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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 US ambassador to Mexico was not invited to a meeting between senior White House adviser Jared Kushner and Mexican officials, including President Enrique Pe?a Nieto, a US official told CNN.Roberta Jacobson, a career diplomat who has more than 30 years of experience in the region, announced her retirement earlier this month effective in May. Her departure comes at a time when US relations with Mexico have been strained over issues related to trade and migration.Kimberly Breier, who was just nominated to be the new assistant secretary for Western Hemisphere -- a senior State Department position Jacobson previously held -- was with Kushner at the Wednesday meeting.The New York Times first reported that Jacobson was not at the meeting.The timing of the meeting came amid NAFTA negotiations and questions over President Donald Trump's tariff proposal. It also comes shortly after Kushner had his security clearance downgraded because he had not obtained his full clearance. 995
The South Korean government says thousands of BMWs will be banned from the country's roads after some vehicles caught fire.The German automaker is facing a public relations crisis in South Korea over the fires, which it has blamed on a problem with the cars' exhaust systems.BMW recalled more than 100,000 vehicles in South Korea last month and has been carrying out emergency inspections. It expanded the checks to Europe last week.As of late Monday, more than 27,000 of the affected BMWs in South Korea still hadn't been checked, according to the South Korean government."Our citizens are deeply concerned," Transportation Minister Kim Hyun-mee said Tuesday. She ordered local authorities to ban people from driving any of the potentially fire-prone BMWs that haven't been brought in for checks. 805
The world’s population has been growing, spiking in the last few centuries, and now sits around 7.6 billion. A study published this week suggests global population will peak around the year 2064 at roughly 9.73 billion people.Researchers looking at the models believe the world’s population will then begin declining, reaching roughly 8.79 billion in the year 2100. Their reasoning for the decline is that “continued trends in female educational attainment and access to contraception will hasten declines in fertility and slow population growth.”According to the study, funded in part by the Bill and Melinda Gates Foundation and published in The Lancet, the five largest countries, population-wise, in 2100 are projected to be India, Nigeria, China, the U.S. and Pakistan. They are projecting America will have a population of roughly 336 million people in 2100. Currently, there are an estimated 331 million people living in the U.S.The average life expectancy in 2100 will be around 80 years old. The current global life expectancy is estimated at 72 years old. 1073
The University of Florida's football team is suspending activities following an “increase” in COVID-19 cases among members of the team, the university announced on Tuesday.The announcement comes just days after head coach Dan Mullen called on the university to open Ben Hill Griffin Stadium to a full capacity of 90,000 for the rest of the season. The state of Florida currently does not have a capacity restriction on stadiums."I know our governor passed that rule, so certainly, hopefully the university administration decides to let us pack the Swamp against LSU … 100 percent, because that crowd was a major factor in the game,” Mullen said following last Saturday’s 41-38 loss against Texas A&M. “So, I certainly hope our university administration follows the governor. The governor has passed a rule that we're allowed to pack the Swamp and have 90,000 in the Swamp to give us the home-field advantage Texas A&M had."The stadium is currently open at 20% capacity.Athletics director Scott Stricklin said the suspension was out of an “abundance of caution.”Sports Illustrated reported that the Gators had five new coronavirus cases identified on Tuesday.As of Tuesday afternoon, this Saturday’s game between Florida and LSU is still on as scheduled. 1269