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The Hill
18 minutes ago
- The Hill
FDA may pull authorization for Pfizer COVID shot for kids under 5
The Food and Drug Administration (FDA) is considering revoking the authorization of Pfizer's COVID-19 vaccine for healthy children under 5 years old, the company confirmed Wednesday. The move would add another barrier for parents who want to vaccinate healthy children, as shots from Moderna and Novavax were approved for more limited populations. In May, Health and Human Services Secretary Robert F. Kennedy Jr. said that the Centers for Disease Control and Prevention (CDC) would no longer recommend COVID-19 vaccines for healthy children or pregnant women. The CDC then updated its immunization schedule to reflect that children with no underlying health condition 'may receive' COVID-19 vaccines after consulting with a health care provider — what's known as 'shared decision-making.' If FDA pulls its emergency use authorization, Pfizer's vaccine would no longer be available to any children younger than 5. Right now, Moderna and Novavax shots could be administered 'off label' to healthy children. 'We are currently in discussions with the agency on potential paths forward and have requested that the EUA for this age group remain in place for the 2025-2026 season,' a Pfizer spokesman told The Hill. 'It is important to note that these deliberations are not related to the safety and efficacy of the vaccine which continues to demonstrate a favorable profile,' the company added. The Guardian first reported on the FDA's potential move. In a statement to The Hill, HHS said it wouldn't comment on potential changes. 'The COVID-19 pandemic ended with the expiration of the federal public health emergency in May 2023. We do not comment on potential, future regulatory changes. Unless officially announced by HHS, discussion about future agency action should be regarded as pure speculation,' HHS spokesman Andrew Nixon said. Pfizer has had full FDA approval for its COVID-19 vaccine for individuals age 12 and older since 2022.
CNBC
2 hours ago
- CNBC
Healthy Returns: FDA launches program to streamline creation of new U.S. drug manufacturing sites
A new program from the Trump administration aims to make setting up manufacturing plants in the U.S. less of a headache for the pharmaceutical industry. The Food and Drug Administration on Thursday announced a new "PreCheck" program, which will use a two-phase approach to help boost domestic drug manufacturing after it shrunk dramatically over the past two decades. The announcement is a direct response to President Donald Trump's executive order in May calling on the FDA to reduce regulatory hurdles for domestic drug production in the U.S.. That order asked the agency to cut the amount of time it takes to approve new plants by eliminating unnecessary requirements, while also increasing the fees for and inspections of manufacturing facilities abroad. It follows a flurry of plans for new U.S. manufacturing investments from several drugmakers, such as Johnson & Johnson, AbbVie and Eli Lilly, in a bid to build goodwill with Trump. Still, the president could impose tariffs on pharmaceuticals imported into the U.S. any day now — a move that the industry argues could harm innovation and patient access to certain treatments. So, why has Trump made reshoring drug production a key facet of his trade policy? More than half of pharmaceuticals distributed in the U.S. are manufactured overseas, according to a release from the FDA. Only 11% of companies that produce active pharmaceutical ingredients are based in the U.S., while a significant share are in China and India, the agency added. The White House also estimates that it can currently take five to 10 years to build new manufacturing capacity for pharmaceuticals, which it previously called "unacceptable from a national-security standpoint." "Our gradual overreliance on foreign drug manufacturing has created national security risks," FDA Commissioner Dr. Marty Makary said in the release on Thursday. "The FDA PreCheck initiative is one of many steps FDA is taking that can help reverse America's reliance on foreign drug manufacturing and ensure that Americans have a resilient, strong, and domestic drug supply." Here's how the two phases of the program work: The FDA will host a public meeting on Sept. 30, where it will present on the program and discuss other proposals to "overcome current onshoring challenge," among other issues. Until then, concrete details on the program are sparse. It's unclear what requirements the FDA could eliminate, and how much less time it could take to approve new sites. We'll continue to watch as this program gets finalized and implemented, so stay tuned for our coverage! Feel free to send any tips, suggestions, story ideas and data to Annika at Like it or not, more and more patients are turning to OpenAI's artificial intelligence chatbot ChatGPT to