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The S & P 500 rose 8.3% in the second quarter to extended its 2023 advance to 15.9%. Here's a closer look at the Club's best and worst performers in the first half of 2023, starting with the four winningest stocks. West Texas Intermediate crude ended the second quarter under $71 per barrel, about $10 below where it started the year. Humana (HUM) dropped 12.7% in the first half of 2023, rounding out the bottom-four Club stocks between January and June. The common denominator among the worst-performing Club stocks is a bit less obvious than with the winners.
Persons: It's, Dow, Here's, Mark Zuckerberg, Palo, Lisa Su, , Eli Lilly, Locker, Foot Locker's, Estee Lauder, Estee, Halliburton haven't, encouragingly, Halliburton, Jim Cramer's, Jim Cramer, Jim, Jen, Hsun Huang, Huang, Andrej Sokolow Organizations: Nasdaq, Dow Jones, Nvidia, FactSet, Meta, Investors, Facebook, Networks, Palo Alto Networks, Alto, AMD, Devices, Palo, would've, The, HAL, Halliburton, West Texas, Coterra, Humana, Disney, DIS, CNBC, Consumer, Audi, Getty Locations: China, Meta, Palo, Palo Alto, Las Vegas, USA
The STOXX 600 (.STOXX) index closed 0.3% lower after data showed euro zone business growth stalled this month as the downturn in manufacturing deepened. "A hike was fully expected, but the magnitude of the rise surprised most," said RBC Brewin Dolphin’s head of asset allocation, Paul Danis. Germany's DAX index (.GDAXI) shed 1.0%, leading losses among regional peers as shares of Siemens Energy (ENR1n.DE) sank 37.3%. DATA DIGESTWhile euro zone business growth stalled in June, a separate reading showed German business activity slowed notably this month. French business activity contracted this month for the first time in five months, data showed.
Persons: Germany's DAX, Paul Danis, DAX, Clemente De Lucia, Shreyashi Sanyal, Bansari, Eileen Soreng, Jonathan Oatis Organizations: Siemens Energy, GSK, Bank of England, Norges Bank, Swiss National Bank, Investors, RBC, Bank, Siemens, Deutsche Bank Research, Thomson Locations: U.S, Stockholm, Helsinki, Bengaluru
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
Cancer drugmakers rise as industry meet fuels investor interest
  + stars: | 2023-06-05 | by ( ) www.reuters.com   time to read: +2 min
June 5 (Reuters) - Shares of several cancer drug firms surged on Monday after the companies reported positive clinical trial data from their therapies at an ongoing industry conference in Chicago. ImmunoGen Inc's experimental drug, Elahere, to treat a type of ovarian cancer showed 35% reduction in the risk of tumor progression or death compared to chemotherapy in a late-stage study. Shares of Evaxion rose 5.4% to $1.55 after the smaller drug developer said its vaccine to prevent a type of skin cancer met safety goals in an early-stage study. Shares of Blueprint Medicines Corp (BPMC.O) fell 9.4% to $52.76 after analysts flagged potential safety issues about its experimental drug to treat a type of lung cancer. Reporting by Manas Mishra and Mariam Sunny in Bengaluru; Editing by Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.
Persons: William Blair, Manas Mishra, Mariam Sunny, Shailesh Organizations: Immunogen Inc, Evaxion, Therapeutics, American Society of Clinical Oncology, Arcus, Medicines Corp, Thomson Locations: Chicago, Bengaluru
LONDON, June 4 (Reuters) - AstraZeneca's lung cancer therapy, Tagrisso, cut the risk of death by more than half in patients with a certain form of lung cancer who were diagnosed early enough to have their tumour surgically removed, trial data showed. The drug has regulatory approvals across multiple geographies for certain patients with so-called non small cell lung cancer (NSCLC) who have a mutation of the EGFR gene. In the trial, Tagrisso or a placebo was given to patients to assess whether the AstraZeneca therapy could keep their cancer at bay. An estimated 88% of patients treated with Tagrisso were alive at five years compared to 78% on placebo, trial data also showed. AstraZeneca is also expecting to provide details on the impact of combining Tagrisso with chemotherapy in patients with advanced EGFR-mutated lung cancer later this year.
