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REUTERS/Johanna Geron/File PhotoJune 1 (Reuters) - Pfizer Inc (PFE.N) said on Thursday data from late-stage trials showed its experimental combination of antibiotics was effective in treating deadly infections caused by drug-resistant bacteria. Deaths from antibiotic-resistant bacteria, also known as superbugs, have been on the rise globally, and health regulators have called for the development of newer treatments as resistance to older antibiotics grows. The late-stage studies compared the experimental combination of the antibiotics aztreonam-avibactam (ATM-AVI) and existing generic drug metronidazole with a combination of two older antibiotics - meropenem and colistin - to treat complicated intra-abdominal infections and types of hospital-acquired pneumonia. Pfizer said the data from the studies shows the antibiotic combination of ATM-AVI is effective and well-tolerated in treating infections caused by gram-negative bacteria. For patients with types of hospital-acquired pneumonia and ventilator‐associated pneumonia, the cure rate was 45.9% for Pfizer's antibiotic combination with metronidazole, versus 41.7% for other, older treatments.
Persons: Johanna Geron, Leroy Leo, Sriparna Roy, Pooja Desai Organizations: Pfizer, REUTERS, Pfizer Inc, Disease Control, Thomson Locations: Puurs, Belgium, United States, Bengaluru
We are selling 50 shares of Eli Lilly (LLY) at roughly $442 each. Following Monday's trade, Jim Cramer's Charitable Trust will own 150 shares of LLY, decreasing its weighting in the portfolio to about 2.5% from 3.33%. We're taking some Eli Lilly off the table Monday afternoon on the stock's breakout to another new all-time high. The FDA in early January granted accelerated approval to a drug similar to donanemab, which was developed by Japanese pharmaceutical firm Eisai and U.S.-based partner Biogen (BIIB). Like Pfizer's drug, Lilly is working on an oral type-2 diabetes and chronic weight management drug called orforglipron, which could be similar to the Mounjaro injectable.
Scott Olson | Getty ImagesThree years and billions of Covid vaccinations into the pandemic, Pfizer and Moderna say their work is far from over. Here's what Moderna and Pfizer say is next for their Covid shots. Annual Covid shotsPfizer and Moderna aim to keep up with a shift in the U.S. toward annual Covid shots rather than frequent booster doses. Miller, who helped lead the development of Moderna's Covid shot in 2020, said the advantages of using mRNA became evident earlier on in the pandemic. 'Next-generation' Covid shotsPfizer's and Moderna's Covid vaccines both deliver robust protection against the virus, but that immunity can start to fade after four to six months.
TipRanks leveraged its Experts Center tool to recognize the ones with a high success rate. We also analyzed each stock recommendation made by health care sector analysts in the past decade. TipRanks' algorithms calculated the statistical significance of each rating, average return and the analysts' overall success rate. The buy recommendation generated a return of 397.9% from May 12, 2020 to May 12, 2021. Boris Peaker - TD CowenBoris Peaker has the 10th spot on the list, with a success rate of 47%.
[1/3] A vial labelled "CureVac COVID-19 Vaccine" is seen in this illustration taken January 16, 2022. REUTERS/Dado Ruvic/IllustrationMay 19 (Reuters) - CureVac NV said on Friday it had filed an expanded patent infringement claim against Pfizer Inc (PFE.N) and BioNTech over the use of mRNA technology and that a U.S. court had granted its request to transfer the trial. In July 2022, CureVac had filed a patent lawsuit against BioNTech over the use of mRNA technology in the companies' COVID-19 vaccine. Pfizer and BioNTech in response had filed a complaint with the U.S. District Court in Massachusetts, seeking a judgment that they did not infringe U.S. patents held by CureVac. The companies have previously told the court that their COVID vaccine Comirnaty does not work in the same way as CureVac's patented technology.
