A Tennessee Bloods gang member was sentenced today to serve 10 years in prison, to be followed by three years of supervised release for his role in a violent racketeering conspiracy

Four members of the Two Six Nation street gang and four of their associates have been indicted for their roles in a racketeering conspiracy spanning more than 20 years, as well as murder and drug trafficking charges

The United States filed a complaint in federal court in Chicago to bar Laurie G. Helfer, aka Laurie G. Powell, individually and through her businesses Laurie’s Freelance & Tax Preparation Services and Tax Lady Laurie Inc., from preparing federal tax returns for others, the Justice Department announced today

A Maryland MS-13 gang member pleaded guilty today to conspiracy to participate in a racketeering enterprise known as the La Mara Salvatrucha, or MS-13, and acknowledged his involvement in attempted murder and extortion in furtherance of MS-13.

John Francis Mills, the owner of more than a dozen properties in Malone, New York, and Terrance Allen, the maintenance manager of Mills’ properties, were sentenced today by U.S. District Judge Thomas J. McAvoy to serve 21 months each in prison for conspiring to violate the Clean Air Act standards for the safe removal of asbestos.

A 26-year-old man from Newport News, Virginia, was sentenced today to serve 255 months in prison, followed by five years of supervised release, for engaging in numerous gang-related crimes as a member of the Black P-Stones, including the shooting of a rival gang member, marijuana dealing and lying to a federal grand jury.

An East Side Bloods (ESB) gang member from Scottsdale, Arizona, was sentenced late yesterday to serve 30 years in prison for his role in the violent street gang, which operated on the Salt River Pima-Maricopa Indian Community reservation.

Claude Arthur Verbal II, formerly of Raleigh, North Carolina, and now of Miami, was sentenced today to serve 135 months in prison for tax fraud, healthcare fraud and money laundering crimes in two separate cases in federal court

A former salesman at a prominent Los Angeles car dealership and another Southern California man were charged with odometer tampering, the Justice Department announced today.

A federal court in New Orleans has permanently barred Shawanda Nevers, of La Place, Louisiana, from preparing federal income tax returns for others, the Justice Department announced today.

A federal district judge in the U.S. District Court for the Middle District of Florida has permanently barred Jeanne Covington, of Tampa, Florida, and her company, Jeanne’s Tax Preparation and Bookkeeping Inc., from preparing federal income tax returns for others.

Remarks as prepared for delivery

Thank you, Buddy [Wilmer Parker], for that kind introduction

By Ashley Henderson, PhD, CATO SMS Scientist 1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to the conduct of clinical trials including quarantines, travel limitations, site closures, and interruptions in the supply chain of investigational products. In acknowledgement of these challenges, the Food and Drug Administration (FDA) recognizes that protocol modifications …

Continue reading »

High rates of opioid prescribing have contributed to the current U.S. opioid epidemic and the steady increase in overdose deaths across the country. Prescribers wrote an all-time high of 255 million opioid prescriptions in 2012, and though that rate has since declined.

The perennial drug pricing debate has reached a fever pitch, as loud as it’s ever been over the past few decades. Politicians on both sides are bashing the drug industry with the typical talking points about exorbitant prices, countered of

The post Venturing A Perspective On The Drug Pricing Debate appeared first on LifeSciVC.

In the throes of a full COVID-19 pandemic, most business leaders’ top priority is rightfully the health and safety of their employees, families, and communities. Even though business disruptions are significant and overwhelming, the primary efforts focused on both safety

The post Strategic Planning In Biotech During A Pandemic Crisis appeared first on LifeSciVC.

Another leading athlete has joined Arla Foods Ingredients’ growing number of brand ambassadors for Lacprodan® HYDRO.365.

In this INSIDER Q&A, experts in contract manufacturing discuss aspects a brand owner should evaluate, what should be outlined in an agreement and what ongoing QA checks to conduct during the partnership.

Rousselot, the collagen-based ingredients producer, has revealed a new study which it says provides important answers surrounding the bioavailability of collagen peptides and the modifications they undergo during digestion.

Leaders from around the world gathered at the United Nations General Assembly in New York on 23 September for the first-ever United Nations High-Level Meeting (UNHLM) on Universal Health Coverage (UHC): Moving Together to Build a Healthier World.

APEC member economies launched the APEC Women in STEM Principles and Actions, a set of suggested principles and actions for encouraging women’s participation in the fields of science, technology, engineering, and mathematics, commonly referred to as STEM.

Media Registration is Open for the APEC Informal Senior Officials’ Meeting

APEC’s 21 member economies will finalize in 2020 a new vision for the forum’s next phase, said the APEC Secretariat’s Executive Director Dr Rebecca Sta Maria.

