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The US Food and Drug Administration approved two cancer treatments, Vitrakvi and Xospata, this week after expedited reviews.Vitrakvi, approved Monday, is "a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker)."The FDA said in a statement that it is the second approved cancer treatment that is based on a tumor biomarker instead of the place in the body where the tumor originated.Vitrakvi will be used for the treatment of solid tumors that have an NTRK (neurotrophic receptor tyrosine kinase) gene fusion that do not have a known resistance mutation, that are not metastatic or where surgical removal is likely to lead to severe morbidity, and that have no alternative treatments or have progressed after treatments.NTRK genes are rare but occur in many types of cancer, the FDA said, such as mammary analogue secretory carcinoma and infantile fibrosarcoma.Xospata tablets, approved Wednesday, are for the "treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation," according to the FDA.Alongside the tablets, the agency also approved a diagnostic to detect the mutation."Approximately 25 to 30 percent of patients with AML have a mutation in the FLT3 gene. These mutations are associated with a particularly aggressive form of the disease and a higher risk of relapse," Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence, said in the statement.AML is a rapidly progressing cancer that affects the numbers of normal blood cells and calls for continuous transfusions, the FDA said.Both treatments were granted Priority Review designation.Priority Review, established in 1992, means the FDA aims to review the drug or treatment within six months, opposed to 10 months for a standard review."A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications," the FDA says.Both treatments also received?orphan drug?designation, a status granted to drugs for rare diseases or conditions. 2261

The U.S. Centers for Disease Control and Prevention reported Monday that there are 155 patients under investigation this year for acute flaccid myelitis, a condition that that can cause paralysis and mostly affects children.Of these, 62 have been confirmed by the CDC in 22 states, and the remainder continue to be investigated.Acute flaccid myelitis, also called AFM, is a rare but serious condition that affects the nervous system -- specifically, the area of the spinal cord called gray matter. It affects fewer than one in a million people each year across the country, the CDC estimates.The number of patients under investigation is up from 127 patients a week ago, though no new confirmed cases have been reported.The average age of patients confirmed to have the condition is just 4 years old, and more than 90 percent of cases overall occur in children 18 and younger, according to Dr. Nancy Messonnier, director of the agency's National Center for Immunization and Respiratory Diseases. 1003

