Bayer said an experimental stem cell therapy developed by its U.S. subsidiary BlueRock had shown signs of easing Parkinson's disease symptoms in an early 12-patient trial.
The German drugmaker announced the trial had succeeded in a brief summary in June, saying it was a first for a stem-cell Parkinson's therapy, but held back details for a medical conference.
In a statement on Monday it said that one year after the treatment, the seven participants on a high dose had 2.16 hours longer on average with well-controlled symptoms per day and the time of worsening symptoms was 1.91 hours shorter per day for them.
The five participants on a lower dose experienced 0.72 hours longer per day with well-controlled symptoms on average and the time of worsening symptoms was 0.75 hours shorter per day for them.
The treatment was well tolerated with no major safety issues.
"The positive outcome of this Phase I clinical trial is a clear step forward," said Christian Rommel, Bayer's head of drug research and development.
For BlueRock's experimental therapy, the researchers took human pluripotent embryonic stem cells and transformed them into dopamine-producing nerve cells. They were implanted into the brain to restore neural networks destroyed by Parkinson's.
Drugs to prevent the immune system from attacking the new cells were also given.
The results were presented at the International Congress of Parkinson's Disease and Movement Disorders in Copenhagen, Denmark.
The hunt for a treatment of Parkinson's, which causes a lack of the molecule dopamine which helps regulate several basic brain functions, has seen many setbacks over decades.
A slew of research projects around the globe, including Bayer's, have recently honed in on the approach to transplant modified cells to restore a dopamine-producing area of the brain.
Some of this work is being done by Britain's' Cambridge University, South Korea's Bundang CHA Hospital, International Stem Cell Corp's Cyto Therapeutics in Australia, the Chinese Academy of Sciences, Harvard University in the United States and Japan's Kyoto University Hospital.
Bayer reiterated it would advance testing on humans to the second of three stages. Patient enrolment, also for a comparative group that will not receive the treatment, would start in the first half of 2024.
Parkinson's, for which there is no cure and which affects more than 10 million people worldwide, causes progressive brain damage. Common symptoms are loss of muscle control, tremors and muscle rigidity while dementia is seen in some patients
The Biden Department of Homeland Security (DHS) has refused to release monthly totals on how many illegal immigrants are allowed into the United States following encounters by US authorities at the border, according to Just the News, citing a former US immigration judge.
Retired judge Andrew Arthur, who served for eight years at the now-closed immigration court in York, Pennsylvania, told JTN that Homeland Security does keep track of the total number of migrants released following encounters, however making that data available to the public would be 'problematic' for the Biden administration.
"The only reason why ICE and OFO [Office of Field Operations] would refuse to disclose that information is to hide the fact that it is releasing more than 100,000 aliens per month into the United States, and to conceal the effects of those migrant releases on communities across the United States," said Arthur.
Arthur also said that DHS should be required to release the information the same way that the monthly data on encounters of illegal immigrants is posted online.
Arthur also said the "monthly court-ordered disclosures in Texas v. Biden," the lawsuit over the Remain in Mexico policy, demonstrated DHS "can provide the American people with statistics on the tens of thousands of illegal entrants that CBP encounters at the southwest border whom DHS releases" into the U.S. The agency has "refused to do so since those orders were vacated in August 2022," Arthur explained. -Just the News
Arthur also explained that OFO "publishes statistics on the number of aliens its officers encounter at the ports monthly who are placed into removal proceedings with the filing of a 'Notice to Appear' (NTA), but separate monthly disclosure lines on the number of those aliens who are released or alternatively are detained are blank—reading '0' across the months. That is a legal and factual impossibility, because those aliens are either released or detained—there is no third option."
As JTN further educates us, US immigration judges - formerly known as "special inquiry officers," aren't actually part of the federal judiciary at all. Instead, they're DOJ employees who report to the Attorney General.
According to the Federation for American Immigration Reform (FAIR), the Biden administration isn't being transparent with the public, and should be "required to release all pertinent information to the public," a spokesman told Just the News. "It should be done as a matter of course because the public has a right to know. But if it requires an act of Congress, then so be it."
Meanwhile, a spokesperson for Rep. Darrell Issa (R-CA) told JTN that the number of released migrants should be reported to Congress on a daily basis, and "obvious why the Biden Admin does everything it can to minimize transparency."
