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☆ US declines to force lower price on cancer drug Xtandi
▼ + stars: | 2023-03-21 | by ( ) www.reuters.com time to read: +2 min

WASHINGTON, March 21 (Reuters) - The U.S. government will not force Pfizer Inc (PFE.N) and Astellas Pharma Inc (4503.T) to lower the price of their prostate cancer drug Xtandi using its emergency "march-in" authority, the National Institutes of Health (NIH) said on Tuesday. Patient group the Union for Affordable Cancer Treatment first filed a petition calling on the NIH to use its authority to lower the drug's price in March 2016. The NIH said in a letter made public on Tuesday that its analyses in response to the petition found the prostate cancer treatment was widely available. "NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug," the letter said. Progressive lawmakers in the Democratic Party have been calling on President Joe Biden's administration to use its march-in authority to lower drug prices.

☆ Candida auris fungus spreading in U.S. hospitals - CDC
▼ + stars: | 2023-03-21 | by ( ) www.reuters.com time to read: +2 min

FollowMarch 21 (Reuters) - Potentially deadly fungal infections with Candida auris are spreading rapidly in U.S. healthcare facilities, with cases nearly doubling between 2020 and 2021, the Centers for Disease Control and Prevention said. A high fever with chills that does not get better after taking antibiotics may be a sign of Candida auris infection. The CDC noted that spread of the infections in 2021 may have been exacerbated as the healthcare system was hit by pandemic-related stressors, such as staff and equipment shortages. Other countries have also reported increased spread of the fungus, the researchers said. Reporting by Leroy Leo in Bengaluru; editing by Caroline Humer, Nancy Lapid and Jonathan OatisOur Standards: The Thomson Reuters Trust Principles.

☆ Moderna expects to price its COVID vaccine at about $130 in the US
▼ + stars: | 2023-03-21 | by ( Patrick Wingrove | ) www.reuters.com time to read: +2 min

REUTERS/Hannah BeierMarch 20 (Reuters) - Moderna Inc (MRNA.O) expects to price its COVID-19 vaccine at around $130 per dose in the U.S. going forward as purchases move to the private sector from the government, the company’s president Stephen Hoge said in an interview on Monday. Hoge said the government's Medicare health plan for seniors pays $70 per dose for the seasonal influenza vaccine. Sanders, chair of the Senate’s powerful Health, Education, Labor and Pensions Committee, has said Moderna should not raise the price of its vaccine because of the government funding it received. He plans to question Moderna Chief Executive Stephane Bancel on the price increase at the hearing on Wednesday. Moderna in February forecast significantly declining 2023 COVID-19 vaccine sales, which reached $18.4 billion in 2022.

The Alzheimer's Association and the pharmaceutical industry say the drug companies are not directly involved in the campaign. But the Alzheimer's Association says patients simply don't have the time to spare. The agency did not address the Alzheimer's Association campaign. Association members have met 30 times with staffers for the state's 20 members of Congress, Ryan Schiff, the chapter's public policy manager, said. Spokespeople for all three companies said they do not work with the Association on its campaign to expand Medicare coverage of the drugs.

[1/3] A pharmacist holds a bottle of the drug Eliquis, made by Bristol Myers Squibb and Pfizer, at a pharmacy in Provo, Utah, U.S. January 9, 2020. The government will launch the negotiation process in September by naming the first drugs it plans to target. "We couldn't have the other parts of the IRA without this Medicare negotiation," said Sean Dickson, director of the West Health Policy Center, a non-partisan healthcare think tank. Eliquis, which Bristol Myers (BMY.N) shares with Pfizer (PFE.N), Ibrance, and Imbruvica, sold by AbbVie and Johnson & Johnson (JNJ.N), appear on every list. Pfizer, Novo Nordisk and J&J declined to comment on the likelihood their drugs would be included in the first round of negotiations.

Feb 28 (Reuters) - A panel of outside advisers to the U.S. health regulator on Tuesday recommended Pfizer Inc's (PFE.N) respiratory syncytial virus (RSV) vaccine, bringing it closer to becoming one of the first approved RSV shots for older adults in the United States. GSK (GSK.L), which is another forerunner in a crowded race to develop the first RSV vaccine, will face scrutiny from a panel of experts to the FDA on Wednesday. "The population where the vaccine is going to potentially have the biggest impact is less represented in this study," said Hana Sahly, one of the 12 FDA panelists. The FDA is scheduled to decide on the vaccines by May, and typically follows the recommendations of its independent panel of experts. Pfizer's vaccine was 66.7% effective in preventing RSV-related lower respiratory tract illness with over two symptoms, while GSK's vaccine was 82.6% effective in preventing lower respiratory tract disease in people aged 60 and over.

