- Closing expected in the third quarter of 2026, subject to TruBridge shareholder and regulatory approvals.
Thursday, April 23, 2026
IKS Health to acquire TruBridge for $26.25 per share in cash
CRL for Grace Therapeutics' GTx-104 NDA citing CMC and non-clinical issues
FDA issues Complete Response Letter for Grace Therapeutics' GTx-104 NDA citing CMC and non-clinical issues
- FDA letter cites CMC and non-clinical issues but does not request any additional clinical data for GTx-104.
- Grace Therapeutics plans to resubmit the GTx-104 NDA to address the Complete Response Letter deficiencies.
US accelerates Medicare access for select medical devices
Today, the Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, a new pathway designed to expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for people with Medicare.
“FDA and CMS each play a critical role in getting new medical devices to patients, and they work most effectively when aligned sooner in that process,” said CMS Administrator Dr. Mehmet Oz. “The RAPID coverage pathway brings our two agencies together earlier, cutting red tape for innovators, and helping beneficiaries access new, life-changing health technology faster.”
“The American people deserve timely access to meaningful treatments without red tape or high costs," said FDA Commissioner Marty Makary, M.D., M.P.H. "In this administration, FDA and CMS are functioning as a single team to deliver life-saving Breakthrough Devices to American patients as soon as we know they work,” said FDA Commissioner Marty Makary, M.D., M.P.H.
The RAPID coverage pathway allows CMS and the FDA to work together, with innovators, earlier in the technology development lifecycle so that evidence generated for FDA review can also support Medicare coverage decisions. By aligning regulatory and coverage expectations in advance, the RAPID coverage pathway is designed to significantly reduce delays that have historically occurred between FDA market authorization and Medicare national coverage determinations. This is a critical first step towards delivering on the Trump Administration’s commitment to provide accelerated and more predictable coverage following FDA market authorization for Breakthrough technologies that clinically benefit the Medicare population.
Early Alignment on Evidence That Matters for Medicare
Through the RAPID coverage pathway, CMS will now be a part of the early and frequent engagement between the FDA and device innovators. The coverage pathway will link manufacturers to CMS experts early in development to understand what clinical outcomes are most relevant for Medicare beneficiaries.
The RAPID coverage pathway is for Breakthrough Devices that address unmet medical needs among Medicare beneficiaries and is available for certain Class II devices participating in the FDA Total Product Life Cycle Advisory Program (TAP) and Class III devices regardless of whether they are participating in TAP. To be eligible for the RAPID coverage pathway, devices must be the subject of an Investigational Device Exemption (IDE) study that enrolls Medicare beneficiaries and studies clinical health outcomes agreed upon by the FDA and CMS.
This coordinated approach allows CMS and the FDA to rely on premarket evidence to inform both the FDA premarket review and Medicare coverage processes. Aligning evidence expectations earlier reduces duplication, improves efficiency, and provides increased transparency to innovators.
A More Predictable Pathway for Coverage
The RAPID coverage pathway establishes a predictable timeline and process that can safely expedite national Medicare coverage for eligible Class II and Class III Breakthrough Devices by better synchronizing FDA market authorization with CMS’ National Coverage Determination (NCD) process.
Under the RAPID coverage pathway, CMS will issue a proposed NCD the same day an eligible device participating in this pathway receives FDA market authorization, triggering the statutorily required 30-day public comment period. This streamlined approach could enable predictable Medicare national coverage and payment as soon as two months after market authorization, compared to approximately a year or more under the current pathway, helping Medicare beneficiaries access new technologies sooner while increasing transparency, predictability, and cost savings for innovators and clinicians.
Relationship with Other Medicare Coverage Pathways
CMS will continue to offer multiple pathways to support access to medical technologies, including the standard process for opening, deciding, or reconsidering national coverage determinations. The Transitional Coverage for Emerging Technologies (TCET) Pathway will be paused for new candidates as CMS focuses on the successful implementation of the RAPID coverage pathway. CMS will apply lessons learned across coverage pathways to strengthen and improve Medicare coverage processes over time.
A proposed procedural notice outlining the RAPID coverage pathway will soon be published in the Federal Register. The public will have 60 days to provide comments on the procedural notice. CMS will respond to public comments in a subsequent final notice. The effective date of the new pathway is expected to occur upon publication of the final notice in the Federal Register. Interested parties should look to the upcoming Federal Register publication for details on the RAPID coverage pathway and how to provide comments.
Trump to tap government contracting expert to head TSA, sources say
President Donald Trump intends to nominate a longtime business executive and government contracting expert to head the Transportation Security Administration, two sources told Reuters on Thursday.
