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Showing posts with the label Biotechnology

Eli Lilly beats on quarterly profit, hikes full-year guidance on strong sales of Zepbound, Mounjaro

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[ad_1] Eli Lilly logo is shown on one of the company's offices in San Diego, California, U.S., September 17, 2020.  Mike Blake | Reuters Eli Lilly on Tuesday reported first-quarter adjusted profit that topped Wall Street's expectations and hiked its full-year guidance on strong sales of its blockbuster diabetes drug Mounjaro and newly launched weight loss treatment Zepbound. The drugmaker now expects full-year adjusted earnings of $13.50 to $14.00 per share, up from previous guidance of $12.20 to $12.70 per share. Eli Lilly also expects revenue for the year to come in between $42.4 billion and $43.6 billion, an increase of $2 billion at either end of the range. Analysts surveyed by LSEG expected full-year adjusted earnings of $12.50 per share and sales of $41.44 billion.  The company said the boosted guidance is in part due to optimism around increased production of Zepbound, Mounjaro and similar drugs for the rest of the year. "Now that we're four months into th

Eli Lilly says FDA delays approval of Alzheimer's drug in surprise move

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[ad_1] Eli Lilly headquarters in Indianapolis, Indiana, US, on Wednesday, May 3, 2023. Eli Lilly & Co.'s shares climbed in early US trading after its experimental drug for Alzheimer's slowed the progress of the disease in a final-stage trial, paving the way for the company to apply for US approval. AJ Mast | Bloomberg | Getty Images Eli Lilly said Friday that the Food and Drug Administration has pushed back its approval decision deadline for the drugmaker's experimental Alzheimer's treatment donanemab in a surprise move. The agency plans to call a last-minute meeting of its outside advisors to further review the treatment's safety and efficacy in a late-stage trial, Eli Lilly said. The FDA has not disclosed the date of that meeting, so a potential approval would likely come after this month. The FDA was expected to decide whether to greenlight the medicine by the end of the first quarter. That deadline was already delayed from an expected approval last ye

Pfizer will have to pay rebates to Medicare for five drugs under Biden plan to lower Rx costs

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[ad_1] President Joe Biden delivers remarks about the Build Back Better legislation's new rules around prescription drug prices in the East Room of the White House on December 06, 2021 in Washington, DC. Chip Somodevilla | Getty Images Five of Pfizer's drugs will cost less for Medicare recipients starting next month as part of President Joe Biden's plan to lower prescription drug costs, the Department of Health and Human Services said Wednesday.  Pfizer's drugs are among the first set of 27 Part B prescription drugs that will be subject to Medicare inflation rebates starting April 1, according to the department. That requires Pfizer and other prescription drug companies to refund Medicare through rebates because the prices for those drugs rose faster than the rate of inflation.  Pfizer's drugs include the blood thinner Fragmin , which was approved by the Food and Drug Administration in 1994. It also includes Atgam , a medicine used to treat symptoms of Renal

Updated Covid vaccines need to target XBB omicron variants this fall, FDA staff says

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[ad_1] Syringe with Covid-19 vaccine against the XBB Variant. Fight against virus Covid-19 Coronavirus, Vaccination and immunization. Undefined Undefined | Istock | Getty Images U.S. Food and Drug Administration staff on Monday said updated Covid boosters should target XBB omicron subvariants for the upcoming fall and winter vaccination campaign.  The U.S. should use a monovalent vaccine targeting either XBB.1.5, XBB.1.16, or XBB.2.3, collectively the dominant strains nationwide, the staff said in a briefing document .  related investing news The FDA staff made the conclusion ahead of a meeting on Thursday, when a panel of external advisors to the agency will recommend a strain for new Covid shots to target later this year. There is no set date for when the vaccination campaign will begin. Vaccine manufacturers will be expected to update their shots once that strain is selected. Pfizer , Moderna and Novavax are already developing versions of their respective vaccines targeti

