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Medscape
a minute ago
- Medscape
EMA Says No to Knee Cartilage Repair Therapy Jelrix
At its July 2025 meeting, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended refusing marketing authorization for Jelrix (autologous cartilage-derived articular chondrocytes), a product intended to repair injury-related cartilage defects in the knee. Jelrix is an advanced therapy medicinal product that uses a patient's own cartilage cells that are expanded in a lab and then implanted back into the knee to repair the defect. It was developed for patients with symptomatic cartilage defects of 2 cm² to 12 cm² whose bones have finished growing. In its decision, the EMA cited concerns about the lack of data to ensure consistent quality of the medicine through its manufacturing process and control strategy. No Verifiable Improvement The application was supported by a main study involving 100 patients with cartilage defects in the knee. The primary effectiveness measure was the patient-reported Knee injury and Osteoarthritis Outcome Score (KOOS), which evaluates pain, symptoms, and quality of life on a 0-100 scale, with higher scores indicating fewer symptoms. Assessments were conducted at 24 and 60 months post-treatment. Results were compared indirectly to outcomes from a separate microfracture registry rather than via a randomized control group. While patients who received Jelrix showed improvement in their KOOS scores at 24 and 60 months, the EMA noted that the study lacked a comparator group. This means the improvements could not be definitively attributed to Jelrix, as they might have resulted from the surgery and rehabilitation all participants received. Therefore, the agency concluded that the benefits of Jelrix did not outweigh its risks. The company confirmed there are no ongoing clinical trials or compassionate use/expanded access programs involving Jelrix in the EU. The applicant, Tissue Engineering Technologies AG, may request reexamination within 15 calendar days of receiving EMA's opinion. If pursued, CHMP will reassess their application based on any additional data provided.
Fast Company
a minute ago
- Fast Company
Twin meteor showers will light up the July sky: Here's when to catch shooting stars tonight ahead of the Perseids
This summer's best evening light show is taking place tonight, so don't forget to go outside and look up. Although the Perseid meteor shower doesn't peak until next month, tonight is forecast to be the best time to view stars shoot across the night sky. Here's why and what to know. What is a meteor shower? Meteor showers, or shooting stars, occur as Earth passes through the trail of dusty debris left by a comet, according to NASA; and are usually named after a star or constellation close to where the meteors first appear. What's happening tonight? Late each summer, the Perseids, and the lesser-known Delta Aquariids meteor showers appear; and this year are forecast to run steadily from late July through early August. The first of the showers, the Southern Delta Aquariid and the Alpha Capricornids are set to peak tonight, Tuesday, July 29 into tomorrow morning, Wednesday, July 30, according to the Associated Press. Visibility should be good because the moon is only about a quarter full; and sky-watchers could see some 20 to 30 meteors per hour, astronomer Nick Moskovitz of the Lowell Observatory in Arizona told National Public Radio. Perseid meteor shower set to peak in early August Meanwhile, the Perseid meteor shower is forecast to peak on Tuesday, August 12 into August 13, right after a full moon, but bright moonlight will likely obscure the view at its peak. NASA viewing tips for meteor showers Our friends at NASA offer these general tips (as Fast Company has previously reported): Find a viewing spot away from city or street lights. Lie flat on your back with your feet facing east. You may want to bring a blanket or a lounge chair. Look up, taking in as much of the sky as possible. After about 30 minutes in the dark, your eyes will adapt and you will begin to see meteors. Be patient. The show could last awhile, so you have plenty of time to catch a glimpse.
Scientific American
a minute ago
- Scientific American
Hurricane Forecasters Keep Crucial Satellite Data Online after Threatened Cuts
Satellite data that are useful for weather forecasting—and particularly crucial to monitoring hurricanes —will not be cut off by the Department of Defense at the end of the month as originally planned. The data, which provide an X-ray-like view of a hurricane's internal structure, will remain accessible to the National Oceanic and Atmospheric Administration for the satellites' lifespans, a NOAA spokesperson confirmed in an email to Scientific American. The data come from sensors onboard Defense Meteorological Satellite Program (DMSP) satellites that detect the microwave portion of the electromagnetic spectrum. Microwaves are useful in monitoring hurricanes, because their long wavelengths mean they penetrate the tops of clouds, giving forecasters a view of a hurricane's inner workings—particularly changes to its eye and eye wall (the circle of clouds that surrounds the eye and makes up the strongest part of the storm). Such changes can indicate if a hurricane is strengthening or weakening. On supporting science journalism If you're enjoying this article, consider supporting our award-winning journalism by subscribing. By purchasing a subscription you are helping to ensure the future of impactful stories about the discoveries and ideas shaping our world today. These data are particularly useful for monitoring storms at night, when visible satellite imagery is unavailable, and for catching rapid intensification —when a storm's winds jump by at least 35 miles per hour in 24 hours. The faster forecasters note a storm is quickly ramping up in intensity, the faster they can warn people in harm's way. Because the microwaves emitted from Earth are weak, they can only be detected by satellites in very low-Earth orbit. (The geostationary satellites that provide visible imagery orbit farther out.) But satellites in these low orbits can only see small portions of the planet at a time, meaning many of them are needed to adequately monitor the planet and there are longer time gaps between when these sensors 'revisit' a given spot. Those limitations mean microwave data are already scarce. Currently six satellites provide that information for U.S. weather forecasting purposes, and they are useful for hurricane forecasting only if they serendipitously pass overhead at the right time. In June, NOAA announced that data from three would no longer be available to its scientists. The shutoff was deemed necessary because the system that processes the DMSP data is running on an operating system that is too old to update and that posed cybersecurity concerns. It is not clear why the shutoff will no longer take place as planned. Meteorologists welcome the continued availability of the data, as the Atlantic hurricane season will enter its typical period of peak activity in August. But many have expressed continued concerns about other factors that could affect forecasts and public safety, particularly staffing and budget cuts at the National Weather Service. 'While this is good news, constant uncertainty about decision-making and availability of funding, staffing, and services is a horrible way to operate,' meteorologist Chris Vagasky wrote on Bluesky. 'People, companies, and governments have to be able to look ahead to know what decisions to make, and uncertainty destroys that capability.'