☆ Novavax raises doubts about ability to remain in business, shares fall
▼ + stars: | 2023-02-28 | by ( Michael Erman | ) www.reuters.com time to read: +5 min

The company lost $182 million, or $2.28 per share, in the fourth quarter on weaker-than-expected sales of $357 million. Novavax's shares closed at $9.26 on Tuesday and fell to $6.90 in extended trading after reporting on its financial situation. "We're in the process of assessing the global footprint of Novavax, rationalizing our supply chain, rationalizing the portfolio and rationalizing the company structure and our infrastructure," he said. In the U.S., where the Novavax vaccine was authorized in July 2022, only around 80,000 of its shots have been administered. Jacobs said that while Novavax's vaccine may take longer to manufacture than its rivals from Pfizer (PFE.N)/BioNTech (22UAy.DE) and Moderna (MRNA.O), he believes FDA regulators want a protein-based option this fall for U.S. citizens.

☆ FDA neurosciences chief Billy Dunn to leave immediately, analysts raise concern
▼ + stars: | 2023-02-28 | by ( ) www.reuters.com time to read: +2 min

Feb 28 (Reuters) - The U.S. Food and Drug Administration neurosciences head Billy Dunn will retire from his role effective immediately, the health regulator told Reuters on Tuesday. Wall Street analysts said Dunn's departure could impact the regulator's stance on neurological drug decisions in the near term, sending down shares of Reata Pharmaceuticals Inc (RETA.O) 30% on Monday when media reports on the exit surfaced. Texas-based Reata is expecting FDA's decision by Tuesday on its drug to treat a rare neuromuscular disorder called Friedreich's ataxia. The departure of Dunn, 53, was announced in an internal message to the agency's employees on Monday. Newly appointed deputy director Teresa Buracchio will also serve in Dunn's role on an interim basis at the Office of Neuroscience, the agency told Reuters.

☆ Novavax raises doubts about its ability to remain in business
▼ + stars: | 2023-02-28 | by ( Michael Erman | ) www.reuters.com time to read: +4 min

NEW YORK, Feb 28 (Reuters) - COVID-19 vaccine maker Novavax Inc (NVAX.O) on Tuesday raised doubts about its ability to remain in business and announced plans to slash spending as it works to prepare for a fall vaccination campaign. The company lost $182 million, or $2.28 per share, in the fourth quarter on weaker-than-expected sales of $357 million. "We're in the process of assessing the global footprint of Novavax, rationalizing our supply chain, rationalizing the portfolio and rationalizing the company structure and our infrastructure," he said. In the U.S., where the Novavax vaccine was authorized in July 2022, only around 80,000 of its shots have been administered. Jacobs said that while Novavax's vaccine may take longer to manufacture than its rivals from Pfizer (PFE.N)/BioNTech (22UAy.DE) and Moderna (MRNA.O), he believes FDA regulators want a protein-based option this fall for U.S. citizens.

☆ Pfizer, GSK face FDA panel review in race for RSV vaccines
▼ + stars: | 2023-02-28 | by ( Manas Mishra | ) www.reuters.com time to read: +2 min

Feb 28 (Reuters) - The frontrunners in a crowded race to develop the first respiratory syncytial virus (RSV) vaccine - Pfizer Inc (PFE.N) and GSK (GSK.L) - will face scrutiny from a panel of experts to the U.S. Food and Drug Administration this week. Merck & Co Inc (MRK.N), Moderna Inc (MRNA.O), Johnson & Johnson (JNJ.N) are conducting trials of their own RSV vaccines. Pfizer and GSK grabbed a lead last year after data from separate late-stage studies showed their shots prevented respiratory disease caused by RSV. GSK's vaccine was 82.6% effective in preventing lower respiratory tract disease in people aged 60 and over, and 94.1% effective in preventing severe disease. Dr. Schaffner expects a positive vote on the vaccines when the advisory panel discusses Pfizer's vaccine on Feb. 28, and GSK's vaccine on March 1.

☆ Infected in the first wave, they navigated long COVID without a roadmap
▼ + stars: | 2023-02-20 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +6 min

Three years later, at least 65 million people worldwide are estimated to have long COVID, according to an evidence review published last month in Nature Reviews Microbiology. An analysis of thousands of health records by the RECOVER trial found that non-Hispanic white women in wealthier areas were more likely than others to have a long COVID diagnosis. Researchers said that likely reflected disparities in access to healthcare, and suggests that many cases of long COVID among people of color are not being diagnosed. She has since been diagnosed with long COVID and can no longer work. Other infections such as Lyme disease can result in long-term symptoms, many of which overlap with long COVID.

