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[1/2] Test tubes are seen in front of displayed Pfizer and Biontech logos in this illustration taken, May 21, 2021. Moderna first sued Pfizer in August, accusing the company of violating its rights in three patents related to innovations that Cambridge, Massachusetts-based Moderna said it pioneered before the COVID-19 pandemic. Moderna has also filed a related lawsuit against Pfizer and BioNTech in Germany. In its lawsuit, Moderna asked for an undisclosed amount of money damages from Pfizer COVID-19 vaccines sold since March. Pfizer and BioNTech said in their Monday filing that they developed their vaccine independently, calling Moderna's lawsuit "revisionist history" and arguing its patents "far exceed its actual contributions to the field."
Vials with Pfizer-BioNTech and Moderna coronavirus disease (COVID-19) vaccine labels are seen in this illustration picture taken March 19, 2021. Pfizer has rejected allegations made by rival Moderna that its Covid-19 vaccine is a copy, accusing the Boston biotech company of rewriting history to lay claim to technology developed by a field of scientists over many years. Pfizer asked a federal court in Massachusetts on Monday to dismiss Moderna's lawsuit seeking monetary damages for alleged patent violations related to the Boston company's Covid vaccine. "The Moderna inventions that Pfizer and BioNTech chose to copy were foundational for the success of their vaccine," the company claimed. Pfizer and BioNTech did not copy Moderna's technology," Pfizer said in its response.
Dec 1 (Reuters) - Biotech firm Roivant Sciences (ROIV.O) on Thursday launched a company with Pfizer Inc (PFE.N) focused on an experimental bowel disease treatment, as the drugmakers seek to tap into a multibillion dollar market. The drug, RVT-3101, was originally developed by Pfizer, which will hold a 25% stake in the new business, with Roivant holding the majority interest. SVB Securities analyst David Risinger says the deal shows how Pfizer is prioritizing research spending for its oral ulcerative colitis drug, etrasimod, which holds a near-term blockbuster opportunity. RVT-3101 could represent a nearly $15 billion commercial opportunity in the United States for Roivant as a treatment for both ulcerative colitis and Crohn’s disease, said Risinger. Pfizer has also licensed its inflammatory autoimmune disease drug brepocitinib to Roivant in exchange for a 25% stake in another jointly held company called Priovant.
Big Pharma will muscle in on obesity gold rush
  + stars: | 2022-11-28 | by ( Aimee Donnellan | ) www.reuters.com   time to read: +4 min
LONDON, Nov 28 (Reuters Breakingviews) - Obesity drugs are a modern day gold rush for drugmakers. By then, the obesity market could total $50 billion, according to Morgan Stanley. But a plausible 50% price cut would lower annual sales to $25 billion. Reuters GraphicsFollow @aimeedonnellan on TwitterCONTEXT NEWSSales of Novo Nordisk’s obesity drugs Wegovy and Saxenda reached nearly $1.2 billion in 2021, up 50% versus the previous year. Morgan Stanley analysts expect the obesity market to grow to $50 billion in annual sales by 2030.
In October 2021, Da’Vion Miller was found unconscious in the bathroom of his home in Detroit a week after receiving his first dose of Pfizer's Covid vaccine. Courtesy Da’Vion MillerMiller is one of a very small group of people in the United States who have experienced myocarditis following vaccination with the Pfizer-BioNTech or the Moderna Covid vaccines based on mRNA technology. Video: CDC says waiting longer between Covid vaccine doses could reduce myocarditis risk. Cooper joined an expert advisory panel formed by Moderna to monitor its Covid vaccine safety. The Pfizer study will include people who were previously hospitalized with vaccine-associated myocarditis, and it will also follow those who were more recently diagnosed.
