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SEOUL, July 4 (Reuters) - South Korea's Samsung Biologics (207940.KS) announced on Tuesday two deals with Pfizer (PFE.N) worth a combined $897 million to manufacture products for the U.S. pharmaceutical giant. The latest orders bring this year's combined tally of orders from Pfizer to $1.08 billion, Samsung Biologics said in a statement. Samsung Biologics welcomed the orders as an expansion of a strategic partnership, adding that its total contracts so far this year had already surpassed last year's annual contract volume. Earlier this year, Samsung Biologics signed deals with Eli Lilly Kinsale and GlaxoSmithKline (GLAX.NS). In March, Samsung Biologics announced a plan to invest 2 trillion won ($1.54 billion) through September 2025 to build a new factory in South Korea.
Persons: Samsung Biologics, Eli Lilly Kinsale, 1,302.8100, Hyunsu Yim, Ed Davies Organizations: Samsung, Pfizer, Samsung Group, GlaxoSmithKline, Samsung Biologics, Thomson Locations: SEOUL, South Korea
Wegovy was approved as an obesity treatment in June 2021 , but Ozempic, a Type 2 diabetes treatment, has been used off-label for weight loss. Mounjaro uses GLP-1 and gastric inhibitory polypeptide, or GIP, to help patients lose weight. Eli Lilly's oral drug, orforglipron, has an even better profile . They also could be helpful in assisting patients in maintaining weight loss after they've used the injectable versions, he said. Some have highlighted that oral drugs also may be more manageable for patients who can't handle the idea of giving themselves a once-a-week injection.
Persons: Eli Lilly, we're, Jonathan Wolleben, Wegovy, Lilly's tirzepatide, It's, Mounjaro, Wolleben, Eli Lilly's tirzepatide, Lilly, , Novo, Eli, it's, they've, FactSet, Altimmune's pemvidutide, Morgan Stanley, Mark Purcell, Purcell, Graig Suvannavejh, Suvannavejh, Roth, Dylan Dupuis, Dupuis, Trung Huynh, Goldman Sachs, Chris Shibutani, Shibutani Organizations: Novo Nordisk, JMP Securities, Citizens Company, Nordisk's Ozempic, Food and Drug Administration, Nordisk, Novo, Zealand Pharma, Shandong Suncadia, GSBR, Biosciences, Fujian Shengdi Pharmaceutical, Mizuho Securities, Terns Pharmaceuticals, American Diabetes Association, Viking Therapeutics, Pfizer, Credit Suisse, AstraZeneca, Therapeutics, Medicare, Medicaid, CNBC Pro's Locations: Danish, Shandong, Fujian, Viking
Sandoz launches rival version of AbbVie's arthritis drug Humira
  + stars: | 2023-07-01 | by ( ) www.reuters.com   time to read: +2 min
[1/2] The logo of Swiss drugmaker Novartis and its divisions Sandoz and Alcon are seen at an office building in Rotkreuz, Switzerland, January 29, 2020. REUTERS/Arnd Wiegmann/Fle PhotoJuly 1 (Reuters) - Swiss drugmaker Sandoz said on Saturday it had launched a biosimilar version of AbbVie Inc's (ABBV.N) big selling arthritis treatment Humira, adding to U.S. competition for the drug that started in January. The Novartis (NOVN.S)-owned company said its drug, Hyrimoz, will be priced at a 5% discount off Humira’s current list price of $6,922 per month, but that it was also offering an unbranded version of Humira at an 81% discount. The lower-priced version may attract healthcare systems that act as both an insurer and a provider and typically do not seek after-market discounts, as pharmacy benefit managers do. Rival Amgen Inc (AMGN.O) was the first to launch a biosimilar of Humira earlier this year, which debuted at a 5% and 55% discount to Humira, depending on who was purchasing.