The Centers for Medicare and Medicaid (CMS) said it would test the models in the Medicare health program for people age 65 or over and the disabled and the Medicaid program for the poor. The agency also said it would work on developing a mandatory model for payment methods for drugs approved by the U.S. Food and Drug Administration (FDA) under its Accelerated Approval Program (APP). CMS will announce the first model's start date "as soon as operationally feasible", it said. Development on the Medicaid gene and cell therapy model will start in 2023 and launch for testing in 2026. The agency will start working with the FDA on the accelerated approval model in 2023 but has no planned launched date yet.

Around 8.4 million of the 37 million people in the United States with diabetes use insulin, according to the American Diabetes Association (ADA). They tried, and failed, to extend the benefit to everyone with health insurance when they were voting on the IRA. Without Congressional approval, the Biden administration cannot impose the cap on private insurance plans and is unlikely able to create a subsidy for the uninsured, experts said. Some Medicaid plans for low-income individuals and private insurance plans also cap the monthly cost of insulin at $35. It is unclear if his proposal would include those without health insurance, who often have to pay the full price for the life-sustaining drug.

"When you think about traditional drug and vaccine development and longevity of sales, it's usually much more spread out," Morningstar analyst Damien Conover said. The sudden inflow of revenue should prod companies to strike deals and link up with new partners, he said. Vaccine maker Moderna also expects 2023 revenue to fall sharply. The company's only product - its messenger RNA COVID vaccine - pulled in around $18.4 billion in 2022. Eli Lilly and Co (LLY.N) made $2 billion in 2022 from monoclonal antibody COVID treatments and is not expecting any revenue from the business in 2023.

☆ U.S. to end COVID-19 emergency declarations on May 11
▼ + stars: | 2023-01-30 | by ( ) www.reuters.com time to read: +2 min

WASHINGTON, Jan 30 (Reuters) - President Joe Biden's administration on Monday said it will end COVID-19 emergency declarations on May 11, nearly three years after the United States imposed sweeping pandemic measures to curb the spread of the illness. The COVID-19 national emergency and public health emergency (PHE) were put in place in 2020 by then-President Donald Trump. Biden has repeatedly extended the measures, which allow millions of Americans to receive free tests, vaccines and treatments. The government has been paying for COVID-19 vaccines, some tests and certain treatments under the PHE declaration. COVID-19 cases are declining in the United States, though more than 500 people continue to die each day from the disease, government data showed.

Analysts say they have based their 2023 Paxlovid sales estimates primarily on public details of announced deals, with a token amount of estimated China sales from before the country dropped the Zero-COVID policy. Their current estimates for over $10 billion in 2023 Paxlovid sales is less than half the $22 billion Pfizer is expected to report for 2022, according to Refinitiv data. Billions of dollars in Paxlovid sales could be at stake for Pfizer. Even without a deal to sell Paxlovid broadly in China, the company can still sell it there on the private market. China is "probably the only region that we're modeling a year-over-year increase in 2023" for Paxlovid, Conover said.

☆ U.S. FDA calls for new regulatory framework for use of cannabis compound CBD
▼ + stars: | 2023-01-26 | by ( ) www.reuters.com time to read: +2 min

The first-ever cannabis farmer's market in Los Angeles began on July 4 and opens weekly from Friday to Sunday. The health regulator said it would work with Congress to develop a new, cross-agency regulatory framework. The FDA has generally pursued limited enforcement activity regarding CBD, focusing primarily on food and beverage products that make unsubstantiated health claims. "A new regulatory pathway for CBD is needed that balances individuals' desire for access to CBD products with the regulatory oversight needed to manage risks," the agency said. Cannabis products, excluding Jazz Pharmaceuticals Plc's (JAZZ.O) epilepsy drug Epidiolex, are illegal at the federal level in the United States, although some states allow their use.

"Today we have additional evidence to show that these updated vaccines are protecting people against the latest COVID-19 variants," Dr. Brendan Jackson, head of the U.S. Centers for Disease Control and Prevention's COVID-19 response, told reporters in a briefing. Released last fall, the updated boosters target the BA.4 and BA.5 Omicron variants of the SARS-CoV-2 virus, which are no longer dominant. It showed that the updated vaccine helped prevent illness in roughly half of the people who had previously received two to four doses of the original COVID-19 vaccine, CDC said. The CDC said the updated vaccine worked similarly against BA.5-related infections and XBB/XBB.1.5-related infections. Given the findings, the CDC urged people to stay up to date on their recommended COVID-19 vaccines.

