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SAN DIEGO (KGTV) -- The 21-year-old killed while driving across the trolley tracks near Encanto has been identified.The San Diego County Medical Examiner says Alex Garza, 21, was believed to be distracted, possibly on the phone, when he reportedly tried to drive his Toyota Prius across the tracks just before midnight at 60th Street and Imperial Avenue. The vehicle was struck by a trolley before it became pinned against a poll.San Diego Police and fire units responded to the scene where Garza was pronounced dead. 525

SAN DIEGO (KGTV) — The Department of Defense has awarded a San Diego biotech company up to million to help develop a next-generation drug to fight COVID-19.Sorrento Therapeutics calls the drug a “rapid countermeasure” against the disease, one that might serve as a vaccine substitute in certain populations or a critical stopgap tool if the virus mutates.“With this, we have a new platform potentially that can respond very quickly to any type of emerging threat,” said CEO Dr. Henry Ji.Sorrento is trying to become the first company to develop an approved DNA-encoded monoclonal antibody treatment. The approach is similar to the experimental monoclonal antibody treatment used on President Trump, but Sorrento’s concept is a more advanced version that offers several benefits.Sorrento’s drug is designed to be used as either a treatment in infected patients or a fast-forming layer of defense in healthy people. The company said its solution should be cheaper and easier to deploy than existing monoclonal antibodies, while offering vaccine-like protective effects that last for several months rather than just two or three weeks.Antibodies are one of the body’s key defense mechanisms. They seek out pathogens and bind to them, marking the invader for destruction like ground troops marking an enemy base for an airstrike. In some cases, antibodies can even neutralize an invader themselves by blocking its method of entry into cells.Monoclonal antibodies are antibodies designed by scientists to neutralize a pathogen. They are hand-picked, genetically modified super antibodies that are cloned in labs.However, the process of growing these super soldiers in the lab is difficult, transporting them requires a cold chain, and as a result, monoclonal antibodies are among the most expensive drugs in the world.Instead of giving people an infusion of pre-made antibodies, Sorrento’s idea is to give people a shot of DNA that instructs some of their cells to churn out perfectly pre-designed antibodies.“It's much easier to make enough DNA to treat a large number of people than it is to make enough protein to treat a large number of people. That’s just a fact about manufacturing,” said Dr. Robert Allen, Sorrento’s chief scientific officer on the project.Dr. Allen said the company is hopeful the drug will induce cells to make protective antibodies for six months or more.This DNA approach to an antibody treatment has never been approved for any disease but other companies are working on their own versions of it. Another biotech with ties to San Diego, Inovio Pharmaceuticals, became the first company to test this approach in humans in 2019 for a drug targeting the Zika virus.Sorrento’s approach is similar to the way DNA vaccines work, but it cuts out intermediary steps and jumpstarts the production of antibodies, rather than leaving the production of antibodies up to the body’s immune system. The result is that protective antibodies can start circulating in days after injection rather than weeks, the company said.“What this is capable of doing is it bypasses the need for the immune system,” said Dr. Mark Brunswick, Sorrento’s senior vice president for regulatory affairs.The drug is unlikely to replace a vaccine in most situations because vaccines can produce other defense mechanisms like T-cells that work in conjunction with antibodies. But the drug might work better than a vaccine for the elderly and others with weakened immune systems who are unable to produce a robust number of antibodies on their own, Brunswick said.Still, the company still has a lot of pre-clinical work and testing to go. Sorrento is hoping to have the drug ready for human trials in four to six months.By then, vaccines from Pfizer and Moderna will likely be widely available, but Dr. Ji said the world needs to prepare for the possibility this virus will mutate.“When you vaccinate hundreds of millions, potentially billions of people, the virus is under tremendous evolution pressure,” he said. “It will escape. It’s guaranteed that the virus is going to mutate and escape all of the vaccines we’re trying to create.”If it does, he said Sorrento will be ready to rapidly deploy its DNA-based countermeasure. 4223