Persons: Arnd, drugmaker Sandoz, drugmakers, Patrick Wingrove, Edwina Gibbs Organizations: Swiss, Novartis, Sandoz, REUTERS, Amgen, Pfizer Inc, Thomson Locations: Rotkreuz, Switzerland, KS, United States
LONDON, June 30 (Reuters) - The European Commission has contracted Pfizer (PFE.N) and several European companies to reserve capacity to make up to 325 million vaccines per year in case of a future global health emergency, it said on Friday. The European Commission said in a statement announcing the deal that the COVID pandemic showed that Europe needs to be better prepared for future health emergencies. But vaccine equity activists said the EU risked a repeat of what the World Health Organization dubbed "vaccine apartheid" during COVID-19. The Commission has selected Pfizer's plants in Ireland and Belgium to reserve capacity to produce mRNA vaccines. It selected Spanish companies Reig Jofre (RJFE.MC) and Laboratorios Hipra SA to reserve capacity for protein-based vaccines and Bilthoven Biologicals B.V. of the Netherlands for vector-based vaccines.
Persons: Mohga Kamal, Reig, Maggie Fick, Jennifer Rigby, Elaine Hardcastle Organizations: European Commission, Pfizer, Reuters, EU, World Health Organization, People’s Vaccine, Laboratorios Hipra SA, World Health, Thomson Locations: Europe, Ireland, Belgium, Netherlands, London
U.S. banks go 23 for 23, passing this year's Fed's stress test, including Club names Wells Fargo (WFC) and Morgan Stanley (MS). KeyBanc downgrades Club name Disney (DIS) to sector weight from overweight (hold from buy) without a price target. Piper upgrades to neutral from underweight (hold from sell), Bank of America increases price target to $76 per share from $68. Piper Sandler initiates coverage on the off-price retailers, starting Club holding TJX Companies (TJX) with a buy-equivalent overweight rating and a $110-per-share price target. Cuts price target to $40 per share from $47.
Persons: Premarket, Wells, Morgan Stanley, KeyBanc, Sanjay Mehrotra, McCormick, Piper Sandler, Piper, Eli Lilly, Warren Buffett's Berkshire, Jim Cramer's, Jim Cramer, Jim Organizations: Dow, Nasdaq, Citi, Disney, Micron, Bank of America, Netflix, TJX Companies, Marshalls, Ross Stores, Burlington Stores, Pfizer, Credit Suisse, Occidental Petroleum, Warren, Warren Buffett's Berkshire Hathaway, Berkshire, Energy, Halliburton, HAL, JPMorgan, Jim Cramer's Charitable, CNBC Locations: Big, Maxx, HomeGoods
Pfizer 's underperformance could be here to stay, Credit Suisse warned. Analyst Trung Huynh downgraded the pharmaceutical stock to neutral from outperform and cut his price target by $7 to $40. Pfizer said it still has other plans for focusing on obesity, which has been a closely followed area in the pharmaceutical development world. Pfizer has been his worst performing call since the outperform rating at the end of November, with shares underperforming major pharmaceutical peers in the U.S. by 26%. He said concerns that have weighed on the stock include over-optimism on Covid vaccination and booster rates, "ambiguous" guidance on the drug pipeline and negative events for projects in the drug pipeline.
Persons: Trung Huynh, Huynh, CNBC's Michael Bloom Organizations: Pfizer, Credit Suisse Locations: U.S, Covid
Both A and B viruses are responsible for seasonal flu epidemics each year and currently available flu shots work against both strains. "To succeed in mRNA flu, you need the next generation of mRNA technology, which is exactly what we are working on," Thomas Triomphe, head of vaccines at Sanofi, told Reuters. Pfizer (PFE.N) last year started a large late-stage trial testing an mRNA-based flu vaccine candidate. Sanofi, which is among the top four global vaccines makers by sales, trailing GSK (GSK.L), Merck & Co (MRK.N) and Pfizer (PFE.N), has a broad vaccines offering, including flu, childhood shots and travel vaccines. The French company's vaccine sales accounted for 7.2 billion euros ($7.85 billion) of 43 billion euros in group sales last year.
