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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 state of Oregon became the first in the nation to decriminalize small amounts of hard drugs like heroin and cocaine by overwhelmingly passing Measure 110 on Tuesday.According to The Oregonian, the measure will reduce misdemeanor drug possession to a non-criminal violation, punishable by measures similar to a traffic stop. Violators will be given a ticket and a 0 fine, or be given the option of being screened for a subtance abuse disorder.Those found with larger amounts of drugs, who would have previously been charged with a felony, will now face a misdemeanor charge. The measure also redirects tax revenue from the sale of legal marijuana in the state toward Addiction Recover Centers, where people are screened for drug use and can also receive treatment for drug addiction.Supporters of the measure say the new policy will reduce the state's jail population, and in particular, free many offenders of non-violent crimes. Supporters also say the bill will promote racial equality in the state, as drug laws disproportionately affect Black people and other people of color.Opponents of the measure say it promotes drug use and will lead to more overdose deaths and overwhelm addiction centers in the state.The Oregonian also reports that the measure received funding from many out-of-state donors, including Facebook founder and CEO Mark Zuckerberg.The Associated Press reports that the measure passed with about 60% support.In addition to decriminalizing hard drug use, Oregon also legalized the sale and recreational use of Psilocybin, or magic mushrooms. The Associated Press reports that the measure passed with 56% support. 1650
The Woolsey Fire is 100 percent contained, according to the most recent update from Cal Fire.The fire burned 96,949 acres across Los Angeles County and Ventura County. Three people died in the fire and three firefighters were injured. More than 1,500 structures were destroyed and 341 were damaged.The cause of the fire is still under investigation. New imagery from NASA shows a dark scar from the deadly and destructive fire, which burned near Malibu, California. The damage the fire left is still being assessed.NASA's Terra satellite was able to capture this new view of the damage through a false-color image from its Advanced Spaceborne Thermal Emission and Reflection Radiometer.The burnt areas are brown; unburned vegetation is green. The light gray or white areas are buildings, roads and other developed areas. 838
The recount effort underway in Georgia has uncovered roughly 2,600 ballots that hadn’t originally been included in the tally.State officials say county election officials in Floyd County didn’t upload in-person early votes from a memory card into a ballot scanning machine, according to the Atlanta Journal Constitution newspaper.Floyd County is located in northwest Georgia.In the uncounted votes, there were 1,643 new votes for President Donald Trump and 865 votes for President-elect Joe Biden. County officials say these ballots rectify their discrepancy between the number of people who checked-in to vote and the number of ballots counted in Floyd County.President Trump's campaign issued a statement Tuesday afternoon in response to reports of the previously unaccounted ballots."Recent revelations from Georgia's ongoing statewide recount have shown that President Trump was absolutely correct to raise concerns about widespread voting irregularities that have favored the Biden-Harris ticket," the statement reads. "The State of Georgia must not certify its results until the recount is done accurately and the results are correct."“It’s not an equipment issue. It’s a person not executing their job properly,” said Gabriel Sterling, the state’s voting system manager. “This is the kind of situation that requires a change at the top of their management side."The head of the Republican Party in Floyd County said the issue was concerning, but “doesn’t appear to be a widespread issue,” and he was glad the ballot audit revealed it.Georgia’s audit of the nearly 5 million ballots cast is set to be finalized Friday. 1632
The Trump campaign has dropped a central part of its lawsuit that seeks to delay the certification of election results in Pennsylvania, the state which proved to be the tipping point for Joe Biden in clinching the presidency.On Sunday, the Trump campaign dropped a portion of a lawsuit that alleged that more than 600,000 mail-in and absentee ballots were processed without Republican poll-watchers present. The claim has been a central part of President Donald Trump's argument that the 2020 election has been beset by widespread voter fraud.The Trump campaign's lawsuit now only focuses on claims that Republicans were "illegally disadvantaged" because some voters in Democratic-leaning counties were afforded the ability to fix mistakes on their mail-in ballots, a process called "curing." The Washington Post reports that the issue would likely only affect a small number of votes.Ballot curing is a process that takes place in several states. According to The Associated Press, there is no provision in Pennsylvania state law that prevents counties from affording voters the opportunity to cure ballots.Biden currently holds a lead of about 70,000 votes over Trump, with nearly all of the votes counted.Despite his campaign's altered lawsuit, Trump on Sunday continued to claim on Twitter — without providing evidence — that poll watchers "were thrown out of vote counting rooms in many of our States."Late Sunday evening, Trump tweeted, "I WON THE ELECTION!" a claim that quickly prompted Twitter to add a clarification to his message clarifying that "official sources have called this election differently." 1622