FDA advisors recommend AstraZeneca, Sanofi antibody to protect babies from RSV

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[ad_1] A panel of independent advisors to the Food and Drug Administration unanimously recommended Thursday that the antibody nirsevimab be approved for use to protect infants from respiratory syncytial virus , the leading cause of hospitalization among newborns. If the FDA approves nirsevimab, the antibody would become the first medical intervention available in the U.S. that can protect all infants from RSV . The FDA, which is not obligated to follow the recommendation of its advisory panel, is expected to make a final decision on nirsevimab in the third quarter. Nirsevimab is a monoclonal antibody made by AstraZeneca . The medication would be marketed by Sanofi . The advisory panel voted 21-0 to recommend its approval. In a separate vote, the advisors also recommended nirsevimab's use in children up to 2 years old who remain vulnerable to the virus in their second RSV season. That vote was 19-2. RSV kills nearly 100 babies in the United States every year, according to sci

Novavax updated Covid vaccine wins FDA, CDC backing, paving way to reach Americans within days

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[ad_1] A vial labelled "Novavax V COVID-19 Vaccine" is seen in this illustration taken January 16, 2022.  Dado Ruvic | Reuters Novavax 's updated Covid vaccine won the backing of U.S. regulators on Tuesday, putting the shot on track to roll out weeks after new jabs from Pfizer and Moderna reached Americans. The Food and Drug Administration authorized Novavax's single-strain vaccine, which targets omicron subvariant XBB.1.5 , for emergency use in people ages 12 and up. The Centers for Disease Control and Prevention is now including Novavax's shot in the same recommendation it issued last month for updated vaccines from Pfizer and Moderna. That recommendation says all Americans ages six months and older can receive an updated Covid jab. Novavax said in a statement that doses of the shot will likely be available within the next few days. "Novavax's authorization today means people will now have the choice of a protein-based non-MRNA option to help

Novo Nordisk CEO says experimental weight loss pill could become a best-in-class drug

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[ad_1] Novo Nordisk CEO Lars Fruergaard Jørgensen on Friday said the company's experimental weight loss pill , amycretin, could eventually become a best-in-class treatment for obesity.  The Danish drugmaker is racing to capitalize on the runaway success of its blockbuster weight loss drug Wegovy by developing a new generation of treatments for obesity, including more convenient and potentially cheaper pills.  His remarks came one day after Novo Nordisk impressed investors with early-stage trial data on amycretin. Patients on the pill lost about 13.1% of their weight after 12 weeks, Jørgensen said on CNBC's "Money Movers."  That surpasses the 6% weight loss seen in those who took Wegovy after the same time period. It also adds to the growing enthusiasm around the potential of weight loss pills.  Lars Fruergaard Jørgensen, CEO of Novo Nordisk, speaks during an interview in New York on Aug. 10, 2022. Christopher Goodney | Bloomberg | Getty Images Along with conv

Kenvue CEO looks to brand, product innovation to drive growth after IPO

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[ad_1] Thibaut Mongon, CEO of Kenvue Inc. a Johnson & Johnson consumer-health business, speaks during an interview with CNBC during his company's IPO at the New York Stock Exchange (NYSE), May 4, 2023. Brendan McDermid | Reuters Kenvue CEO Thibaut Mongon is betting on brand and product innovation to drive growth at the newly spun-out company after its solid debut on the public market Thursday.  "In the next quarter and frankly, in the years to come, we are going to continue to do what we do best, which is innovating to find new ways to serve consumers and help them take better care of their health," Mongon told CNBC in an interview shortly after shares of Kenvue started trading on the New York Stock Exchange.   related investing news Shares of the company gained 22% Thursday to close at $26.90 per share. The stock hovered around that level in early trading Friday, giving the company a market value of roughly $50 billion.  Kenvue, spun out of Johnson & Joh

Biden administration examining role of supply chain middlemen in generic drug shortages

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[ad_1] A variety of generic pills and capsules.  Nenov | Moment | Getty Images The Federal Trade Commission on Wednesday said it is examining the role that drug wholesalers and companies that purchase medicines for U.S. health-care providers play in shortages of generic drugs, which account for the majority of Americans' prescriptions. The move follows an unprecedented shortfall of crucial medicine ranging from injectable cancer therapies to generics, or cheaper versions of brand-name medicines, over the last year, which has forced hospitals and patients to ration drugs. Problems from manufacturing quality control to demand surges can drive supply issues. But the Biden administration is zeroing in on other players in the drug supply chain to uncover the "root causes and potential solutions" to ongoing shortages.  In a joint request for information, the FTC and the Department of Health and Human Services are seeking public comment on the contracting practices, m

