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WASHINGTON, July 3 (Reuters) - U.S. President Joe Biden has nominated Virginia Solicitor General Andrew Ferguson and Utah Solicitor General Melissa Holyoak to fill Republican slots at the Federal Trade Commission, the White House said Monday. The FTC "operates best at full strength, and I will look forward to working with them," she said. A native of Virginia, Ferguson has an undergraduate degree from the University of Virginia and a law degree from the University of Virginia School of Law. Holyoak is the Utah Solicitor General with the Utah Attorney General's Office. Her undergraduate degree is from the University of Utah, as is her law degree.
Persons: Joe Biden, Andrew Ferguson, Melissa Holyoak, Lina Khan, Khan, Ferguson, Holyoak, Biden, Donald Trump's, Mitch McConnell, Lindsey Graham, Chuck Grassley, Myers, Amgen's, Black Knight, Diane Bartz, Kanishka Singh, Eric Beech, David Gregorio Our Organizations: Federal Trade Commission, U.S, Senate, FTC, Democratic, Facebook, Amazon.com, Albertsons, Senate Republican, University of Virginia, University of Virginia School of Law, Utah Attorney General's, Myers LLP, Hamilton Lincoln Law Institute, Competitive Enterprise Institute, Center for, University of Utah, Activision, Horizon Therapeutics, Black, Thomson Locations: Utah, Virginia
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
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
WASHINGTON, June 22 (Reuters) - The states of California, New York, Illinois, Minnesota, Washington and Wisconsin have joined a Federal Trade Commission (FTC) lawsuit to stop Amgen's (AMGN.O) $27.8 billion deal to buy Horizon Therapeutics (HZNP.O), according to a court filing on Thursday. Washington Attorney General Bob Ferguson said his state had joined the lawsuit because "monopolies harm consumers" and the merger could allow Amgen to "dominate" prescription drug markets. The FTC acquisition marks a change for the agency, which previously had typically flagged therapeutic overlaps in companies and waved deals through after requiring one of the medicines to be divested. Amgen said in a statement last month it was disappointed by the FTC decision and it believed it had "overwhelmingly demonstrated" that the deal had no legitimate competitive issues. The last major pharmaceutical deal approved by the FTC was AstraZeneca's (AZN.L) $39 billion acquisition of Alexion Pharma in April 2021, about two months before FTC Chair Lina Khan was appointed by the Biden administration.
Persons: Bob Ferguson, Rob Bonta, Amgen, Lina Khan, Biden, David Shepardson, Jamie Freed Organizations: Federal Trade Commission, Horizon Therapeutics, . Washington, FTC, Horizon, Alexion Pharma, Thomson Locations: California , New York , Illinois, Minnesota, Washington, Wisconsin, California
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
Stelara, introduced in 2009, has been J&J’s top-selling drug since 2019, with sales reaching $9.7 billion in 2022. J&J is forecasting $57 billion in pharmaceutical sales by 2025 after reducing its previous view of $60 billion in April, citing currency dynamics that hurt its pharmaceutical business in 2022. That would add around $4.6 billion to average estimates for pharmaceutical sales, as long as no biosimilars enter the market before 2025. Amgen said last month the confidential settlement it signed with J&J will allow it to sell its Stelara biosimilar no later than Jan. 1, 2025. “If no Stelara biosimilars enter in 2024, I think growth should continue at around 4% in 2023 and 2024,” Huynh said.
Persons: Johnson, Amgen, , Vamil, Trung Huynh, ” Huynh, Teva, biosimilar, Divan, Alvotech, Patrick Wingrove, Caroline Humer, Bill Berkrot Organizations: Amgen Inc, Analysts, Stelara, Reuters Graphics Reuters, Reuters, New, J, Credit Suisse, Food and Drug Administration, Alvotech’s, Thomson Locations: New Brunswick , New Jersey, Alvotech’s Reykjavik
May 18 (Reuters) - Amgen Inc (AMGN.O) has agreed not to quickly close on its $27.8 billion acquisition of Horizon Therapeutics (HZNP.O) after the U.S. Federal Trade Commission (FTC) filed suit to block the deal. Absent an agreement, Amgen could have sought to close the deal as early as Monday. Under the order, Amgen and Horizon will not close their transaction until the earlier of Sept. 15, or the second business day after the court rules on the FTC's request for a preliminary injunction. Amgen said it had made an offer to the FTC in the hope of resolving the issue. "We committed that we would not bundle the Horizon products raised as issues," Amgen said in a statement.
