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[ad_1] A person receives a COVID-19 vaccination dose, during a free distribution of COVID-19 rapid test kits for those who received vaccination shots or booster shots, at Union Station on January 7, 2022 in Los Angeles, California. Mario Tama | Getty Images The U.S. Food and Drug Administration 's independent panel of advisors raised doubts about the need to "periodically" update Covid vaccines, noting that it's unclear if the virus is seasonal like the flu. Advisors on Thursday unanimously voted that new jabs for the fall should be monovalent — meaning they are designed against one variant of Covid — and target one of the omicron XBB strains . Those are now the dominant variants nationwide.  But the original voting question included language about whether the panel recommends a "periodic update" to Covid shots.  Dr. Peter Marks, head of the FDA's vaccine division, asked the panel's chair to strike the wording from the question after severa...

[ad_1] Life expectancy in the U.S. is between three and five years lower than the average in other high-income countries — and the gap comes in part from misinformation, Food and Drug Administration Commissioner Dr. Robert Califf said. "It's looking worse, not better, over the last several years," Califf told CNBC in an interview Thursday at the agency's headquarters in Silver Spring, Maryland. It's not just the Covid pandemic contributing to the decline, he said, pointing out the gap with peer nations is widening. Califf said a new factor has joined the list of known causes of life-expectancy disparities like race, ethnicity, income and education: living in a rural area, where he noted that people are exposed to different information sources. "Why aren't we using medical products as effectively and efficiently as our peer countries? A lot of it has to do with choices that people make because of the things that influenced their thinking," Calif...

[ad_1] The newly FDA approved Alzheimer's treatment Leqembi is prepared at Abington Neurological Associates in Abington, PA., on Tuesday, November 7, 2023.  Hannah Yoon | The Washington Post | Getty Images The breakthrough Alzheimer's drug Leqembi slowed disease progression in patients over three years, demonstrating the need for them to stay on the treatment long term, according to new data released Tuesday by Japanese drugmaker Eisai .  The study results on Leqembi, which Eisai shares with Biogen , also found that a patient's Alzheimer's disease worsens after they stop treatment. Rates of adverse side effects associated with Leqembi, including brain bleeding and swelling, dropped after six months of treatment, Dr. Lynn Kramer, Eisai's chief clinical officer of deep human biology learning, told CNBC.  That decline is critical: Those side effects in the brain have raised concerns among some doctors and are the main reason a European drug regulator recommend...

[ad_1] A nurse prepares a dose of Moderna Covid-19 vaccine at Oltepesi Dispensary in Kajiado, Kenya, on September 9, 2021. Patrick Meinhardt | AFP | Getty Images Moderna on Thursday said it has paused plans to build a vaccine-manufacturing site in Kenya after a steep drop in demand for its Covid vaccines . The biotech company said it has not received any vaccine orders for Africa since 2022 and has taken more than $1 billion in losses and write-downs related to the cancellation of previous orders from the continent. Moderna's decision aligns with its broader effort to cut costs by resizing its Covid vaccine-manufacturing footprint. The company's business took a major hit last year as demand for those jabs waned worldwide, with people relying less on protective vaccines and treatments against the virus. Shares of Moderna fell 45% last year, but the stock is up around 6% this year. In March 2022, the company said it would invest about $500 million in the Kenyan site and...

[ad_1] A messy legal fight over the Food and Drug Administration's approval of the abortion pill mifepristone poses risks to the biopharma industry that go beyond the single drug. If a subsequent decision tosses out the pill's approval, it could potentially stifle innovation in the sector and deter investments in the development of life-changing drugs, biopharma companies and experts in law and economics say.  related investing news The ruling Friday by U.S. District Judge Matthew Kacsmaryk of Amarillo, Texas, appears to be the first time a court has suspended the FDA's approval of a medication. The 5th U.S. Circuit Court of Appeals late Wednesday partly granted the Biden administration's request to put the order on hold, making mifepristone available for now but with significant restrictions .  The Justice Department will seek emergency intervention from the U.S. Supreme Court, it said Thursday. Nationwide access to mifepristone still hangs in the balance as the...

[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...

[ad_1] A photo showing the logo of Swiss pharmaceutical giant Roche in Basel. SEBASTIEN BOZON | AFP | Getty Images Swiss health care company Roche announced it would acquire Telavant Holdings Monday, in a deal worth $7.1 billion. Telavant creates drugs for people suffering from inflammatory and fibrotic diseases, and is in the process of developing a "promising new therapy" for patients with Crohn's disease, Roche said in a press release. This is a breaking news story, please check back later for more. [ad_2] Source link https://worldnews2023.com/top-stories/swiss-pharma-giant-roche-agrees-7-1-billion-deal-to-buy-telavant-holdings/?feed_id=305695&_unique_id=66650006a8e9d

[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...

[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...

[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...

[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...

[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...

[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...

[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...