Weight loss drugs boost sales at retail pharmacies, but they may not help profits much

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[ad_1] A pharmacist displays boxes of Ozempic, a semaglutide injection drug used for treating type 2 diabetes made by Novo Nordisk, at Rock Canyon Pharmacy in Provo, Utah, U.S. March 29, 2023.  George Frey | Reuters Drugmakers aren't the only ones feeling the impact of the weight loss industry gold rush.  Retailers with pharmacy businesses, such as Walmart , Kroger and Rite Aid , said increased demand for prescription weight loss drugs helped boost sales for the second quarter.  But analysts note that those blockbuster treatments are minimally profitable for retail pharmacies – and may even come with margin headwinds. "More recently, you're starting to hear retailers talk about these drugs. But I wouldn't say they're necessarily beneficiaries of the increased popularity," Arun Sundaram, an analyst at CFRA Research, told CNBC. "They're really not making much of a profit on the drugs. So it's really just a traffic driver and not really a p

Fall Covid shot rollout gets off to a bumpy start as some patients see insurance delays

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[ad_1] Pharmacist Ani Martirosyan administers an immunization to a patient at a CVS on Tuesday, Sept. 12, 2023 in Glendale, CA. Brian Van Der Brug | Los Angeles Times | Getty Images The rollout of a new round of Covid vaccines in the U.S. is off to a bumpy start as some patients report delays in health insurance coverage for the shots.  Private insurance plans and government payers such as Medicare are required to cover the new jabs from Pfizer and Moderna , which became available late last week. U.S. regulators have recommended all Americans ages 6 months and up get the new round of vaccines.  The Centers for Medicare & Medicaid Services, some private health-care providers and CVS confirmed the temporary delays in coverage and emphasized that Americans can access Covid vaccines at no cost through insurance plans. They said the reason for the delays is that some insurers are still working to update their plans to include the new vaccines. Dozens of posts on social medi

More than 75,000 workers strike at hundreds of Kaiser Permanente health facilities across U.S.

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[ad_1] People hold placards, as a coalition of Kaiser Permanente Unions representing 75,000 healthcare workers at Kaiser Permanente start a three day strike across the United States over a new contract, in San Diego, California, U.S. October 4, 2023.  Mike Blake | Reuters More than 75,000 workers at Kaiser Permanente — the nation's largest health-care nonprofit organization — went on strike Wednesday at hospitals and medical offices in five states after the company and labor negotiators failed to resolve a dispute over staffing levels. The Coalition of Kaiser Permanente Unions says the work stoppage is the largest strike of health-care workers in U.S. history. The strike targets Kaiser hospitals and medical offices in California, Colorado, Oregon, Virginia, the District of Columbia and Washington. Kaiser Permanente serves nearly 13 million patients and operates 39 hospitals and more than 600 medical offices across eight states and the District of Columbia. The striking wo

Biotech company Illumina pushes back against Carl Icahn’s proxy fight over $7.1 billion Grail deal

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[ad_1] Carl Icahn Adam Jeffery | CNBC Biotech company Illumina pushed back Monday against Carl Icahn's proxy fight over the company's acquisition of cancer test developer Grail, saying the activist investor's board nominees "do not add value."  The San Diego-based DNA sequencing company released its latest response to Icahn's sharp criticism of the $7.1 billion deal it completed in 2021, saying it's committed to maximizing shareholder value as it works with antitrust regulators to "define GRAIL's path forward as expeditiously as possible." Icahn, who owns a 1.4% stake in Illumina, sent an open letter to the company's shareholders last week saying the DNA sequencing company paid too much for Grail and completed the "reckless" deal without getting European antitrust regulatory approval. He claimed those actions have wiped out $50 billion in Illumina's market value and "clearly shows that shareholders have lost fai