Persons: Tagrisso, Susan Galbraith, Dave Fredrickson, Natalie Grover, Angus MacSwan Organizations: American Society of Clinical Oncology, AstraZeneca, Reuters, Thomson Locations: Swedish, London
May 22 (Reuters) - The benefits of Sanofi (SASY.PA) and Regeneron's (REGN.O) anti-inflammatory drug Dupixent set in quickly during a trial to treat "smoker's lung" and lasted for the duration of the 1-year study, French drugmaker Sanofi said late on Sunday. The company said it was discussing with major watchdogs across the world whether the trial results are substantial enough to support a regulatory review or whether that will require the results of another ongoing trial. Sanofi presented details on the successful study at the American Thoracic Society congress in Washington over the weekend. "Within two weeks we saw improvement in lung function and improvement in quality of life," said Naimish Patel, Sanofi head of global development for immunology and inflammation. "We will take these results to regulators and have a discussion about what can be done ahead of the read-out of the second trial," Patel said.
The U.S. Food and Drug Administration's (FDA) briefing document highlighted increased risk of diabetes and liver injury from using the obeticholic acid (OCA) oral tablets for the treatment of nonalcoholic steatohepatitis (NASH). "During the course of our review, FDA identified modest benefits and serious risks of OCA for treatment of NASH," the staff said in the document and listed increased risk of sludge formation in the gall bladder and imbalance of certain lipids. The staff asked the regulator's panel of outside advisors, who are meeting on Friday, to consider whether the modest benefits from using the drugs for NASH treatment outweigh the serious risks associated with it. The panel's meeting on Friday is the first such meeting for a NASH treatment. However, due to risks of serious liver injury, FDA restricted its usage in 2021 to primary biliary cholangitis patients with advanced cirrhosis, or severe liver scarring.
[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
May 10 (Reuters) - The U.S. Food and Drug Administration's staff reviewers raised concerns over limited data on Sarepta Therapeutics Inc's (SRPT.O) gene therapy for a muscle-wasting disorder, ahead of a meeting of the agency's advisers on Friday. The agency's staff on Wednesday highlighted several issues with the data and said that existing studies did not provide "unambigious evidence" that the gene therapy will benefit patients with Duchenne muscular dystrophy. The FDA also highlighted that DMD, a rare disorder that mainly affects young boys, is an urgent unmet medical need. The advisory committee's vote on Friday and an eventual decision by the FDA is seen as a test of the agency's accelerated approval pathway for gene therapies. Sarepta has three drugs available for the disease for people with different types of genetic mutations but they have to be given as weekly intravenous infusion, while the experimental gene therapy is a one-time treatment.
US FDA declines to approve Ascendis' hormone disorder therapy
  + stars: | 2023-05-01 | by ( ) www.reuters.com   time to read: +2 min
Companies Ascendis Pharma A/S FollowMay 1 (Reuters) - Ascendis Pharma A/S (A71.F) said on Monday the U.S. Food & Drug Administration had declined to approve the Danish drugmaker's experimental therapy to treat adult patients with a hormone disorder called hypoparathyroidism, citing concerns linked to manufacturing control of the drug and device combination. Ascendis said it would request a meeting with the FDA as soon as possible on the best path forward. Shares have lost about 35% of their value through Friday's close of $69.96 since the FDA early last month identified unspecified deficiencies in the company's application for approval of the therapy, TransCon PTH. In a note on Friday, TD Cowen analyst Yaron Werber raised concerns about the lack of clarity around the FDA decision following the Ascendis' post-earnings conference late Thursday. He said the stock would slump if the FDA sought another pre-clinical or clinical study as this would delay approval by 1.5-2 years.
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.
Watch CNBC's full interview with Eli Lilly CEO David Ricks
  + stars: | 2023-04-27 | by ( ) www.cnbc.com   time to read: 1 min
Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailWatch CNBC's full interview with Eli Lilly CEO David RicksEli Lilly CEO David Ricks joins 'Squawk Box' to discuss the drugmaker's Q1 earnings results, which missed on earnings but beat on revenue, and the company outlook for the rest of the year.
Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailEli Lilly CEO David Ricks on Q1 earnings: This will be a year of both growth and investmentEli Lilly CEO David Ricks joins 'Squawk Box' to discuss the drugmaker's Q1 earnings results, which missed on earnings but beat on revenue, and the company outlook for the rest of the year.
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LONDON, March 30 (Reuters) - British drugmaker GSK (GSK.L) has signed deals with three companies allowing them to make inexpensive generic versions of its long-acting HIV preventive medicine for use in lower-income countries, where the majority of new HIV cases occur. The injected drug cabotegravir was approved by regulators in the United States in late 2021. Last July, GSK announced a program with the United Nations-backed healthcare organisation, the Medicines Patent Pool, aiming to get poor countries access to new HIV therapies far earlier than they did for previous HIV medicines. GSK said last year the new program could result in the generic form of its injection being available in lower-income countries beginning in 2026. The generic copies will be supplied in 90 countries, subject to regulatory approvals there, the statement said.
The Swiss firm's shares jumped 5.8% on Monday to a four-week high by 0734 GMT, after it said a panel of independent supervisors recommended stopping the trial early because an interim analysis had shown a clear benefit. Kisqali has been approved to treat hormone-driven breast cancer that has spread to other body parts, where it has taken market share from Pfizer's (PFE.N) Ibrance. Rival drug Verzenio by Eli Lilly (LLY.N) has approval in the early setting for women at high risk of recurrence after surgery. Kisqali, which saw sales gain 31% to $1.2 billion last year, is one of two new drugs with a particularly important role for the group's future sales growth. Detailed trial results will be presented at a medical conference, Novartis said, without identifying the meeting or its timing.
The trial will be the first test of how Zantac cancer claims will fare before a jury. GSK said in a statement it disagreed with the ruling and would defend the case at trial. Originally marketed by a forerunner of GSK, it was later sold successively to Pfizer (PFE.N), Boehringer Ingelheim and finally Sanofi (SASY.PA). While NDMA is found in low levels in food and water, it is known to cause cancer in larger amounts. Analysts said it was not surprising that Grillo ruled differently from the federal court because California's courts are known to be friendlier to plaintiffs.
In a late stage trial Dupixent, jointly developed with Regeneron (REGN.O), led to a 30% reduction in moderate or severe acute exacerbations of chronic obstructive pulmonary disease (COPD), a potentially deadly disease marked by progressive lung function decline. Sanofi previously forecast Dupixent would generate up to 13 billion euros ($14.2 billion) in sales in its best year as it seeks to widen its use across several inflammatory conditions. The anti-inflammatory drug accounted for 8.3 billion euros, or more than 19%, of the French group's overall sales of 43 billion euros last year. Sanofi reports combined global Dupixent sales from its alliance with Regeneron. Dupixent was also approved by the EC to treat eosinophilic esophagitis, a condition that damages the esophagus, in January.
Sanofi and Regeneron said in a statement on Thursday a Phase III trial involving 939 current or former smokers also showed improvements in lung function, quality of life and COPD respiratory symptoms. JP Morgan analyst Richard Vosser said the trial update had "blow-out data" in store for investors, and that market consensus for 2027 Dupixent sales of 15.7 billion euros would likely be topped-up by between 1 and 2 billion euros. The anti-inflammatory drug accounted for 8.3 billion euros, or more than 19% of the French group's overall sales of 43 billion euros, last year. Sanofi reports combined global Dupixent sales from its alliance with Regeneron. Sanofi and Regeneron on Tuesday announced the European Commission had approved Dupixent to treat severe atopic dermatitis in young children.
