Drug maker in trouble with FDA for failing to report side effects

first_img About the Author Reprints Blame it on the contractor.That’s the reason Heritage Pharmaceuticals gave the Food and Drug Administration after an agency inspector found 10 instances in which the generic drug maker failed to convey side effect reports about its medicines, which is required by law.Between 2010 and 2014, the company did not submit an unspecified number of side effect reports concerning an undisclosed number of its drugs, according to a Nov. 5 warning letter that the agency sent to the drug maker.advertisement Whenever a drug maker receives a side effect report about one of its medicines, the information is supposed to be conveyed periodically to the FDA. APStock Tags drug makersFDAside effects Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Such violations are rare.Whenever a drug maker receives a side effect report about one of its medicines, the information is supposed to be conveyed periodically to the FDA. This is standard procedure, but one that is taken seriously by regulators, since they must detect troubling trends with drugs.advertisement [email protected] center_img PharmalotDrug maker in trouble with FDA for failing to report side effects Ed Silverman By and large, drug makers are keen to comply with this requirement. Not only do companies fear the wrath of FDA officials, they want to avoid the suggestion they are unwilling to disclose side effects. In fact, only once during the past four years has a company not filed required reports, according to the FDA database. And there have only been eight other instances during the past decade.But in its annual reports filed with the agency between 2010 and 2014, Heritage noted that there were no side effect reports. Yet, an agency inspector found at least 10 such instances. So what was the problem? When confronted with the discrepancy, Heritage blamed a regulatory affairs contractor for the failure, according to the warning letter.Not surprisingly, this did not sit well with the FDA. “The complete omission of [side effect reports] required to be submitted … for a period of over four years raises concerns about your firm’s ability to monitor the safety of drug products.”The FDA had another issue. Heritage lacks suitable procedures for gathering and evaluating side effect reports. And its policy of keeping these reports for no less than three years doesn’t jibe with FDA requirements, which state side effect reports must be kept for 10 years.We reached out to Heritage for comment and will pass along any reply.For the record, the FDA cited Galena BioPharma for the same problem last April. Before that, though, the most recent incident involved Sanofi in January 2011. Other companies cited in years past for the same infraction included Pfizer and GlaxoSmithKline. By Ed Silverman Nov. 18, 2015 Reprints @Pharmalot last_img read more

Doctor: Trump would be ‘healthiest individual ever’ elected president

first_imgPoliticsDoctor: Trump would be ‘healthiest individual ever’ elected president A voters guide to the health of the presidential candidates That was the conclusion from the presidential candidate’s personal physician, Dr. Harold N. Bornstein of Lenox Hill Hospital in New York, in a one-page letter released by the Trump campaign. It didn’t show “perfection,” as Trump said it would when he tweeted earlier this month about the upcoming release. But the tone was so enthusiastic that it came close. Donald Trump has had “no significant medical problems” over the last 39 years, his doctor said. Scott Olson/Getty Images By David Nather Dec. 14, 2015 Reprints Related:center_img WASHINGTON — Donald Trump released a physician’s report on his health on Monday, as promised, and there wasn’t a lot of detail — but there were a lot of superlatives.Like “astonishingly excellent.” And “extraordinary.”And this one: “If elected, Mr. Trump, I can state unequivocally, will be the healthiest individual ever elected to the presidency.”advertisement Bornstein said Trump, 69, has had “no significant medical problems” over the last 39 years, noting that he takes 81 milligrams of aspirin and a “low dose” of statin every day. The doctor said his blood pressure and laboratory tests were “astonishingly excellent,” adding that Trump has lost 15 pounds in the last year and has never used alcohol or tobacco.advertisement Tags Donald TrumppolicyPresidential campaign Bornstein also wrote that Trump “has suffered no form of cancer,” and characterized his level of prostate-specific antigens as “very low.” A high PSA level can be an indication of prostate cancer. The doctor said Trump “has never had a knee, hip, or shoulder replacement” and that his only surgery was an appendectomy when he was 10.The doctor also claimed that Trump’s “physical strength and stamina are extraordinary” — using a phrase that echoes Trump’s taunts of Democratic presidential candidate Hillary Clinton, whom he has accused of not having the “strength or stamina to be president.”The other presidential candidates who have released their health information — Clinton, Jeb Bush, and Chris Christie — have all done so through summaries from their personal physicians as well. But Trump’s letter is shorter than the others, and both Clinton and Bush have acknowledged health issues.Clinton’s letter detailed the concussion she suffered as secretary of state, and Bush’s statement acknowledged “vitamin D insufficiency, gastritis, colon polyps, sinusitis, and low-back pain.”last_img read more