Here's the latest:ELECTRIC VEHICLE FRICTIONBiden's domestic policy is embodied in working to electrify roadways across the United States. Getting more electric vehicles on the roads is central to his climate change agenda, ensuring the vehicles are "Made in America" is part of his commitment to restore manufacturing jobs. But the IRA's consumer tax credits are tightly linked to the cars' and batteries being made in the U.S., roiling allies in Europe and Asia whose companies sell into U.S. markets. Instead, Japanese and U.S. officials struck a trade deal on electric vehicle battery minerals that expands eligibility for the $7,500 per vehicle EV tax credits in the IRA. NEW RACE FOR SUBSIDIESThe promise of corporate tax credits has renewed interest in investing in the U.S., and Europe has responded with subsidies of their own.
WHO recommends new COVID shots should target only XBB variants
  + stars: | 2023-05-18 | by ( ) www.reuters.com   time to read: +2 min
May 18 (Reuters) - A World Health Organization (WHO) advisory group on Thursday recommended that this year's COVID-19 booster shots be updated to target one of the currently dominant XBB variants. New formulations should aim to produce antibody responses to the XBB.1.5 or XBB.1.16 variants, the advisory group said, adding that other formulations or platforms that achieve neutralizing antibody responses against XBB lineages could also be considered. The U.S. Food and Drug Administration is also set to hold a meeting of outside experts in June to discuss the strain compositions of COVID-19 shots for later this year; vaccine manufacturers will be expected to update their shots once the strains are selected. The bivalent booster shots developed and distributed last year targeted two different strains - the Omicron variant as well as the original virus. WHO's advisory group, which recommends if changes are needed to the composition of future COVID-19 shots, said currently approved vaccines should continue to be used in accordance with the agency's recommendations.
May 18 (Reuters) - Charles Schwab Corp (SCHW.N) is looking to raise up to $2.5 billion through a debt offering, the brokerage said on Thursday as more companies aim to benefit from investors trying to capitalize on a spike in yields. The Texas-based company will raise the debt in two parts, via notes due in 2029 and 2034 and will use it for its corporate needs. If held to maturity, the 2029 notes would yield 205 basis points more than the benchmark, risk-free U.S. 5-year Treasury , while the yield on 2034 notes would be 227 bps above the U.S. 10-year Treasury yield. On Wednesday, Pfizer Inc (PFE.N) announced its largest debt offering of $31 billion to fund its proposed acquisition of Seagen Inc (SGEN.O). BofA Securities, Citigroup, Credit Suisse Securities, Goldman Sachs, J.P. Morgan Securities and Wells Fargo Securities are the joint book-running managers for the offering.
May 16 (Reuters) - Pfizer Inc (PFE.N) is planning to raise $31 billion through its largest debt offering to finance its proposed acquisition of Seagen Inc (SGEN.O), the drugmaker said late on Tuesday. Rival Abbvie Inc (ABBV.N) had in 2019 made a $30 billion debt offering, which was used to finance its $63 billion buyout of Botox maker Allergan. The amount is more than double that of Pfizer's 2009 debt raise of $13.5 billion. The debt offering, which would be in eight tranches, is expected to close on May 19. Yield to maturity on Pfizer's 10-year bonds would be 125 basis points higher than the benchmark risk-free U.S. 10-year Treasury .
Even shares of drug companies that do not have pending deals but are seen by analysts and investors as potential acquisition targets were hit. FTC officials did not respond to a request for comment on whether they planned to challenge any other pharmaceutical acquisitions. "We could see similar challenges to the Pfizer/Seagen deal" BMO analysts wrote in a note, arguing that the FTC could target other major drug companies with the resources to engage in bundling. UNDER THE RADARConversely, investors and analysts are hoping that smaller pharmaceutical acquisitions will continue to fly under the radar of regulators. Reporting by David Carnevali in New York; Editing by Greg Roumeliotis and Jamie FreedOur Standards: The Thomson Reuters Trust Principles.
