ag How Can Congress Agree to Appropriations for FY 21? By strengthenfda.org Published On :: Fri, 24 Apr 2020 17:35:23 +0000 Q: Congress must act on FY 21 appropriations. What are the possible ways for Congress to address this? A: Congress must decide if they will do substantive work on the 12 appropriations bills with the goal of passing full-year funding bills before October 1. One alternative would be to fund the beginning of the fiscal year […] Full Article Analysis and Commentary appropriation cap Congress continuing resolution
ag New Bipartisan ChiPACC Act Provides Better Medicaid Coverage to Children in Need By childhoodcancer-mccaul.house.gov Published On :: Fri, 27 Jul 2018 04:00:00 +0000 WASHINGTON, D.C. – Five lawmakers introduced a bipartisan bill giving a full range of medical services to families with children who have life-limiting illnesses and who qualify for Medicaid, which currently has gaps in such coverage. The Children’s Program of All-Inclusive Coordinated Care (ChiPACC) Act (H.R. 6560) would let states create comprehensive care programs for these children. Its authors are the Co-Chairs of the Congressional Childhood Cancer Caucus: Representatives Michael McCaul (R-TX), Jackie Speier (D-CA), G.K. Butterfield (D-NC), and Mike Kelly (R-PA), together with Representative Diana DeGette (D-CO), a senior member of the House Energy and Commerce Committee. “Families with children facing life-limiting illnesses need all the support they can get, and they should be empowered to seek out that support,” the bill’s sponsors said in a joint statement. “We owe it to these kids and their loved ones to help ensure more compassionate care in their most trying times.” Gaps in Medicaid coverage of hospice and palliative services have deprived many beneficiaries of the care they need because the program does not cover some of children’s unique medical needs. Under this bill, the family of every child who qualifies for Medicaid will receive a specialized care plan covering a range of services – palliative, counseling, respite, expressive therapy and bereavement – providing them and their families greater comfort and peace of mind. ### Full Article
ag Mogrify and Sangamo in license agreement for ‘off-the-shelf’ CAR-Treg By www.biopharma-reporter.com Published On :: Thu, 23 Apr 2020 12:16:00 +0100 Sangamo plans to utilize Mogrifyâs cell conversion technology to develop CAR-Treg cell therapies. Full Article Bio Developments
ag Takeda agrees license to strengthen plasma pipeline By www.biopharma-reporter.com Published On :: Mon, 27 Apr 2020 14:53:00 +0100 Takeda in global licensing agreement with ProThera to develop plasma-based therapies for inflammatory conditions. Full Article Markets & Regulations
ag AskBio buys BrainVectis for early-stage gene therapies By www.biopharma-reporter.com Published On :: Mon, 27 Apr 2020 15:00:00 +0100 AskBio acquires gene therapy biotech working on treatments for neurodegenerative disorders. Full Article Markets & Regulations
ag Alexion in $1.4bn buyout for reversal agent By www.biopharma-reporter.com Published On :: Thu, 07 May 2020 14:42:00 +0100 Alexion agrees deal for Portola to gain access to its lead product, Andexxa, a treatment that counteracts anticoagulants. Full Article Markets & Regulations
ag The Language of “Recovery” in the Age of COVID-19 By eyeonfda.com Published On :: Wed, 22 Apr 2020 12:02:16 +0000 There have been many parallels drawn between this pandemic and the AIDS pandemic that began in 1981. And in fact while many obvious differences exist there are many valid comparisons. Moreover, there are some common threads that run through crises … Continue reading → Full Article COVID19
ag “Similar to Times of War”: The Staggering Toll of COVID-19 on Filipino Health Care Workers By tracking.feedpress.it Published On :: 2020-05-03T05:00:00-04:00 by Nina Martin and Bernice Yeung ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. When Alfredo Pabatao told his family that he had helped move a suspected coronavirus patient through the hospital where he’d worked as an orderly for nearly 20 years, he didn’t make a big deal out of it. “My parents are the type of parents who don’t like to make us worry,” his youngest daughter, Sheryl, recalled. But Sheryl was concerned that her father’s vulnerabilities weren’t being given more consideration as he toiled on the pandemic’s front lines in hard-hit northern New Jersey. “Why would they let a 68-year-old man with an underlying heart condition … transport a suspected COVID patient when there’s younger transporters in the hospital who could do it?” Sheryl’s mother, Susana, was an assistant nurse in a long-term care facility where she often pulled double shifts, saving money for her annual trips back to the Philippines. At 64, she wasn’t much younger than the elderly patients she helped bathe and feed, and she had diabetes, which increased her risk of severe complications if she got sick. The nursing home wasn’t providing adequate personal protection equipment, Susana reported, so Sheryl brought home a stash of surgical masks for her mother to wear on the job. That didn’t go over well with Susana’s managers, Sheryl said: “They gave her a warning, saying she shouldn’t be wearing that. … She was really mad.” Alfredo fell ill first, his symptoms flaring on March 17. Susana soon developed a fever. The couple had grown up on the same street in Manila and shared a romance that reminded their daughter of a telenovela; after 44 years of marriage and five children, they were all but inseparable. “Where mom goes, my dad goes. Where my dad goes, my mom goes. That’s the way they are,” Sheryl said. The day Alfredo was admitted to the ICU, his heart failing, Susana checked into the same hospital. They died four days apart. Filipino American medical workers have suffered some of the most staggering losses in the coronavirus pandemic. In the New York-New Jersey region alone, ProPublica learned of at least 30 deaths of Filipino health care workers since the end of March and many more deaths in those peoples’ extended families. The virus has struck hardest where a huge concentration of the community lives and works. They are at “the epicenter of the epicenter,” said Bernadette Ellorin, a community organizer. Some of the largest Filipino enclaves on the East Coast are in the New York City borough of Queens and northern New Jersey — the very places now being ravaged by COVID-19. Filipinos are on the front lines there and across the country, four times more likely to be nurses than any other ethnic group in the U.S., experts say. In the New York-New Jersey region, nearly a quarter of adults