FDA OKs Inflatable Penile Prosthesis for Erectile Dysfunction

 The FDA approved the Titan Prime inflatable penile prosthesis for men with erectile dysfunction, Coloplast announced on Wednesday.

This prosthesis is indicated for men who are considered to be candidates for implantation of a penile prosthesis, and is "designed to emulate the appearance and performance of a natural erection, supporting device performance for patients, surgeons, and partners," the company said.

The device is made with a proprietary material called Bioflex -- a polymer engineered for greater strength and durability than silicone -- and is implanted through a single outpatient procedure.

Patients should expect a recovery time of 4 to 6 weeks after implant before they can resume sexual activity.

A systematic review and meta-analysis published in 2022 reported that the median survival time of inflatable penile prostheses is approximately 20 years, with a device survival of 93.3% at 1 year, 91% at 3 years, 87.2% at 5 years, 76.8% at 10 years, 63.7% at 15 years, and 52.9% at 20 years.

The Titan Prime prosthesis is contraindicated in patients who have an active infection present anywhere in the body, especially a urinary tract or genital infection, a documented hypersensitivity or allergic reaction to silicone or polyurethane, unresolved problems affecting urination (such as elevated residual urine volume secondary to bladder outlet obstruction or neurogenic bladder), and those unwilling to undergo any further surgery for device revision.

Warnings include the potential for re-surgery, and the possible increased risk of infection in diabetic and immunocompromised patients that could result in permanent damage to tissue/organs.

Adverse events that can occur with penile prosthesis procedures and implants (and which may require revision surgery or device removal) include acquired phimosis, adhesions, bladder storage symptoms, capsular contracture, deformity, delayed/impaired/abnormal wound healing, discomfort, erosion/extrusion, fistula, foreign body reaction, hematoma/seroma, hemorrhage/bleeding, hernia, hypersensitivity/allergic reaction, induration, infection, inflammation, male dyspareunia, necrosis, obstruction/occlusion, pain, scar tissue, sexual dysfunction, tactile disorders, urinary incontinence symptoms, urinary tract infection, voiding symptoms, and perforation or injury of soft tissue, structures, or organs.

The Titan Prime inflatable penile prosthesis will be available in the U.S. later this year.

https://www.medpagetoday.com/urology/erectiledysfunction/121585

FDA Approves Oral Antiviral to Prevent COVID-19 After Exposure

 The FDA approved the oral antiviral agent ensitrelvir (Xocova) to help prevent COVID-19 in people ages 12 years or older who were exposed to the SARS-CoV-2 virus, drugmaker Shionogi announced.

Ensitrelvir is a SARS-CoV-2 main protease inhibitor also approved in Japan as COVID-19 postexposure prophylaxis (PEP) and as a treatment for mild to moderate COVID. The drug is not approved to treat COVID-19 in the U.S.

The FDA's decision was based on the phase III SCORPIO-PEP trial, which showed the risk of getting sick from a household contact with COVID-19 dropped by more than half among those who took ensitrelvir compared with placebo.

In a modified intention-to-treat (ITT) population of a COVID patient's household contacts, 2.9% of those who took at least one dose of oral ensitrelvir PEP developed COVID within 10 days compared with 9% of those receiving placebo (P<0.001). In SCORPIO-PEP's full ITT population, 4.4% of ensitrelvir patients developed COVID by that point compared with 10.2% of the placebo group (P<0.001).

Ensitrelvir "provides an important new approach to preventing COVID-19, which continues to impact lives," SCORPIO-PEP investigator Frederick Hayden, MD, of the University of Virginia in Charlottesville, said in a statement. "It could be useful not only in household settings but also in other exposure circumstances, such as outbreaks in nursing homes, chronic or acute care facilities, and following travel-related exposures."

Patients in the ensitrelvir and placebo groups saw similar adverse event rates (15.1% vs 15.5%) in the phase III trial. The most common events occurring in at least 1% of those taking ensitrelvir and at a greater frequency compared with placebo were headache, diarrhea, and cough. There were no reports of altered taste attributed to ensitrelvir in the trial.

Ensitrelvir should be started within 72 hours of contact with someone who has COVID. The antiviral's 5-day regimen begins with three 125-mg tablets taken on day 1 and one 125-mg tablet taken on days 2 through 5.

