Healio News

Topline data show upadacitinib improved severe alopecia

AbbVie released positive topline data from its phase 3 UP-AA trial demonstrating safety and efficacy for upadacitinib for severe alopecia areata in adults and adolescents.“The sudden and often unpredictable hair loss people living with [alopecia areata (AA)] experience can profoundly impact their self-esteem and mental well-being," Arash Mostaghimi, MD, MPA, MPH, associate professor of dermatol

ogy and vice chair of clinical trials and innovation, Brigham & Women's Hospital, Harvard Medical School, said in the press release. “There is a pressing need for more treatments that

3 hours 23 min ago

Health – Dominican Today

Santiago advances health tourism with new medical center

Santiago de los Caballeros.- Executives from the Specialized Hospital for Advanced Medicine (HEMA) announced that construction is nearly complete, with the grand opening scheduled for November 30, 2025. Located at kilometer 8.5 of the Duarte Highway in Puñal, Santiago, HEMA is poised to become a key player in both national healthcare and international health tourism.

Santiago de los Caballeros.- Executives from the Specialized Hospital for Advanced Medicine (HEMA) announced that construction is nearly complete, with the grand opening scheduled for November 30, 2025. Located at kilometer 8.5 of the Duarte Highway in Puñal, Santiago, HEMA is poised to become a key player in both national healthcare and international health tourism.

The hospital will feature 177 rooms, 40 permanent and 40 mobile medical offices, and specialized units for cardiology, dialysis, robotic surgery, mental health, sports medicine, and intensive care for adults, children, and newborns. The facility also includes nine operating rooms, a high-tech clinical laboratory, an imaging and pathology unit, and a modern emergency department with 26 treatment stations and 11 observation posts.

With a projected 1,140 direct and 4,000 indirect jobs in its first phase, HEMA is expected to significantly boost the regional economy.

3 hours 39 min ago

Health

STAT

STAT+: Moderna announces layoffs, and Alnylam’s heart drug sees quick uptake

Today we talk about an advance in an experimental mRNA vaccine for HIV, dive deep on Vinay Prasad’s sudden FDA departure, and more.

The need-to-know this morning

Today we talk about an advance in an experimental mRNA vaccine for HIV, dive deep on Vinay Prasad’s sudden FDA departure, and more.

The need-to-know this morning

Inside the undoing of Vinay Prasad at the FDA

Vinay Prasad’s short-lived but polarizing run as head of the FDA’s biologics division ended just 84 days in, after his aggressive push to tighten oversight on gene therapies and Covid-19 vaccines drew heat from all sides — Trump allies, RFK Jr. loyalists, Democrats, and Duchenne patient advocates.

His decision-making on Sarepta Therapeutics’ gene therapy— which he viewed as backed by staff and rooted in safety concerns — fueled political pressure that only mounted after far-right influencer Laura Loomer launched a campaign highlighting his progressive leanings and past anti-Trump comments. A powerful and extremely online regulator ran out of friends when it mattered most.

Continue to STAT+ to read the full story…

4 hours 26 min ago

Biotech, Business, Pharma, The Readout, biotechnology, drug development, drug prices, Research

STAT

STAT+: Pharmalittle: We’re reading about Prasad’s downfall at FDA, Moderna job cuts, and much more

Rise and shine, everyone, another busy day is on the way. And it is getting off to a good start here on the Pharmalot campus, where we have bright sunshine and much less humidity than in recent days. Who could ask for anything more? Actually, we could — it is time to reheat the coffee kettle for another cup of stimulation. Our choice today is … mint chocolate chip, a tasty treat.