with Filipino ancestry work in hospitals or other medical fields, a ProPublica analysis of 2017 U.S. census data found. The statistic bears repeating: Of every man and woman in the Filipino community there, one in four works in the health care industry. “So many people can rattle off five, 10 relations that are working in the medical field,” said filmmaker Marissa Aroy, whose most recent documentary is about Filipino nurses. Her parents were registered nurses in California, and various relatives are in health care professions, including a cousin who works in a rehab center in the Bronx and recently recovered from COVID-19. “Think about all of those family members who are going to be affected,” Aroy said. “We’re talking about huge family structures here.” The scale of the trauma and the way it is unfolding are “similar to times of war,” said Kevin Nadal, a professor of psychology at John Jay College of Criminal Justice and The Graduate Center of the City University of New York who has written extensively about Filipino American psychology and culture. Pabatao lights a candle for her parents’ urn. (Rosem Morton, special to ProPublica) The majority of the reported deaths have involved nurses, including Susan Sisgundo and Ernesto “Audie” DeLeon, who worked at Bellevue Hospital in New York City, and Marlino Cagas, who spent 40 years as a pharmacy tech at Harlem Hospital before embarking on a nursing career at the age of 60. A handful, including Jessie Ariel Ferreras, a family practitioner in Bergen County, were doctors. Others worked in support roles, like Louis Torres, 47, the director of food services at a nursing home in Woodside, Queens, and his 73-year-old mother, Lolita, or Lely, a clerk at a nearby hospital. They lived together and fell sick around the same time, both developing pneumonia. Lolita died on April 7, her son, the following day. Don Ryan Batayola, a 40-year-old occupational therapist, was from a big, tight-knit family and lived in Springfield Township, New Jersey. He is believed to have caught the virus from a patient and was rushed to the hospital on March 31. By April 4, he had improved enough to FaceTime with his wife, also an occupational therapist who was sick and self-isolating at home, their children sheltering with relatives. Then, an hour later, he went into cardiac arrest. One of the most wrenching aspects of the epidemic is the sense of disconnection and helplessness in a community that stakes its economic well-being on providing care and comfort and cherishes its closeness. So many members of Batayola’s extended family are health care workers, “we could almost open our own hospital,” said his oldest sister Aimee Canton, an oncology nurse in Northern California. But to protect each other, they’ve had to remain apart, with no idea when they’ll be able to come together again. “It’s so sad when you’re a nurse,” Canton said, “and you can’t even help your own family.” Almost all the deaths of Filipino American health care workers that ProPublica found involve people, like the Batayolas, who immigrated during the 1970s to 2000s, when critical shortages created opportunities for medical personnel with the right training. But the story of Filipino nurses in the U.S. goes back much further, to the end of the Spanish-American War in 1898, when the Philippines became a U.S. territory, said Catherine Ceniza Choy, a professor of ethnic studies at the University of California, Berkeley, and author of “Empire of Care: Nursing and Migration in Filipino American History.” One legacy of the colonial era is a network of hundreds of Americanized nursing schools that eventually produced tens of thousands of caregivers a year, making the country “the leading exporter of nurses in the world,” Choy said. Nursing offered an escape route from economic and political instability and a path to the middle class for those who had few other options. It also appealed to deeply held cultural values: “kapwa,” Tagalog for “a feeling of interconnectedness to all people, putting others before yourself and taking care of the community,” Nadal said, and “utang ng loob,” the idea that people owe a debt to each other and to those who came before. Most nurses trained in the Philippines who sought work abroad hoped to end up in the U.S. (They also migrated in large numbers to the Middle East and the U.K.) American immigration policies ebbed and flowed depending on labor shortages and political expediency. In the first third of the 20th century, the numbers of Filipino nurses were small; most workers from the islands were sent to the fields of California and the plantations of Hawaii. Then, in the wake of the Great Depression, Filipino immigrants were capped at just 50 per year, rising to 100 after World War II. After the war, U.S. nursing shortages grew acute. Even as the passage of Medicare and Medicaid made health care more accessible to the elderly and poor, the rise of the feminist movement, which opened up professional opportunities for American women, made caregiver work less appealing, Choy said. The Immigration Act of 1965 swept aside the long-standing system of country-based quotas, instead giving preference to immigrants with professional degrees. Tens of thousands of Filipino nurses answered the call. Caregivers on the Front Lines The scale of losses among Filipino Americans from COVID-19 is only beginning to sink in. Clockwise from top left: Don Ryan Batayola, an occupational therapist; Alfredo Pabatao, a hospital orderly; Susan Sisgundo, a neonatal ICU nurse; Ernesto “Audie” DeLeon, a hospital nurse; Susana Pabatao, a long-term care nurse; Daisy Doronila, a correctional facility nurse. Clockwise from top left: Courtesy of Aimee Canton, courtesy of Sheryl Pabatao, courtesy of New York State Nurses Association (both Sisgundo and DeLeon), courtesy of Sheryl Pabatao, courtesy of Denise Rendor. Many ended up at inner-city and rural hospitals that had the greatest difficulty recruiting staff, often working the least desirable jobs and shifts, including, in the 1980s and ’90s, on the front lines of the AIDS epidemic. It was part of a historical pattern, said Nadal, of “immigrants doing a lot of the dirty work that people don’t want to do... being painted as heroes, when in reality they are only put in these positions because their lives are viewed as disposable.” Yet it was a template for economic security that many of their American-born children and grandchildren embraced. “It’s like any kind of family dynamic,” Aroy said. “You see your parents do the job. And so then you know that that’s accessible to you. As a second- generation kid, I always knew that