Attorney General Eric Holder released the following statement Thursday announcing Joyce Branda as Acting Assistant Attorney General for the Civil Division.

Today the U.S. Department of Justice Office of Community Oriented Policing Services (COPS Office) released Implementing a Body-Worn Camera Program: Recommendations and Lessons Learned. The report analyzes some of the costs and benefits of law enforcement using body-worn video technology.

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.

Buenas tardes. Muchas gracias por sus emotivas palabras y su calurosa bienvenida. It’s a privilege to help welcome the Hispanic National Bar Association to our nation’s capital for your 39th Annual Convention. And it’s a great pleasure, as always, to be in such distinguished company.

Attorney General Eric Holder announced Monday that the Justice Department will launch a new series of pilot programs in cities across the country to bring together community representatives, public safety officials and religious leaders to counter violent extremism. The new programs will be run in partnership with the White House, the Department of Homeland Security, and the National Counterterrorism Center.

The Justice Department announced Monday that Attorney General Eric Holder has recorded a video message as part of the Cartoon Network’s “I Speak Up” campaign to combat bullying. The project urges young people to speak up in order to help bring bullying situations to an end.

A federal court has permanently barred Sea Nine Associates Inc. from promoting and selling an alleged nationwide tax scheme that involved using welfare benefit plans to unlawfully increase and accelerate tax deductions and avoid income taxes.

Episcopal Ministries to the Aging Inc., a Maryland not-for-profit corporation that owns skilled nursing facilities, has agreed to pay $1.3 million to the government for submitting false claims to Medicare for unreasonable or unnecessary rehabilitation therapy purportedly provided by RehabCare Group East Inc., a subsidiary of Kindred Healthcare Inc.

Thank you, John, not only for that kind introduction but also for your exemplary leadership as chair of the LSC Board. LSC really exemplifies that spirit Attorney General Robert Kennedy used to talk about – that as lawyers, we have an obligation to enlist our skills and ourselves in engagements that reach beyond the horizons of our parochial legal practices. And over the last five-and-a-half years I’ve served in this Administration, I’ve been fortunate to get to know John and LSC President Jim Sandman, and I know the movement for expanding access to justice in this country is better and stronger because they’re helping to lead this effort, so my thanks to them.

Assistant Attorney General Bill Baer of the Department of Justice’s Antitrust Division has signed an antitrust cooperation agreement with the Colombian antitrust agency on behalf of the Department of Justice. The agreement also was signed by Federal Trade Commission Chairwoman Edith Ramirez, and went into effect today with the signature of Pablo Felipe Robledo, Colombia’s Superintendent of Industry and Commerce.

A Detroit-area hematologist-oncologist pleaded guilty today for his role in a health care fraud scheme, admitting that he administered unnecessary chemotherapy to fraudulently bill the Medicare program and private insurance companies. According to court records, the scheme enabled the doctor to submit approximately $225 million in claims to Medicare over six years.

Attorney General Eric Holder is set to announce a partnership between the Department of Justice’s Office of Juvenile Justice and Delinquency Prevention (OJJDP) and the Department of Housing and Urban Development (HUD). HUD will offer new grants to support collaborations between HUD-funded organizations, and civil legal aid programs and public defender offices. The grant funded collaborations will focus on expunging and sealing juvenile records – improving the chances that reentering youth will be able to obtain degrees, find work and secure housing. The announcement is set to be made this evening during the Attorney General’s remarks to the Legal Services Corporation 40th anniversary celebration.

Thank you, Dean [Martha] Minow, for those kind words – and thank you all for being here. I also want to recognize, and thank, my good friends John Levi and Jim Sandman for their leadership of the Legal Services Corporation over the years – and for the lifetimes of tireless work that they have dedicated to vulnerable populations from coast to coast. Finally, I want to thank each and every one of you – the dedicated men and women who are making LSC’s work possible; who are helping to shine a light on the current challenges facing the legal aid community; and who are leading us to redouble our efforts to forge the more just society that all Americans deserve. It’s gratifying to see so many diverse people and interests – from academia and government service, to private practice and corporate enterprise – converging to support equal justice under law.

Qui tam cases are a vital part of the Criminal Division’s future efforts. We encourage you to reach out to criminal authorities in appropriate cases, even when you are discussing the case with civil authorities. The sooner we on the criminal side learn about potential criminal conduct, the sooner we can investigate.

