Ability to dose TERN-701 without regard to food represents a key potential differentiator within the allosteric BCR-ABL inhibitor class
Pharmacokinetic data show no clinically significant difference in exposure between fed and fasted dosing
Phase 1 CARDINAL trial evaluating TERN-701 in 2L+ CML patients remains ongoing, with interim data from initial cohorts anticipated in second half of 2024
Health insurance plans run by U.S. states must cover gender-affirming surgeries for transgender people, a U.S. appeals court ruled on Monday.
The 8-6 opinion from the Richmond, Virginia-based 4th U.S. Circuit Court of Appeals upheld two lower court rulings, which had found that North Carolina's state employee health insurance plan discriminated against transgender people by not covering surgeries for "sex changes or modifications," and that West Virginia's Medicaid program discriminated by excluding "transsexual surgeries."
Circuit Judge Roger Gregory, who was appointed by Democratic former President Bill Clinton, wrote for the majority that such policies were "obviously discriminatory" because they did not cover medically necessary treatments for transgender people that they did cover for others. For example, he wrote, they would cover a mastectomy to treat cancer but not gender dysphoria, the distress caused by identifying as a gender different from the one assigned at birth.
North Carolina Treasurer Dale Folwell said in a statement that the state employee plan was "facing the real risk of looming insolvency" and "cannot be everything for everyone." He said he would "follow every legal avenue available to protect the Plan and its members."
West Virginia Attorney General Patrick Morrisey said the state would appeal to the U.S. Supreme Court.
"Our state should have the ability to determine how to spend our resources to care for the vital medical needs of our citizens," he said.
The case began with separate lawsuits brought by transgender people challenging each state's insurance program. The appeals were combined because they involved similar legal issues.
"The court's decision sends a clear message that gender-affirming care is critical medical care for transgender people and that denying it is harmful and unlawful," said Omar Gonzalez-Pagan, a lawyer at the LGBT group Lambda Legal, which represented the plaintiffs.
The states had argued that their programs' exclusions did not discriminate because they were based on patients' diagnosis and treatment, not transgender identity.
Gregory rejected that claim, saying the states' basis for denying coverage was a "proxy" for discriminating against transgender people.
Circuit Judge Jay Richardson, who was appointed by Republican former President Donald Trump, wrote in a dissent that states "can reasonably decide that certain gender dysphoria services are not cost-justified, in part because they question the services' medical efficacy and necessity."
Monday's ruling comes as part of a broader battle over healthcare for transgender people in the United States.
At least 22 Republican-controlled states have passed laws restricting gender-affirming care for people under 18, leading to legal challenges that have so far had mixed outcomes.
The U.S. Supreme Court earlier this month allowed Idaho to enforce its ban for now, while an Ohio court temporarily blocked a ban there.
At current exchange rates, sales fell by 6% over the first three months of the year. The erosion in sales is minimal, but has been ongoing for two years, and is no doubt partly linked to the Swiss franc's trajectory over the period; in this quarter, the currency effect alone wiped out all growth in the pharmaceuticals segment.
The Group's publication emphasizes growth in "base business", adjusted for the surge in activity linked to Covid, as well as performance at constant exchange rates, in order to defend another balance sheet, with, in theory, 7% growth for the quarter. Financial communication gimmick or legitimate reinterpretation of results? It's up to investors to decide which version they find more credible.
What is certain is that Roche has embarked on a slimming cure. As an R&D titan and oncology heavyweight, the Swiss group used to maintain an extraordinarily dense pipeline. But in the last six months, under the leadership of its new CEO Thomas Schinecker, one-fifth of its research programs for new molecules have been abandoned.
Manufacturing operations are also under the microscope. Last month, Roche sold Genentech's Vacaville facility in California to its compatriot Lonza for $1.2 billion. This complex restructuring program is still in its early stages; it is part of a geographical and technical pivot for the Group, which intends to develop new production capacities in gene therapy.
Roche should receive the green light from the regulator in the coming months to market its treatments for paroxysmal nocturnal hemoglobinuria and a class of breast cancers. Unlike Bayer, for example, the Group is not beset by patent expiry deadlines; to date, 55% of its portfolio of marketed treatments is still considered innovative.
Among these, the Ocrevus , Hemlibra , Tecentriq and Alecensa franchises - for the treatment of multiple sclerosis, hemophilia and lung cancer - account for two-thirds of sales; the other third is largely dominated by the ophthalmic treatment Vabysmo.
Covid-related distortion aside, the Group's long-term economic and financial performance remains remarkably stable. In the pantheon of major pharmaceutical groups, Roche also remains the most respected institution in R&D - despite some recent setbacks, notably in the fight against Alzheimer's disease and the abandonment of Carmot Therpautics' anti-obesity treatment, despite its acquisition a few months ago.
By falling to a valuation floor of fifteen times earnings, the Group's market capitalization is back on a low it hasn't seen since 2012; over the last decade, it traded at an average of twenty times earnings.
“Numerous” police officers were wounded when gunfire erupted Monday in a suburban neighborhood outside of Charlotte, North Carolina, according to police.
The shooting broke out just before 2 p.m., with “multiple” people having been taken to the hospital in unknown conditions, police said.
The Charlotte-Mecklenburg Police Department (CMPD) described the situation as “still active” and advised people to avoid the area.
“This is an active investigation, if you are in the area, please remain in your residence or steer clear of the scene,” CMPD said.