The University of Utah nurse at the center of a highly controversial arrest that was recorded on the officers' body cameras has reached a 0,000 settlement with all parties involved.In addition, Alex Wubbels announced Tuesday afternoon that she will use part of that money to launch a new initiative to make body camera video more accessible to all residents in Utah involved in a police incident."I am not in the business of setting anyone up for failure. I want us to be successful in moving forward. And I think this is a small step we can provide to enable that potential success if we are going to start asking the police departments to have body cameras,” Wubbels said outside the Salt Lake City Police Department while standing next to her attorney, Karra Porter.The nurse added "it's shocking" that today's police forces don’t all have body cameras."We all deserve to know the truth. And the truth comes when you see the actual raw footage. And that’s what happened in my case. No matter how truthful I was in telling my story, it was nothing compared to what people saw and the visceral reaction people experienced when watching the footage," she said.Wubbels' widely publicized arrest happened July 26 when Salt Lake detective Jeff Payne was sent to University Hospital to collect blood from a man injured in a crash that killed the driver who caused it. Wubbels — citing policy agreed upon by the hospital and the police department — declined to tell Payne where the patient was or allow him to draw blood.The detective, with direction from his supervisor that day, Lt. James Tracy, ultimately arrested the screaming nurse after physically pushing her out of the emergency room and holding her against a wall while handcuffing her. Police body camera video of the incident caused outcries of protest from across the country and prompted Salt Lake City Mayor Jackie Biskupski and Salt Lake Police Chief Mike Brown to personally apologize to Wubbels for the way she was treated while doing her job.Payne was fired from the police department. Tracy was demoted to the rank of officer. Both men have since appealed their discipline. Their appeals remained pending as of Tuesday.Wubbels and Porter — who never filed a civil lawsuit — announced she had reached a settlement with all "U.-related and Salt Lake City-related parties" who would have potentially been named if a lawsuit had been filed."There will be no legal lawsuit. This part of this is over. We’re hopping the discussion about body cameras continues,” Porter said.Matthew Rojas, spokesman for Salt Lake Mayor Jackie Biskupski, said both the city and the university agreed to pay 0,000 each."Salt Lake City has been focused first and foremost on ensuring policies and procedures are changed so things like this don’t happen again, and we are glad we could come to a resolution with nurse Wubbles," he said.Since Wubbels went public with the arrest video, Porter said her client has had several goals, including changes to policy on how police interact with nurses; accountability by the officers involved; starting a public discussion on the importance of body camera video; compensation; and helping others.Wubbels is working with the American Nurses Association on a campaign to prevent what happened to her from happening elsewhere. She also would like to speak before the Utah Legislature during the next session about the importance of making body cameras mandatory for all police agencies. And she and Porter want to help all Utahns have access to body camera video for their own cases."Thanks to Alex, there will be more transparency as body cam footage becomes more readily available in Utah,” Porter said.Wubbels said she was grateful for how Salt Lake City has responded to her arrest and the settlement, but also noted she still becomes emotional when thinking about the incident."This landed in my lap. This is not something I sought out. I didn’t seek out the last four months," she said. "I’m incredibly humbled by change that’s happened."This is very emotional," Wubbels continued, "This is an emotional situation. … I’m still processing this. I mean, this is something I never expected to happen. But I’m also honored by the weight of it and honored to be the one to help make progress in our society at large."Porter said body cameras are also important for protecting officers, with both Wubbels and Porter emphasizing there are many good officers. They stressed that fact when talking about the fatal shooting and manhunt at the university that forced the campus to go into lockdown Monday night."I literally park where this incident happened. I walk, in the dark, every night to my work, back and forth to my car where this incident happened,” Wubbels said, adding the police "did a really good thing today. And that’s a highlight for what comes out when good cops do good work."Watch the original body camera video here: 4923

The White House is again rejecting calls for a national mask-wearing mandate.White House chief of staff Mark Meadows says in an appearance on “Fox and Friends” Monday morning that the president sees the issue as a “state-to-state” matter.He says that, “certainly a national mandate is not in order” and that “we’re allowing our local governors and our local mayors to weigh in on that.”New Jersey’s Democratic Gov. Phil Murphy has said he’d like to see a national strategy on the coronavirus, including a mask requirement. He says his state is seeing “small spikes in reinfection” from residents coming back from Florida, South Carolina and other virus hotspots, and the U.S. is “as strong as our weakest link right now.”Vice President Mike Pence has also rejected the idea of a national mandate, saying that’s up to governors and local health officials. 862

The World Health Organization announced Wednesday that a coalition of nations and organizations are contributing billion to assist poorer nations fight the coronavirus.The two biggest contributors were the United Kingdom and Canada.The WHO says the “ACT-Accelerator, which was launched just five months ago, is an unprecedented global collaboration of the world’s top international health organizations working together to accelerate the development, production, and equitable delivery of COVID-19 tests, treatments, and vaccines.”The WHO said an additional billion is needed to realize its goals of producing 2 billion vaccine doses, 245 million treatments and 500 million tests. The WHO is working with the World Bank to secure billion in funding, which has to be first ratified by its shareholders.The United States government did not contribute to the fund as the government stopped funding the WHO in April. The Bill and Melinda Gates Foundation, however, were among the organizations to contribute to the fund.“One thing I've learned studying the history of pandemics is that they create a surprising dynamic when it comes to self-interest and altruism,” Bill Gates said. “Pandemics are rare cases where a country’s instinct to help itself is tightly aligned with its instinct to help others. The self-interested thing and the altruistic thing–making sure poor nations have access to vaccines–are one and the same.”The UK contributed 1 million to help poorer nations in providing support to battle the virus.“We have a duty to ensure vaccines, treatments and tests for COVID-19 are available to all—stopping the global spread of the pandemic protects the British people and will put humanity on the road to recovery. Collaboration through the ACT-Accelerator is critical to promoting development, production and access for all countries,” said UK Foreign Secretary Dominic Raab. 1906