ICE publishes monthly statistics on the number of migrants CBP transfers to its custody as well as the number of aliens ICE itself releases monthly, "but it fails to disclose how many of the aliens it releases monthly" were originally encountered at the southwest border and "transferred to ICE are released monthly," Arthur also said.
"When ICE was under a court order in Texas, it did release that information, so it plainly keeps the statistics," he added. -Just the News
According to a "conservative" estimate by FAIR, at least 2.3 million illegal immigrants had entered the US "either because they were released by CBP, or they eluded apprehension."
"This is a conservative estimate on FAIR’s part based on verifiable data. The report does not speculate about numbers that cannot be verified," the spokesperson told JTN.
Catalent Inc is close to reaching a settlement with Elliott Investment Management that would lead to a shake-up of the U.S. contract drug manufacturer's board of directors after its share price lost half of its value in the last year.
The company is poised to agree to add four new directors proposed by Elliott to its board, which currently has 12 members, people familiar with the situation said on Monday.
The sources declined to be identified because the information is confidential and cautioned a deal could still collapse at the last minute.
Spokespeople for Catalent and Elliott declined to comment.
The stock price jumped nearly 6% in after hours trading.
The deal would allow Elliott, one of the industry's busiest activist investors, to help sway Catalent's strategy at a time the company has been the target of takeover interest from both private equity firms and strategic buyers. Earlier this year, Danaher, which on Monday agreed to acquire Abcam, was reported as a possible suitor.
Catalent, which is valued at roughly $8 billion and played a critical role during the pandemic to fill vials with the COVID-19 vaccine for several companies including AstraZeneca, Johnson & Johnson and Moderna, has grappled with a variety of problems recently.
Its chief financial officer left in April, when the company warned “productivity issues” and higher-than-expected costs at three of its manufacturing sites would hit fiscal 2023 results.
Catalent also warned in June when it released thrice-delayed quarterly earnings that the corrective actions it was undertaking to address quality control lapses identified by U.S. drug regulators at its Brussels factory required more time to fix.
The company is scheduled to report quarterly earnings before the U.S. market opens on Tuesday.
In the past when Elliott has pushed for sales of pieces or the entire target company, including at eBay and Switch Inc., and then won board representation, significant ownership changes have followed. Sell side analysts, including Deutsche Bank, note that Danaher, which is valued at $193 billion, has untapped M&A capacity even after buying Abcam.
The Biden administration Monday scoffed at the notion it’s to blame for any of New York City’s migrant crisis, saying the Big Apple’s and state’s own issues caused the catastrophic mess.
Homeland Security Secretary Alejandro Mayorkas, in letters fired off to Mayor Eric Adams and Gov. Kathy Hochul, still provided no real local relief over the federal debacle — more than a year after tens of thousands of migrants began flooding the city and overwhelming its services.
Instead, Mayorkas promised in his bureaucratic note only vague “recommendations” from his team “as soon as possible’’ — adding insult to injury by claiming the issues solely came to light because of the feds’ brief recent visit.
“The structural issues include governance and organization of the migrant operations, including issues of authority, structure, personnel, and information flow,” Mayorkas wrote in the letters first obtained by Politico.
“The operational issues include the subjects of data collection, planning, case management, communications, and other aspects of day-to-day operations.”
Mayorkas noted that the issues with the city’s migrant operations were discovered when a federal assessment team was dispatched to the Big Apple four days earlier this month to view shelter sites — including the Roosevelt Hotel intake center.
Homeland Security Secretary Alejandro Mayorkas fired off letters to Mayor Eric Adams and Gov. Kathy Hochul on Monday about the surging migrant crisis.AP
He added that the federal government’s recommendations to improve operations would be shared directly with city and state officials “as soon as possible.”
The recommendations include, in part, improving data collection when migrants are first processed and better communication with asylum seekers on how to apply for a work permit, a source familiar with the guidance told the outlet.
“We are hopeful that our recommendations will equip the city to take additional steps to improve the migrant operations and maximize the value of our continued partnership and your support,” Mayorkas wrote.
Mayor Eric Adams and Gov. Kathy Hochul have repeatedly called on the federal government to offer up more assistance for the “national crisis.”G.N.Miller/NYPost
Both Adams and Hochul have publicly decried the lack of extra assistance from the feds, arguing the city and state have instead been left to burden a national crisis.
Hizzoner has directly called on President Biden to step up and act more than three dozen times since the crisis began in Spring 2022, while the governor publicly clapped back at the feds for the first time last week.