SWAT teams from the department have been dispatched to the scene, cops said.
https://nypost.com/2024/04/29/us-news/police-officers-wounded-in-shooting-near-charlotte/
An OnlyFans creator and TikTok star has claimed she was paid to spread “political propaganda” for the Biden administration on social media — and that she was asked to hide the fact it was advertising.
Farha Khalidi said she’d been asked to help boast about then-Judge Ketanji Brown Jackson to her tens of thousands of social media followers after Brown Jackson was nominated to the Supreme Court by President Biden.
“I was doing full-on political propaganda,” the social media personality said during a recent podcast interview with commentator Richard Hanania.
“The funny thing is they’re, like, ‘Do not disclose this as an ad’ because they [were], like, ‘Technically, it’s not a product, so you don’t have to disclose it’s an ad.’ Because I think they just wanted, like, some edgy girl of color to just tell people — like when they nominated Ketanji Brown Jackson, they’re, like, ‘Can you say “as a person of color,” you know, that you feel “reflected”?’”
When probed about the Biden admin, Khalidi, who boasts more than 119,000 Instagram followers, clarified that she was dealing with a “conduit” third-party media company at the time.
“It’s not Biden, but it’s, like, a third party. You know what I mean? It’s, like, a media company that’s doing it on his behalf. I’m not blaming him for this,” Khalidi said.
She went on to say that she ultimately pushed back against the “script” because it was a white woman from the media company telling her what to say.
“And I’m, like, ‘No,’ and she’s like, ‘Please,’ and I’m like, ‘No.’ I’ll talk about the news of it, but I’m not gonna be like — I’m not gonna have a white person tell me to be, like, ‘This is how I feel as a person of color.’ It’s just so — I think that black-pilled me slightly on political propaganda,” Khalidi said.
“Yeah, they’re basically, ‘As, like, another black person, can you just say that you feel reflected by Ketanji?’ I’m like, ‘No, I’ll talk about Ketanji’s background and her accomplishments,’ but you know what I mean? I’ll never — I’m not gonna say, like, the corny stuff, even if it was a brown person emailing it to me.”
The White House didn’t immediately respond to The Post’s request for comment.
Elsewhere in the interview, Khalidi said the political payments were just one way she was raking in cash during college.
“I was taking ads by the time I graduated college from, like, the Biden administration, Planned Parenthood and, like, dating apps and stuff. So it was, like, fully financially sustaining me,” Khalidi said.
It wasn’t immediately clear exactly how much Khalidi was paid.
The Centers for Medicare and Medicaid Services (CMS) announced the delay of the implementation of its restrictions on accessing Medicare and Medicaid data. Initially, the agency planned to start implementation in August 2024, regardless of public feedback. These restrictions would erect data access barriers, hinder research activities, and shield Medicare and Medicaid programs from public scrutiny. What prompted CMS to change course?
CMS apparently did not seek input from data users before announcing the restrictions on February 12th, causing an immediate revolt in the research community. Columbia University professor Adam Sacarny broke the news on social media, which was then picked up by Dan Diamond at the Washington Post the following day. On February 15th, hundreds of researchers signed a letter to CMS protesting the restrictions.
Subsequently, Christian Miller at ProPublica wrote a news story. STAT News, Briefing Book, and Forbes published opinion pieces by academics Rachel Werner (the University of Pennsylvania), Joshua Gottlieb (the University of Chicago), Kevin Rinz (the U.S. Census Bureau), and myself (Johns Hopkins University). Michael Cannon at the Cato Institute also wrote an article to lend support. Meanwhile, the research community ran a grassroots campaign through both public discourse and engagements with the agency and lawmakers behind the scenes.
The climax occurred on March 15th during a U.S. Senate Finance Committee hearing. Senator Bill Cassidy (R-LA) questioned Health and Human Services Secretary Xavier Becerra on CMS’s actions and requested changes. Senator Cassidy, a physician and senior Republican leader, wields substantial power in healthcare policy. Soon after his intervention, CMS announced the delay of implementation and its willingness to “carefully consider and be responsive to comments and concerns.”
While it remains unclear what CMS will ultimately do, lessons should be learned from this battle for data access and government program accountability. It’s important not only for researchers but also for all stakeholders in U.S. healthcare, which is heavily shaped by government policies.
First, individuals making decisions in government agencies do not possess perfect knowledge of the consequences of their decisions, which can cause far more harm than intended benefits to the public. While government workers should recognize their limitations, it’s up to the public to proactively express concerns and debate the optimal option.
Second, the self-interest of individuals making agency decisions is often not well aligned with the interests of stakeholders affected by those decisions, such as in the case of COVID-19 “free” tests. Just as the public demands stakeholders’ monitoring of decisionmakers in corporate America (referred to as “governance” in environmental, social, and governance or ESG), we should also be vigilant about misaligned incentives and strengthen public monitoring of government agencies.
Third, where there’s political will, there’s a political way, even without lobbying dollars. Political will without orchestrated financial support can still overpower deep-pocketed special interest groups. Washington, D.C. operates around not only money, but also public sentiment.
Government agencies are run by human beings with flaws—just like all of us, not by individuals with perfect knowledge and incentives totally aligned with the public interest. The curiosity to seek truth among researchers is as formidable as the aspiration to push boundaries among innovators. This force is the ultimate driver of our economy and prosperity, fostering the political will not to be conquered.