Persons: Thomas Triomphe, BioNTech, Ludwig Burger, Elaine Hardcastle Organizations: Sanofi, Reuters, Pfizer, COVID, GSK, Merck & Co, Thomson
The company's chief rival, Denmark-based Novo Nordisk (NVO), also published promising data on drugs in its pipeline, including its own oral weight-loss treatment. Other pharmaceutical companies are racing to compete with Novo Nordisk and Eli Lilly, including Amgen (AMGN) and Pfizer (PFE). Barclays on Tuesday projected Eli Lilly's three leading obesity-and-diabetes drugs could generate nearly $49 billion in combined sales in 2030. Eli Lilly Eli Lilly has multiple drugs in development that fall under the GLP-1 umbrella in various stages of clinical development. Novo Nordisk Novo Nordisk currently dominates the market for GLP-1 drugs, with three products in the class on the U.S. market already: Ozempic, Wegovy and Rybelsus.
Persons: It's, Eli Lilly, Eli Lilly's, retatrutide, Lilly, there's, Lilly's, Geoff Meacham, Eli Lilly Eli Lilly, Jim Cramer, Evan David Seigerman, , — Morgan Stanley, Wegovy, Rybelsus, Jim Cramer's, Jim, Mike Segar Organizations: Club, Novo Nordisk, New England, of Medicine, American Diabetes Association, Pfizer, Reuters, Barclays, Bank of America, CNBC, JPMorgan, Drug Administration, Equity, BMO Capital, Novo Nordisk Novo Nordisk, GLP, FDA, Nordisk, Company Locations: San Diego, Denmark, GLP, It's, Novo, Novo Nordisk's, Branchburg , New Jersey
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
More than 40% of Americans are obese, according to the U.S. Centers for Disease Control and Prevention, and demand is strong for treatments to reduce body weight as well as maintain weight loss. The company said it would continue to develop its twice-daily weight loss drug candidate. Structure Therapeutics (GPCR.O) is developing oral obesity drugs that it says are simpler to manufacture than the current injectables. "We define weight loss quality as the percentage of weight loss attributed to fat loss," said Versanis Chief Scientific Officer Lloyd Klickstein. "With diets, bariatric surgery, incretin drugs or other weight loss drugs, two-thirds to three-quarters of the weight loss is fat, but one-quarter to one-third is lean."
Persons: Robert Gabbay, Eli Lilly, Lilly's, Wegovy, Mico Guevarra, Lilly, Jeff Emmick, Ray Stevens, Boehringer Ingelheim, Versanis, Lloyd Klickstein, Chaguturu, Deena Beasley, Michele Gershberg, Jamie Freed Organizations: DIEGO, Novo Nordisk's, American Diabetes Association, Novo, U.S . Centers for Disease Control, ADA, Pfizer, Therapeutics, Zealand Pharma, Novartis, CVS Health, Aetna, Thomson Locations: San Diego, GLP
Adding to uncertainty was the start of the second quarter's final week on Monday, weeks ahead of the financial reporting season. Traders work on the floor of the New York Stock Exchange (NYSE) in New York City, U.S., November 15, 2022. But Carnival (CCL.N) slumped 7.6% after the cruise operator forecast third-quarter earnings below Wall Street expectations. The S&P 500 posted 18 new 52-week highs and two new lows; the Nasdaq Composite recorded 53 new highs and 154 new lows. On U.S. exchanges 9.28 billion shares changed hands compared with the 11.62 billion average for the last 20 sessions.