That would appear to contradict the FTC's practice of preventing companies from using market power to push up prices. The FTC lawsuit spurred concern among investors who had brushed off the antitrust risk in Amgen's deal because of its limited business overlap with Horizon. "Our complaint is firmly rooted in longstanding antitrust law and we look forward to making our argument in court," an FTC spokesperson said. AMGEN OFFERS REMEDYAmgen said on Tuesday it had made an offer to the FTC in hopes of resolving the issue. "These are valid concerns that FTC has raised but what a court will do about it is uncertain," he said.
WASHINGTON, May 18 (Reuters) - The U.S. Supreme Court on Thursday ruled against Amgen Inc (AMGN.O) in its bid to revive patents on its cholesterol-lowering drug Repatha over a legal challenge by French rival Sanofi SA (SASY.PA). Amgen sought to patent a group of antibodies that help reduce so-called "bad" cholesterol. In 2014, Amgen sued Sanofi and Regeneron for patent infringement over their rival drug Praluent, which works by a similar mechanism as Repatha. The justices said that Supreme Court precedent weighed against Amgen. President Joe Biden's administration, arguing in support of Sanofi, told the justices that Amgen had not disclosed the information needed to make to make its patents valid.
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.
The Commerce Department reported retail sales rose 0.4% in April, short of the estimate for an increase of 0.8%. That slowing along with recent negotiations over the U.S. debt ceiling has focused attention on when the central bank will pause hiking, or cut interest rates. While the market is currently pricing in a rate cut by the end of the year, recent comments from Fed officials suggested they are not ready to cut rates soon. Cleveland Fed President Loretta Mester said she does not think the central bank can hold interest rates steady yet. (This story has been corrected to say 'a rate cut,' instead of 'a rate hike,' in paragraph 8)Reporting by Shreyashi Sanyal in Bengaluru; Editing by Maju SamuelOur Standards: The Thomson Reuters Trust Principles.
Home Depot (HD.N) shed 1.73%, the biggest drag on the Dow Industrials and among the heaviest weights on the S&P 500 after the home improvement retailer cut its annual sales forecast and projected a steeper-than-expected decline in profit. The Commerce Department reported retail sales rose 0.4% in April, short of the estimate for an increase of 0.8%. That slowing along with recent negotiations over the U.S. debt ceiling has focused attention on when the central bank will pause hiking, or cut interest rates. Cleveland Fed President Loretta Mester said she does not think the central bank can hold interest rates steady yet. The S&P 500 posted 10 new 52-week highs and 12 new lows; the Nasdaq Composite recorded 42 new highs and 163 new lows.
The Commerce Department reported retail sales rose 0.4% in April, at half the pace against an expected increase of 0.8%. "The retail sales data has been positive in several months, but it's still weak," said Jamie Cox, managing partner at Harris Financial Group. You are probably seeing the end of the decline in retail sales, but it's not going to be a smooth ride from here." Dow Jones Industrial Average (.DJI) component Home Depot (HD.N) shed 1.4%, hitting its lowest level in over six months after the company lowered its annual sales forecast. Shares of Capital One Financial Corp (COF.N) jumped 2.4%, rising the most on the S&P 500, after Berkshire Hathaway Inc (BRKa.N) on Monday disclosed it has begun investing in the consumer lender.
WASHINGTON, May 16 (Reuters) - The U.S. Federal Trade Commission said on Tuesday it would sue to stop Amgen Inc's (AMGN.O) $27.8 billion deal to buy Horizon Therapeutics Plc (HZNP.O). The agency said it was opposing the deal because it would give Amgen "monopoly positions" for medicines used to treat thyroid eye disease and chronic refractory gout. The deal, which was announced in December 2022, would give Amgen two fast-growing drugs, the thyroid eye disease treatment Tepezza and gout treatment Krystexxa. Other key drugs in Amgen's product portfolio, such as psoriasis therapy Otezla, face the loss of patent protections over the next few years. It is unusual for the agency to sue to stop a pharmaceutical deal.
WASHINGTON, May 16 (Reuters) - The U.S. Federal Trade Commission said on Tuesday that it would sue to stop Amgen Inc's (AMGN.O) $27.8 billion deal to buy Horizon Therapeutics Plc (HZNP.O). The deal, which was announced in December 2022, would give Amgen two fast-growing drugs, the thyroid eye disease treatment Tepezza and gout treatment Krystexxa. Amgen hopes they can act as a bulwark against competition for its blockbuster arthritis drug Enbrel. Furthermore, other key drugs in its portfolio, such as psoriasis therapy Otezla, face loss of patents over the next few years. Reporting by Diane Bartz; editing by Tim AhmannOur Standards: The Thomson Reuters Trust Principles.