Please feel free to join us. Remember, no prescription is required. And now, here are your tidbits. Hope you have a productive and meaningful day, and, as always, please do keep in touch. We have adjusted our settings to accept postcards and telegrams. …

Vinay Prasad had a problem. Several, actually, STAT tells us. His staff at the U.S. Food and Drug Administration kept leaking to the press. He was under attack by President Trump’s allies after moving to pull a gene therapy off the market. Democrats  were unhappy with his Covid vaccine restrictions and anti-vaccine advocates were lambasting him for approving the shots at all. He sent off an email to his team on Saturday evening, attempting to control the backlash. The agency’s recent crackdown on the gene therapy product was driven by a scientific consensus, he said. Not just him. “The motivation is solely what we think is in the public interest— the accurate judgment of benefits and risks,” Prasad wrote. By Tuesday, he was out of a job. His tenure as director of the FDA Center for Biologics Evaluation and Research lasted just 84 days. U.S. Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary opposed dismissing Prasad, but were overruled by President Trump, according to POLITICO. Meanwhile, George Tidmarsh, the FDA’s top drug regulator, was named acting director of the FDA’s Center for Biologics Evaluation and Research, STAT notes.

Eli Lilly’s blockbuster diabetes drug Mounjaro matched the ability of an older treatment to prevent major heart complications in a large trial, results that show the medication has cardiovascular benefits on top of helping lower blood sugar and weight, STAT says. Type 2 diabetes patients taking Mounjaro experienced an 8% lower risk of cardiovascular-related death, heart attack, or stroke compared to people taking Trulicity. The data mean the drug met the study goal of showing “non-inferiority” — that is, Mounjaro did not perform worse than Trulicity, but Mounjaro was not proven to be better than Trulicity. Some doctors had hoped Mounjaro would outperform Trulicity. In a survey conducted by TD Cowen analysts, doctors assigned Moujaro a 60% chance of superiority. The demonstration of non-inferiority confirms the widely held belief that Mounjaro does benefit the heart. Doctors are likely to continue prescribing the drug at the same rate, given it is already shown to be highly effective in lowering blood sugar and reducing weight.

Continue to STAT+ to read the full story…

4 hours 50 min ago

Pharma, Pharmalot, pharmalittle, STAT+

Medical News, Health News Latest, Medical News Today - Medical Dialogues |

AbbVie Eyes USD 1 Billion Buyout of Mental Health Drugmaker Gilgamesh

Bengaluru: Drugmaker AbbVie is in talks to acquire privately-held mental health therapeutics company Gilgamesh Pharmaceuticals in a deal worth about USD 1 billion, Bloomberg News reported on Wednesday, citing people familar with matter.

The U.S. drugmaker has spent over $20 billion on acquisitions since 2023 as its flagship rheumatoid arthritis treatment, Humira, lost patent protection.

Gilgamesh is a clinical-stage company developing therapies for psychiatric disorders, including depression, anxiety and post-traumatic stress disorder.

In May, AbbVie said it is partnering with Gilgamesh to develop therapies for psychiatric disorders, under which Gilgamesh could receive up to $1.95 billion in option fees and milestone payments.

Deliberations over the acquisition are ongoing and could be delayed or fall apart, Bloomberg News reported.

AbbVie and Gilgamesh did not immediately respond to Reuters' requests for comment.

Also Read: AbbVie seeks USFDA nod for combination regimen of Venclexta, Acalabrutinib for previously untreated patients with Chronic Lymphocytic Leukemia

12 hours 50 min ago

News,Industry,Pharma News,Latest Industry News

Health | NOW Grenada

GFNC headquarters officially on Archibald Avenue

The Grenada Food and Nutrition Council (GFNC) is headquarters is now located on Archibald Avenue in St George’s

View the full post GFNC headquarters officially on Archibald Avenue on NOW Grenada.

The Grenada Food and Nutrition Council (GFNC) is headquarters is now located on Archibald Avenue in St George’s

View the full post GFNC headquarters officially on Archibald Avenue on NOW Grenada.