Persons: Tesla, Aston Martin, Vladimir Putin's, Putin, Jerome Powell, Carol Schleif, they've, Schleif, Chris Zaccarelli, Zaccarelli, Brendan McDermid, Powell, Goldman Sachs, UK's Aston Martin, decliners, Sinéad Carew, Sruthi Shankar, Johann M, Shinjini Ganguli, Richard Chang Organizations: Pfizer, Aston, Dow, Nasdaq, Monday, U.S . State Department, Meta Platforms Inc, Inc, Tesla Inc, BMO, Investors, Independent, Alliance, Dow Jones, New York Stock Exchange, REUTERS, University of, Pfizer Inc, UBS, Ares Management, NYSE, Thomson Locations: Russia, Minneapolis, Charlotte, North Carolina, New York City, U.S, New York, Bengaluru
June 26 (Reuters) - U.S. stocks closed lower on Monday, as investors were wary of making riskier bets after Russia's aborted weekend mutiny. Investors were uncertain about the implications of the rebellion by Russian mercenaries that raised questions about President Vladimir Putin's future. Growth stocks weighed the most on the main indexes, with Meta Platforms Inc (META.O), Alphabet Inc (GOOGL.O) and Tesla Inc (TSLA.O) falling sharply. With this uncertainty in mind Schleif noted that investors were taking some profits in growth stocks that had advanced sharply this year. But Carnival (CCL.N) slumped after the cruise operator forecast third-quarter earnings below Wall Street expectations.
Persons: Vladimir Putin's, Putin, Jerome Powell, Carol Schleif, they've, Schleif, Chris Zaccarelli, Zaccarelli, Goldman Sachs, UK's Aston Martin, Sinéad Carew, Sruthi Shankar, Johann M, Shinjini Ganguli, Richard Chang Organizations: Monday, U.S . State Department, Meta Platforms Inc, Inc, Tesla Inc, Nasdaq, BMO, Independent, Alliance, Dow Jones, University of, Pfizer Inc, UBS, Ares Management, Thomson Locations: Russia, Minneapolis, Charlotte, North Carolina, U.S, New York, Bengaluru
Technology (.SPLRCT) and real estate sectors (.SPLRCR) were the other top gainers among the 11 major S&P 500 sectors. ET, the Dow Jones Industrial Average (.DJI) was down 19.60 points, or 0.06%, at 33,707.83, the S&P 500 (.SPX) was up 6.90 points, or 0.16%, at 4,355.23, and the Nasdaq Composite (.IXIC) was up 51.68 points, or 0.38%, at 13,544.20. Advancing issues outnumbered decliners by a 2.97-to-1 ratio on the NYSE and 1.37-to-1 ratio on the Nasdaq. The S&P index recorded 17 new 52-week highs and one new low, while the Nasdaq recorded 37 new highs and 67 new lows. Reporting by Sruthi Shankar and Johann M Cherian in Bengaluru; Editing by Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.
Persons: Tesla, Aston Martin, Jerome Powell, Randy Frederick, Charles Schwab, Goldman Sachs, UK's Aston Martin, Lockheed Martin, Sruthi Shankar, Johann M, Shinjini Organizations: Pfizer, Aston, Dow, Nasdaq, Technology, University of, Dow Jones, Pfizer Inc, Inc, UBS, Tesla, Ares Management, Lockheed, Northrop Grumman Corp, Raytheon Technologies, NYSE, Thomson Locations: Russian, U.S, Russia, Bengaluru
Eli Lilly (LLY) bolstered its position in the budding weight-loss drug market after new data showed its oral obesity pill was highly effective in a mid-stage study. Eli Lilly shares are taking a breather Monday, but we see no reason to join the sellers. Eli Lilly funded the trial. Eli Lilly stock is down about 1.3% Monday afternoon, likely on some profit-taking following a solid move up last week. Eli Lilly and Company, Pharmaceutical company headquarters in Alcobendas, Madrid, Spain.
Persons: Eli Lilly, LLY, orforglipron, Orforglipron, Eli Lilly's Mounjaro, Mounjaro, Jim Cramer, Lilly's, Geoff Meacham, Meacham, Lilly, It's, we've, Jim Cramer's, Jim, Cristina Arias Organizations: Club, New England, of Medicine, Nordisk, U.S . Food, Drug Administration, Novo Nordisk, Sunday, Bank of America, CNBC, UBS, Pfizer, Company, Pharmaceutical Locations: U.S, Alcobendas, Madrid, Spain
Stick with Palo Alto Networks Palo Alto Networks (PANW) is well on its way to becoming the first cybersecurity company to reach a $100 billion market capitalization, Morgan Stanley said Monday. Jeff Marks, the Club's director of portfolio analysis, said Monday that investors should be patient with Palo Alto shares as the stock hit a fresh all-time high Monday, climbing to around $247 apiece. Watch Wells Fargo Wells Fargo (WFC) will be in the spotlight after Wednesday's close when the Federal Reserve releases the results of its annual bank stress tests. Wells Fargo stock was up slightly Monday morning, trading around $40.60 a share. THE ABOVE INVESTING CLUB INFORMATION IS SUBJECT TO OUR TERMS AND CONDITIONS AND PRIVACY POLICY , TOGETHER WITH OUR DISCLAIMER .
