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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 world has spent the last several months wearing masks in public, avoiding gatherings and, in general, spending less time outside the home. But a new report suggests household transmission is one of the most common ways COVID-19 is spreading; an individual is most likely to contract COVID-19 from their spouse or significant other.That conclusion is part of a new report from the University of Florida which was published in the journal JAMA Network Open on Monday. Researchers looked at the results of 54 studies across 20 countries that included nearly 78,000 subjects.They found more than one in three, roughly 38%, of COVID-19 patients passed the virus to their spouses or significant others they live with."Infection risk was highest for spouses, followed by non-spouse family members and other relatives, which were all higher than other [close] contacts," the authors wrote.In the studies, about 17% of COVID-19 patients transmitted the virus to children they live with.Anyone living in the same home as someone who has contracted the coronavirus is at a heightened risk, but researchers say spouses and significant others are more likely to pass along the virus for various reasons, including "intimacy, sleeping in the same room, or longer or more direct exposure to index cases," according to the report's authors.The researchers found no significant difference between male and female transmission rates inside the home.A recent study from the Centers for Disease Control and Prevention found that 53% of people who live with someone who has COVID-19 will contract the virus within seven days.Health experts have urged those who have COVID-19 or have symptoms to wear a mask in their home, and isolate within the home as much as possible away from others under the same roof. 1798
The Trump administration has proposed further slashing the number of refugees the United States accepts to a new record low in the coming year.In a notice sent to Congress late Wednesday, just 34 minutes before a statutory deadline to do so, the administration said it intended to admit a maximum of 15,000 refugees in fiscal year 2021. That’s 3,000 fewer than the 18,000 ceiling the administration had set for fiscal year 2020, which expired at midnight Wednesday.The proposal will now be reviewed by Congress, where there are strong objections to the cuts, but lawmakers will be largely powerless to force changes.The more than 16.5% reduction was announced shortly after President Donald Trump vilified refugees as an unwanted burden at a campaign rally in Duluth, Minnesota, where he assailed his opponent, former Vice President Joe Biden. He claimed Biden wants to flood the state with foreigners.“Biden will turn Minnesota into a refugee camp, and he said that — overwhelming public resources, overcrowding schools and inundating hospitals. You know that. It’s already there. It’s a disgrace what they’ve done to your state,” Trump told supporters.Trump froze refugee admissions in March amid the coronavirus pandemic, citing a need to protect American jobs as fallout from the coronavirus crashed the economy.Secretary of State Mike Pompeo said the administration is committed to the country’s history of leading the world in providing a safe place for refugees.“We continue to be the single greatest contributor to the relief of humanitarian crisis all around the world, and we will continue to do so,” Pompeo told reporters in Rome on the sidelines of a conference on religious freedom organized by the U.S. Embassy. “Certainly so long as President Trump is in office, I can promise you this administration is deeply committed to that.”But advocates say the government’s actions do not show that. Since taking office, Trump has slashed the number of refugees allowed into the country by more than 80%, reflecting his broader efforts to drastically reduce both legal and illegal immigration.The U.S. allowed in just over 10,800 refugees — a little more than half of the 18,000 cap set by Trump for 2020 — before the State Department suspended the program because of the coronavirus.The 18,000 cap was already the lowest in the history of the program. In addition, the State Department announced last week that it would no longer provide some statistical information on refugee resettlement, sparking more concerns.Advocates say the Trump administration is dismantling a program that has long enjoyed bipartisan support and has been considered a model for protecting the world’s most vulnerable people.Scores of resettlement offices have closed because of the drop in federal funding, which is tied to the number of refugees placed in the U.S.And the damage is reverberating beyond American borders as other countries close their doors to refugees as well.“We’re talking about tens of millions of desperate families with no place to go and having no hope for protection in the near term,” said Krish Vignarajah, president of the Lutheran Immigration and Refugee Service, a federally funded agency charged with resettling refugees in the United States.Bisrat Sibhatu, an Eritrean refugee, does not want to think about the possibility of another year passing without reuniting with his wife.For the past 2 1/2 years, he has called the caseworker who helped him resettle in Milwaukee every two weeks to inquire about the status of his wife’s refugee case.The answer is always the same — nothing to report.“My wife is always asking me: ‘Is there news?’” said Sibhatu, who talks to her daily over a messaging app. “It’s very tough. How would you feel if you were separated from your husband? It’s not easy. I don’t know what to say to her.”He said the couple fled Eritrea’s authoritarian government and went to neighboring Ethiopia, which hosts more than 170,000 Eritrean refugees and asylum-seekers. Between 2017 and 2019, his wife, Ruta, was interviewed, vetted and approved to be admitted to the United States as a refugee. Then everything came to a halt.Sibhatu, who works as a machine operator at a spa factory, sends her about 0 every month to cover her living expenses in Ethiopia.“I worry about her, about her life,” Sibhatu said, noting Ethiopia’s spiraling violence and the pandemic. “But there is nothing we can do.”He hopes his wife will be among the refugees who make it to the United States in 2021.___Lee reported from Washington. 4558
The White House on Tuesday said the Justice Department should consider a criminal prosecution of former FBI Director James Comey, claiming he had leaked privileged information to the press and offered false testimony to Congress."It's something they should certainly look at," press secretary Sarah Sanders told reporters when asked whether the administration should prosecute Comey. She acknowledged that it was "not the President's role" to determine which criminal investigations are taken up by the Justice Department.The question arose as Sanders defended Trump's decision to fire Comey earlier this year, a choice Trump's former chief strategist called a mistake this week.Speaking to "60 Minutes" on CBS, Steve Bannon called the Comey decision the worst mistake in "modern political history." 812
The Trump administration plans to eliminate routine audits of lenders for violations of the Military Lending Act, according to internal agency documents, The New York Times reported on Friday.Mick Mulvaney, the interim director of the Consumer Financial Protection Bureau, plans to terminate the supervisory examinations of lenders, arguing proactive oversight is not laid out in the legislation, according to the report.The proposal to weaken oversight under the Military Lending Act, which was created to protect military service members and their families from financial fraud, predatory loans and credit card gouging, came as a surprise to advocates of military families, the report stated. Those advocates have pressed the government to put a stop to unethical lenders.The agency has been critical in fighting lender misconduct, rolling out mortgage and payday-lender rules and cracking down on bad behavior by penalizing Citigroup, Wells Fargo and many other lenders.In lieu of conducting examinations, the agency will rely on complaints from its websites, hotlines, the military and people who believe they are victims of fraud, the Times reported.President Donald Trump has tapped Kathleen Kraninger to succeed Mulvaney as chief of the consumer watchdog agency. Kraninger, who works under Mulvaney, is expected to face a tough Senate confirmation battle.Under Mulvaney, the bureau has undergone major changes opposed by both Democrats and consumer advocates. In June, Mulvaney effectively terminated a board of advocates who advised the agency about fair lending and underserved communities. The advisers were told on a conference call that the board would not meet until new members were appointed. The CFPB, however, insisted nobody had been fired.The government watchdog agency, which is charged with consumer protection in the financial sector, was created after the financial crisis with the passage of the 2010 Dodd-Frank Act. 1948