Ensitrelvir should not be taken with drugs that are primarily metabolized by CYP3A. Pregnant women and females of reproductive potential should be advised that ensitrelvir may cause fetal harm. Breastfeeding should be stopped during treatment and for 2 weeks after the final ensitrelvir dose.

https://www.medpagetoday.com/infectiousdisease/covid19/121530

Novel Concept, 'Immune Dimming,' Explored in Rheumatoid Arthritis

 In yet another effort to repurpose oncology drugs for autoimmune disease, a researcher reported here that low doses of blinatumomab (Blincyto, Amgen) given to patients with treatment-resistant rheumatoid arthritis (RA), while not reprogramming the immune system to a fully normal state, did restore patients' responsiveness to more conventional RA drugs.

Of 15 patients receiving blinatumomab under this protocol, initially all of them obtained some degree of clinical improvement, with 11 achieving ACR50 response (50% reduction in RA severity by American College of Rheumatology criteria), but 14 of the group relapsed after a mean of 5 months, according to Laura Bucci, MD, of Friedrich-Alexander-Universität Erlangen-Nürnberg in Germany.

Some of those 14 were then treated again with targeted disease-modifying anti-rheumatic drugs (DMARDs), usually the same ones they had previously tried and failed -- and this time, a majority showed responses that lasted up to 6 months, she told attendees at the European Alliance of Associations for Rheumatology's (EULAR) annual meeting.

The concept, Bucci said, is called "immune dimming," in that it does not "reset" the immune system to terminate all anti-self activity, as is the goal with chimeric antigen receptor (CAR) T-cell therapy, pioneered a few years ago for autoimmune diseases by Georg Schett, MD, at the same institution. (Schett is a co-author for the current study.)

How low-dose blinatumomab works to restore DMARD responsiveness in these patients, all of whom had previously received multiple targeted therapies without lasting success, remains uncertain, Bucci acknowledged when an audience member asked following her talk. "We need more patients and more studies" to figure that out, she said.

Both for oncology and rheumatology, blinatumomab is an unusual drug. It's considered a "bispecific T-cell engager": it has two different protein-binding elements, one that binds the CD19 antigen on B cells, the other targeting the CD3 T-cell protein on T cells, inducing the latter to destroy the former. The drug is approved for a variety of B-cell malignancies, but -- as with CAR T-cell therapy, also originally developed for such cancers -- it might also be adapted for autoimmune conditions driven by rogue B cells.

RA hasn't traditionally been considered one of those, but B cells are still involved in it; autoantibodies are present in most RA cases (albeit with uncertain pathological importance). An earlier presentation at EULAR this week (also, naturally, with Schett as co-author) found that CAR T-cell treatment could indeed lead to remission in heavily pretreated RA.

The new study is actually a follow-up to one Bucci had reported 2 years ago at EULAR, in which six patients at that point had received low-dose blinatumomab. Findings then were very positive, with all six patients showing strong clinical and biomarker responses. Treatment then was provided to nine additional patients, with similarly positive early responses.

Blinatumomab was administered in two or three cycles, starting with 9 μg by infusion, raised to 28 μg in the second cycle for some patients. Those given a third cycle got the same dose as in the second.

However, closer examination revealed that B cells were not fully depleted within lymph nodes, and as noted above, all but one of the patients relapsed over the following months. Some reduction in immunoglobulins were seen but they were not as deep as with CAR-T treatment. Autoantibodies rebounded in many patients after the initial decline.

Bucci said some patients were retreated with blinatumomab, but they still had the same pattern of initial response followed by relapse. Consequently, it was decided to try again with standard targeted DMARDs in a subset of the cohort. Qualitative results were as follows:

• Five patients had previously received abatacept (Orencia); two were retreated; one showed a significant response
• Five patients had previously received a JAK inhibitor; four were retreated; all four showed significant responses
• Three patients had previously received a tumor necrosis factor inhibitor; all three were retreated; two showed significant responses

In total, eight patients remained on DMARD therapy with follow-up of 11 to 18 months after completing the blinatumomab regimen.

One patient of the 14 who relapsed after blinatumomab was lost to follow-up and another was not restarted on a regular DMARD but was instead given teclistamab (Tecvayli), also a bispecific T-cell engager, which also failed.

Bucci said controlled studies are required to determine whether "immune dimming" is a viable approach in RA, or, for that matter, other autoimmune disorders.

Disclosures

Bucci declared she had no relevant financial interests. Certain co-authors reported relationships with numerous pharmaceutical companies.

Primary Source

European Alliance of Associations for Rheumatology

Source Reference: Bucci L, et al "'Immune dimming' with low-dose blinatumomab reverses the treatment-resistant state in rheumatoid arthritis" EULAR 2026; Abstract OP0203.

https://www.medpagetoday.com/meetingcoverage/eular/121591

Robinhood launches World Cup prediction markets

 Robinhood Markets, Inc. launched on Thursday the World Cup prediction markets via Rothera, a new exchange jointly owned by Robinhood and Susquehanna International Group.