was a path for me if I wanted it.” Today, people of Filipino ancestry comprise about 1% of the U.S. population but more than 7% of the hospital and health care workforce in the United States — nearly 500,000 workers, according to census data. They find themselves fighting not just a potentially lethal illness, but the scapegoating stoked by President Donald Trump and supporters who have taken to calling COVID-19 the “Chinese virus.” Since late March, civil rights organizations have received nearly 1,500 reports of anti-Asian hate incidents, mostly from California and New York, including against Filipino Americans. “This anti-Asian racism that’s happening right now,” Aroy said, “what it makes me want to do is scream out: ‘How dare you treat us like the carriers? We are your caregivers.’” A host of factors, from medical to cultural, have put large numbers of Filipinos in harm’s way and made them vulnerable to the types of severe complications that often turn deadly. They begin with the specific type of health care work they do. A survey by the Philippine Nurses Association of America published in 2018 found that a large proportion of respondents were concentrated in bedside and critical care — “the opposite of social distancing,” said executive director Leo-Felix Jurado, who teaches nursing at William Paterson University in Wayne, New Jersey. Many of the organization’s members have contracted the virus, he said, including the current president, New Jersey-based registered nurse Madelyn Yu; she is recovering, but her husband died. For Daisy Doronila, employed at the Hudson County Correctional Facility in northern New Jersey for more than two decades, the profession was almost a religious calling. “My mom had a very, very humble beginning,” said her only child, Denise Rendor. “She really wanted to take care of people that no one wanted to take care of.” Doronila saw her responsibilities to her colleagues no less seriously. The single mother and devout Catholic “was always the most reliable person at the job,” Rendor said. “If there was a snowstorm, people called out, nope, not her: ‘I’ll be there.’” As a kid, Rendor sometimes resented the missed volleyball games and dance recitals. Looking back now, “I don’t think I would have the life that I had had my mom not worked so hard.” It’s not clear how Doronila contracted the virus, though the Hudson County jail has had at least four deaths. Once she fell ill in mid-March, she was turned away for testing by clinics and doctors on three occasions because her symptoms didn’t meet the criteria at the time, Rendor said. On March 21, Doronila started feeling breathless and drove herself to urgent care, which sent her by ambulance to the hospital. She died on April 5 at the age of 60. If she hadn’t gotten sick, Rendor is sure she would have been volunteering for extra shifts. “That’s just who my mother was. She was just always willing to help.” That selflessness is common among Filipino immigrants, said Zenei Cortez, a registered nurse in the San Francisco Bay Area who is the president of the California Nurses Association/National Nurses United. “They have such a profound willingness to work that they would forget their own well-being,” she said. “They would think of their loved ones in the Philippines — if they don’t work, then they can’t send money back home.” In 2019, Filipinos abroad sent $35 billion back to the Philippines, making it the fourth-largest recipient of overseas remittances in the world; many are also helping to support networks of relatives in the U.S. “That’s the economic factor that is on the minds of a lot of Filipino nurses,” Cortez said. “If we miss work, there will be no income.” It’s a worry that keeps many Filipinos doing sometimes-grueling labor well into their 70s. Doronila’s colleague at the Hudson County jail, nurse Edwin Montanano, was 73 when he died in early April. Jesus Villaluz, a much-beloved patient transporter at Holy Name Medical Center in Teaneck, one of the worst-hit hospitals in northern New Jersey, was 75. “They cannot in their conscience walk away from patients who need them,” said Maria Castaneda, a registered nurse and the secretary-treasurer of 1199SEIU United Healthcare Workers East, who immigrated from the Philippines in 1984. “At the same time, they are there in solidarity with other co-workers. If they are not there, it adds to the burden of those who are working.” COVID-19 risks are magnified in people who are older or suffer underlying chronic conditions. Filipinos have very high rates of Type II diabetes and cardiovascular disease, both of which render the virus more dangerous. “They’re doing amazing things and helping others to survive,” Nadal said. “But they’re putting themselves at risk because they have immuno-compromised traits that make them susceptible to severe sickness and death.” And in many situations, they’ve been forced to do that work without proper PPE and other safeguards, said Ellorin, the Queens-based community organizer and executive director of the advocacy group Mission to End Modern-Day Slavery. They are “being infected and not being protected, and then their families, or whoever they live with, are getting infected.” Sheryl Pabatao thinks of the many people she knows who are working in hospitals and other medical settings and feel unable to speak out. “Even though they don’t want to do things, they still do it because they don’t want to lose their jobs.” When they first applied to immigrate to the U.S. in the 1980s, Alfredo Pabatao was in the car business; Susana was a former nursing student turned housewife and mother of two. By the time their petition was approved about 14 years later, their two eldest children were too old to qualify to come to the U.S. with their parents, so the Pabataos were forced to leave them behind, bringing only their youngest two daughters and son. “To this day, that was one of the hardest things — being separated from everyone,” Sheryl said. One of the few photos of Susana and Alfredo Pabatao and all five of their children. (Rosem Morton, special to ProPublica) They arrived in the U.S. a few weeks after 9/11. One of Alfredo’s sisters, a registered nurse, helped him get a job transporting patients at her hospital, now known as Hackensack Meridian Health Palisades Medical Center, in North Bergen, New Jersey. “My father grew up with wealth, and when he came here, he had to be modest and humble,” Sheryl said. Susana earned her assistant nursing certification while working as a grocery store cashier, then went to work at what is now called Bergen New Bridge Medical Center in Paramus, the largest hospital and licensed