Bluebird Bio’s gene therapy for blood disorders yields some impressive results ― but also raises questions

first_img Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. [email protected] Biotech STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. About the Author Reprints GET STARTED Log In | Learn More What is it? By Adam Feuerstein June 23, 2017 Reprints @adamfeuerstein center_img The field of gene therapy is making significant strides towards the day when a one-time treatment ― inserting a healthy gene into patients ― could cure a host of inherited, often fatal diseases. But it’s been a rocky road. And new clinical data presented this morning by Bluebird Bio make clear that success is far from guaranteed. Bluebird is testing a gene therapy for two inherited blood disorders ― and the data managed both to impress and to leave important questions unanswered.On the impressive side: A patient with the inherited blood disease beta-thalassemia, which causes severe anemia, was able to stop regular blood transfusions one month after treatment and achieved a normal level of hemoglobin in six months, according to interim data from an ongoing phase 3 clinical trial. The positive outcome for this patient suggests, but does not yet prove, that manufacturing changes made by Bluebird last year to improve the efficacy of its investigational therapy, Lentiglobin, are having the desired effect. Bluebird Bio’s gene therapy for blood disorders yields some impressive results ― but also raises questions Adam Feuerstein What’s included? Gerry Broome/AP Senior Writer, Biotech Adam is STAT’s national biotech columnist, reporting on the intersection of biotech and Wall Street. He’s also a co-host of “The Readout LOUD” podcast. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Tags biotechnologyclinical trialsdrug developmentgeneticsrare diseaseslast_img read more

