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GSK provides update on US FDA advisory committee review of Blenrep

GSK provides update on US FDA advisory committee review of Blenrep

GSK (GSK) notes that the U.S. FDA Oncologic Drugs Advisory Committee voted against the overall benefit/risk profile at the proposed dosage of Blenrep combinations. The belantamab mafodotin combinations were evaluated in adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. The FDA will consider the recommendation of the committee as it finalises its review on Blenrep in advance of the July 23 PDUFA date. GSK remains confident in the benefit/risk profile of Blenrep and will continue to work closely with the FDA as they complete their review for Blenrep in patients with relapsed or refractory multiple myeloma where there is high unmet need for novel treatment options that extend survival.
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Man dies after being pulled into MRI machine by metal necklace he was wearing
Man dies after being pulled into MRI machine by metal necklace he was wearing

Yahoo

timean hour ago

  • Yahoo

Man dies after being pulled into MRI machine by metal necklace he was wearing

A man has died after getting sucked into an MRI machine. The accident occurred on July 16 at the Nassau Open MRI in Westbury, New York, according to a press release from the Nassau County Police Department in Long Island. Officers responded to a 911 call at around 4:30 p.m. at the MRI center, which provides diagnostic radiology services. Are Full-body Scans Worth The Money? Doctors Share What You Should Know "Upon arrival, officers were informed that a male, 61, entered an unauthorized Magnetic Resonance Imaging (MRI) room while the scan was in progress," the release stated. "The male victim was wearing a large metallic chain around his neck, causing him to be drawn into the machine, which resulted in a medical episode." Read On The Fox News App The man was transported to a local hospital, where he succumbed to his injuries the next day, on July 17. The investigation is ongoing, according to the police department. Nassau Open MRI states on its website that anything metallic should be removed prior to an MRI, including hearing aids, partial plates, dentures, jewelry and hair pins. Cancer Screenings: Here Are 5 Types And Critical Information To Know About Each On a web page detailing the benefits and risks of MRIs, the U.S. Food and Drug Administration (FDA) notes that "the strong, static magnetic field will attract magnetic objects (from small items such as keys and cell phones, to large, heavy items such as oxygen tanks and floor buffers) and may cause damage to the scanner or injury to the patient or medical professionals if those objects become projectiles." "Careful screening of people and objects entering the MR environment is critical to ensure nothing enters the magnet area that may become a projectile." For patients with magnetic implants, external devices and accessory medical devices, there is the risk that the MRI will "pull on magnetic materials" and cause "unwanted movement" of the device, the same source cautions. The FDA also notes that "adverse events" related to MRI scans are "very rare." Out of millions of MRI scans in the U.S. each year, the agency receives around 300 reports of adverse events — primarily burns and other thermal injuries. 5 Cancer Types Where Screenings Save The Most Lives "Other reported problems include injuries from projectile events (objects being drawn toward the MRI scanner), crushed and pinched fingers from the patient table, patient falls, and hearing loss or a ringing in the ear (tinnitus)," the FDA states. The MRI is a machine that uses a large magnet to produce "very intricate pictures" of the human body, according to Kenneth J. Perry, M.D., an emergency medicine attending physician in Charleston, South Carolina. This can be very helpful in capturing images of specific parts of the body, he said, such as the spinal cord, brain or pregnant abdomen. "Unlike other imaging modalities, such as X-ray or CT scan, it does not use radiation, which means it is safe for children as well as pregnant women," Perry told Fox News Digital. The only major issue with an MRI machine, the doctor cautioned, is that the magnetic function is never off. "This means that when approaching an MRI machine, it is impossible to be near it with anything magnetic without having that piece of clothing or device get pulled into the device," Perry said. "This is different from a CT scanner, which is only causing radiation at the time that it is on obtaining imaging." The best way to prevent these types of accidents is to have a "robust MRI protocol" in place, Perry advised. "Most hospitals will have different zones built into the MRI process. Within each zone, there is a discussion about which devices or pieces of clothing are safe for the MRI," the doctor noted. In the actual machine area, there should be no magnetic material on the patients. "Adhering to these very important protocols will be very helpful in preventing major issues," Perry said. It is best to discuss with the care team in advance about any potential concerns related to MRI safety, such as implanted devices, the doctor said. For more Health articles, visit "In the end, MRI is a very safe imaging modality that can give very helpful and important information to physicians to help take better care of patients," Perry added. Fox News Digital reached out to Nassau Open MRI requesting article source: Man dies after being pulled into MRI machine by metal necklace he was wearing Solve the daily Crossword

Man dies after being sucked into MRI machine by his own metal necklace
Man dies after being sucked into MRI machine by his own metal necklace