A true cooperator – whether a mobster or a company – must forthrightly provide all the available facts and evidence so that the most culpable individuals can be prosecuted. If a corporation wants credit for cooperation, it must engage in comprehensive and timely cooperation; lip service simply will not do. Corporations do not act criminally, but for the actions of individuals. The Criminal Division intends to prosecute those individuals, whether they’re sitting on a sales desk or in a corporate suite.

Thank you, Professor [Jennifer] Arlen, for those kind words – and thank you all for being here. It’s a privilege to be at New York University this afternoon

Preet Bharara, the United States Attorney for the Southern District of New York, Diego Rodriguez, the Assistant Director-in-Charge of the New York Field Office of the Federal Bureau of Investigation (“FBI”), and Philip R

Remarks as prepared for delivery

Thank you, Professor [Jennifer] Arlen, for that kind introduction and for everything you and your colleagues have accomplished at NYU

Remarks as prepared for delivery

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

The Justice Department, the Department of Housing and Urban Development (HUD) and the Consumer Financial Protection Bureau, along with 49 state attorneys general and the District of Columbia’s attorney general, have reached a $470 million agreement with HSBC Bank USA NA and its affiliates (collectively, HSBC) to address mortgage origination, servicing and foreclosure abuses

ALEXANDRIA, Va

NEWPORT NEWS, Va

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 …

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Axsome Therapeutics Inc.'s (AXSM) phase II/III trial of investigational drug AXS-05 in Alzheimer's disease agitation has met the primary endpoint.

Shares of Relmada Therapeutics Inc. (RLMD) have gained 19 percent so far this year and trade around $37.

The federal government in March released a pair of long-awaited rules that will give patients greater access to their health data and improve the flow of information across care settings.

More than 56 million people in the United States live in areas with dentist shortages. Dental therapy is a proven solution that has helped increase access to care. Dental therapists are midlevel providers who deliver preventive and routine restorative treatment at schools, nursing homes, and veterans homes to people who would otherwise struggle to get access to care.

Neuroscience has had a tough run of news lately. With Amgen deprioritizing neuro this year, Pfizer doing the same last year, and others like BMS, GSK, and AZ cutting back on CNS a few years earlier, it would seem dark

The post The Promise Of Precision Neuroscience And Launch Of Arkuda Therapeutics appeared first on LifeSciVC.

Today Alkermes announced its acquisition of Rodin Therapeutics, a leader in the field of synaptic dysfunction and neuronal epigenetics. Alkermes extensive experience in CNS diseases made them an ideal partner for Rodin, and this acquisition helps expand Alkermes’ efforts into

The post Thinking Boldly: Alkermes Acquires Rodin Therapeutics appeared first on LifeSciVC.

This blog post was written by Deanna Petersen, CBO of AVROBIO, as part of the From The Trenches feature of LifeSciVC. When AVROBIO went public in June 2018, I found myself on the steep end of an unexpected but interesting

The post Recipe For Managing Data Disclosure Successfully With Academic Partners: A Public Gene Therapy Company Perspective appeared first on LifeSciVC.

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.

Stronger cooperation is essential for APEC as economies address inequality, environmental health, and the digital economy – the region’s critical challenges – said the APEC Secretariat’s Executive Director Dr Rebecca Sta Maria.

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous Dear RAPS members, I am preparing a submission for a device that has no special controls and we have identified the following standards to name a few. 62304-  ANSI AAMI IEC   62304:2006/A1:2016 62366-1:2015-  Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices 14971- Medical Devices - Applications Of Risk Management To Medical Devices I am trying to see what approach will be good. Should I prepare a DOC or [More]

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous I'd recommend a statement that you are using these standards as general use. A Declaration of Conformity allows you to submit less testing information, but FDA still may request it. In the case of the standards you mentioned, FDA will require that information (e.g. software documentation, risk management, etc). So I would not bother with the DoC as you still have to submit all that material. Here was a nice thread discussing the topic [More]

From : Communities>>Regulatory Open Forum
Hello Anonymous  You will be generating software documents (which is data of a sort), in accordance  with  ANSI-AAMI IEC 62304, and there is output from ISO 14971 which goes into the submission.   I just think DoCs are wasteful busy time and would do as few as possible. Regarding IEC 62366-1, maybe if you want mention it and do a DoC, but if the device  usability  study is not required in a submission don't  put it in there unless asked.  Just my opinion. Biocompatibility if used, is generating test [More]