As part of her plea, Hochul urged the Biden admin to offer up any federally-owned sites that could potentially house arriving migrants and expedite work authorization permits.
Mayorkas’ recommendations include improving data collection when processing migrants and communicating with them on how to get working permits.Photo by Anna Moneymaker/Getty ImagesMigrants arriving at the Port Authority Bus Terminal in Manhattan on August 17, 2023.Seth Gottfried for NY Post
Mayorkas wrote in his letter that the federal government had already provided the city with a hangar at John F. Kennedy Airport and had since identified 11 other sites across the state.
“We look forward to hearing from the city and state on the viability of these sites,” he wrote.
In response to the letter, the Adams administration fired back, insisting that the Big Apple’s requests for federal help remained “unaddressed.”
“New York City has led the nation in handling this humanitarian crisis for more than a year, and we are grateful that our federal partners are now engaging in a collaborative process, but New Yorkers deserve the facts, so let’s be clear: Our requests from the federal government remain the same, and quite frankly, unaddressed,” a City Hall spokesperson said.
More than 104,400 migrants had poured into the Big Apple since the crisis started escalating in April 2022.Seth Gottfried for NY Post
“We continue to call on the Biden administration to take the lead in implementing a decompression strategy at the border, expedite pathways to work authorizations for asylum seekers, to declare a state of emergency facilitating swift allocation of federal funds to address our pressing challenges, and to provide more funding to match the reality of the course on the ground.
“Today’s conversation also did not address the situation on the ground where thousands of asylum seekers continue to arrive in our city with no end in sight.”
Hochul, meanwhile, doubled down on her calls to accelerate the work permit process.
“As Governor Hochul has repeatedly said, this crisis will only abate once the federal government takes action on work authorization that allows migrants to be resettled permanently, and we are grateful to the Department of Homeland Security for today’s informative briefing,” her spokesperson said in a statement.
More than 104,400 migrants have poured into the Big Apple since the crisis started escalating in April 2022. There are currently over 59,400 asylum seekers staying in the 200-odd city-run shelters across the five boroughs, according to City Hall’s latest data.
State officials warned New York school districts Monday that any policy they institute to block — or even make difficult — the enrollment of migrant kids could lead to lawsuits and fines.
The threat of legal action from Attorney General Letitia James and state Education Commissioner Betty Rosa was triggered by their discovery of discriminatory practices in some districts, such as requiring a voter ID from parents registering their kids, as schools across the state prepare for the new year and a flood of asylum-seeking children, they said.
“The [Office of the Attorney General] and [state Education Department] have recently learned that some districts employ enrollment policies that make it difficult or impossible for noncitizens, undocumented students, and people who rent their homes without a formal lease to register for school,” the pair’s letter released Monday reads, adding that “several registration policies are of particular concern.”
The questionable practices — which also include requiring a student’s residency to be more than 30 days old or providing proof of where they live on a regular basis — may “violate constitutional and statutory protections, exposing school districts to lawsuits and liability,” the state officials said.
New York Attorney General Letitia James (above), along with state Education Commissioner Betty Rosa, threatened schools with legal action Monday over the migrant crisis.Gabriella BassState schools chief Betty Rosa joined New York’s AG in writing a threatening letter to school districts.New York State Education Department
“The law is clear: Every New Yorker is entitled to a free public education, and anyone who lives in our state is a New Yorker,” said James in announcing the warning.
Under state law, all kids between ages 5 and 21, including any migrant or undocumented students, are guaranteed a public education in New York.
New York City alone expects nearly 19,000 kids to attend its public schools this upcoming year, but it has still not announced any plans on how to handle the influx, with just days until the school year starts.
Thousands of migrant kids are expected to enroll in New York schools by this fall.G.N.Miller/NYPost
It is unclear how many kids statewide are expected to enroll in New York’s schools.
“All school and district leaders must continue to faithfully carry out their duty to accept and provide educational support services for these students and their families,” Rosa warned in a statement.
The warning comes on the heels of Gov. Kathy Hochul pinning part of the blame for thecrisis on fellow Democrat President Biden, urging his administration to step up and do more by providing shelters and funding to the state as well as fast-tracking work authorizations for migrants.
Mayor Eric Adams slammed the governor for not going far enough in her remarks, imploring her to ask the president to declare a state of emergency, which would quickly free up federal funds.