Come for a new hip, stay for SeaWorld? San Diego bets on medical tourism

first_img Among the many issues that need to be addressed: Local hotels need to be equipped appropriately to handle patients recuperating from various types of treatments. Hospitals need to train their doctors to be culturally sensitive to patients coming from different parts of the world. They may need more interpreters. Or special prayer rooms. Or luxury cars to ferry patients to and from the hospital.Their cafeterias need to brush up on global flavors and culinary favorites, as well as faith-based dietary restrictions.Just building out that infrastructure can cost as much as $1 million for each culture or part of the world a medical tourism campaign targets, Woodman said.San Diego, however, is undaunted. City boosters have looked at the competition, and they like their odds. By Meghana Keshavan Nov. 29, 2017 Reprints San Diego civic leaders hope their sun-kissed beaches will lure medical tourists. David McNew/Getty Images Meghana Keshavan “We have sun. We have beach. We have hotel. We have hospital. We have doctor. Throw them all in a bowl and call it medical tourism?” said Maria Todd, a business consultant who focuses on health tourism strategy. “No, it doesn’t work like that.”“It’s a tough sell,” said Josef Woodman, who runs Patients Beyond Borders, a yearly publication that analyzes the medical tourism industry.advertisement Related: About the Author Reprints Related: In Jamaica, a push to market island getaways — with a side of surgery Privacy Policy “If we can get people to recognize that we offer exceptional health care — well, would you rather go to San Diego for a couple weeks in December, or Minnesota?” said Joe Terzi, president and CEO of the San Diego Tourism Authority.San Diego certainly has some top-notch hospital systems, including University of California, San Diego, Sharp HealthCare, Scripps Health, and Rady Children’s Hospital. It also boasts private practices like Human Longevity, which offers comprehensive diagnostics (at top dollar) from genomics pioneer J. Craig Venter.Such services might allow the city to position itself as a hub for “well care” — helping patients avoid medical crisis. Civic leaders are also pondering a campaign that would highlight certain highly ranked medical specialties (though they haven’t yet decided which ones to tout). Leave this field empty if you’re human: “Marketing was the last thing we brought to the table,” said Doug Geinzer, CEO of Las Vegas HEALS, the city’s medical tourism initiative. He didn’t have specific numbers on how many patients the campaign has attracted but said most are from the U.S.For now, San Diego is setting a modest goal of simple public awareness.“We don’t think we’re going to compete with MD Anderson or Mayo Clinic — they have worldwide reputations and names they’ve developed,” Terzi said. “We’re really just trying to elevate the opportunity for people to understand that San Diego is a center of health care.” Please enter a valid email address. “Why come to San Diego instead of Harvard, or Mayo, or Cleveland Clinic?” Joe Terzi, San Diego Tourism Authority Tags cancerhospitalspatientsstates “What’s totally irrelevant is the destination,” Pollard said. “The environment, the attraction of the destination — some cities have tried to sell themselves on that basis, but at the end of the day, that’s the last thing that people are interested in.”Funding for DestinationCare San Diego comes largely from local philanthropist Malin Burnham. The city plans to spend $150,000 in the coming year and another $250,000 annually thereafter.For inspiration, campaign organizers might well turn to Las Vegas, which has built a medical tourism industry by zeroing in on plastic surgery, bariatric surgery, fertility services, and some orthopedic procedures.But it hasn’t been easy. Before even launching the campaign, the city secured cooperation from the hotel and gaming industries, which draw most of the 43 million visitors who flock to Las Vegas each year. Then came the painstaking infrastructure development — from mapping out patient-friendly hotels to planning transportation logistics.Figuring out bundled payments, in particular, was critical: Patients flying in from around the world want to know the exact price of their procedure before they arrive. Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. A taxpayer gamble on medical tourism: Louisiana subsidizes proton therapy to boost its economy @megkesh BusinessCome for a new hip, stay for SeaWorld? San Diego bets on medical tourism Keith Pollard, International Medical Travel Journal. SAN DIEGO — It’s got sun, sand, top-flight biomedical research, and highly rated hospitals. But can San Diego really become a hub for medical tourism?City leaders sure hope so. They recently launched a marketing initiative — funded mostly by a local philanthropist — that aims to attract patients from across  the country and around the world. The pitch: Get your hip replaced or your cancer treated by top specialists — and then take your family to Legoland or SeaWorld.The Mayo Clinic in Rochester, Minn., and the Cleveland Clinic in Ohio are also bidding to become hot destinations for patient care — though they can’t promise any sparkling beaches. But experts say it takes a lot more than a slick marketing campaign to create a true medical tourism hub.advertisement [email protected] Biotech Correspondent Meghana covers biotech and contributes to The Readout newsletter. Local health care centers generally back the medical tourism campaign. In fact, some already have international reach. Sharp, for instance, for years has run a Global Patient Services division that evacuates patients who need emergency medical care abroad.But none of the hospitals is putting up any cash — at least not yet — to boost the marketing program. A spokesman for Sharp said that it’s simply too early to comment on the initiative. And the campaign, dubbed DestinationCare San Diego, hasn’t laid out much of a plan beyond internet marketing.While the term “medical tourism” can be a touch pejorative — it often refers to cheaper cosmetic surgery and dental care offered in countries like Mexico or Malaysia — it has a different meaning in countries like the U.S., Germany, and the U.K. Patients come here for high-end specialized care, usually to treat cancer, heart disease, or rare conditions.Patients from China and the Middle East, in particular, are often wealthy enough to pay U.S. prices out of pocket — and tend to perceive that that stateside care is world-class. But when they think of top U.S. hospitals, they’re usually not thinking of UC San Diego.“And there’s your challenge: Why come to San Diego instead of Harvard, or Mayo, or Cleveland Clinic?” said Keith Pollard, managing editor of the International Medical Travel Journal. Patients travel to hospitals based on reputation, not locale, he said. “Would you rather go to San Diego for a couple weeks in December, or Minnesota?”last_img read more

Pharmalittle: Insulin study causes a big flap; Glaxo gets a reprieve thanks to a Novartis setback