Persons: Jim Cramer, , Morgan Stanley, Jeff Marks, Watch Wells, Marks, Jim Cramer's, Jim Organizations: CNBC, Alto Networks Watch Wells, Wall, Natural Resources, Coterra Energy, Halliburton, HAL, , Pfizer, Alto Networks, Palo, Watch, Federal Reserve, Silicon Valley Bank, Deposit Insurance Corporation, Wells Locations: Wells Fargo, Silicon, Wells
Pfizer CEO Albert Bourla has said an obesity pill could eventually be a $10-billion-a-year product for Pfizer. Truist Securities analyst Robyn Karnauskas said Lilly is now ahead in the race for a once-a-day obesity pill. Pfizer said last month that danuglipron helped patients lose weight on par with Novo Nordisk's (NOVOb.CO) Ozempic in a mid-stage study that tested it in patients with Type 2 diabetes. None of the patients in the lotiglipron trials reported liver-related symptoms or side effects, there was no evidence of liver failure and none required treatment, Pfizer said. Liver enzyme elevations observed in lotiglipron trials have not been seen in patients enrolled in danuglipron trials, the company added.
Persons: Albert Bourla, Eli Lilly, LLY.N, Robyn Karnauskas, Lilly, Pfizer, danuglipron, Manas Mishra, Leroy Leo, Michael Erman, Pooja Desai, Jason Neely, Deepa Babington Organizations: Pfizer Inc, Pfizer, NYSE Arca Pharmaceutical, Truist Securities, Novo Nordisk's, Thomson Locations: United States, Bengaluru, New Jersey
GSK on Friday said the settlement reflected its desire to avoid distraction related to protracted litigation in this case. It did not admit any liability and said it would vigorously defend itself in any other Zantac cases. The trial was due to start on July 24, the first test of how Zantac cancer claims would fare before a jury. Lucy Coutts, investment director at wealth management firm JM Finn, which holds GSK shares, said the Goetz settlement could create a precedent to settle other cases. "It also removes the distraction of any protracted litigation as the company must focus on its future pipeline which is where value will be created for shareholders," she said.
Persons: drugmaker, James Goetz, Emily Field, Lucy Coutts, JM Finn, Goetz, Dado Ruvic, Boehringer Ingelheim, Zantac, Natalie Grover, Eva Mathews, Dhanya Ann Thoppil, Barbara Lewis Organizations: GSK, Barclays, GlaxoSmithKline, REUTERS, Pfizer, Sanofi, Companies, Bank of America, FDA, Thomson Locations: U.S, British, California, Delaware, London, Bengaluru
CompaniesCompanies Law Firms Pfizer Inc FollowSanofi SA FollowJune 23 (Reuters) - GSK (GSK.L) reached a settlement with a U.S. citizen who alleged its discontinued heartburn drug Zantac caused cancer, the British pharmaceutical giant said on Friday, preventing the first such lawsuit from going to trial. The case, brought by California resident James Goetz in Alameda County Superior Court, was to go to trial on July 24 and would have been the first test of how Zantac cancer claims fared before a jury. The parties reached a confidential settlement and the trial will be dismissed, GSK said. Originally marketed by a forerunner of GSK Plc, Zantac was later sold successively to Pfizer (PFE.N), Boehringer Ingelheim and finally Sanofi (SASY.PA). Last month, a Canadian court dismissed a proposed class action against Zantac over increased cancer risk.