From : Communities>>Regulatory Open Forum
Hello, I agree with Ginger, when you look at standards there will most likely be an output of documents from following those standards, i.e. risk management file, usability report, all the software documentation.  These would be included in the different sections of the 510(k) so you can claim them as recognised standards you are following.  I have mentioned in previous posts, we take a simple approach for the declaration of conformity to standards that is a small table describing what we are complying, [More]

Guangping Gao, the head of the Horae Gene Therapy Center at the University of Massachusetts Medical School, will partner with Philadelphia-based Spark Therapeutics to figure out better ways to get disease-curing genes into cells. The collaboration, announced this morning, gives Spark (Nasdaq: ONCE) the option for an exclusive, world-wide license for any intellectual property to come out of it. No financial terms were disclosed. Earlier this year, Gao was featured in Newsweek magazine for seemingly…

- Libtayo decreased the risk of death by 32.4% compared to chemotherapy

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.

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The facility will be the companyâs second facility in Carlsbad specifically for its BioReliance viral and gene therapy service.

AskBio acquires gene therapy biotech working on treatments for neurodegenerative disorders.

by Joaquin Sapien

New York Attorney General Letitia James is looking into allegations that a Queens adult care facility has failed to protect residents from the deadly coronavirus and misled families about its spread, according to two lawmakers who asked for the inquiry and a relative of a resident who spoke to an investigator with the attorney general’s office.

In a separate action Tuesday, three residents of the Queens Adult Care Center sued the facility in federal court over similar allegations.

Both developments were prompted largely by ProPublica’s recent coverage of the facility, which houses both frail elderly residents and those with mental health issues. On April 2, we reported that workers and residents at the home were becoming ill with the coronavirus as residents wandered in and out of the home without any personal protective equipment. Family members later told ProPublica the management said no residents were sick with the virus at the time.

On April 25, ProPublica published a story and a short film with the PBS series Frontline about the harrowing experience of Natasha Roland, who rescued her father in the middle of the night as he suffered coronavirus symptoms so severe he could barely breathe. Roland, in heart-wrenching detail, described how the management of the Queens Adult Care Center repeatedly assured her that her 82-year-old father, Willie Roland, was safe, even as the virus swept through the facility. She said workers were too scared to care for him, forcing his girlfriend, Annetta King-Simpson, to do so. King-Simpson later fell ill herself. Roland and King-Simpson are now suing the facility in federal court.

In an interview, Assemblywoman Catalina Cruz, whose district covers Corona, Elmhurst and Jackson Heights, said she was troubled by what ProPublica reported. She said she hoped the attorney general can determine whether the Queens Adult Care Center had broken any laws.

“It didn’t sit right with me. I thought something was off here. So I said let’s have the experts look at whether there was a crime or a civil violation,” she said. “Folks who live in this adult home deserve the same dignity as everyone else, and if their rights have been violated, someone needs to pay for that.”

Cruz said she had been suspicious of the facility for several years and had come across a community Facebook page where people posted complaints about treatment of residents at the center. When she saw the ProPublica stories, she said she decided to take action, along with City Council member Daniel Dromm, who had already written to the New York State Department of Health and the office of Gov. Andrew Cuomo about the spread of the coronavirus in the facility on several occasions.

“The plight of those living in adult care centers during this crisis was highlighted in a recent article published by ProPublica, which focused on the perils faced by the residents at the Queens Adult Day Care Center,” the lawmakers wrote in their April 27 letter to the attorney general and the governor’s office. “Failure to inform families about the health of loved ones, to lying and covering up deaths have become regular concerns we have received. We are aware that adult care centers are struggling to keep COVID-19 from affecting their residents and we also know that minorities have been disproportionately affected by the virus. It seems to us that management at this particular center have struggled to implement procedures and policies to protect the lives of its residents.”

Cruz said she received an update from the attorney general’s office on May 5, saying it was looking into the matter but would not provide specific details.

Days after the lawmakers sent the letter, Natasha Roland, 35, said she received a phone call from an investigator with the attorney general’s office. Roland said she recapped what she had previously told ProPublica: She began to worry about her father’s safety when nearby Elmhurst Hospital became a viral hot spot, but the management repeatedly told her there were no coronavirus cases in the facility. She said she only found out the truth weeks later when a worker she was friendly with advised her to come and pick up her father because the virus was raging through the facility and aides were becoming too scared to check on residents. In a subsequent interview, that worker denied telling Roland to pick up her dad.