According to the company, Rothera will handle contracts tied to individual matches, group and tournament winners, player performance, spreads, player contracts, and combos. Robinhood also stated that the contracts will be available to all eligible customers in the coming days.

"The World Cup is a global phenomenon and is the perfect event to launch Rothera. We're now delivering even more value for customers as we continue on our mission to make Robinhood the best place to trade prediction markets," VP and GM of Futures and Prediction Markets at Robinhood, JB Mackenzie, noted.

https://breakingthenews.net/Article/Robinhood-launches-World-Cup-prediction-markets/66439719

UN nuclear watchdog urges Iran to urgently cooperate, implement NPT

 

• The UN nuclear watchdog sent a report to member states on Thursday repeating its calls on Iran to urgently inform the agency of the fate of its enriched uranium since its atomic sites were bombed a year ago and let inspections resume fully, Reuters reported, citing a confidential report.

https://www.iranintl.com/en/liveblog/202605308417

Three Iranian Kurdish parties deny receiving US, Israeli arms

 

Three Iranian Kurdish opposition parties told Iran International they had received no weapons from Israel or the United States, rejecting the reports as entirely false.

Abdullah Mohtadi, secretary-general of the Komala Party of Iranian Kurdistan, told Iran International that his party has not received any weapons from Israel or the United States.

Khalid Azizi, spokesman for the Democratic Party of Iranian Kurdistan, also told Iran International that his party has received no weapons from Israel or the United States, saying the reports are “completely untrue.”

Reza Kaabi, secretary-general of the Komala Party of Toilers of Kurdistan, also denied receiving any weapons from Israel or the United States and said other Iranian Kurdish parties had not received any weapons from the two countries either.

https://www.iranintl.com/en/liveblog/202605308417

California loses Fortune 500 crown to Texas as billionaire tax threat looms

 A shifting economic landscape has culminated in Texas, dethroning California as the nation's premier hub for Fortune 500 companies.

Data from the 2026 Fortune 500 list show Texas leading with 57 headquarters, compared with California’s 56, marking a reversal from two years ago, when California held the lead.

Additionally, corporations in Texas generated $2.8 trillion in revenue, while those in California reported $2.7 trillion in revenue.

"Texas is the undisputed headquarters of headquarters," Texas Gov. Greg Abbott said in a press release reacting to the news. "The world’s leading businesses invest with confidence in Texas because of our welcoming business climate, predictable regulatory environment, and skilled and growing workforce. People and businesses are choosing Texas because Texas works."

In the past year alone, companies including ExxonMobil, Chevron, Samsung Electronics America, SpaceX and X have either moved their headquarters or their legal incorporation to Texas — mostly from California, with two moving from New Jersey.

Company relocations have also been accompanied by billionaires and public figures moving their homes and personal portfolios to the Lone Star State. Most recently, Uber co-founder Travis Kalanick revealed his move to Austin, while Elon Musk, Mark Cuban, Palantir co-founder Joe Lonsdale and David Sacks have made their mark on Texas in recent years.

"Americans are voting with their feet. They want places that are livable. They want places that are workable. They want places that are sustainable and affordable," Texas REALTORS Chair Jennifer Wauhob previously told Fox News Digital. "And so I think this migration, as we call it, is really turning into a long-term shift."

The migration of major corporations and prominent business figures comes amid mounting concern over California's proposed tax policies, including a controversial one-time 5% wealth tax on the state’s wealthiest residents.

The Service Employees International Union–United Healthcare Workers West (SEIU-UHW) said it has collected more than 1.55 million signatures, according to a press release, nearly double the 875,000-signature requirement — to place a one-time tax on billionaire assets on the California ballot.

The California Billionaire Tax Act would target the net worth of roughly 200 residents and impose a one-time 5% tax on the net worth of California residents with assets exceeding $1 billion. The tax would be due in 2027, and taxpayers could spread payments over five years, with interest, according to the Legislative Analyst’s Office.

If the measure is approved by voters in November, anyone who was a California resident on Jan. 1, 2026, would owe the tax, according to the proposal. In practical terms, a resident with $20 billion in net worth on that date would owe a one-time tax of $1 billion, payable over five years.

Supporters argue the billionaire tax is a direct response to "cuts to Medicaid and other federal health insurance programs by the Trump administration last year," while opponents of the measure have warned the tax could kill an estimated 108,000 high-paying jobs over the next 20 years.

https://www.foxbusiness.com/economy/california-loses-fortune-500-crown-texas-billionaire-tax-threat-looms