1 day 1 hour ago

Health, Notice, PRESS RELEASE, archibald avenue, gfnc, grenada food and nutrition council

PAHO/WHO | Pan American Health Organization

PAHO’s Virtual Campus for Public Health surpasses 4 million users

PAHO’s Virtual Campus for Public Health surpasses 4 million users

Cristina Mitchell

30 Jul 2025

PAHO’s Virtual Campus for Public Health surpasses 4 million users

Cristina Mitchell

30 Jul 2025

1 day 4 hours ago

Medical News, Health News Latest, Medical News Today - Medical Dialogues |

AbbVie seeks USFDA nod for combination regimen of Venclexta, Acalabrutinib for previously untreated patients with Chronic Lymphocytic Leukemia

North Chicago: AbbVie has announced the submission of a supplemental New Drug Application (sNDA) to the U.S.

North Chicago: AbbVie has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the fixed-duration, all-oral combination regimen of VENCLEXTA (venetoclax) and acalabrutinib in previously untreated patients with Chronic Lymphocytic Leukemia (CLL), offering CLL patients another VENCLEXTA combination regimen with the potential for time-limited treatment.

The submission is based on the positive results from the Phase 3 AMPLIFY trial. The combination regimen of VENCLEXTA and acalabrutinib improved progression-free survival (PFS) compared to standard chemoimmunotherapy in previously untreated patients with CLL.

"This FDA submission marks a milestone for CLL treatment with the potential approval for the first oral combination regimen of VENCLEXTA and acalabrutinib for previously untreated patients with chronic blood cancer. This new fixed-treatment duration approach could allow patients the opportunity for time off treatment, if approved, and be potentially practice-changing in frontline CLL care," said Svetlana Kobina, vice president, global medical affairs, oncology, AbbVie.

AMPLIFY is an AstraZeneca-sponsored, global, multi-center Phase 3 trial evaluating VENCLEXTA plus acalabrutinib alone or combined with obinutuzumab versus chemoimmunotherapy in patients with previously untreated CLL without del(17p) or TP53 mutation.

Data presented at the 2024 American Society of Hematology Annual Meeting showed that the fixed-duration combination regimen of VENCLEXTA and acalabrutinib reduced the risk of disease progression or death by 35% vs chemoimmunotherapy (HR 0.65; 95% CI: 0.49-0.87; p=0.004). The safety profile of the VENCLEXTA and acalabrutinib combination regimen is consistent with the known safety profile of each individual therapy alone.

VENCLEXTA (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLEXTA targets the BCL-2 protein and works to help restore the process of apoptosis.

VENCLEXTA is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Venetoclax is approved in more than 80 countries, including the U.S.

1 day 11 hours ago

News,Industry,Pharma News,Latest Industry News

Health

How to sleep like a baby

WHEN PEOPLE talk about sleeping like a baby, they usually mean that they slept deeply and soundly. Sleep is such an integrated part of our lives, yet we tend to not give it much thought. To improve sleep, prioritise your exposure to bright light,...

WHEN PEOPLE talk about sleeping like a baby, they usually mean that they slept deeply and soundly. Sleep is such an integrated part of our lives, yet we tend to not give it much thought. To improve sleep, prioritise your exposure to bright light,...

1 day 12 hours ago

Health

Kiwanis International, Chain of Hope unite to save lives

FOUR-YEAR-OLD Allicia Samuels is a vivacious and playful child. The second of two children for Omar Samuels and Nadine Kelsey, her world has changed dramatically over the last year. In 2024, she suffered a seizure and was taken to the doctor in her...

FOUR-YEAR-OLD Allicia Samuels is a vivacious and playful child. The second of two children for Omar Samuels and Nadine Kelsey, her world has changed dramatically over the last year. In 2024, she suffered a seizure and was taken to the doctor in her...

1 day 12 hours ago

Health and Science

Trump's pharmaceutical tariffs could affect some drugmakers more than others

AbbVie, Bristol Myers Squibb and Eli Lilly appear "relatively well-positioned," while Novartis and Roche look more at risk, TD Cowen analyst Steve Scala said.

AbbVie, Bristol Myers Squibb and Eli Lilly appear "relatively well-positioned," while Novartis and Roche look more at risk, TD Cowen analyst Steve Scala said.