nursing home in the state. Taking care of elderly people helped ease the sadness and guilt at what she had left behind. “She was not able to take care of her own mother,” Sheryl said. “So when she does her job here, she cares for them like her own.” America proved to be both generous and hard. The couple prospered enough to buy a house, then lost it in the Great Recession. They managed to rebuild their lives and gained their U.S. citizenship, the kids choosing careers in the pharmaceutical side of health care. After 18 years in the same job, Alfredo was waiting for Susana to retire so he could, too. Then came the pandemic. Sheryl had been following the news reports from China since early February and was concerned enough about her family to procure a small supply of masks before vendors ran out; “I’d put my parents in a bubble if I can,” she said. Her father was more easygoing: “He has survived so many things in his life. His attitude is: ‘If I get it, I get it. I’ll be OK with it.’” Sheryl doesn’t know how the responsibility fell to him to transport a patient suspected of having COVID-19 during the second week in March. “But knowing my dad, he agrees to anything. He has that work ethic: ‘This is my job. If I can do it, l do it.’ Knowing him, if one of the other [orderlies] didn’t want to transfer the patient, they asked him and he said yes.” When Susana found out her husband had been exposed to the virus that way, she was not happy, Sheryl said. Susana was having her own issues at the nursing home. In mid-March, she received an email from her bosses that warned in boldface, “Facemasks are to be used only by staff who have an authorized or clinical reason to use them. Do not wear non-hospital issued facemasks.” It was a policy Susana complained was being made by people who weren’t doing bedside care and didn’t understand the real risks. She was also told the masks would scare patients. She pretended to obey the directive when her managers were around, Sheryl said, “but my mom was stubborn, so when they left, she put [her mask] back on.” Before she died, Susana gave her children a black notebook filled with the essential information they need to put their parents’ affairs in order. (Rosem Morton, special to ProPublica) Bergen New Bridge called Susana a “valued” employee who is “greatly missed.” The hospital denied that it has experienced any PPE shortages, but it noted that “guidance from federal and state health officials regarding the use of PPE has been evolving.” Early on, “it was recommended that masks were to be worn only by those individuals who were sick or those who were caring for COVID-19 patients.” Once the virus began spreading within the community, “we quickly moved to universal masking of all employees,” the hospital said. “Like all healthcare facilities, our Medical Center has stressed the importance of using hospital-issued PPE, as guided by the CDC.” As of April 29, New Bridge’s long-term care facility had recorded 120 confirmed COVID-19 cases and 26 deaths. Hackensack Meridian Health didn’t respond to ProPublica’s requests for comment about Alfredo’s case. It wasn’t just Alfredo and Susana who fell ill. Sheryl and her brother, both living at home, caught the virus, too. The weekend before Alfredo’s symptoms emerged, he and the rest of the family attended a gathering in honor of a relative who had died in January from cancer. Alfredo spent much of the party talking to his younger brother; later, the brother ended up with COVID-19 and on a ventilator for nearly three weeks. An aunt of Sheryl’s who is a housekeeper in the same hospital system as Alfredo wasn’t at the gathering but fell ill anyway and was out sick for two weeks. Her symptoms weren’t as severe as those of some of the others; she’s already back at work. The spread of the virus has been unrelenting for Sheryl. When she returned to her own job as a pharmacy tech this past week, a month after her parents died, she learned that someone who worked at her company — who was also Filipino — had died during her absence. “You have no idea about the extent of this,” she said, “until it hits you.” Sophie Chou contributed reporting. Correction, May 5, 2020: This story originally misspelled the first name of the president of the California Nurses Association/National Nurses United. She is Zenei Cortez, not Zeine. Correction, May 5, 2020: This story originally misspelled the first name of the president of the California Nurses Association/National Nurses United. She is Zenei Cortez, not Zeine. Full Article
ag ProPublica and Local Reporting Partner Anchorage Daily News Win Pulitzer Prizes for National Reporting and Public Service By tracking.feedpress.it Published On :: 2020-05-04T15:18:00-04:00 by ProPublica ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. The Pulitzer Board announced Monday that two series published by ProPublica were awarded Pulitzer Prizes. “Lawless,” a ProPublica Local Reporting Network project by the Anchorage Daily News that revealed how indigenous people in Alaska are denied public safety services, was awarded the prize for public service. “Disaster in the Pacific,” an investigation on the staggering leadership failures that led to deadly accidents in the Navy and Marines, won a national reporting prize. The two designations are ProPublica’s 6th Pulitzer win in 12 years and the first Pulitzer awarded to a Local Reporting Network partner. Led by Daily News reporter Kyle Hopkins, “Lawless” was the first comprehensive investigation to lay bare Alaska’s failing, two-tiered justice system in which Native villages are denied access to first responders. In much of rural Alaska, villages can only be reached by plane, and calling 911 to report an emergency often means waiting hours or days for help to arrive. The series evolved from a string of stories that Hopkins reported in 2018 for the Daily News, recounting horrific incidents of sexual assault in Alaska — which has the nation’s highest rate of sexual violence — and policing failures that have allowed offenders to continue the abuse with impunity. To fully investigate issues of lawlessness and sexual assault in the most remote communities in the U.S., the Daily News applied to participate in ProPublica’s Local Reporting Network. The program partners with newsrooms across the country, paying the salary and a stipend for benefits for local reporters who spend a year tackling big investigative stories that are crucial to their communities. Participating reporters work with a ProPublica senior editor and receive support, including from ProPublica’s data, research and engagement teams. The collaboration’s first