The first Senior Officials Meeting for APEC Malaysia 2020 begins

Enable trade and investments to generate concrete outcomes for the people.

“I would like to express our appreciation to APEC member economies that put their faith in Malaysia’s leadership and made it a point to participate.”

From : Communities>>Regulatory Open Forum
Dear Roy, You do not mention any important functions of the syringe/applicator, other than the Primary Packaging function for which you have identified testing to assess impact. The determination of these functions (e.g. deliverable dose or dose accuracy) could provide important testing to verify that no impact on performance. Also, an assessment on the impact of the change on the usability could be required (particularly if the ergonomics/forces change) or patient risk would be prudent, which [More]

From : Communities>>Regulatory Open Forum
Dear Lee & Spyros, Many thanks for your invaluable advice - really appreciate your time in considering and providing deep insight. Kind regards, Roy Jamieson (BPharm Hons) Regulatory CMC Consultant

In response to the COVID-19 pandemic, authorities in Australia and the European Union have allowed drug producers to collaborate to ensure medicine production and supply.

April saw the company add new CEO, receive approval for lead ADC drug, and launch a public offering of stock.

Much attention has been paid to the impact of the COVID-19 pandemic on the supply chain for medicines we rely on, but there has been less focus on the impact of medicines yet to come. The advancements in cancer care … Continue reading →

by Nina Martin and Bernice Yeung

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.

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.

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.

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.”

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.

UPDATE 2: On August 21, 2019, the government filed a notice of appeal in this case.

UPDATE: On July 8, 2019, the judge in the pending litigation described below issued an order setting aside the CMS rule. The full opinion is available here.

If nothing changes, the new rule about including drug pricing in TV ads from CMS will go into effect one week from today on July 9, 2019.

There are a few wrinkles to keep in mind as we approach this deadline. First, there's a lawsuit pending that could delay the rule's implementation. Second, the operational challenges of abiding by the rule are the biggest hurdle including the expanded 2253 filing requirements. Third, the rule's scope is still unclear. Fourth, the rule doesn't preclude or preempt the PhRMA Principles change from April. Finally, the overlapping but non-identical scope of the rules could lead to some confusion and compliance hiccups. This post addresses each of these points in turn.

Pending Litigation

Operational Challenges 

Rule Scope Unclear

CMS Rule Adds to (Doesn't Replace) PhRMA's Pricing Requirements

TL;DR

PhillyCooke Consulting has added new services from the humble start more than five years ago, when I used to joke that the company included both me and my laptop.

In addition to continuing to provide regulatory consulting services, PhillyCooke Consulting now offers:

• Submission Preparation Services for Ad Agencies
• Medical Editing
• Proofreading, and 
• Medical Writing. 

Pharmacy staff who are thought to have died as a result of the COVID-19 pandemic are to be among the healthcare workers remembered with a minute’s silence on 28 April 2020.

To read the whole article click on the headline

Community pharmacies need millions of pounds extra “to keep their heads above water” during the COVID-19 pandemic, pharmacy bodies have warned.

To read the whole article click on the headline

Pfizer and partner BioNTech are right in the middle of one of the most important vaccine trials in the world right now, but that doesn’t mean the Big Pharma is taking its eyes off the inoculation ball elsewhere.

Temple University researchers discovered that boosting levels of a protein called Lin28 in injured spinal cords of mice prompts the regrowth of axons and repairs communication between the brain and body. They believe the discovery could be used to develop new treatments for both spinal cord and optic nerve injuries.

Australia’s largest biotech company CSL says it is working on a plasma-based therapy for patients with more severe forms of COVID-19.

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The dietary supplement industry as a whole is enjoying booming sales as consumer stock up on products to support optimum health. But an industry strategist warns that that sales bump is likely to be ephemeral, and brands that are not strategizing vigorously now may be caught out in the near future.

"Today, 75 years later, we are forced to commemorate alone, but we are not alone!" Germany's President Frank-Walter Steinmeier says, celebrating international unity in the post-war era.

When it rains guidance, it pours. The MDCG just released Guidance on temporary extraordinary measures related to medical devices Notified Body audits during COVID-19 quarantine orders and travel restrictions. The guidance takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation. It […]

The daft showdown over coronavirus masks wouldn't matter if we didn't live in the political tinderbox that is Trump's America.

As nations across the globe try to fight a pandemic, many also stop to mark the close of another conflict: the end of World War II in Europe.

Marriage, like many aspects of life, has changed. Here's what you need to know about getting a license and the rest of a process that was already complicated.

From cash and snacks to a verbal 'thank you,' there are options when it comes to showing your appreciation for delivery drivers.

The U.S. death toll in the coronavirus outbreak surpasses 77,000 as states continue to ease restrictions and President Trump pushes for faster reopening.