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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 suspect in the deadly terror attack in New York wasn't only a driver for Uber. He also worked for its rival Lyft.Lyft said late Wednesday that Sayfullo Saipov drove for its ride-hailing app in the past but that it deactivated his account as soon as he was identified as a suspect in the attack.Saipov, a 29-year-old from Uzbekistan who was living in New Jersey, has been charged with federal terrorism offenses in connection with Tuesday's attack in Manhattan in which eight people were killed.Uber said Tuesday that Saipov started driving for it in New Jersey just over six months ago, making more than 1,400 trips. It also banned him from its platform after the attack.Lyft didn't provide details on how long Saipov drove for its app or how many trips he made. It's not unusual for drivers to work for both companies.Saipov's case is drawing renewed attention to the background checks that ride-hailing companies carry out on their drivers.Records show Saipov received multiple traffic citations in the past, including failure to equip a motor vehicle carrier with or maintain a required brake system.Both Uber and Lyft said they hadn't come across any complaints about Saipov's safety as a driver for them.New Jersey rules for ride-hailing services like Uber and Lyft require the companies to conduct criminal background checks, which are usually outsourced to specialist firms. Convictions for crimes like reckless driving automatically disqualify a driver.Uber applies different criteria for background checks depending on state regulations. In general, drivers cannot have more than three minor moving violations, such as speeding tickets, in the past three years.Lyft's website says potential drivers are screened for "driving incidents" but doesn't specify what would disqualify them.Both Uber and Lyft say they are in contact with law enforcement authorities over the New York attack."Our thoughts are with those affected by this tragic act," Lyft said. 1999

The Trump administration is taking steps to give telehealth a broader role under Medicare, with an executive order that serves as a call for Congress to make doctor visits via personal technology a permanent fixture of the program. The order President Donald Trump signed Monday applies to one segment of Medicare recipients — people living in rural communities. But administration officials say it’s intended as a signal to Congress that Trump is ready to sign more significant legislation that would permanently open up telehealth as an option for all people with Medicare. Trump says his administration is “taking action to make sure telehealth is here to stay.”"When the invisible enemy struck our shores, we took immediate action to eliminate regulatory barriers to telehealth, making it easier for patients to consult with doctors from safety and convenience and really, they have great safety and great convenience right from their homes," Trump said. While the CDC said in June it was working on expanding access to telehealth, it did list some drawbacks to the service:Situations in which in-person visits are more appropriate due to urgency, underlying health conditions, or inability to perform an adequate physical examThe need to address sensitive topics, especially if there is patient discomfort or concern for privacyLimited access to technological devices (e.g., smartphone, tablet, computer) needed for a telehealth visit or connectivity issuesLevel of comfort with technology for HCP and patientsCultural acceptance of conducting virtual visits in lieu of in-person visits by HCP and patientsInterstate licensure challenges and other regulatory issues that may vary by state 1701

The Supreme Court decided on Monday that they will not reexamine a doctrine that protects law enforcement and government officials from being sued over their actions while on the job.The doctrine, which the justices created nearly 50 years ago, gives "qualified immunity" for law enforcement officers, which protects them from frivolous lawsuits CNN reported.The decision comes amid protests over the death of George Floyd, who died while in police custody in Minneapolis.According to CBS News, the courts were to hear one case about a man in Tennessee that was bitten by a police dog, although he was sitting on the ground with his hands raised.NPR reports that two justices, Sonia Sotomayor and Clarence Thomas, have both been skeptical of the doctrine. 763

The United States is on pace to see its highest number of overdose deaths ever since record keeping began.Between October 2019 and October 2020, 74,000 overdose deaths were reported in the country, up from 68,000 during the same time period the previous year.In local municipalities, the numbers are even more staggering as many cities already surpassed their 2019 numbers through the first nine months of this year, and experts say the pandemic is only fueling the rise.The Associated Press analyzed preliminary overdose statistics in nine states across the country: Colorado, Kentucky, Texas, Connecticut, Massachusetts, Missouri, Rhode Island, New Jersey, and Washington. All of the states showed marked increased in overdose numbers from 2019 to 2020.In Colorado, for example, overdose deaths increased by 28%. In Denver, specifically, that rise was being fueled by the opiate fentanyl, which has been trafficked more across the U.S. Mexico border during the pandemic due to its strength.According Denver’s Medical Examiner’s Office, fentanyl deaths increased tenfold between 2018 and 2020. In 2019, the city reported 56 overdoses from the drug. Through October of this year, that number has skyrocketed to 108.“Drug overdoses are exceeding every metric that we’ve seen for the last decade,” said Dr. Jim Caruso, who is the coroner for the City and County of Denver. “We have had fentanyl related deaths in individuals as young as nine years old. Kids are always tough and they’ve been tough my whole career because you’re looking at the most lost years of productive life.”Dr. Ken Leonard is the Director of the Research Institute on Addictions at the University of Buffalo and says since the start of the pandemic, overdose deaths have only increased at a faster rate, particularly among those with existing drug issues.According to the AP’s analysis, deaths in all nine states peaked in either April or May, just after the tightest stages of quarantine began.Dr. Leonard says the economic consequences of the pandemic forced many drug treatment centers to either furlough or cut employees to save money, affecting accessibility to treatment. He says the isolation from support networks during quarantine may have also played a role in the rise.“The pandemic and the isolation, for a lot of people the unemployment, it all creates a tremendous amount of stress,” said Leonard.Because it takes months to tabulate national overdose death numbers, the true extent of what is happening may not be known until next year, despite early indicators that we are already in the midst of an unprecedented drug epidemic taking place during this pandemic. 2656