answer questions about their health care. And the company is paying attention. OpenAI launched its latest large-scale AI model called GPT-5 last week, and the startup said it's the "best model yet" for health-related queries. The product is designed to proactively flag health concerns, ask relevant questions and generate more precise and reliable responses, the company said in a blog post. "Health care is maybe the area where there's the strongest improvement of any (is this one extra?) of any category," OpenAI CEO Sam Altman told CNBC's "Squawk Box" in an interview about GPT-5 on Friday. Altman said health-related questions make up a "huge fraction" of ChatGPT usage. In a post on X, he said he hopes GPT-5's health capabilities will "provide real service to people." OpenAI said GPT-5 scores "significantly higher" than previous models on its health-care AI benchmark called Health Bench. The company released Health Bench in May, and it's designed to measure how well AI models perform in realistic health scenarios. HealthBench was developed alongside 262 doctors from 60 countries. OpenAI said it's based on 5,000 conversations that simulate interactions between individual users or clinicians and AI models. OpenAI is also touting GPT-5 as a helpful tool for medical research. The company released a two-minute-long video with Dr. Derya Unutmaz, a professor and human immunologist, which demonstrates how he has been using the model. Unutmaz said GPT-5 is able to help him brainstorm, interpret data and save him time by predicting outcomes of potential experiments. "I think GPT-5 will help the patients to advocate for themselves, and I think that will empower the patients to feel more confident when they talk to their doctors," Unutmaz said in the video. Feel free to send any tips, suggestions, story ideas and data to Ashley at
Newsweek
2 hours ago
- Newsweek
Diabetes Warning Issued Over Insulin Pump Error
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. A medical device manufacturer has issued an urgent correction for select insulin pumps due to a possible error that could result in insulin not being delivered, the U.S. Food and Drug Administration (FDA) announced. Tandem Diabetes Care, Inc., based in California, said the error appears as a Malfunction 16 alarm to users, and may stop insulin delivery. It can also halt communication between the insulin pump and the continuous glucose monitoring (CGM) device. Newsweek contacted Tandem Diabetes Care, Inc. for comment by email outside of regular working hours. Stock image. Tandem Diabetes Care, Inc. has issued a correction for select insulin pumps due to a possible error that could result in insulin not being delivered. Stock image. Tandem Diabetes Care, Inc. has issued a correction for select insulin pumps due to a possible error that could result in insulin not being delivered. Jens Kalaene/picture-alliance/dpa/AP Why It Matters The FDA said that if the error is not addressed it could lead to hyperglycemia - high blood sugar - in users due to insulin not being delivered. "In severe cases of hyperglycemia, the user may require hospitalization or intervention from a medical professional," it said. Hyperglycemia symptoms include extreme thirst, blurry vision, weakness, dry mouth, headaches, and frequent urination, according to the Centers for Disease Control and Prevention. What To Know The device affected by the urgent correction is the following: t:slim X2 insulin pumps. As of August 12, there had been 700 confirmed adverse events - incidents of confirmed high blood sugar or an event requiring medical intervention - and 59 reported injuries related to the device error, according to the FDA. No deaths had been reported. The FDA said that notices were sent directly to customers across the U.S. between July 22 and 24 with instructions on what to do in the event of a Malfunction 16 alarm. The company is set to release a software update to boost early detection of speaker failures, according to the FDA. The update will also introduce persistent vibration alerts to reduce potential safety risks. What People Are Saying Tandem Diabetes Care, Inc. said in its urgent medical device correction notice: "A Malfunction 16 will stop insulin delivery and terminate communication between the insulin pump and the CGM device, as well as the Tandem t:slim mobile app. If not addressed, this could result in hyperglycemia due to the malfunction resulting in the stoppage of insulin delivery and real time CGM Estimated Glucose Values (EGVs) and CGM trends. In severe cases of hyperglycemia, the user may require hospitalization or intervention from a medical professional. "Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax." What Happens Next The company will notify affected pump users when the software update is available and request that the update is completed. Users who have concerns about their pumps can contact the company on techsupport@ or call 1-877-801-6901.