first_img Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Ed Silverman Pharmalot Pharmalittle: Insulin study causes a big flap; Glaxo gets a reprieve thanks to a Novartis setback Rise and shine, everyone, another busy day is on the way. Our journey is made more tolerable today thanks to a bright and shiny sun enveloping the otherwise chilly Pharmalot campus. To keep warm, yes, we are quaffing a few welcome cups of stimulation, alternating between peppermint mocha and blueberry. Feel free to join us. What have you got to lose? Meanwhile, here are some tidbits. Hope you have a smashing day and, as always, we would like to remind you that we accept tips, encrypted messages, and secret dossiers from overseas …Preliminary research suggesting some diabetes patients may be injecting medicine that has partially disintegrated is causing concern even as serious questions are raised about the research itself, the Associated Press writes. The study author, a pharmacist, bought 18 vials of insulin at several pharmacies and found, on average, the vials had less than half of what was listed on the label and none met a minimum standard. But the methods used to test the insulin are being questioned, and insulin makers, patient advocate groups, and diabetes experts say patients would be getting sick if the findings were accurate. The study was published in the Journal of Diabetes Science & Technology. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED [email protected] About the Author Reprints Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. By Ed Silverman Feb. 8, 2018 Reprintscenter_img GET STARTED @Pharmalot STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Alex Hogan/STAT What is it? What’s included? Log In | Learn More Tags gene therapyopioidspharmaceuticalspharmalittlepolicySTAT+last_img read more

NIH is pressed to ensure affordable pricing before awarding a license for a CAR-T therapy

first_imgPharmalot Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Log In | Learn More @Pharmalot About the Author Reprints Ed Silverman Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. GET STARTED What’s included? [email protected] center_img NIH is pressed to ensure affordable pricing before awarding a license for a CAR-T therapy By Ed Silverman Dec. 6, 2018 Reprints A plan by the National Institutes of Health to award an exclusive license for a CAR-T therapy that was funded by U.S. taxpayers to a group of biotech venture capitalists has sparked concerns among advocacy groups over pricing and access in the U.S. and elsewhere.At issue are patent rights for an acute myeloid leukemia treatment the agency recently indicated would be awarded to an obscure company called ElevateBio, which was created by four current or former partners at MPM Capital. The venture capital firm has invested in dozens of companies, including 23andMe and Pharmasset, which is credited with discovering the breakthrough Sovaldi hepatitis C medicine. What is it? STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Alex Hogan/STAT Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Tags drug pricinglegalpharmaceuticalsSTAT+last_img read more

Biotech in the time of the coronavirus: A semi-regular column on the outbreak’s impact on drug makers

first_img This is the first in a series of semi-regular columns on the Covid-19 pandemic. In this edition: CVRs at risk, new hurdles for DBV Technologies, a trial suspension for Provention, and more. If the Food and Drug Administration slows or halts ongoing drug reviews due to the coronavirus, payout of the Bristol Myers Squibb contingent value rights might be in jeopardy. STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Senior Writer, Biotech Adam is STAT’s national biotech columnist, reporting on the intersection of biotech and Wall Street. He’s also a co-host of “The Readout LOUD” podcast. Mike Reddy/STAT What’s included? About the Author Reprints @adamfeuerstein What is it? Log In | Learn More Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.center_img Adam’s Take GET STARTED Adam Feuerstein Tags biotechnologypharmaceuticalsSTAT+ Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED By Adam Feuerstein March 17, 2020 Reprints Biotech in the time of the coronavirus: A semi-regular column on the outbreak’s impact on drug makers [email protected] last_img read more

How the wave of telehealth SPACs during the pandemic could create a ‘perfect storm’ for investors

first_img [email protected] Health Tech STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Alex Hogan/STAT How the wave of telehealth SPACs during the pandemic could create a ‘perfect storm’ for investors Casey Ross Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+. First 30 days free. GET STARTED Tags financemedical technologySTAT+ In little more than a year, telehealth has gone from a backwater of American health care to a booming business. Billion-dollar valuations, once a rarity, are now common as companies seize on a dramatic increase in demand to raise money and enter the public markets during the coronavirus pandemic.But the overnight change in fortunes for the industry is also raising alarms of a bubble, especially as more telehealth providers merge with shell companies known as SPACs — special purpose acquisition corporations — that offer a faster and easier road to going public. Experts in health finance said the rush to capitalize on sudden changes in supply and demand may cause companies and investors to overlook significant risks, such as a reemergence of regulatory barriers waived during the pandemic or clinical studies that may call the value or quality of telehealth care into question.center_img National Technology Correspondent Casey covers the use of artificial intelligence in medicine and its underlying questions of safety, fairness, and privacy. He is the co-author of the newsletter STAT Health Tech. @caseymross About the Author Reprints What is it? What’s included? Log In | Learn More GET STARTED By Casey Ross March 19, 2021 Reprintslast_img read more