Trump plans to tap David Cummins, a senior vice president of Serco North America who oversees its federal, state, and local government civilian customer portfolio. Earlier this month, Trump proposed privatizing much of TSA's operations and cutting nearly 10,000 employees.
Trump fired the head of TSA, David Pekoske, on the president's first day in office in 2025 and has not nominated a replacement in more than 15 months. Trump had nominated Pekoske during his first term and former President Joe Biden nominated him for a second five-year term.
A lengthy government shutdown this spring forced 50,000 TSA workers to go without pay for six weeks, resulting in major disruptions, including airport security waits extending four hours or more.
Trump's budget calls for cutting TSA by more than $1.5 billion and seeks to require smaller airports to use private security instead of TSA as a first step toward privatizing the agency created after the September 11, 2001, attacks.
The White House said this change would cut the TSA payroll by more than 4,500 jobs. The TSA proposes to cut another 4,800 jobs by improving efficiency, ending staffing at ?exit lanes and eliminating redundancies.
The employee cuts would save more than $500 million.
The proposal would cut the agency's $7.8 billion budget by about 20% and comes after TSA lost more than 1,600 workers during government funding disruptions last fall and this spring.
The Biden administration increased the size of the TSA. It screened 904 million passengers in 2024, a record high and a 5% increase over 2023.
Last year, the White House said, "TSA has consistently failed audits while implementing intrusive screening measures that violate Americans' privacy and dignity."
In September, the Homeland Security Department said it was removing five senior officials on suspicion of targeting Biden's political opponents with a now-abolished aviation security watchlist.
TSA's "Quiet Skies" program, scrapped in June, had required enhanced screening for some air passengers deemed to be a higher security risk.
FDA Requests Additional Information on AbbVie's Application for Neurotoxin
The Food and Drug Administration requested further information regarding AbbVie's application for a neurotoxin aimed at facial aesthetics.
AbbVie said Thursday the FDA's complete response letter to its biologics license application for trenibotulinumtoxinE requested additional information about manufacturing processes. The letter didn't identify any safety or efficacy concerns for the neurotoxin, the company said.
AbbVie expects to submit a response in the coming months. The company said it believes trenibotulinumtoxinE has the potential to expand patients' options in facial aesthetics.
"Though disappointed, we remain confident in the strength and integrity of our application, and we are well positioned to respond to the agency's feedback promptly to support completion of the review," said Roopal Thakkar, executive vice president, research and development, chief scientific officer at AbbVie.
Regulatory reviews for the neurotoxin in other countries are ongoing and progressing as expected, AbbVie said.
12 AGs Petition Court To Defend Trump's Executive Order On Citizenship Verification In Elections
by Janice Hisle via The Epoch Times,
Attorneys general from a dozen states on April 20 asked to intervene in two lawsuits that oppose President Donald Trump’s executive order on citizenship verification and other election integrity efforts.
The coalition of attorneys general filed motions in Massachusetts and the District of Columbia, expressing support for the president’s March 31 executive order, titled “Ensuring Citizenship Verification and Integrity in Federal Elections.”
After Trump issued the order, “left-leaning activists and progressive states” immediately challenged it, Missouri Attorney General Catherine Hanaway’s office said in a news release, “claiming it represents a federal intrusion on state authority over elections.”
She characterized Trump’s actions as “common-sense election integrity measures” in a statement and resolved to “defend every lawful step that promotes accurate [voter] rolls, secure absentee processes, and transparent administration.”
The president also issued a broader order in March 2025, titled “Preserving and Protecting the Integrity of American Elections.”
Both election-related orders have spawned numerous courtroom battles.
On April 17, a federal judge in Rhode Island became at least the fifth to rule against the Trump’ administration’s voter-roll-collection attempts. Some states agreed to turn over the requested data, but the Trump administration sued 30 states and the District of Columbia for refusing to do so.
Trump’s 2026 order requires federal agencies to compile a state citizenship list to assist state election officials in confirming which people are U.S. citizens, over 18, and residents of the state—all mandatory to be eligible to vote.
The order also instructs the U.S. Postal Service to improve security of mail-in ballots, using means such as barcodes that allow tracking of official election mail.
“Missouri and the other states are fighting for access to these resources and to work alongside the federal government in guarding the integrity of American elections,” Hanaway wrote.
Attorneys general who joined Hanaway’s coalition hail from Alabama, Florida, Indiana, Kansas, Louisiana, Montana, Nebraska, Oklahoma, South Carolina, South Dakota, and Texas.