Amgen to cut 450 jobs in second round of layoffs this year
  + stars: | 2023-03-17 | by ( ) www.reuters.com   time to read: +1 min
March 16 (Reuters) - Amgen Inc (AMGN.O) said on Thursday it would cut 450 jobs, or less than 2% of its workforce, making it the company's second round of layoffs this year amid intensifying pressure on drug prices and high inflation. "We made these changes to realign our expense base in the face of intensifying pressure on drug prices and high levels of inflation," a company spokeswoman said in a statement to Reuters. Layoffs by U.S. companies over January and February this year touched the highest since 2009, a report showed. The biotech company forecasted 2023 revenue in a range of $26 billion to $27.2 billion, while analysts had estimated $27.17 billion. Reporting by Akanksha Khushi and Deena Beasley; Editing by Rashmi Aich and Subhranshu SahuOur Standards: The Thomson Reuters Trust Principles.
How GSK plans to replenish its depleted medicine cabinet
  + stars: | 2023-03-15 | by ( Maggie Fick | ) www.reuters.com   time to read: +6 min
GSK has since suffered a series of clinical trial setbacks in its cancer drugs portfolio, most recently last year involving ovarian cancer drug Zejula and blood cancer drug Blenrep. BLOCKBUSTER POTENTIALAnalysts say that despite a string of strong quarterly earnings, lingering concerns over the company's drug pipeline reflect in GSK's share price. The investor said he does not see enough GSK drugs, either on the market or in development, with potential to be a so-called "blockbusters" with annual sales exceeding $1 billion. But Wood said the overhauled R&D department has put GSK in a strong position to meet growth targets. U.S. regulatory approval on GSK's vaccine, and a rival vaccine developed by Pfizer, is expected in May.
If approved, the combo vaccine could simplify the immunisation schedule in the United States and likely expand GSK's already dominant market share there for vaccines used to prevent illnesses caused by meningococcal bacteria. These responses were compared to participants who received GSK's approved vaccines, Bexsero and Menveo. In the United States, a four-shot regimen of Bexsero and Menveo is needed to protect against the five most common strains of meningococcal bacteria. There is no combination vaccine on the market - a gap GSK intends to fill with the new combination. GSK has the world's largest vaccine R&D department and has a broad portfolio of shots, including its blockbuster shingles vaccine Shingrix.
The U.S. Food and Drug Administration's (FDA) committee is scheduled to meet on April 28. The companies' are seeking approval of the drug Lynparza in combination with other medications – abiraterone and prednisone or prednisolone – for the treatment of a type of treatment-resistant prostate cancer in adult patients. Lynparza was approved in March last year by the FDA as a treatment for patients with early-stage breast cancer with certain mutations. The drug is also approved in the United States as a standalone treatment for another form of prostate cancer. Prostate cancer is the most common form of cancer among men in the United States with about 288,300 new cases of prostate cancer in 2023, according to the American Cancer Society’s estimates.
Eli Lilly, along with Sanofi (SASY.PA) and Novo Nordisk (NOVOb.CO) make up 90% of the U.S. market for insulin. Biden, a Democrat, on Tuesday called on Congress and other manufacturers to lower the price of insulin as Lilly had done. The list price for Lispro, a cheaper version of its Humalog insulin, is currently $82.41 for 100 units/mL vials. List prices for drugs often differ from what patients actually pay, including after insurance and other assistance programs. Ricks said the company's insulin price cuts had been planned for some time and were accounted for in Eli Lilly's December financial forecast, which projected 2023 revenue of at least $30.3 billion.
Lilly to cut U.S. insulin prices by 70% from fourth quarter
  + stars: | 2023-03-01 | by ( ) www.reuters.com   time to read: +2 min
March 1 (Reuters) - Eli Lilly and Co (LLY.N) will cut list prices by 70% for its most commonly prescribed forms of insulin, Humalog and Humulin, beginning from the fourth quarter of this year, the drugmaker said on Wednesday. Around 8.4 million of the 37 million people in the United States with diabetes use insulin, according to the American Diabetes Association. Eli Lilly, along with Sanofi (SASY.PA) and Novo Nordisk (NOVOb.CO) make up 90% of the U.S. market for insulin. Drugmakers had previously priced insulin at more than $275 a vial, representing a 1,200% increase in price over the past 20 years, according to the advocacy group Insulin Initiative. Reporting by Bhanvi Satija in Bengaluru; Additional reporting by Susan Heavey, Editing by Arun KoyyurOur Standards: The Thomson Reuters Trust Principles.
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