Pfizer plans $31 bln debt offering to fund Seagen takeover
  + stars: | 2023-05-17 | by ( ) www.reuters.com   time to read: +1 min
May 16 (Reuters) - Pfizer Inc (PFE.N) said on Tuesday it plans to raise $31 billion from a debt offering to finance its proposed acquisition of Seagen Inc (SGEN.O). Pfizer struck a $43 billion deal in March to acquire Seagen and its targeted cancer therapies as it prepares for a steep fall in COVID-19 sales and generic competition for some top-selling drugs. The company has been pumping billions of dollars into research and acquisitions to mitigate an anticipated $17 billion hit to revenue by 2030 from patent expirations for top drugs, and a decline in demand for COVID products. The debt offering, which would be in eight tranches, is expected to close on May 19, the company said, adding that BofA Securities, Citigroup (C.N), Goldman Sachs (GS.N) and J.P. Morgan (JPM.N) are acting as the joint lead managers and joint book-running managers. Reporting by Kanjyik Ghosh in BengaluruOur Standards: The Thomson Reuters Trust Principles.
[1/4] Twitter, X Corp., and Tesla CEO Elon Musk poses with French President Emmanuel Macron prior to their talks, Monday, May 15, 2023 at the Elysee Palace in Paris, France. Some 200 business leaders attending the event in Versailles close to Paris have so far made commitments to invest a combined 13 billion euros ($14 billion), the most since Macron first held the summit in 2018, his office said. Musk, who also lunched with Finance Minister Bruno Le Maire, said he was confident Tesla would make "significant investments" in France in the future, without giving a timetable. "No announcement today but I am very impressed with President Macron and the French government and how welcoming they are," he told reporters. Morgan Stanley plans to increase headcount in France by 200 by 2025, bringing total staff in the country to 500.
PARIS, May 14 (Reuters) - France is poised to win record foreign investment pledges when President Emmanuel Macron receives global business leaders, including Tesla's Elon Musk, on Monday at the annual Choose France summit in Versailles. Executives attending the event in Versailles close to Paris have so far made commitments to invest a combined 13 billion euros ($14 billion), the most since Macron first held the summit in 2018. Billionaire entrepreneur Elon Musk, the CEO of Tesla (TSLA.O), met Macron at his official residence the Elysee Palace. France previously tried to convince Musk to build a European gigafactory in the country, but he chose Germany, his only European gigafactory so far. PALATIAL BACKDROPOver the last five years, Macron has invited top CEOs to the opulent Versailles Palace to try to secure billions in foreign investments.
PARIS, May 14 (Reuters) - France is set to win record foreign investment pledges when President Emmanuel Macron rolls out the red carpet for global CEOs on Monday at the annual 'Choose France' summit in Versailles, his office said on Sunday. Executives attending the event have made commitments to invest a combined 13 billion euros ($14 billion), the most since Macron started hosting the summit in 2018 in the former royal palace outside Paris. Over the past five years, Macron has invited top CEOs to the glamorous setting of Versailles Palace in hope of securing billions in foreign investments he says justifies his pro-business reform drive. Ikea has plans to invest 906 million euros by 2026 while Pfizer aims has budgeted 500 million euros to expand in France over the same period followed by British rival GSK with 400 million euros, Macron's office said. ($1 = 0.9084 euros)Reporting by Leigh Thomas Editing by Christina FincherOur Standards: The Thomson Reuters Trust Principles.
[1/2] A selection of injector pens for the Wegovy weight loss drug are shown in this photo illustration in Chicago, Illinois, U.S., March 31, 2023. AMGENAmgen's (AMGN.O) experimental obesity drug, AMG133, showed a mean weight loss of 14.5% after 12 weeks of treatment at the highest monthly dose. The company plans to test higher doses of the drug over a longer treatment window in a mid-stage trial. ZEALAND PHARMADenmark's Zealand Pharma (ZELA.CO) and Boehringer Ingelheim's experimental obesity treatment achieved up to 14.9% weight loss in a mid-stage trial on Wednesday. OPKO HEALTH Opko Health (OPK.O) has completed a mid-stage trial of its obesity drug, pegapamodutide, which it expects will have fewer side effects.