SAN DIEGO (KGTV) — The Food and Drug Administration has released new guidelines to vaccine makers with added safety measures that experts say will push back the timeline, making the release of a COVID-19 vaccine before the election highly unlikely.The guidelines lay out what it will take for companies to secure a fast-tracked authorization for a vaccine, known as an emergency use authorization or EUA.The new guidelines require vaccine makers to follow the volunteers in their clinical trials for a median of two months after their final dose.It’s an important step to see if anyone has a bad reaction, says Dr. Christian Ramers of Family Health Centers of San Diego.“Some of the safety issues that people like me are concerned about might take months actually to develop,” Dr. Ramers said. “My analysis of this is that it's the FDA standing up and saying, ‘We're going to adhere to our rigorous scientific process.’”The White House had resisted the new guidelines from the FDA for more than two weeks. After their release, President Trump described them as a “political hit job.”“New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” the president wrote on Twitter Tuesday night.It’s hard to gauge exactly how the two-month buffer affect the vaccine timeline because clinical trials do not start all at once; volunteers are enrolled on a rolling basis. But Dr. Sydney Wolfe of the consumer group Public Citizen said the drug makers have offered clues.“The companies one-by-one are saying, ‘We can’t get anything in until the end of November or the end of December or the beginning of January,’ and that’s a relief,” he said.In a clinical trial, half of the volunteers get the vaccine and half get a fake drug called a placebo.The updated guidelines require companies to have an estimated effectiveness of at least 50 percent, meaning there are 50 percent fewer cases of infection in the group receiving the vaccine compared to the placebo group.The guidelines also instruct companies to have a plan to continue collecting data in their clinical trial even after they get an EUA and the vaccine hits the market.“The worst thing that could happen here is something meets that minimum bar of 50% efficacy, meaning it works pretty well, but then the bottom just falls out from these clinical trials and we don't get the information we need,” he said.Dr. Ramers was initially skeptical of fast-tracking a vaccine with an EUA rather than waiting for full approval since it’s only been done once before, but he’s supportive of the process under the updated guidelines.“I think that's the best way to balance speed and safety,” he said.Still, experts like Dr. Wolfe think going with an EUA over a full approval could backfire. He points out the new guidelines allow up to half of the people in the clinical trial to be tracked for less than two months after their final dose.“All things aren’t equal [between an EUA and full approval] because you don’t have all the information and B, people know that,” he said.Dr. Wolfe is concerned the public will be reluctant to roll up their sleeves and embrace the vaccine if it just has an emergency authorization. Now that the FDA has made the EUA guidelines more rigorous, he thinks waiting for full approval might take just a few more months.The FDA’s new guidance notes that an Oct. 22 meeting of its Vaccines and Related Biological Products Advisory Committee will not be to discuss specific vaccine candidates.Trump previously said he would consider overruling the FDA on its vaccine guidelines in hopes of speeding up the process. There is both health and economic pressure for a vaccine to be developed as the coronavirus continues to claim an average of 800 US lives a day, according to Johns Hopkins University data.However, Dr. Wolfe said the possibility of the president overruling the FDA is unlikely to have an impact now because the vaccine developers themselves have indicated they will follow the FDA guidelines.Additional reporting by Justin Boggs 4090

SAN DIEGO (KGTV) — The next attraction to hit Disneyland's "Star Wars: Galaxy's Edge" is set for early next year."Star Wars: Rise of the Resistance" opens at Disneyland on Jan. 17, 2020, and Walt Disney Wold on Dec. 5, 2019, the park announced Thursday.The second ride to hit "Galaxy's Edge" at the Anaheim park promises guests an immersive adventure that will "blur the lines between fantasy and reality." Riders will find themselves in the middle of a climatic battle between the First Order and the Resistance.MORE 'GALAXY'S EDGE': What to know | Park Map | Food | Merchandise | Millennium Falcon: Smuggler's Run | Park Video Walkthrough | Retail Shops | RestaurantsRiders will be recruited by Rey and General Leia Organa at a secret base inside "Galaxy's Edge." But, in typical "Star Wars" fashion, danger lurks around every corner. A First Order Star Destroyer will capture this new rag-tag group of heroes and, with the help of the Resistance, riders will have to break out and escape the Star Destroyer, protect their base, and avoid Kylo Ren's plans.Teasing the ride back in April, Scott Trowbridge, Portfolio Creative Executive at Walt Disney Imagineering, said "Rise of the Resistance" will be, "the biggest, it is one of the most complex attraction experiences that [Disneyland] or anyone else has ever built."RELATED: Disneyland offering annual passholders a 'bring a friend' discountThe "Star Wars: Galaxy's Edge" ride builds upon the new themed-area's immersive experience that transports guests to a galaxy far, far away to the planet Batuu. Those who venture into the Black Spire Outpost can live out their "Star Wars" fantasies building their own lightsaber or droid, flying the Millennium Falcon on the "Smuggler's Run" ride, or sinking their teeth into some Endorian tip-Yip or Braised Shaak Roast. 1827

SAN DIEGO (KGTV) -- The non-profit organization Border Angels hosted its 32nd-anniversary dinner on Saturday. The dinner raises money to help continue providing the services they offer to immigrants in the community, including water drops for border crossers, legal services, and shelter. The migrant caravan and the upcoming election were hot topics of conversation during the dinner. This year the organization honorees were Margarita Zavala, Kirsten Zittlau and Jacqueline Arellano. Zavala and Zittlau are attorneys. Arellano is the water drop coordinator for Border Angels. Border Angels' founder Enrique Morones tells 10News that he decided to honor women this year. He also encouraged everyone to go out and vote on November 6th saying the president is sending the wrong message about immigrants. Guests at the event also reacted to President Donald Trump deploying the military to the border. At a campaign event, the president was not backing down, saying migrants need to come to the U.S. legally.   1051

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