1 day 21 hours ago

PAHO/WHO | Pan American Health Organization

PAHO Director warns of intensifying climate threats to health in the Americas at global conference in Brazil

PAHO Director warns of intensifying climate threats to health in the Americas at global conference in Brazil

Cristina Mitchell

29 Jul 2025

PAHO Director warns of intensifying climate threats to health in the Americas at global conference in Brazil

Cristina Mitchell

29 Jul 2025

2 days 4 hours ago

Health – Dominican Today

Undernourishment in the Dominican Republic drops to 3.6%, FAO reports

Santo Domingo.- The Dominican Republic has significantly reduced its undernourishment rate to 3.6% of the population, according to the latest report from the Food and Agriculture Organization (FAO) of the United Nations. This marks a steady improvement from 8.7% in 2020 and 4.6% in 2024, reflecting continued progress toward eradicating hunger.

Santo Domingo.- The Dominican Republic has significantly reduced its undernourishment rate to 3.6% of the population, according to the latest report from the Food and Agriculture Organization (FAO) of the United Nations. This marks a steady improvement from 8.7% in 2020 and 4.6% in 2024, reflecting continued progress toward eradicating hunger.

Minister of the Presidency José Ignacio Paliza celebrated the achievement, calling it “good news” and emphasizing that the country is moving closer to meeting the United Nations’ Sustainable Development Goal of “Zero Hunger” by 2030.

The FAO attributes this success to targeted public policies that have enhanced agricultural production, increased access to food, and improved living conditions for vulnerable communities across the country.

2 days 5 hours ago

Health, Food and Agriculture Organization (FAO), undernourishment, United Nations’ Sustainable Development Goal of “Zero Hunger”

KFF Health News

Lawfully Present Immigrants Help Stabilize ACA Plans. Why Does the GOP Want Them Out?

If you want to create a perfect storm at Covered California and other Affordable Care Act marketplaces, all you have to do is make enrollment more time-consuming, ratchet up the toll on consumers’ pocketbooks, and terminate financial aid for some of the youngest and healthiest enrollees.

And presto: You’ve got people dropping coverage; rising costs; and a smaller, sicker group of enrollees, which translates to higher premiums.

The Trump administration and congressional Republicans have just checked that achievement off their list.

They have done it with the sprawling tax and spending law President Donald Trump signed on July 4 and a related set of new regulations released by the Centers for Medicare & Medicaid Services that will govern how the ACA marketplaces are run.

Among the many provisions, there’s this: Large numbers of lawfully present immigrants currently enrolled in Obamacare health plans will lose their subsidies and be forced to pay full fare or drop their coverage.

Wait. What?

I understand that proponents of the new policies think the government spends too much on taxpayer subsidies, especially those who believe the ACA marketplaces are rife with fraud. It makes sense that they would support toughening enrollment and eligibility procedures and even slashing subsidies. But taking coverage away from people who live here legally is not health care policy. It’s an echo of the federal immigration raids in Los Angeles and elsewhere.

“It’s creating a very hostile environment for them, especially after having to leave their countries because of some very traumatic experiences,” says Arturo Vargas Bustamante, a professor of health policy and management at UCLA’s Fielding School of Public Health. “For those who believe health care is a human right, this is like excluding that population from something that should be a given.”

In Covered California, 112,600 immigrants, or nearly 6% of total enrollees, stand to lose their federal tax subsidies when the policy takes effect in 2027, according to data provided by the exchange. In the Massachusetts and Maryland marketplaces, the figure is closer to 14%, according to their directors, Audrey Morse Gasteier and Michele Eberle, respectively.

It’s not clear exactly how much financial aid those immigrants currently receive in ACA marketplaces. But in Covered California, for example, the average for all subsidized enrollees is $561 per month, which covers 80% of the $698 average monthly premium per person. And immigrants, who tend to have lower-than-average incomes, are likely to get more of a subsidy.