story, based on more than 750 public records requests and interviews, found that one in three rural Alaska communities has no local law enforcement of any kind. These indigenous communities are also among the country’s most vulnerable, with the highest rates of sexual assault, suicide and domestic violence. The series’ second major installment found that dozens of Alaska communities, desperate for police of any kind, hired officers convicted of felonies, domestic violence, assault and other offenses that would make them ineligible to work in law enforcement or even as security guards anywhere else in the country. Next, Hopkins revealed how the state’s 40-year-old Village Public Safety Officer Program, designed to recruit villagers to work as life-saving first responders, has failed by every measure. Alaska had quietly denied funding for basic recruitment and equipment costs for these unarmed village officers while publicly claiming to prioritize public safety spending. “Lawless” also exposed how the Alaska State Troopers agency, created to protect Alaska Native villages, instead patrols mostly white suburbs surrounding cities on the road system like Wasilla. The series ended with a list of six practical solutions to Alaska’s law enforcement crisis, based on interviews with experts, village leaders, the Alaska congressional delegation and sexual assault survivors. The Daily News and ProPublica faced a number of challenges in reporting the series. The first: No one knew which remote Alaska villages had police officers of any kind. So they built the first-ever statewide policing database by drawing on payroll, arrest and hiring records from communities spread across the state. They also contacted every village city government, sovereign tribal administrator and Alaska Native corporation in the state — more than 600 organizations. The vastness of the state and the fact that 80% of communities aren’t on the road system posed another challenge. Journalists flew hundreds of miles, sleeping on the floors of schoolhouse libraries and riding in sleds and on snowmobiles. To aid the reporting, they also held a community meeting in Kotzebue, Alaska, where a 10-year-old girl had been raped and murdered in 2018, providing residents, advocates, tribal leaders and law enforcement their first chance for a public discussion on sexual violence. Throughout the year the reporters spoke to more than 300 people across the state. Following publication of the first major story, U.S. Attorney General William Barr visited the state and declared the lack of law enforcement in rural Alaska to be a federal emergency. The declaration led the Department of Justice to promise more than $52 million in federal funding for public safety in Alaska villages. The U.S. Attorney’s Office in Anchorage announced the hiring of additional rural prosecutors, while Gov. Mike Dunleavy said the state will post 15 additional state troopers in rural Alaska. In addition, the Alaska Police Standards Council has proposed changing state regulations that govern the hiring and screening of village police officers, and Alaska legislators proposed legislation that would increase pay for VPSOs and overhaul funding of the program. The Daily News’ Loren Holmes, Bill Roth, Marc Lester, David Hulen, Anne Raup, Vicky Ho, Alex Demarban, Jeff Parrott, Michelle Theriault Boots, Tess Williams, Tegan Hanlon, Zaz Hollander, Annie Zak, Shady Grove Oliver and Kevin Powell, as well as ProPublica’s Charles Ornstein, Adriana Gallardo, Alex Mierjeski, Beena Raghavendran, Nadia Sussman, Lylla Younes, Agnel Philip, Setareh Baig and David Sleight also contributed to the series. “The ProPublica Local Reporting Network was started to give local newsrooms across America the resources and support they need to execute investigative journalism that digs deep and holds power to account,” Ornstein, a ProPublica deputy managing editor, said. “This powerful collaboration with the Anchorage Daily News investigation does exactly that, going far beyond reporting on isolated incidents to provide meticulous research and context on how the justice system has failed Alaska’s most remote and vulnerable communities. Most importantly, it has been a force for real change.” In their “Disaster in the Pacific” series, ProPublica reporters T. Christian Miller, Megan Rose and Robert Faturechi centered on three deadly accidents in the Navy and Marines in 2017 and 2018. They exposed America’s vaunted 7th Fleet as being in crisis with broken ships and planes, poor training for and multiple warnings ignored by its commanders. The costs: 17 dead sailors in crashes involving Navy warships, and six Marines killed in a training accident. The back-to-back accidents in 2017 and 2018 gained initial attention from Congress and the national media, but they had been told an incomplete, misleading and dangerous story of half-truths and cover-ups. ProPublica’s series provided the first full accounting of culpability, tracing responsibility to the highest uniformed and civilian ranks of the Navy. The reporting team spent 18 months on the investigation, obtaining more than 13,000 pages of confidential Navy records and interviewing hundreds of officials up and down the chain-of-command. The first article in the series, “Fight the Ship,” reconstructed a 2017 crash involving the USS Fitzgerald, one of the deadliest accidents in the history of the Navy. The story showed that the accident was entirely preventable, and that the Navy’s senior leadership had endangered the warship by sending a shorthanded and undertrained crew to sea with outdated and poorly maintained equipment. To show readers what happened, ProPublica hired designer Xaquín G.V. Working with investigations producer Lucas Waldron, Xaquín used geodata on the ships’ locations, mapped the path of each vessel and created a graphic that simulated the crash, down to the moment the Fitzgerald was sent spinning out of control, rotating 360 degrees. The team also collected radar images, ship blueprints, hand-drawn images made by surviving sailors and video taken inside the ship, which allowed them to portray the disaster from the perspective of the sailors onboard. A second story, “Years of Warnings, Then Death and Disaster,” detailed how the fatal crash of the USS Fitzgerald, and of the USS McCain weeks later, were the result of a congressional gutting of the Navy and the Navy’s prioritization of building new ships. Top Navy officials gave urgent, repeated warnings to Navy Secretary Ray Mabus about the deadly risks facing its fleet, including being short of sailors, sailors poorly trained and worked to exhaustion, warships