CNN —Pfizer and BioNTech said Friday that the immune responses against Omicron BA.4/BA.5 subvariants were “substantially higher” in people who got its new bivalent booster compared with people who received the companies’ original Covid-19 vaccine. The bivalent booster that targets the original coronavirus strain and the Omicron BA.4 and BA.5 subvariants became available in the US in early September. When someone gets any vaccine, it can take a few weeks to build up immunity and generate its full protection. The Omicron BA.5 subvariant had dominated US Covid-19 infections since July, but a mix of other Omicron subvariants have been gaining against it. So far, 26.3 million people age 5 and older in the United States have received updated Covid-19 boosters.
Pfizer on Tuesday raised its 2022 earnings guidance after booking a strong third quarter that beat Wall Street expectations. Pfizer raised its full year sales guidance for its Covid-19 vaccine to $34 billion this year, up $2 billion from the company's previous expectations. The company sold $4.4 billion of its Covid vaccine worldwide in the quarter, a decrease of 66% compared to the third-quarter of 2021. Pfizer's antiviral treatment Paxlovid also had a strong quarter, generating $7.5 billion in sales worldwide though mostly in the U.S. Pfizer booked net income of $8.6 billion for the third quarter, a 6% increase over the same quarter last year.
Uber – Shares of Uber jumped 12% after the company reported revenue that exceeded Wall Street's expectations. J&J shares fell 1%. Molson Coors Beverage – Shares of Molson Coors fell 3.8% after the beer giant reported earnings that fell short of expectations. Goodyear Tire – Shares fell 13% after the tire company's earnings fell short of expectations due in part to higher costs and a surging dollar. Gartner – The research firm was up 7.5% after it beat per-share earnings expectations, according to StreetAccount, and issued positive full-year guidance.
Club holding J ohnson & Johnson (JNJ) buys Abiomed (ABMD), premier heart pumping company, in a deal valued at $16.6 billion. J & J is paying a hefty premium: $380-per-share upfront, plus extra $35-per-share if certain milestones are met. J & J juiced growth ahead of its separation into two companies: one, pharma and the other, consumer brands. This will raise the growth rate of the MedTech portion of new J & J company. Adjusted earnings before interest, taxes, depreciation, and amortization (EBITDA) very good: $516 million versus $470 million expected.
Pfizer’s vaccine candidate is administered to pregnant women who then make antibodies that cross the placenta and protect the baby after birth. In March, the FDA designated Pfizer’s RSV vaccine a breakthrough therapy, a status that speeds its review. Pfizer’s vaccine contains the virus’ F-protein, the site that it uses to attach to human cells. Pfizer’s RSV vaccine is bivalent, containing F-proteins from both the A and B subgroups of the RSV virus, which are the two most commonly circulating strains. “Further analysis to better understand safety data from these trials is ongoing,” spokesperson Alison Hunt said in a statement to CNN.
Pfizer's vaccine against respiratory syncytial virus, or RSV, is highly effective at protecting newborns when the shot is given to the mothers late in their pregnancy, according to clinical trial data published Tuesday. RSV is a common respiratory virus that generally causes mild cold-like symptoms, but it can be dangerous for infants younger than 6 months. The vaccine was well tolerated with no safety concerns for the mothers or their newborns, according to Pfizer. Infants almost always show symptoms, but for babies younger than six months these symptoms can be more subtle, according to the CDC. Irritability, decreased activity and appetite, as well as pausing while breathing are all signs that an infant might have RSV, according to the CDC.
The recently authorized booster vaccine protects against the original SARS-CoV-2 virus and the more recent omicron variants, BA.4 and BA.5. The Food and Drug Administration said two studies this week showing that the new omicron boosters weren't that much better than the old shots were too small to come to any real conclusions. The antibody responses were slightly higher with the omicron boosters, though the studies concluded the difference wasn't significant. The studies are of public interest because there's very limited human data on how the omicron BA.5 boosters perform right now. The FDA also looked at data directly on the BA.5 shots that came from animal studies.