The Commerce Department reported retail sales rose 0.4% in April, at half the pace against an expected increase of 0.8%. "The retail sales data has been positive in several months, but it's still weak," said Jamie Cox, managing partner at Harris Financial Group. You are probably seeing the end of the decline in retail sales, but it's not going to be a smooth ride from here." "There is little chance we will see a resolution to the U.S. debt ceiling issue today," said Ipek Ozkardeskaya, senior analyst at Swissquote Bank. "The negotiations will likely remain tight as Republicans ask decent spending cuts to accept a debt ceiling relief, while Biden is not willing to compromise on spending into the election year."
The main indexes started the week with modest gains as trading was range-bound amid a wrangling in Washington between the White House and Republicans. "There is little chance we will see a resolution to the U.S. debt ceiling issue today," said Ipek Ozkardeskaya, senior analyst at Swissquote Bank. Shares of rival Lowe's Companies Inc (LOW.N) fell 3.2%, while retail giant Walmart Inc (WMT.N) slipped 0.4%. Focus will also be on economic data, with retail sales expected to increase by 0.8% in April after falling 0.6% in the month before. ET, Dow e-minis were down 80 points, or 0.24%, S&P 500 e-minis were down 3 points, or 0.07%, and Nasdaq 100 e-minis were up 5.25 points, or 0.04%.
May 15 (Reuters) - The U.S. Federal Trade Commission is expected to file a lawsuit as early as Tuesday to block Amgen Inc's (AMGN.O) $27.8 billion deal to buy Horizon Therapeutics PLC (HZNP.O), a person familiar with the matter told Reuters. Amgen struck a deal last year to buy Horizon to strengthen its rare diseases drugs portfolio. Senator Elizabeth Warren, an outspoken critic of corporate consolidation, wrote to the FTC earlier this year expressing her concerns about pharmaceutical deals including the Amgen purchase of Horizon. The Democratic Senator said both Amgen and Horizon Therapeutics "have engaged in brazen price increases," including on Amgen's Enbrel for arthritis and Horizon’s Krystexxa, a gout medication. The deal would give Amgen two fast-growing drugs, the thyroid eye disease treatment Tepezza and Krystexxa.
The Commerce Department reported retail sales rose 0.4% in April, at half the pace against an expected increase of 0.8%. "The retail sales data has been positive in several months, but it's still weak," said Jamie Cox, managing partner at Harris Financial Group. You are probably seeing the end of the decline in retail sales, but it's not going to be a smooth ride from here." The S&P 500 retail index (.SPXRT) lost 0.6%. Shares of Capital One Financial Corp (COF.N) jumped 5.4%, rising the most on the S&P 500, after Berkshire Hathaway Inc (BRKa.N) on Monday disclosed it has begun investing in the consumer lender.
Jim Cramer's top things to watch in the stock market Tuesday
  + stars: | 2023-05-16 | by ( Jim Cramer | ) www.cnbc.com   time to read: +3 min
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[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 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.
Here are 10 ways to protect against losses and volatility in this long-lasting bear market. "It went beyond dodging a bullet," Steve Sosnick, the chief strategist at Interactive Brokers, said of first quarter earnings results in a late April interview with Insider. Weaker earnings raise valuation concernsBut some investors aren't impressed by Q1 earnings — at least not enough to get bullish. Besides weaker earnings growth and lofty valuations, another risk for stocks is that upcoming quarterly results will miss higher expectations in a shaky economy. "We're still looking at fairly high-single-digit earnings growth for the next couple of quarters overall," Sosnick said.
April 27 (Reuters) - AbbVie Inc (ABBV.N) on Thursday missed quarterly revenue estimates for its newer treatments, fueling concerns over the drugmaker's attempts to cushion the blow to sales from blockbuster Humira losing patent exclusivity. The company's shares tumbled 6% in premarket trade as investors shrugged off a raised annual profit forecast. In the first quarter, Humira recorded sales of $3.54 billion, compared with analysts' average estimate of $3.58 billion. That helped Abbvie beat sales expectations. AbbVie had trimmed its full-year profit expectations earlier this month by 8 cents, citing a $150 million hit from acquired in-process research and development (IPR&D) and milestone expenses.
Stocks stuck to a holding pattern this week as investors brace for an incoming wave of Big Tech earnings and the Fed's favorite inflation reading. Earnings reports have generally been better than expected so far this first quarter. Humana (HUM) reports before the bell Wednesday; Meta Platforms and Pioneer Natural Resources (PXD) report after the bell Wednesday. ET: Personal Spending & Income (includes PCE Price Index) Club trades this week Just one trade: We added 150 shares of Coterra Energy (CTRA) on Wednesday. As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade.
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