Persons: Jim Vondruska, Wegovy, Eli Lilly, ELI LILLY Lilly, Mounjaro, LLY.N, danuglipron, AMGEN, ALTIMMUNE, Mariam Sunny, Pratik Jain, Sriparna Roy, Sriraj Kalluvila, Anil D'Silva Organizations: REUTERS, Novo Nordisk, Pfizer, NOVO NORDISK Novo Nordisk, Novo, PFIZER Pfizer Inc, danuglipron, THERAPEUTICS, Therapeutics, ZEALAND PHARMA Denmark's Zealand Pharma, Thomson Locations: Chicago , Illinois, U.S, Bengaluru
The emergency is also tied to telehealth flexibilities, Medicaid enrollment safeguards, and the ability of government health agencies to collect data on the spread of the coronavirus. Here is what will change after Thursday, and what does not:WILL THERE BE A COST FOR VACCINES, TESTS AND TREATMENTS? They will face co-pay or co-insurance costs for certain covered treatments and the full price of those that are not covered. People enrolled in state government Medicaid health plans for the poor will also get zero-cost vaccines. The U.S. Centers for Disease Control and Prevention (CDC) will have less authority to collect certain types of public health data after the emergency expires.
Novavax, whose COVID vaccine is its lone marketed product after 35 years in business, is relying on launching an updated COVID shot this fall to match circulating strains and cost cuts to improve its prospects. Novavax said $800 million of that was from "locked-in" overseas purchase contracts for the COVID shot that it has committed to ship this year. Novavax is working to produce an update version of its protein-based vaccine in time for the fall COVID-19 booster season. Novavax expects the cost cuts to reduce its annual research and commercial expenses by 20% to 25% from last year. Data from a mid-stage trial in adults aged 50 to 80 years showed that the combination shot produced an immune response comparable to its protein-based COVID vaccine and already approved influenza shots, Novavax said.
The Biden Administration’s signature drug pricing reform, part of the Inflation Reduction Act (IRA), aims to save $25 billion through price negotiations by 2031 for Americans who pay more for medicines than any other country. The first ever Medicare drug price reduction process begins in September, when the Centers for Medicare and Medicaid Services(CMS) identifies its 10 most costly drugs. Reuters has seen responses to CMS from five of the world's top drugmakers raising legal concerns with the law and the agency's proposed roadmap. Former CMS head Andy Slavitt, who now works at a venture capital company focused on healthcare, said the Medicare agency would have consulted lawyers. One said the Medicare roadmap, which did not go through a formal process with proposed and final rules, could be challenged in court for being unlawful as well.
BioNTech reaffirmed its outlook for revenues from the shot to reach about 5 billion euros in 2023, down from 17.2 billion euros last year. It also repeated that its research and development (R&D) budget would be between 2.4 and 2.6 billion euros this year, up from 1.54 billion euros last year, as it hires scientists and initiates more expensive late-stage trials. And it reiterated that it remained in talks with the European Union about deferred or reduced COVID-19 vaccine deliveries as it re-negotiates a bulk purchase contract. The company declined comment on the state of discussions on the price to be paid per shot. ($1 = 0.9052 euros)Reporting by Ludwig Burger and Patricia Weiss, Editing by Rachel MoreOur Standards: The Thomson Reuters Trust Principles.
LONDON, May 8 (Reuters) - Diabetes drugs that also promote weight loss such as Novo Nordisk’s (NOVOb.CO) Ozempic, becoming a darling of celebrities and investors, are being studied to tackle some of the most difficult-to-treat brain disorders, including Alzheimer’s disease. Those successes followed decades of futility that had left many questioning the validity of the amyloid theory behind most experimental Alzheimer's drugs. She said she has since been approached by pharmaceutical companies at an increasing pace, and is currently running an Alzheimer’s trial evaluating intranasal insulin in combination with another diabetes drug. Four companies with GLP-1 drugs, including two larger drugmakers, say they are watching for results of trials testing Novo's drug in Alzheimer's. Dementia affects more than 55 million people globally and the market for Alzheimer’s drugs is expected to grow to $9.4 billion by 2028 and for Parkinson’s to $6.6 billion, according to pharmaceutical data provider Citeline.