Commerce Secretary Howard Lutnick (L) and President Donald Trump before signing an executive order on election integrity in the Oval Office on March 31, 2026. Brendan Smialowski/AFP via Getty Images
The Washington lawsuit against Trump, filed on April 1 by the Democratic Senatorial Campaign Committee and other Democrats, frames Trump’s order as another attempt to “rewrite election rules for his own perceived partisan advantage.”
The lawsuit also calls provisions of Trump’s order “convoluted and confusing,” adding, “What is clear is that it dramatically restricts the ability of Americans to vote by mail, impinging on traditional state authority.”
In a separate action filed in the District of Columbia court on April 21, a grassroots organization, Common Cause, is asking a judge to stop what it calls “an illegal and unprecedented quest to stockpile millions of Americans’ confidential voter data.”
Common Cause requested the court to “hold unlawful, stay, vacate, and set aside” the national Voter Registration Nationalization Policy and to prohibit the Justice Department from “unlawful disclosure and use” of voter data.
The Massachusetts lawsuit, filed April 2, alleges that Trump’s order “violates the constitutional separation of powers because the president doesn’t have authority to set election rules. Only the states and Congress may do so,” a news release from the Brennan Center for Justice says.
The Brennan Center’s attorneys worked with lawyers from other groups to file the federal complaint on behalf of the lead plaintiff, the League of Women Voters of Massachusetts, and additional organizations.
Euthanasia Is Now 6% Of All Deaths In The Netherlands
Euthanasia is now responsible for 6 percent of all deaths in the Netherlands, and this figure is increasing every year.
According to a report by the regional euthanasia review committee (RTE), cited by the news portal Hirado, 10,341 people died by euthanasia in 2025, and while three-quarters of the applicants were over 70 years old, one case involved someone between the age of 12 and 18.
The number of those choosing to die by euthanasia due to mental illnesses decreased by almost a fifth (174 cases), but more than 85 percent suffered from physical diseases such as cancer, nervous system disorders, and lung or cardiovascular diseases.
There were 499 cases of euthanasia performed on patients with dementia, and the RTE investigated 11 cases where the patient was no longer competent. In addition, 475 cases involved the co-existence of multiple age-related illnesses, and 278 cases involved “other reasons.”
Pro-life advocates have argued that these “other reasons” often include selfish human interests, such as family members pressuring or emotionally manipulating an older relative to go through with euthanasia in order to obtain inheritance faster. In these cases, euthanasia is often carried out even when, according to supporters, it could not be justified.
Another seven cases involved doctors who did not fully comply with the required standards of care, and these are under investigation.
Just recently in Spain, a 25-year-old woman, Noelia Castillo Ramos, ended her life, despite her parents waging a two-year legal battle, fighting until the last minute for their daughter’s life. Although a ruling by the Constitutional Court in Madrid states that euthanasia cannot be used in cases where the source of suffering is mental illness, since “the state has the duty to protect these individuals from the risk of suicide,” Castillo Ramos was nevertheless was allowed to go through with euthanasia.
According to the Christian Lawyers organization, which represented the woman’s parents at various levels during the legal battle, “this case highlights the failure of the euthanasia law, since it facilitates suicide without the individual having received prior mental health treatment,” meaning that they would have had a chance to recover and live a full and happy life.
Spain’s Catholic bishops warned that “euthanasia and assisted suicide are not medical acts, but deliberate interruptions of the bond of care, and represent a social defeat when presented as a response to human suffering.”
In Castillo’s specific case, they added, “we are not dealing with a fatal illness, but with deep wounds that cry out for attention, treatment and hope.” Their call was also significant because it could help prevent further cases that lead to the taking of innocent lives.
The Spanish bishops also reminded society that “the dignity of the human person does not depend on their state of health, their subjective perception of life or their degree of autonomy,” but rather “is an intrinsic value that must be recognized, protected and helped in all circumstances.” For this reason, the response to human suffering “can never be to cause death, but rather to offer closeness, accompaniment, appropriate care and comprehensive support.”
“When life hurts, the answer is not to shorten the path, but to walk it together. Only in this way can we build a truly just society, where no one feels alone or excluded,” they concluded.
A group of Dutch experts in the field of child psychiatry recently called attention to the need to be particularly careful when it comes to cases of young people under the age of 25 requesting euthanasia due to psychological suffering. Their research suggests that the decision-making abilities of members of this age group can be influenced by brain development and a number of external influences.
According to the professors cited, the condition of those under the age of 25 is less likely to be considered permanent than that of those older than them. In addition, they are more exposed to social pressure and online influences, which can cause significant damage and lead them to make a compulsive and short-sighted decision.
https://www.zerohedge.com/medical/euthanasia-now-6-all-deaths-netherlands
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