Over 55,000 Palestinians have been killed in the Israel-Hamas war, Gaza health officials say
DEIR AL-BALAH, Gaza Strip (AP) — Over 55,000 Palestinians have been killed in the Israel-Hamas war, Gaza health officials say.
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Yahoo
2 hours ago
- Yahoo
US FDA approves UroGen's bladder cancer drug
By Padmanabhan Ananthan and Kamal Choudhury (Reuters) -The U.S. Food and Drug Administration on Thursday approved UroGen Pharma's drug to treat a type of bladder cancer, providing an alternative treatment as opposed to traditional surgical procedures. U.S.-listed shares of the Israel-based company were up about 50% in afternoon trading. The approval follows a late-stage trial with 223 patients, in which 78% of the participants showed a complete response, meaning all signs of cancer disappeared in response to the treatment. The drug, branded Zusduri, will be the first to get approval to treat a type of bladder cancer that has not spread beyond the inner layers of the organ. The disease primarily affects older population. Scotiabank analyst George Farmer called the decision a "major positive outcome," noting that regulators were "moved by the quality of the clinical trial results, despite lack of solid randomized data". The FDA appreciated the non-surgical treatment option, describing it as "a huge win for patients with recurrent low-grade tumors" as it involves "a simple drug instillation in a doctor's office," Farmer added. Zusduri is a gel-based formulation that keeps chemotherapy in the bladder for a longer duration, aiming to reduce tumor recurrence and avoid repeated surgeries. UroGen said it expects the treatment to be available in the U.S. on or around July 1. Last month, an FDA advisory panel narrowly opposed approval of the drug citing concerns that a single arm study for efficacy might not be enough to indicate sustained benefits. The panel warned that such precedents could be problematic given existing surgical alternatives. The disease, a type of non-muscle invasive bladder cancer, affects about 82,000 people in the U.S. each year, with around 59,000 experiencing a recurrence, according to UroGen. Current standard-of-care treatments include surgical procedures such as transurethral resection of bladder tumor, in which doctors insert a thin tube through the urethra to remove the tumor.
Associated Press
2 hours ago
- Associated Press
House passes bill to to combat fentanyl trafficking, sending it to Trump's desk
WASHINGTON (AP) — The House overwhelmingly passed bipartisan legislation Thursday that would solidify federal policies cracking down on the synthetic opioid fentanyl and its analogs in a bid by lawmakers to combat the nation's opioid epidemic. The HALT Fentanyl Act makes permanent a 2018 emergency rule that classifies knockoffs of fentanyl as Schedule I controlled substances, which results in harsher sentences for possession of the drug. The bill passed the House 321-104 and now heads to President Donald Trump for his signature. The legislation, which applies to what are known as known as 'fentanyl-related substances,' garnered support from nearly every Republican and many Democrats despite concerns that the bill does not address the root issues at hand and will add to problems in the criminal justice system. Senate Majority Leader John Thune hailed passage of the bill and promised more legislative action to come. 'I don't need to tell anybody about the horrible impact of drug overdoses in this country, many of them caused by fentanyl,' Thune said on the Senate floor. 'In the coming weeks, we'll be taking up legislation to address another aspect of the fight: securing our borders,' a nod to Republicans' tax package, which includes billions of dollars in additional immigration enforcement and border security funding. Proponents of the legislation argue that the bill will make it easier to stop drug traffickers by making the federal emergency rules permanent. Opponents say the framework does little to stem the epidemic and warn it will make it harder to conduct important research. Congress has regularly renewed the emergency rules since 2018, meaning there is no immediate change to federal policy. The bill does not include increased funding for law enforcement to conduct anti-drug trafficking efforts, nor funding for public health efforts meant to reduce fentanyl addiction and deaths. The bill's supporters say that the reclassification will give anti-trafficking efforts clearer standards to operate under as law enforcement combats the trade. Federal, state and local law enforcement have sought to break up the flow of fentanyl into the U.S. by targeting Mexican drug cartels and local gangs. The Trump administration has declared stemming the flow of fentanyl precursors from China a priority in trade talks with Beijing, an effort that follows a spate of initiatives by the Biden administration to reduce the importation of such substances into the U.S. from China and other illegal supply chains. 'A loophole that the cartels have tried to use to drive their illicit fentanyl into our country is by changing one part of the fentanyl chemical structure to create fentanyl analogs,' said GOP Virginia Rep. Morgan Griffith, one of the bill's co-sponsors, during Wednesday's debate on the House floor. 'The cartels did this in an attempt to evade our criminal laws,' said Griffith, who argued that the bill would help prevent further fentanyl deaths and increase the potential for research into the drug and related substances. And lawmakers appealed to the human cost of fentanyl smuggling. 'We must give our law enforcement the tools to combat this problem. This bill does exactly that,' said GOP California Rep. Jay Obernolte, a co-sponsor of the bill. Obernolte recounted the stories of families impacted by fentanyl overdoses in his district and noted that more than 100,000 Americans died of an overdose last year, mostly from fentanyl. The bill 'gives our law enforcement agencies the tools that they need to begin dealing with this problem,' Obernolte said. Democratic New Jersey Rep. Frank Pallone said during debate that he opposed the bill because it uniformly criminalizes fentanyl related substances. Pallone said it will impede potential research into their benefits rather than provide an 'offramp to substances found to have potential medical applications.' Pallone also chided Republicans for saying they aimed to tackle the opioid epidemic while supporting the Trump administration's cuts to federal agencies tasked with research and public health policy. 'This Republican bill would also exacerbate inequities in our criminal justice system because drugs placed on Schedule I include mandatory minimum sentencing,' Pallone said. 'The bill is essentially recycling an incarceration first response to what I consider mainly a public health challenge.' Schedule I drugs are substances considered by the Drug Enforcement Agency to have 'no currently accepted medical use and a high potential for abuse.' Possession of a Schedule I drug is considered a felony and can be prosecuted as drug smuggling. Drugs currently classified as Schedule I include heroin, marijuana and methaqualone. Fentanyl itself is classified as a Schedule II drug, which the DEA designates as having 'a high potential for abuse.' Schedule II substances include cocaine, methamphetamine, oxycodone and Adderall.