Persons: James Goetz, Zantac, Boehringer Ingelheim, GSK's, Eva Mathews, Dhanya Ann Thoppil, Barbara Lewis Organizations: Law, Pfizer, Sanofi, GSK, Alameda County Superior Court, GSK Plc, U.S . Food, Drug Administration, Thomson Locations: California, Alameda County, U.S, Zantac, Bengaluru
Moderna seeks US FDA authorization for updated COVID vaccine
  + stars: | 2023-06-22 | by ( ) www.reuters.com   time to read: +1 min
June 22 (Reuters) - Moderna (MRNA.O) said on Thursday it has completed a submission to the U.S. Food and Drug Administration seeking authorization for its updated COVID-19 vaccine to target the XBB.1.5 subvariant. The submission from the company follows the FDA's advice last week to manufacturers that are updating their COVID-19 vaccines to develop monovalent shots to target XBB.1.5. Moderna said preliminary clinical data demonstrated a robust immune response by its XBB.1.5 monovalent vaccine against XBB descendent lineage viruses. Pending authorization, the updated shot would be available in time for the fall vaccination, Moderna said. Other COVID vaccine makers Pfizer (PFE.N)/BioNTech (22UAy.DE) and Novavax (NVAX.O) are already developing versions of their respective vaccines targeting XBB.1.5 and other currently circulating subvariants.
Persons: Moderna, Raghav Mahobe, Krishna Chandra Eluri Organizations: U.S . Food, Drug Administration, Pfizer, Thomson Locations: U.S, Bengaluru
FRANKFURT, June 20 (Reuters) - Sanofi (SASY.PA) said on Tuesday that the International Chamber of Commerce rejected rival drugmaker Boehringer Ingelheim's (BI) claims to be indemnified by Sanofi in cancer lawsuits linked to heartburn drug Zantac in the United States. Shares in France's Sanofi, which added that the decision cannot be appealed, gained 2.4% shortly after the 0700 GMT market open, reaching a three-week high. Sanofi and Boehringer had sought arbitration to determine whether liability in lawsuits was transferred to the French group after it acquired the marketing rights from Boehringer in a 2017 deal. Sanofi reiterated that it regarded its defence of the underlying litigation as very strong. "There is no reliable scientific evidence that Zantac causes the alleged injuries in the cases brought against GSK, Pfizer, BI, Sanofi, and others in the U.S. litigation," the company said.
Persons: drugmaker Boehringer, Boehringer, Sanofi, Ludwig Burger, Kirsten Donovan, Emma Rumney Organizations: Sanofi, International Chamber of Commerce, GSK, Pfizer, BI, Thomson Locations: FRANKFURT, United States, Boehringer, U.S
Eli Lilly also is expected to present data on another weight-loss drug called orforglipron, which patients take orally instead of through an injection. Retatrutide, Mounjaro and weight-loss drug Wegovy, produced by rival Novo Nordisk (NVO), are all injectable. But if the data were to fall short of expectations, the analysts don't foresee much downside to J & J shares. However, with JNJ-2113, Morgan Stanley noted that J & J management has touted its efficacy profile "without the baggage of a JAK label." J & J has consistently denied those accusations.
Persons: Eli Lilly, Johnson, Morgan Stanley —, Eli Lilly Eli Lilly, Morgan Stanley, Eli Lilly's Mounjaro, Mounjaro, Lilly's, retatrutide, hasn't, haven't, Jim Cramer's, Jim Cramer, Jim, AJ Mast Organizations: American Diabetes Association, Novo Nordisk, U.S . Food, Drug Administration, Pfizer, Novo Nordisk's, Johnson, American Academy of Dermatology, topline, J's, LTL Management, CNBC, Bloomberg, Getty, & ' $ Locations: U.S, Novo, Indianapolis , Indiana
HAMBURG, June 11 (Reuters) - BioNTech (22UAy.DE) will go to court on Monday to defend itself against a lawsuit from a German woman who is seeking damages for alleged side effects of its COVID-19 vaccine, the first of potentially hundreds of cases in the country. The plaintiff claims she suffered upper-body pain, swollen extremities, fatigue and sleeping disorder due to the vaccine. Tobias Ulbrich, a lawyer at Rogert & Ulbrich, told Reuters he aimed to challenge in court the assessment made by European Union regulators and German vaccine assessment bodies that the BioNTech shot has a positive risk-benefit profile. Almost 768 million vaccine doses have been administered in the European Economic Area (EEA), which includes the 27 EU member states plus Iceland, Liechtenstein and Norway. Rogert & Ulbrich says it has filed about 250 cases for clients seeking damages for alleged side-effects of COVID-19 vaccines.