NEW YORK, Oct 26 (Reuters) - Pfizer Inc (PFE.N) said its fellowship program for minorities serves the public interest, as the drugmaker defends against a lawsuit by a group of medical professionals that claims the program illegally excludes whites and Asian-Americans. Fellows receive two years of full-time jobs, fully-funded master's degrees, and employment at New York-based Pfizer after completing the program. The fellowship program "does what Congress has encouraged and controlling law allows," Pfizer said. Among the precedents at risk is a 2003 Supreme Court decision where Justice Sandra Day O'Connor said race could be used as one factor among many to achieve diversity. The case is Do No Harm v. Pfizer Inc, U.S. District Court, Southern District of New York, No.
Pfizer’s Price Hike Shot in the Arm for Vaccine Makers
  + stars: | 2022-10-21 | by ( David Wainer | ) www.wsj.com   time to read: +1 min
With fewer and fewer Americans opting for Covid-19 vaccine boosters, investors had been growing increasingly skittish about vaccine-makers Pfizer and Moderna Both stocks have underperformed their peers and are among the cheapest healthcare stocks, trading well below the industry average on a price-to-earnings basis. News late Thursday that Pfizer is planning to price its shot at $110 to $130 per dose in the U.S. is giving a lift to both stocks as investors rework their models to reflect the higher revenue starting next year when Pfizer expects to transition its vaccine to the commercial market. The federal government currently covers the cost of vaccines and is paying roughly $30 per dose under the latest contract. While investors had expected a hike as that coverage lapsed, “the magnitude of the price increase was well above expectations,” wrote Chris Schott , an analyst at JP Morgan. Pfizer was up 4.5% while Moderna rose 9% in early afternoon trading.
Last year, many on Wall Street were estimating the number of COVID-19 shots would be in line with the annual flu vaccine, which is the vaccine market leader with more than 160 million shots per year in the United States and 600 million shots globally. A recent poll by Kaiser Family Foundation found that two-thirds of American adults do not plan on getting a COVID vaccine soon. He added that instances of COVID infections in those who have been vaccinated has left many to question the effectiveness of the vaccine. The companies could make up for some of the weaker demand with price increases. That would mean annual revenue of $3 billion to $5 billion over the long-term for a company like Moderna, he added.
This year's relentless market sell-off may have made some stocks way too cheap, based on certain metrics. Still, there are some parts of the market where the selling may be overdone, creating buying opportunities in stocks that could rally going forward. The stock is trading at a forward price-to-earnings ratio of 6.5, and analyst expect Ford earning's to grow by 24.5% this year. The stock is trading at a forward price-to-earnings ratio of 7.9, and analysts see upside of more than 27% on average. This shows the earnings potential of Pfizer beyond the loss of exclusivity of key drugs through the end of the decade.
The authorization of Novavax's booster could significantly increase the role that its shot plays in U.S. vaccination efforts. The Centers for Disease Control and Prevention still has to give the final go ahead before pharmacies can start administering Novavax's booster. Only 35,300 people have received Novavax's shots so far in the U.S., according to data from the CDC. By comparison, some 372.5 million Pfizer shots, 235.8 million Moderna doses and 18.9 million Johnson & Johnson shots have been administered across the U.S. so far. People who received Novavax's vaccine as their primary series are also eligible for Pfizer and BioNTech's new omicron booster.
If you already got your omicron-specific Covid booster, you might have experienced some side effects. But there's no need to worry: Experts and new data say the new shots appear to work — regardless of whether you experience moderate, mild or no side effects at all. The new boosters gained approval from the U.S. Food and Drug Administration and the CDC before they finished clinical trials. Like previous Covid vaccines, the new boosters are designed to help you fight the virus by triggering an immune response in your body. Covid vaccines typically take two to three weeks to fully ramp up your immunity, which can help your body stop an infection from happening or keep it from progressing to severe disease.