Three injured in shooting at family gathering in Homestead

first_imgHOMESTEAD, Fla. (AP) – Three people were injured when someone began shooting at a group gathered outside during a family event in Homestead on Sunday night.A police officer for the Miami-Dade County school system who was at the party returned fire, according to the Associated Press. A man was airlifted to a trauma center and two others were taken to Homestead Hospital. The man that was airlifted was reported to be in good condition, reported AP.Police said the officer was not injured. AdvertisementRecommended ArticlesBrie Larson Reportedly Replacing Robert Downey Jr. As The Face Of The MCURead more81 commentsGal Gadot Reportedly Being Recast As Wonder Woman For The FlashRead more29 comments Woman shot outside Naples Waffle House June 16, 2021 AdvertisementThe gunman ran from the area after opening fire around 9 p.m.The shooting is still being investigated. Two teens arrested in Cape Coral shooting investigation June 16, 2021 Deputies investigate overnight shooting in Golden Gate June 10, 2021 AdvertisementDC Young Fly knocks out heckler (video) – Rolling OutRead more6 comments’Mortal Kombat’ Exceeded Expectations Says WarnerMedia ExecutiveRead more2 commentsDo You Remember Bob’s Big Boy?Read more1 commentsKISS Front Man Paul Stanley Reveals This Is The End Of KISS As A Touring Band, For RealRead more1 commentscenter_img AdvertisementTags: Homesteadshooting RELATEDTOPICS Advertisement Ex-wife of Palm Beach Publix killer responds to sheriff’s criticism June 16, 2021 Advertisementlast_img read more

Overgrown weeds in Naples lake have some residents worried

first_imgAdvertisement AdvertisementDC Young Fly knocks out heckler (video) – Rolling OutRead more6 comments’Mortal Kombat’ Exceeded Expectations Says WarnerMedia ExecutiveRead more2 commentsDo You Remember Bob’s Big Boy?Read more1 commentsKISS Front Man Paul Stanley Reveals This Is The End Of KISS As A Touring Band, For RealRead more1 comments Advertisement“There was nothing here on this side of our property except for those little purple flowers,” Kathi Rambo saidNow, “It’s an eyesore for the city,” Kathi said, “Within the last two years, it has just completely encroached this part of the shoreline.”The couple worries the plants could be toxic. NAPLES, Fla. – A Naples lake once looking straight out of a postcard has transformed into a gardener’s nightmare. The lake sits along 7th Avenue North and Bougainvillea Road in the Olde Naples neighborhood. Neighbors worry these plants could be toxic.Neighbors said weeds growing around the lake haven’t always been there. In just a couple of months, they have grown 10 to 12 feet, and they want it to stop before it takes over their backyard getaway.Kathi and Larry Rambo said when they bought their property 11 years ago, it was for the lake. Over the years, it became their personal sanctuary. Sea turtle caught on camera nesting on Naples beach June 16, 2021 Naples soldier facing charges for wife’s murder June 16, 2021 RELATEDTOPICS “This can’t be good for the fish,” Kathi said, “We can’t get anyone to really give us any answers here.”Ken Baker, an aquatic consultant for The Lake Doctors Inc. said from the surface, “I think there’s alligator weed, primrose, and I think there were a couple of Brazilian Peppers in there. They’re not dangerous per se.”Baker said it could be a different story underneath. “… harbor snakes and those things up on the banks, you could have rats in there and things like that,” Baker said. “…you have to maintain it. Because in Florida, things just grow really quickly, and you need some sort of maintenance program.”Greg Strakaluse, director of Streets & Stormwater Management with the City of Naples said they are working on a revamped maintenance program. Right now, looking over contractor bids to get the job done. Other residents like Lorraine Lonergan said the vegetation adds character to the lake. “From my viewpoint, it’s fine,” Lonergan said, “I think it’s beautiful.” She said she is utting her trust in the city to make the right call. “Whichever is better for the lake I guess is what we should have,” Lonergan said. The city said they will first treat the area lining 7th Avenue North. Then they will ask neighbors whether they want the vegetation along their properties treated. Advertisement AdvertisementRecommended ArticlesBrie Larson Reportedly Replacing Robert Downey Jr. As The Face Of The MCURead more81 commentsGal Gadot Reportedly Being Recast As Wonder Woman For The FlashRead more29 comments Woman shot outside Naples Waffle House June 16, 2021 Study ranks Naples as best beach town in America to live June 16, 2021 AdvertisementTags: napleslast_img read more