MORE COVID-19 SHOTS? Earlier this month, European regulators authorized Pfizer’s updated vaccine for this fall, for adults and children as young as 6 months. CAN I GET A FLU SHOT AND COVID-19 SHOT AT THE SAME TIME?
Persons: Mandy Cohen, haven’t, , , David Montefiori, it's, Carla K, Johnson Organizations: WASHINGTON, Centers for Disease Control, CDC, Food and Drug Administration, Pfizer, Moderna, FDA, Duke, WHO, GSK, AstraZeneca, AP, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group Locations: Novavax, Sanofi
Pfizer’s Covid Boost Crashes to Earth
  + stars: | 2023-08-06 | by ( Jared S. Hopkins | ) www.wsj.com   time to read: 1 min
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The National Institutes of Health said Monday it launched mid-stage clinical trials to test at least four treatments, including Pfizer 's antiviral Covid-19 pill Paxlovid, as potential therapies for long Covid. But the lack of a specific long Covid treatment pushes some patients to seek unproven – and potentially dangerous – remedies for the condition. "NIH is committed to a highly coordinated and scientifically rigorous approach to find treatments that will provide relief for the millions of people living with long COVID." The NIH will test the safety and effectiveness of the treatments – which include both drugs and medical devices – in groups of 100 to 300 patients with long Covid symptoms. The first part of the phase two trial will test a longer dosing regimen of Paxlovid to see if it improves long Covid symptoms.
Persons: Lawrence Tabak Organizations: National Institutes of Health, Pfizer, Health, NIH
A Facebook post included the same video clip and the text: “Pfizer plant in North Carolina hit by a tornado. The Rocky Mount plant did not produce or store COVID vaccines, a Pfizer spokesperson told Reuters in an email. The plant also made vials and syringes, according to the Pfizer website (here). The Rocky Mount Pfizer plant damaged by a tornado produced sterile injectables among other products. There is no evidence that it produced or stored COVID vaccines.
Persons: , Read Organizations: Pfizer, Vaccines, North Carolina ”, Reuters, Mount, UPS, Biotech, Fierce, Rocky Locations: North Carolina, U.S, Kalamazoo , Michigan, Michigan, Wisconsin, Pleasant Prairie , Wisconsin, Louisville , Kentucky, Columbus , Ohio, Wisconsin and Massachusetts
It was also unclear how deeply the destruction would exacerbate existing national drug shortages, which have reached a 10-year high in recent months. Hospitals are on high alert because low-cost generic products manufactured at the site, such as the sedative propofol, are already among the most shortage-prone on the market. The tornado ripped through a 16-mile strip of the Rocky Mount area, about 50 miles east of Raleigh, at about 12:30 p.m. on Wednesday. She said Pfizer and the Food and Drug Administration had teams on-site to assess the damage. It also makes vancomycin, an antibiotic administered to fight severe infections, and muscle blockers including succinylcholine, also used in surgery.
Persons: I’m, , Michael Ganio, Mittal Sutaria, Sutaria, Vizient Organizations: American Society of Health, Pharmacists, National Weather Service, Pfizer, Food and Drug Administration Locations: Rocky, Raleigh, Vizient
Eli Lilly gorges on obesity options
  + stars: | 2023-06-27 | by ( ) www.reuters.com   time to read: +2 min
NEW YORK, June 27 (Reuters Breakingviews) - Eli Lilly (LLY.N) has filled its plate with potential obesity treatments, unveiling data from two more on Monday. With so many options under development at Lilly, Novo Nordisk (NOVOb.CO) and others, it raises reasonable questions about capital allocation. Obesity drugs have investors salivating, but is this just more pharmaceutical R&D overkill? Pfizer’s cholesterol-lowering Lipitor, for one, reached consumers after rivals, and a decade after Merck’s version. Lilly’s research budget, projected at 24% of revenue this year, exceeds that of many peers, including Pfizer’s (PFE.N) 19%.
Persons: Eli Lilly, Robert Cyran, Aston Martin, Jeffrey Goldfarb, Sharon Lam Organizations: YORK, Reuters, Novo Nordisk, Twitter, Vodafone, Thomson Locations: Lilly, China, Canada
Pfizer on Monday said it would stop developing its experimental obesity and diabetes pill, lotiglipron, due to elevated liver enzymes in patients who took the drug once a day in mid-stage clinical studies. New York-based Pfizer said it will instead focus on its other oral obesity drug, danuglipron, which is in a fully enrolled phase two clinical trial. Pfizer CEO Albert Bourla has said that an obesity pill could eventually generate $10 billion each year for the company. The new class of obesity drugs is piquing public interest and causing a weight loss industry gold rush. Analysts believe Eli Lilly’s pill has an edge over Pfizer’s danuglipron.