physically coming apart, and ships routinely failing tests to see if they were prepared to handle warfighting duties. They were ignored, told to be quiet or even ordered to resign. Another story captured the Marine Corps multiple failures that were responsible for the deaths of six men in a nighttime training exercise 15,000 feet above the Pacific — an accident that senior leaders had been warned was possible, even likely. ProPublica created an animated short documentary, using a combination of an on-camera interview, 3D animation, 2D illustration and atmospheric footage to bring the excruciating hours of a needless tragedy to light. Through extensive interviews with eyewitnesses, the team reconstructed the moments leading up to the crash, the crash itself and the botched search and rescue effort. The series also illuminated how the Navy’s reckless management of the 7th Fleet was measured not only in fatalities, but also in the hurt and shame of the rank-and-file sailors whom the Navy blamed and prosecuted for the accidents. The Navy’s prosecution of Navy Cmdr. Bryce Benson for what were clearly systemic shortcomings, traceable all the way to the Pentagon, left many of its own furious and demoralized. Weeks after the first story’s publication, the House Armed Services Committee convened a panel to challenge senior Navy leaders over their claims that they had been fully truthful about its failings and its efforts at reform. The reporting forced the Navy to admit to Congress that its claims about its rate of progress on reform were misleading. In light of ProPublica’s reporting on the improper role that the Navy’s top commander played in the prosecution of Benson, one of captains on the USS Fitzgerald, the Navy dropped all criminal charges. U.S. and NATO Navy commands throughout the world have ordered sailors and officers to read the ProPublica accounts as part of training and education. Joseph Sexton, Tracy Weber, Agnes Chang, Katie Campbell, Joe Singer, Kengo Tsutsumi, Ruth Baron, David Sleight, Sisi Wei, Claire Perlman, Joshua Hunt and Nate Schweber also contributed to this series. “The Navy actively blocked reporting at every step, with communications officers attempting to dissuade officials from conducting interviews with ProPublica and leaking positive stories to competing media outlets in an attempt to front-run our stories,” ProPublica Managing Editor Robin Fields said. “The military even threatened that we could be criminally prosecuted for publishing the material we obtained. This tour de force of investigative journalism is a testament to the unflinching tenacity of the reporters and the innovation of ProPublica’s data, graphics, research and design teams. Their essential work laid bare the avoidance of responsibility by the military’s most senior leaders.” Full Article
ag 2020 CDER Guidance Agenda Released By regulatoryrx.blogspot.com Published On :: Mon, 03 Feb 2020 14:54:00 +0000 UPDATE: The guidance mentioned below was released. Here's the link.The FDA has released the CDER Guidance Agenda. For ad-promo professionals, the most most significant item is the inclusion of an item labeled:Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products--Questions and Answers Also notable is that no other advertising or promotional guidances are listed. The draft guidance on presenting risk information turned 10 years old last year. It seemed ripe for an update and perhaps even finalization. That seemed even more likely in the context of OPDP's study of the so-called one-click rule. That study was first announced in 2017. There's no update on the FDA website about the study, but I expected it to be completed last year.FDA's social science research has clearly been influencing recent guidances, so I assumed (and continue to assume) that FDA would want to update the risk presentation guidance in light of its most recent research about presenting risks, including the one-click study. Apparently, we'll have to keep waiting.BTW, for those interested in the topic of biosimilar promotion, the Drug Information Association's Advertising & Promotion Regulatory Affairs Conference will have a session covering this topic. Full disclosure: I sit on the programming committee for the conference and will be leading the medical device primer the day before the full conference kicks off. Full Article biosimilars CDER DIA Guidance Guidance Agenda OPDP
ag COVID-19 Outbreak Pausing Live Speaking Engagements By regulatoryrx.blogspot.com Published On :: Fri, 20 Mar 2020 17:26:00 +0000 I live in Pennsylvania, just outside Philadelphia, in Montgomery County. Currently, Montco is the worst hit county in Pennsylvania for the COVID-19 outbreak. Consequently, the governor ordered all non-essential businesses to close more than a week ago in Montco, and yesterday expanded that order statewide.Because most of my work is from home, the outbreak has not yet affected my ability to provide client service; however, for the foreseeable future all live speaking engagements are cancelled.I was scheduled to deliver the device workshop at DIA advertising conference last week and also had some workshops scheduled with FDAnews for May and June. DIA's conference was been delayed with a decision about how to proceed still to be determined. I'll post an update here when I know more.The May FDAnews workshop has been cancelled, and the June workshop is on hold. When I know more, I'll post an update.In addition, I am part of the leadership committee for the Philadelphia RAPS chapter. We held our last event on March 5 at Temple University, and the next day, RAPS HQ sent out a notice asking chapters to hold off on live meetings for March and April. Currently, the chapter leadership is discussing other options, such as webinars to continue getting information to our membership during the outbreak.While we adjust to life during a pandemic, I'll provide updates as I can. Stay safe and wash your hands! Full Article COVID-19 DIA FDAnews RAPS
ag Manufacturers report 'sporadic' resupply of sertraline following COVID-19 related shortage By feeds.pjonline.com Published On :: Fri, 24 Apr 2020 16:32 GMT Supplies of the selective serotonin reuptake inhibitor, sertraline, are returning to stock after manufacturers reported “industry-wide” supply challenges, exacerbated by export bans and border closures implemented as a result of COVID-19. To read the whole article click on the headline Full Article
ag Manufacturer to move hydroxychloroquine production to the UK to avoid shortages By feeds.pjonline.com Published On :: Tue, 5 May 2020 15:41 GMT A manufacturer has announced plans to move production of hydroxychloroquine — currently being trialled as a COVID-19 treatment — to the UK from abroad to combat potential shortages. To read the whole article click on the headline Full Article