Persons: Tobias Ulbrich, Caesar, Preller, Ludwig Burger, Patricia Weiss, Emilio Parodi, Natalie Grover, Sam Tobin, Josephine Mason, Mark Potter Organizations: Reuters, European Union, Pfizer, European Medicines Agency, EMA, Economic, BioNTech, United, Thomson Locations: HAMBURG, Hamburg, Germany, Iceland, Liechtenstein, Norway, United States, Italy, Milan, London
June 7 (Reuters) - European regulators have approved the region's first vaccine for respiratory syncytial virus (RSV), which causes thousands of hospitalisations and deaths annually. The shot, called Arexvy, is made by British drugmaker GSK (GSK.L) and is designed to protect people aged 60 and over. The complex molecular structure of the virus and safety concerns with previous vaccine attempts had stymied efforts to successfully develop a shot since the virus was first discovered in 1956. Given the different definitions of the trial endpoints across the GSK and Pfizer trials, a direct comparison of efficacy is difficult. In Europe, RSV leads to over 270,000 hospitalisations and about 20,000 in-hospital deaths in adults over 60 each year.
Persons: Luke Miels, Peter Welford, TD Cowen, Steve Scala, Natalie Grover, Eva Mathews, Maggie Fick, Savio D'Souza, Mark Potter Organizations: GSK, European Commission, European Medicines Agency, Reuters, U.S . Food, Drug Administration, Pfizer, Jefferies, Thomson Locations: British, Europe, U.S, London, Bengaluru
The hope is for "a completely new treatment paradigm in cancer that will be better tolerated and unique to individual patients' tumors," said Dr. Jane Healy, an executive overseeing in early cancer treatment development at Merck. The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. Aiming at these unique proteins allows the immune system to kill cancer cells while leaving healthy tissue unscathed. With standard treatment, 90% of pancreatic cancer patients die within five years of diagnosis. The approach first primes the immune system with an older technology called a chimpanzee adenovirus vaccine that targets patients' tumors.
Persons: Andrew Kelly, Keytruda, Jane Healy, Germany's BioNTech, Vinod Balachandran, we've, we're, Andrew Allen, Healy, Julie Steenhuysen, Caroline Humer, Bill Berkrot Organizations: Merck & Co, REUTERS, CHICAGO, Moderna Inc, American Society of Clinical Oncology, Merck, Moderna, Memorial Sloan Kettering Cancer Center, Thomson Locations: Kenilworth , New Jersey, U.S, Chicago, New York, Nature
The company on Friday said the relative risk reduction of cancer recurrence was 25.2% and that the results were broadly consistent regardless of patients' menopausal status or cancer progression status. Kisqali has been approved to treat hormone-driven breast cancer that has spread to other parts of the body, where Novartis has taken market share from Pfizer's (PFE.N) Ibrance. But that is in a subset of women who are at high risk of recurrence after surgery, typically diagnosed based on signs of cancer in the lymph nodes. Here, Novartis will face tough competition because the U.S. drugmaker has said Verzenio reduces the risk of recurrence by 35% in that group. Novartis will request approval for wider use in the U.S. and Europe before the end of the year, it added.
Persons: Kisqali, Eli Lilly, Verzenio, drugmaker, Eli Lilly's Verzenio, Jeff Legos, Vas, Ludwig Burger, Sriraj Organizations: Novartis, American Society of Clinical Oncology, Oncology, Hematology, Thomson Locations: FRANKFURT, Chicago, U.S, Europe
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