San Francisco Chronicle
2 hours ago
- San Francisco Chronicle
House passes bill to to combat fentanyl trafficking, sending it to Trump's desk
WASHINGTON (AP) — The House overwhelmingly passed bipartisan legislation Thursday that would solidify federal policies cracking down on the synthetic opioid fentanyl and its analogs in a bid by lawmakers to combat the nation's opioid epidemic. The HALT Fentanyl Act makes permanent a 2018 emergency rule that classifies knockoffs of fentanyl as Schedule I controlled substances, which results in harsher sentences for possession of the drug. The bill passed the House 321-104 and now heads to President Donald Trump for his signature. The legislation, which applies to what are known as known as 'fentanyl-related substances,' garnered support from nearly every Republican and many Democrats despite concerns that the bill does not address the root issues at hand and will add to problems in the criminal justice system. Senate Majority Leader John Thune hailed passage of the bill and promised more legislative action to come. 'I don't need to tell anybody about the horrible impact of drug overdoses in this country, many of them caused by fentanyl,' Thune said on the Senate floor. 'In the coming weeks, we'll be taking up legislation to address another aspect of the fight: securing our borders,' a nod to Republicans' tax package, which includes billions of dollars in additional immigration enforcement and border security funding. Proponents of the legislation argue that the bill will make it easier to stop drug traffickers by making the federal emergency rules permanent. Opponents say the framework does little to stem the epidemic and warn it will make it harder to conduct important research. Congress has regularly renewed the emergency rules since 2018, meaning there is no immediate change to federal policy. The bill does not include increased funding for law enforcement to conduct anti-drug trafficking efforts, nor funding for public health efforts meant to reduce fentanyl addiction and deaths. The bill's supporters say that the reclassification will give anti-trafficking efforts clearer standards to operate under as law enforcement combats the trade. Federal, state and local law enforcement have sought to break up the flow of fentanyl into the U.S. by targeting Mexican drug cartels and local gangs. The Trump administration has declared stemming the flow of fentanyl precursors from China a priority in trade talks with Beijing, an effort that follows a spate of initiatives by the Biden administration to reduce the importation of such substances into the U.S. from China and other illegal supply chains. 'A loophole that the cartels have tried to use to drive their illicit fentanyl into our country is by changing one part of the fentanyl chemical structure to create fentanyl analogs,' said GOP Virginia Rep. Morgan Griffith, one of the bill's co-sponsors, during Wednesday's debate on the House floor. 'The cartels did this in an attempt to evade our criminal laws,' said Griffith, who argued that the bill would help prevent further fentanyl deaths and increase the potential for research into the drug and related substances. And lawmakers appealed to the human cost of fentanyl smuggling. 'We must give our law enforcement the tools to combat this problem. This bill does exactly that,' said GOP California Rep. Jay Obernolte, a co-sponsor of the bill. Obernolte recounted the stories of families impacted by fentanyl overdoses in his district and noted that more than 100,000 Americans died of an overdose last year, mostly from fentanyl. The bill 'gives our law enforcement agencies the tools that they need to begin dealing with this problem,' Obernolte said. Democratic New Jersey Rep. Frank Pallone said during debate that he opposed the bill because it uniformly criminalizes fentanyl related substances. Pallone said it will impede potential research into their benefits rather than provide an 'offramp to substances found to have potential medical applications.' Pallone also chided Republicans for saying they aimed to tackle the opioid epidemic while supporting the Trump administration's cuts to federal agencies tasked with research and public health policy. 'This Republican bill would also exacerbate inequities in our criminal justice system because drugs placed on Schedule I include mandatory minimum sentencing,' Pallone said. 'The bill is essentially recycling an incarceration first response to what I consider mainly a public health challenge.' Schedule I drugs are substances considered by the Drug Enforcement Agency to have 'no currently accepted medical use and a high potential for abuse.' Possession of a Schedule I drug is considered a felony and can be prosecuted as drug smuggling. Drugs currently classified as Schedule I include heroin, marijuana and methaqualone. Fentanyl itself is classified as a Schedule II drug, which the DEA designates as having 'a high potential for abuse.' Schedule II substances include cocaine, methamphetamine, oxycodone and Adderall.