ag Emergency Relief Package Yields Increased FDA Funding, OTC Revisions By cohealthcom.org Published On :: Mon, 30 Mar 2020 16:04:19 +0000 March 30, 2020 – In addition to providing millions of Americans and many industries with financial support during the coronavirus outbreak, the emergency relief bill passed by Congress and signed into law by President Donald Trump on Friday accrues additional funding for the Food and Drug Administration’s coronavirus efforts and makes important changes to how […] Full Article Legislative Congress Coronavirus COVID-19 emergency relief fda funding Jon Bigelow OTC regulation OTC user fees President Trump sunscreen
ag Oberland Capital nabs $1.05B raise for late-stage plays, handing out cash for royalties By www.fiercebiotech.com Published On :: Tue, 05 May 2020 10:29:40 +0000 Come on in, the water’s warm. After billions already raised by VC firms since the advent of the pandemic for life science companies, Oberland Capital has tossed more than $1 billion into the pot. Full Article
ag Could Sanofi and Regeneron's Dupixent also treat age-related macular degeneration? By www.fiercebiotech.com Published On :: Thu, 07 May 2020 10:57:05 +0000 Sanofi and Regeneron’s Dupixent has become a popular treatment for atopic dermatitis and asthma. Now, a research team in Japan has discovered that IL-4 and its receptor—which Dupixent inhibits—could be promising targets for treating the eye disease age-related macular degeneration. Full Article
ag First coronavirus, now 'murder hornets'? 'The Simpsons' predicts the future again By www.latimes.com Published On :: Thu, 7 May 2020 14:18:01 -0400 Bill Oakley, a writer on "The Simpsons," admitted on Twitter that perhaps the animated TV show did forecast some of our troubling current events. Full Article
ag The Check-In: Justin Turner unsettled at thought of not playing again for the Dodgers By www.latimes.com Published On :: Thu, 7 May 2020 15:01:18 -0400 The Dodgers' Justin Turner and his wife Kourtney have delivered more than 500,000 meals to the needy since March. He'll be a free agent this winter. Full Article
ag 'A wild ride': Expanding coronavirus testing takes center stage with reopening By www.latimes.com Published On :: Thu, 7 May 2020 18:23:11 -0400 Until millions of Americans can be tested weekly for coronavirus, states will walk blindly into restarts. But NIH director has a plan to ramp up. Full Article
ag Protesters stage illegal rally at California Capitol to support law enforcement By www.latimes.com Published On :: Thu, 7 May 2020 20:05:42 -0400 Protesters of California's stay-at-home orders returned for another unsanctioned rally Thursday, telling law enforcement officers they are forgiven for arresting them last week. Full Article
ag Letters to the Editor: Old Americans shouldn't have to prove their value to combat ageism By www.latimes.com Published On :: Fri, 8 May 2020 06:00:18 -0400 The idea that old people are worth something because they contribute significantly to society puts us on a slippery slope. Full Article
ag Op-Ed: We allowed coronavirus to ravage nursing homes. But there's still time to save lives By www.latimes.com Published On :: Fri, 8 May 2020 06:00:22 -0400 Nursing facilities account for a large percentage of COVID-19 deaths. Better protection and testing can change that. Full Article
ag L.A. traffic is starting to pick up again, and travel speeds are slowing down By www.latimes.com Published On :: Fri, 8 May 2020 13:43:27 -0400 California reopening: Traffic volume is steadily creeping up, and travel times are getting longer. Full Article
ag Hold the Champagne: Pandemic, recession fears hammer traditional European products By www.latimes.com Published On :: Fri, 8 May 2020 14:49:10 -0400 A looming recession due to the coronavirus imperils Champagne, buffalo mozzarella and other European delicacies. They're luxuries, but also livelihoods. Full Article
ag Trump's new 2020 message — it's not my fault By www.latimes.com Published On :: Fri, 8 May 2020 17:35:26 -0400 With the economy in free fall and deaths still rising from the coronavirus crisis, President Trump argued Friday that voters shouldn't hold him responsible. Full Article
ag 'Chinese virus' and other COVID-19 racism have designers, stylists of Asian heritage pushing back By www.latimes.com Published On :: Fri, 8 May 2020 19:20:44 -0400 Enough is enough, says a growing number of creatives from the fashion industry, including designer Kimora Lee Simmons, stylist Jeanne Yang and designer Prabal Gurung. Full Article
ag Letters to the Editor: The agony of having family in locked-down nursing homes By www.latimes.com Published On :: Sat, 9 May 2020 06:00:34 -0400 If nursing homes will remain closed until a COVID-19 vaccine is available, there will be no family visits for more than a year. That's intolerable. Full Article
ag Pharmacy Compounders Practicing Pursuant to Section 503A Can Get in the Mix: Compounding Shortage Drugs for Hospital Patients, with Some Limitations By feedproxy.google.com Published On :: Wed, 22 Apr 2020 01:35:08 +0000 By Karla L. Palmer — Full Article COVID19 Prescription Drugs and Biologics
ag Swift Enforcement Against COVID Fraudsters By feedproxy.google.com Published On :: Fri, 01 May 2020 01:35:23 +0000 By Anne K. Walsh & Charles D. Snow* — Full Article Advertising and Promotion (Federal Trade Commission) Advertising and Promotion (OPDP) COVID19 Enforcement
ag These are the most dangerous jobs you can have in the age of coronavirus By www.nbcnews.com Published On :: Fri, 08 May 2020 23:34:48 GMT For millions of Americans, working at home isn't an option. NBC News identified seven occupations in which employees are at especially high risk of COVID-19. Full Article
ag Tesla insists Shanghai production stoppage 'normal' By asia.nikkei.com Published On :: Full Article
ag Trump and Biden use antagonism against Beijing to win votes By asia.nikkei.com Published On :: Full Article
ag Yokogawa Awarded Plant Simulation Project by PUB, Singapore's National Water Agency By www.yokogawa.com Published On :: 2019-10-28T16:00:00+09:00 Yokogawa Electric Corporation (TOKYO: 6841) announced today that its subsidiary, Yokogawa Engineering Asia, has been awarded a contract from PUB, Singapore's National Water Agency, to develop a plant simulation system for the Lower Seletar Waterworks, a 60 million gallons per day (mgd) water treatment facility in Singapore. This is part of PUB's continual investments in innovation and R&D to ensure a safe and sustainable water supply for Singapore. Full Article