The company has two oral GLP-1 drugs in mid-stage trials, and aims to choose one for a late-stage trial this year. He forecasts GLP-1s or similar drugs topping $100 billion in annual sales early in the 2030s, with Lilly's product accounting for more than $50 billion in sales. Smaller biotechs are also vying for a piece of the obesity market and hope large pharmaceutical companies will pay up for partnerships. "I don't know if it's $90 billion or $80 billion or $50 billion. The current GLP-1 drugs can cause nausea and vomiting.
Eli Lilly’s golden ticket is a regrettable winner
  + stars: | 2023-05-03 | by ( Robert Cyran | ) www.reuters.com   time to read: +6 min
NEW YORK, May 3 (Reuters Breakingviews) - Eli Lilly’s (LLY.N) Mounjaro might turn out to be the biggest selling drug ever. The pharmaceutical giant is maximizing the diabetes treatment’s gain by using a golden ticket to speed its U.S. approval for use in a possibly bigger market, obesity. Lilly’s peak sales for treating obesity might be about 10 times as high, Jefferies analysts estimate. At the industry multiple of 5 times revenue, that would pad its $535 billion market value by $30 billion. Lilly may have secured a Willy Wonka-like golden ticket that allows its obesity drug to reach customers quicker.
US FDA approves first RSV vaccine from GSK
  + stars: | 2023-05-03 | by ( ) www.reuters.com   time to read: +1 min
May 3 (Reuters) - The U.S. Food and Drug Administration has approved GSK Plc's (GSK.L) respiratory syncytial virus (RSV) vaccine, the British drugmaker said on Wednesday, making it the first shot to be cleared for protection against a common respiratory disease that can be fatal for older people. The vaccine was approved for people aged 60 and older, the company said. The approval makes GSK, which has been neck-and-neck with Pfizer (PFE.N) in RSV vaccine development, the first company to tap into a multi-billion-dollar market and puts it ahead of rivals such as Moderna Inc (MRNA.O) and Bavarian Nordic (BAVA.CO). Analysts have estimated the market for RSV vaccines to cross $10 billion by 2030. GSK expects the vaccine to be available before the next RSV season in the United States, Chief Commercial Officer Luke Miels told Reuters on Wednesday before the approval.
However, with inflation running well over the central bank's 2% target and a still-strong labor market, chances of rate cuts seem less likely. With Monday's manufacturing data giving the Fed enough room for more near-term tightening, all eyes will be on jobs and factory orders data after the opening bell. ET, Dow e-minis were down 79 points, or 0.23%, S&P 500 e-minis were down 7.5 points, or 0.18%, and Nasdaq 100 e-minis were down 6 points, or 0.05%. Educational services company Chegg (CHGG.N) tanked 45.6% on a downbeat second-quarter revenue forecast on increasing competition from ChatGPT. Icahn Enterprises LP (IEP.O) dropped 11% after U.S. short seller Hindenburg Research said it has a short position in activist investor Carl Icahn-controlled energy-to-pharma conglomerate.
Companies Pfizer Inc FollowMay 2 (Reuters) - Pfizer Inc (PFE.N) on Tuesday beat analysts' estimates for first-quarter profit on strong demand for its newly acquired drugs and steady demand for its COVID products, sending its shares up nearly 3% before the bell. The company has said it expects 2023 to be a "transition year" for its COVID products, before potential returning to growth in 2024. The company said it expects significantly lower sales contributions from COVID products in the second quarter from the first quarter. Excluding COVID products, Pfizer said first-quarter revenue was mostly driven by recently acquired products, including migraine drug Nurtec ODT and sickle cell disease treatment Oxbryta. Pfizer also maintained its annual COVID products revenue forecast of about $21.5 billion from both the vaccine and the pill.
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