Persons: William Sessa, Albert Bourla, Eli Lilly, Eli Lilly’s, danuglipron, Wells, Mohit Bansal, orforglipron, Bansal Organizations: Pfizer, Novo Nordisk, National Institutes of Health Locations: New York, danuglipron
But my enjoyment of his newfound Resistance shtick doesn’t bode well for Christie. The people he needs to win over are not liberal New York Times columnists, but voters who hate liberal New York Times columnists. The trick, for a Republican, is going to be painting Trump as a weak loser who will sabotage right-wing priorities. At times Christie tried to do this, as when he criticized Trump for his failure to build the border wall and repeal the Affordable Care Act. presidential nomination, would he be willing to accept the role of the presidential candidate of a 2024 center-right independent party?” Steinberg wrote in April.
Persons: Christie, , Trump, Alec Baldwin, Ivanka Trump, Jared Kushner —, you’ll, , Kushner, Prince Mohammed bin Salman, doesn’t bode, “ idolizing ” Vladimir Putin, Volodymyr Zelensky, Biden, John McCain, pander, filleting, Marco Rubio, he’s, Alan Steinberg, Bush, ” Steinberg Organizations: Trump, State, New York Times, Republican, Locations: State of New Jersey, Saudi Arabia, Ukraine, Europe
Each year, about 60,000 adults 65 and older are hospitalized with R.S.V. The Centers for Disease Control and Prevention estimated that in one year, more than 21,000 people in that age group would need to take the GSK vaccine to prevent one R.S.V. Several treatments, including a maternal vaccine and a monoclonal antibody for infants against R.S.V., are under agency review. The GSK vaccine, called Arexvy, was nearly 83 percent effective against severe R.S.V. The final vote of the F.D.A.’s advisory panel in favor of the Pfizer vaccine’s safety and efficacy was 7 to 4.
Persons: Miller Fisher, Jerica Pitts Organizations: Disease Control, GSK, Pfizer, Infants, R.S.V
The Food and Drug Administration's independent panel of advisors on Thursday recommended full approval of Pfizer's vaccine that protects infants from RSV, but raised safety concerns over premature births that may be tied to the shot. Ten of the advisors said the safety data on Pfizer's shot was adequate, while four said it was not. The FDA earlier this month approved the first RSV shot for adults ages 60 and older from GlaxoSmithKline. The agency is expected to make a decision within weeks on Pfizer's other RSV shot for that same age group. Pfizer's shot for infants is administered to expectant mothers in the late second or third trimester of their pregnancy.
R.S.V. Vaccine Approved for Older Adults
  + stars: | 2023-05-03 | by ( Christina Jewett | ) www.nytimes.com   time to read: +3 min
advisory panel reviewed data from trials for two vaccines aimed at older adults, one from GSK and one from Pfizer. The virus can lead to pneumonia, which is far more worrisome for older adults and especially for those with underlying medical conditions like heart and lung disease or diabetes. vaccine for older adults is also expected to receive F.D.A. in older adults and said it expected authorization in the first half of this year. Last week, the European Medicines Agency did recommend approval of GSK’s vaccine for adults 60 and older.
Pfizer reaffirmed its outlook to see revenue decline by as much as a third this year from its record high $100 billion in 2022. Photo: Gabby Jones for The Wall Street JournalPfizer ’s first-quarter revenue and earnings were down by nearly a third from a year ago, when the spread of the Omicron variant of Covid-19 buoyed demand for pandemic products. The drugmaker for the first three months of the year logged revenue of $18.28 billion, down 29% from a year ago but still well above Wall Street analyst estimates for $16.61 billion, according to analysts polled by FactSet.
CNN —The US Centers for Disease Control and Prevention is still requiring international visitors boarding flights to the United States to be vaccinated against Covid-19, but it’s easing vaccine requirements for those travelers. International travelers boarding flights to the United States will now be considered fully vaccinated two weeks after getting a single dose of either the Pfizer or Moderna mRNA vaccine any time after August 16, 2022, when bivalent formulations first became available. Previously, foreign travelers entering the United States were considered fully vaccinated two weeks after the second dose of a vaccine that required two primary doses, or two weeks after a vaccine that only required a single shot, such as the Johnson & Johnson vaccine. A number of older, monovalent vaccine regimens also qualify a foreign visitor as fully vaccinated. As part of the update, the older monovalent mRNA Covid-19 vaccines are no longer recommended in the United States, and updated vaccines are recommended for everyone age 6 months and older.
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