ag Yokogawa Releases Plant Resource Manager (PRM) R4.03, a Software Package in the OpreX Asset Management and Integrity Family By www.yokogawa.com Published On :: 2019-11-13T16:05:00+09:00 Yokogawa Electric Corporation (TOKYO: 6841) announces the November 14 release of Plant Resource Manager (PRM) R4.03, the latest version of a software package in the OpreX Asset Management and Integrity family that facilitates the monitoring and control of plant operations by centralizing the management of large volumes of data from instrumentation and manufacturing equipment. PRM R4.03 features powerful device diagnostic functions that help to optimize plant maintenance and ensure safe operations. Full Article
ag Yokogawa Signs Strategic Alliance Agreement with Saudi Basic Industries Corporation By www.yokogawa.com Published On :: 2019-12-26T16:00:00+09:00 Yokogawa Electric Corporation (TOKYO: 6841) announces that it has entered into a strategic alliance framework agreement to accelerate collaboration with Saudi Basic Industries Corporation (SABIC), ranked among the world's largest petrochemical manufacturers. The agreement includes selection of Yokogawa as a preferred supplier of control systems. Full Article
ag Yokogawa Releases Exaquantum R3.20 Plant Information Management System, a Software Package in the OpreX Asset Operations and Optimization Family By www.yokogawa.com Published On :: 2020-01-07T16:00:00+09:00 Yokogawa Electric Corporation (TOKYO: 6841) announces the release of Exaquantum R3.20, an enhanced version of its plant information management system (PIMS) software package in the OpreX Asset Operations and Optimization family. Full Article
ag Yokogawa Makes CDP Water Security A List and Supplier Engagement Leader Board By www.yokogawa.com Published On :: 2020-02-04T18:01:00+09:00 Yokogawa Electric Corporation (TOKYO: 6841) announces that it has made it onto CDP's Water Security A List and Supplier Engagement Leader Board. The A listing is for the company's sustainable water management practices and disclosure of information on these activities, and the selection to the leader board is for the company's leadership in engaging with its suppliers around the world to reduce carbon emissions and combat global warming. Full Article
ag Yokogawa Takes a Stake in All Polymer Battery Maker APB to Drive Expansion of Energy Management System Business By www.yokogawa.com Published On :: 2020-03-04T14:00:00+09:00 Yokogawa Electric Corporation (TOKYO: 6841) announces that it has acquired capital in APB Corporation (APB), a pioneer in the development of a next-generation lithium-ion battery called the “All Polymer Battery,” with the aim of growing Yokogawa’s energy management system (EMS) business. The two companies have agreed that Yokogawa will provide energy management technology needed for the efficient operation and optimization of large-scale storage batteries. Full Article
ag Yokogawa Acquires Danish Startup Grazper Technologies, Specialists in AI for Image Analytics By www.yokogawa.com Published On :: 2020-03-25T11:00:00+09:00 Yokogawa Electric Corporation (TOKYO: 6841) announces that on March 20, 2020, it completed the acquisition of all shares in Denmark-based Grazper Technologies ApS (Grazper), as mutually agreed. Grazper has developed advanced artificial intelligence (AI) technologies for analyzing images, and Yokogawa aims to leverage these technologies within its various existing businesses and to develop new industrial AI solutions. Full Article
ag Hitachi Capital, Yokogawa, and amnimo Enter into a Comprehensive Partnership Agreement for IIoT Business By www.yokogawa.com Published On :: 2020-03-26T11:00:00+09:00 On March 25, 2020, Hitachi Capital Corporation, Yokogawa Electric Corporation (TOKYO: 6841), and amnimo Inc., a subsidiary of Yokogawa, entered into a comprehensive partnership agreement with an aim to provide new services by adding Industrial IoT ("IIoT") to each company's technologies, know-how, and lease equipment. Full Article
ag Yokogawa Acquires Fluid Imaging Technologies, a Provider of Flow Imaging Particle Analysis Solutions By www.yokogawa.com Published On :: 2020-04-16T16:00:00+09:00 Yokogawa Electric Corporation (TOKYO: 6841) announces that on April 8, it completed the acquisition of all shares of Fluid Imaging Technologies, Inc., as mutually agreed. Full Article
ag Inhibition of the autophagic protein ULK1 attenuates axonal degeneration in vitro and in vivo, enhances translation, and modulates splicing By feeds.nature.com Published On :: 2020-04-27 Full Article
ag CD9 induces cellular senescence and aggravates atherosclerotic plaque formation By feeds.nature.com Published On :: 2020-04-28 Full Article
ag Live Imaging of Tumor Initiation in Zebrafish Larvae Reveals a Trophic Role for Leukocyte-Derived PGE2 By feeds.nature.com Published On :: Full Article
ag 2-Hydroxyoleate, a nontoxic membrane binding anticancer drug, induces glioma cell differentiation and autophagy By feeds.nature.com Published On :: Full Article
ag With Coronavirus, ‘Nature is sending us a message’, says UN Environment Chief By www.jagranjosh.com Published On :: 2020-03-27T13:28:00Z Prof Andrew Cunningham from the Zoological Society of London said, “The emergence of COVID-19 was not only predictable, but it was also predicted (in the sense that) there would be another viral emergence from wildlife that would be a public health threat.” Full Article
ag Explained: RBI’s Regulatory Package on COVID-19 Decoded: Loan Moratorium to Liquidity Injection By www.jagranjosh.com Published On :: 2020-03-27T14:37:00Z RBI's COVID-19 Regulatory Package: From Repo Rate & CRR Cuts to 3-months moratorium on term loans, RBI Governor Shaktikanta Das announced several measures while addressing the media after the release of Seventh Bi-monthly Monetary Policy Statement 2019-20. Full Article
ag PSMA PET–CT outperforms conventional imaging in high-risk prostate cancer By feeds.nature.com Published On :: 2020-05-05 Full Article
ag Treatment of peyronie’s disease with combination of clostridium histolyticum collagenase and penile traction therapy: a prospective, multicenter, single-arm study By feeds.nature.com Published On :: 2020-05-04 Full Article
ag Buyout major Carlyle searches for new managing director in India By www.dealstreetasia.com Published On :: Tue, 21 Apr 2020 13:55:43 +0000 Vikram Nirula, who joined in 2018 as managing director, will soon be leaving the company. The post Buyout major Carlyle searches for new managing director in India appeared first on DealStreetAsia. Full Article Carlyle