RSV, which produces symptoms similar to a cold but can be fatal for young children and older adults, causes about 14,000 deaths annually in adults ages 65 and older. Moderna, Pfizer Inc (PFE.N) and GSK Plc (GSK.L) are racing to get their RSV vaccines to market first. Pfizer's RSV vaccine was found to be 66.7% effective against two or more symptoms in late-stage trials. "It's very exciting to see progress in RSV vaccines in older adults, and I think both of those vaccines have shown pretty remarkable results as well," Hoge said. The RSV vaccine market could be worth more than $10 billion globally, half of which would come from the United States, according to Cowen analyst Tyler Van Buren.

☆ Drug companies favor biotech meds over pills, citing new U.S. law
▼ + stars: | 2023-01-13 | by ( Deena Beasley | ) www.reuters.com time to read: +5 min

The pharmaceutical industry, whose members gathered in the thousands this week in San Francisco for the annual JP Morgan Healthcare conference, opposed the legislation and has begun implementing strategies to mitigate its impact. "In 10 years, we'll have far fewer small molecules being developed than we do today." He questioned the benefit of "rules that really just disincentivize investment in what ends up being convenient drugs, drugs for tough conditions like cancer and drugs that get really cheap when they go generic." Most medicines on the market today are small molecules, which can be taken by mouth, absorbed into the bloodstream and easily penetrate cell membranes. He noted it is not unusual for pharmaceutical companies to choose not to pursue a drug they once thought promising.

☆ U.S. childhood vaccinations dip again in 2021-'22 school year -study
▼ + stars: | 2023-01-12 | by ( ) www.reuters.com time to read: +2 min

Overall, those receiving state-required vaccinations declined to about 93% last year, down from 94% in the previous school year and 95% in the 2019-2020 school year, according to the CDC report. All U.S. states require the vaccine against measles and rubella and all but Iowa require a shots against mumps. All states also require the combined diphtheria, tetanus and acellular pertussis shot and the vaccine against poliovirus, while 49 states require inoculations against varicella, or chickenpox. Exemptions for vaccinations, which may be granted by states in cases where parents request them for their children remained low at 2.6%. O'Leary said the data points to U.S. needs for a focus on addressing access and poverty in order to increase vaccination rates.

Jan 6 (Reuters) - Pharmacies across the United States are weighing whether to sell mifepristone, a pill used in medication abortions, following the Food and Drug Administration's announcement earlier this week that they can now do so. The FDA rule will make medication abortion, which accounts for more than half of U.S. abortions, more accessible in states where abortion remains legal, but its impact on pharmacies in the states that have banned abortion remains to be seen. The pharmacy is located near Florida's borders with Georgia and Alabama, where abortion is severely restricted. We're not near an abortion clinic or in a larger city where that happens more," she said. Steve Moore, pharmacist and owner of Condo Pharmacy in Plattsburgh, New York, a state where abortion is legal, plans to dispense the drug.

☆ U.S. new drug price exceeds $200,000 median in 2022
▼ + stars: | 2023-01-05 | by ( Deena Beasley | ) www.reuters.com time to read: +3 min

The median annual price of the 17 novel drugs the U.S. Food and Drug Administration (FDA) approved since July 2022 is $193,900, down from $257,000 in the first half of 2022, Reuters found. For full year 2022, the median was $222,003. Reuters Graphics Reuters GraphicsIn 2021, the median annual price was $180,000 for the 30 drugs first marketed through mid-July, according to a study published recently in JAMA. Health insurers and other payers often demand discounts and rebates for prescription drugs once competing treatments become available. As patents expire, lower-cost generics also mitigate prescription drug price inflation, which in the 12 months through November 2022 was 1.9%, according to the Bureau of Labor Statistics.

According to the group's projections, cases in China would peak around April 1, when deaths would reach 322,000. About a third of China's population will have been infected by then, IHME Director Christopher Murray said. China's national health authority has not reported any official COVID deaths since the lifting of COVID restrictions. Based on China's population of 1.41 billion, and without measures such as a mass vaccination booster campaign, that amounts to 964,400 deaths. China's National Health Commission said on Friday it was ramping up vaccinations and building stocks of ventilators and essential drugs.

"The jury is still out," on which technology will dominate, said Dr. Sadik Esener, director of the Cancer Early Detection Advanced Research Center at the OHSU Knight Cancer Institute in Portland, Oregon. He added it could take as long as 20 years to show that an early cancer detection test saved lives. If proven to work, early cancer detection tests could help doctors identify cancer risk in patients long before symptoms or other indicators develop. DIFFERENT APPROACHESSeveral of the leading contenders take vastly different approaches to cancer detection and it is not yet clear which methods will prove most useful or when. Some are working on blood tests to detect different markers of early cancer, including proteins.

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