To get emergency approval, companies needed to show that the vaccines were safe and prevented vaccinated people from getting ill. They did not have to show that the vaccine would also prevent people from spreading the virus to others. Pfizer ‘vaccine’ wasn’t intended to prevent transmission. The newest family of Omicron variants has further eroded vaccine effectiveness against infection and transmission (here) . But even Omicron does not escape vaccine protection completely.
Pfizer and its German partner BioNTech on Thursday said their new omicron boosters substantially increased protective antibodies against the dominant omicron BA.5 subvariant for adults in the first direct human data released to the public on the new shots. The participants who received the first generation vaccine saw a limited increase in antibodies against BA.5, according to the companies. The early data indicate that the safety profile of the new boosters is the same as the original vaccine, the companies said. The first generation shots were developed only against the first strain of the virus. The FDA authorized the omicron shots without direct human data on how they perform against omicron BA.5, which is causing most infections in the U.S. right now.
White House COVID-19 Response Coordinator Dr. Ashish Jha speaks to reporters during a press briefing with White House Press Secretary Karine Jean-Pierre at the White House on July 25, 2022 in Washington, DC. The U.S. is tracking several coronavirus omicron subvariants that more easily evade immunity, but the new booster shots should protect against them, a top health official said on Tuesday. Health officials are closely watching the subvariants because they render many treatments ineffective, said Dr. Ashish Jha, head of the White House Covid task force. But the new booster shots available in the U.S. should provide a much higher degree of protection against the variants because they all descend from omicron BA.2 or omicron BA.5, Jha told reporters at the White House. The Biden administration had to shift money around to find funding to stockpile the new booster shots.
Americans have two options for a new omicron-specific Covid booster shot: Pfizer or Moderna. Pfizer's booster is cleared for anyone 12 and older, while Moderna's booster is for people 18 and older. "People ages 18 years and older may get a different product for a booster than they got for their primary series, as long as it is [Pfizer or Moderna,]" the CDC's website reads. "It's OK to mix and match Moderna and Pfizer," Dr. Ralph Gonzales, associate dean for clinical innovation at UC San Francisco, said at a campus town hall earlier this month. I definitely felt a stronger response with the Moderna — having had Pfizer before — but either combinations are fine."
Moderna has asked the Food and Drug Administration to authorize its omicron booster shots for children, the company announced on Friday. The Centers for Disease Control and Prevention, in a document published Tuesday, said it expects children to become eligible for the omicron boosters by mid-October pending authorization by the FDA. Pfizer told the CDC advisory committee earlier this month that it expects to ask the FDA to authorize omicron boosters for children ages 5 to 11 in early October. U.S. health regulators cleared Moderna's omicron boosters for adults earlier this month. There is also concern that the original shots' effectiveness at preventing hospitalization and severe illness is starting to decline.
Register now for FREE unlimited access to Reuters.com RegisterA 3D printed Pfizer logo is placed near medicines from the same manufacturer in this illustration taken September 29, 2021. Pfizer said the supply agreement is part of its strategy to facilitate equitable access to oral COVID treatments. Register now for FREE unlimited access to Reuters.com RegisterThe company has made a deal with several generic drugmakers to produce its treatment at a lower price for developing countries. "This agreement with Global Fund is a critical step that will boost equitable access for high-risk patients in low-and-middle income countries," Chief Executive Officer Albert Bourla said in a statement. Register now for FREE unlimited access to Reuters.com RegisterReporting by Mrinalika Roy in Bengaluru; Editing by Vinay DwivediOur Standards: The Thomson Reuters Trust Principles.
A recent Gallup poll found that one in three U.S. workers are "very" or "moderately" concerned about Covid exposure at work. Stay up-to-date on your Covid vaccinesStaying up-to-date on your vaccines is the best way to protect yourself from Covid. That means completing your primary series and receiving the booster shots you're eligible for. You'll need to be at least two months out from your last dose of any Covid shot, the CDC says. Have completed your primary series, but are immunocompromisedHave completed your primary series and are in an area with a substantial or high level spread of Covid.
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