The immigrants who will lose their subsidies include victims of human trafficking and domestic violence, as well as refugees with asylum or with some temporary protected status. And “Dreamers” will no longer be eligible for ACA marketplace health plans because they will not be considered lawfully present. Immigrants who are not in the country legally cannot get coverage through Covered California or most other ACA marketplaces.

The nearly 540,000 Dreamers in the United States arrived in the U.S. as kids without immigration papers and were granted temporary legal status by President Barack Obama in 2012. Of those, an estimated 11,000 have ACA health plans and would lose them, including 2,300 in Covered California.

Supporters of the policy changes enshrined in the CMS rule and budget law think it’s high time to rein in what they say are abuses in the system that started under the Biden administration with expanded tax credits and overly flexible enrollment policies.

“It’s about making Obamacare lawful and implementing it as drafted rather than what Biden turned it into, which was a fraud and a waste-infused program,” says Brian Blase, president of Arlington, Virginia-based Paragon Health Institute, which produces policy papers with a free-market bent and influenced the Republican-driven policies.

But Blase doesn’t have much to say about the termination of Obamacare subsidies for lawfully present immigrants. He says Paragon has not focused much on that subject.

Jessica Altman, executive director of Covered California, expects most immigrants who lose subsidies will discontinue their enrollment. “If you look at where those populations fall on the income scale, the vast majority are not going to be able to afford the full cost of the premium to stay covered,” she says.

Apart from the human hardship cited by Bustamante, the exodus of immigrants could compromise the financial stability of coverage for the rest of Covered California’s 1.9 million enrollees. That’s because immigrants tend to be younger than the average enrollee and use fewer medical resources, thus helping offset the costs of older and sicker people who are more expensive to cover.

Covered California data shows that immigrant enrollees targeted by the new federal policies pose significantly lower medical risk than U.S. citizens. And a significantly higher percentage of immigrants in the exchange are ages 26 to 44, while 55- to 64-year-olds make up a smaller percentage.

Still, it would be manageable if immigrants were the only younger people to leave the exchange. But that is unlikely to be the case. More red tape and higher out-of-pocket costs — especially if enhanced tax credits disappear — could lead a lot of young people to think twice about health insurance.

The covid-era enhanced tax credits, which have more than doubled ACA marketplace enrollment since their advent in 2021, are set to expire at the end of December without congressional action. And, so far, Republicans in Congress do not seem inclined to renew them. Ending them would reverse much of that enrollment gain by jacking up the amount consumers would have to spend on premiums out of their own pockets by an average of 66% at Covered California and more than 75% nationally.

And an analysis by the Congressional Budget Office shows that a consequent exodus of younger, healthier people from the marketplaces would lead to even greater costs over time.

Enhanced tax credits aside, consumers face additional hurdles: The annual enrollment period for Covered California and other marketplaces will be shorter than it is now. Special enrollment periods for people with the lowest incomes will be effectively eliminated. So will automatic renewals, which have greatly simplified the process for a majority of enrollees at Covered California and some other marketplaces. Enrollees will no longer be able to start subsidized coverage, as they can now, before all their information is fully verified.

“Who are the people who are going to decide to go through hours and hours of onerous paperwork?” says Morse Gasteier. “They’re people who have chronic conditions. They have health care issues they need to manage. The folks we would expect not to wade through all that red tape would be the younger, healthier folks.”

California and 20 other states this month challenged some of that red tape in a federal lawsuit to stop provisions of the CMS rule that erect “unreasonable barriers to coverage.” California Attorney General Rob Bonta said he and his fellow attorneys general hoped for a court ruling before the rule takes effect on Aug. 25.

“The Trump administration claims that their final rule will prevent fraud,” Bonta said. “It’s obvious what this is really about. It’s yet another political move to punish vulnerable communities by removing access to vital care and gutting the Affordable Care Act.”

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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2 days 8 hours ago

Asking Never Hurts, california, Health Care Costs, Insurance, States, Immigrants, Legislation, Maryland, Massachusetts, Obamacare Plans, Trump Administration

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