A spokesperson for the attorney general would not confirm or deny a specific, active investigation into the Queens Adult Care Center, but said James has received hundreds of complaints related to COVID-19 inside nursing homes and adult care facilities across the state and is investigating many of them.

For its part, the Queens Adult Care Center has denied any wrongdoing and repeated its belief that Roland’s allegations are “baseless.”

“Sadly, select elected officials and ProPublica have been intentionally misled with baseless assertions and utter fabrications crafted by the daughter of one of our long-term residents,” said Hank Sheinkopf, a crisis communications spokesperson hired by the facility. “We have strong reason to believe that this individual is seeking to use her father and other select residents as pawns in an attempt to extort the facility. We are considering our legal options.”

He said the facility has “worked tirelessly” to protect its residents and is unaware of a “potential investigation,” but understood that “the AG’s office has contacted many nursing homes, adult care, and assisted living facilities seeking information. We are glad to be a resource to the AG’s office and have nothing to hide.”

Bruce Schoengood’s 61-year-old brother, Bryan, lives in the facility and shared a room with one of the first residents to become infected with COVID-19 and subsequently die of the disease. Bruce told ProPublica he only learned that his brother’s roommate had died by happenstance during a casual conversation with his brother, and that he has complained for more than a month about a lack of communication from the facility. He said he had not yet heard from anyone with the attorney general’s office but would welcome such a conversation.

In the meantime, Bryan Schoengood, Willie Roland and King-Simpson are suing the facility under the Americans with Disabilities Act. In a 59-page complaint, the group has asked a federal judge to appoint a special master to oversee the facility at the home’s expense to ensure that residents there are safe.

The lawsuit argues that residents have experienced a “gross failure to provide the most basic level of care to safeguard their health and safety in the context of a global health pandemic. People with disabilities are exposed to high risks of contracting the virus with no or few preventative measures in place. Residents who fall sick are left to languish in their room without proper access to medical care.”

The lawsuit claims that because the facility has failed to follow state and federal guidelines, “COVID-19 is rampant in the facility among residents and staff alike.”

Alan Fuchsberg is the Manhattan-based personal injury and civil rights attorney representing the three Queens Adult Care Center residents.

In an interview, he said that the facility may not have the resources to properly follow the guidelines, which is why a special master should be assigned to work with a team of outside experts to make sure it can.

“Right now the residents are in a tinderbox,” he said. “And if you drop a match in there, all hell breaks loose. It should be run right. We don’t need dozens of people dying in all our nursing homes and adult care facilities. Some are running better than others and QACC sounds like a place that is not run up to standards.”

He and Bruce Schoengood pointed out that they are not currently suing for damages, but rather to persuade a court to immediately intervene and offer support to the facility’s roughly 350 residents.

Schoengood said the goals of the lawsuit are twofold.

“I think it is both short term and long term,” he said. “Immediate intervention to put proper protocols in place to treat the sick and stop the spread of coronavirus and to communicate with family members. And in the long term I would like to see this facility much better prepared to handle another pandemic or a second wave.”

Responding to the charges in the lawsuit, Sheinkopf again said that “the allegations are baseless and utter fabrications. Queens Adult Care Center (QACC) continues to meet all state issued guidelines.”

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The European Medicines Agency has begun a rolling review of data on Gilead’s remdesivir, positioning it to cut the time it takes to decide whether to approve the drug in COVID-19 patients.

Inovio Pharmaceuticals’ stock has climbed higher and higher over the past month since it said it was working on a speedy COVID-19 vaccine.

After penning a deal with Eli Lilly last month with the aim to have an antibody in the clinic within four months, Canadian-based AbCellera has been given a financial boost by its government.

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.

BioMarin Pharmaceutical is boosting its early-stage pipeline by penning a deal with Swiss startup Dinaqor.

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.

PTC Therapeutics is adding to its rare disease pipeline with a midstage biotech buyout with a low upfront payment tied in with stock and biobucks.

Just a few months after Alexion snapped up complement inhibitor biotech Achillion, Gemini Therapeutics has nabbed one of its key R&D execs as its new chief medical officer.