USA Today

timean hour ago

  • USA Today

Man dies after being sucked into MRI machine by his own metal necklace

At the scene, witnesses told officers a 61-year-old man "entered an unauthorized M.R.I. room while the scan was in progress," police said. A man who was violently sucked into an MRI machine by a metal chain around his neck has died, police in New York said. The man was wearing a large metallic chain around his neck, which caused him to be drawn into the machine, the Nassau County Police Department said in a news release. The incident took place at the Nassau Open MRI medical facility in the village of Westbury on the North Shore of Long Island. Police responded to the facility just after 4:30 p.m. on July 16. At the scene, witnesses told officers a 61-year-old man "entered an unauthorized M.R.I. room while the scan was in progress," police said. Multiple injuries in incident: Over 2 dozen people injured after vehicle crashes into crowd in Los Angeles He was transported to a local hospital where he was initially listed in critical condition. He died at the hospital on July 17 at 2:36 p.m., police said. Officials have not yet released the name of the man nor whether he was a visitor to the facility, a patient or if he worked there. Police did not elaborate on the type or extent of the man's injuries. Man drawn into MRI from 'a large metallic chain around his neck' According to police, the machine's magnetic field immediately attracted "a large metallic chain" the victim wore, which quickly pulled him into the machine and "resulted in a medical episode." The investigation into the incident is ongoing, police said. USA TODAY contacted Nassau Open MRI on July 18 but has not received a response. MRI risks may include 'injuries from projectiles' Magnetic resonance imaging, or MRI, is a non-invasive 3D imaging technology used to examine patients' organs, tissues and skeletal system for diagnostic purposes, according to the Mayo Clinic. Adverse events from MRI scans "are rare," according to the U.S. Food and Drug Administration (FDA), which regulates MRI equipment. Millions of MRI scans are performed across the nation every year, the FDA wrote on its website. The agency said it receives around 300 incident reports annually involving MRI scanners and coils from manufacturers, distributors, user facilities and patients. Most of the reports, according to the FDA, include burns, as well as injuries from "projectile events" (objects being drawn toward the MRI scanner). High-powered magnets in the machine quickly draw items, especially metal, into the machine's chamber. "The strong magnetic field can attract metallic objects, potentially causing them to become projectiles and injure patients," the FDA's website reads. The magnetic force "is strong enough to fling a wheelchair across a room," according to the National Institute of Biomedical Imaging and Bioengineering. "Patients should notify their physicians of any form of medical or implant prior to an MR scan."

Gene therapy maker Sarepta tells FDA it won't halt shipments despite patient deaths
Gene therapy maker Sarepta tells FDA it won't halt shipments despite patient deaths

Hamilton Spectator

time2 hours ago

  • Hamilton Spectator

Gene therapy maker Sarepta tells FDA it won't halt shipments despite patient deaths

WASHINGTON (AP) — Drugmaker Sarepta Therapeutics said late Friday it won't comply with a request from the Food and Drug Administration to halt all shipments of its gene therapy following the death of a third patient receiving one of its treatments for muscular dystrophy. The highly unusual move is a latest in a string of events that have hammered the company's stock for weeks and recently forced it to lay off 500 employees. The company's decision not to comply with the FDA also places future availability of its leading therapy, called Elevidys, in doubt. The FDA said in a statement Friday night that officials met with Sarepta and requested it suspend all sales but 'the company refused to do so.' The agency has the authority to pull drugs from the market, but the cumbersome regulatory process can take months or even years. Instead, the agency usually makes an informal request and companies almost always comply. 'We believe in access to drugs for unmet medical needs but are not afraid to take immediate action when a serious safety signal emerges,' FDA Commissioner Marty Makary said in a statement. Elevidys is the first gene therapy approved in the U.S. for Duchenne's muscular dystrophy, the fatal muscle-wasting disease that affects males, though it has faced scrutiny since its clearance in 2023. The one-time treatment received accelerated approval against the recommendations of some FDA scientists who doubted its effectiveness. The FDA granted full approval last year and expanded the therapy's use to patients 4 years and older, including those who can no longer walk. Previously, it was only available for younger patients who were still walking. Sarepta said Friday that its scientific review showed 'no new or changed safety signals' for younger patients with Duchenne's who have earlier stages of the disease. The company said it plans to keep the drug available for those patients. 'We look forward to continued discussions and sharing of information with FDA,' the company said in a statement. Sarepta halted shipments last month of the therapy for older boys with Duchenne's, which gradually destroys muscle and skeletal strength, resulting in early death. The move followed the deaths of two teenage boys taking the therapy. The company also confirmed a third death Friday: a 51-year-old patient who was taking an experimental gene therapy in a trial for a different form of muscular dystrophy. Sarepta said it reported the death to the FDA on June 20. The FDA said Friday it placed that trial on hold. Sarepta noted that the gene therapy involved in the incident uses 'a different dose and is manufactured using a different process,' than Elevidys. All three patient deaths were linked to liver injury, a side effect noted in Sarepta's prescribing information. Earlier this week Sarepta announced it would add a bold warning to drug and lay off a third of its employees. The company did not mention the third patient death in its news release or conference call announcing those changes, sparking pointed criticism from Wall Street analysts. Company shares fell more than 35% Friday to close at $14.07. Cambridge, Massachusetts-based Sarepta has received FDA approval for three other Duchenne's drugs since 2016, none of which have been confirmed to work. The company has long been criticized for failing to complete several studies needed to secure full FDA approval of its drugs. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

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