The toy company Hasbro Inc. said it discovered unauthorized access in its network on Saturday and has taken certain systems offline.
As the investigation continues, the company has implemented business continuity plans that will allow it to continue taking orders, shipping products and other “key operations,” according to a Wednesday filing with the US Securities and Exchange Commission. Those interim measures may last several weeks and could result in delays, the company said.
FOR IMMEDIATE RELEASE – March 19, 2026– West Sacramento, CA, Gear Isle is voluntarily recalling the following products to the consumer level. The products have been found to contain undeclared active pharmaceutical ingredients, sildenafil and tadalafil.
Gold Lion Aphrodisiac Chocolate Sachet, UPC 795847916279, LOT# no lot number, Expires: 06/2027 ilum Sex Chocolate, UPC 1002448578911, LOT# no lot number, Expires: 12/25/2027.
Risk Statement: Use of products with undeclared active ingredients sildenafil and tadalafil may pose a threat to consumers because the active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life-threatening. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are most at risk from these products. To date, Gear Isle has not received any reports of adverse events related to this recall.
The product is labeled as a dietary supplement and is packaged as indicated in the table below. The product can also be identified by using the attached images. The products were distributed nationwide via internet sales.
Product | Packaging size | UPC | Lot # | Expiration date |
|---|---|---|---|---|
Gold Lion Aphrodisiac Chocolate Male Enhancement Sachet | 1-count | 795847916279 | No lot number | 06/2027 |
ilum Sex Chocolate Male Sexual Enhancement Booster | 1-count | 1002448578911 | No lot number | 12/25/2027 |
Gear Isle is notifying its customers by notification letter and is arranging for returns and refunds of all recalled products. Consumers who have the product(s) (see table) that are being recalled should stop using them and return them for a refund.
Consumers with questions regarding this recall can contact Gear Isle customer service by calling 888-387-4753 or emailing info@gearisle.com on Monday to Friday from 10 am to 4 pm PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
The chief executive of America’s largest public hospital system says he is prepared to start replacing radiologists with artificial intelligence in some circumstances, once the regulatory landscape catches up.
Mitchell H. Katz, MD, president and CEO of NYC Health + Hospitals, recently spoke during a panel discussion held by Crain’s New York Business. The trained internal medicine specialist noted how AI is increasingly being used to interpret mammograms and X-rays.
This presents an opportunity to save on how much hospitals spend on radiologists, who have become more costly amid rising demand for imaging, Crain’s reported Thursday.
“We could replace a great deal of radiologists with AI at this moment, if we are ready to do the regulatory challenge,” Katz said at the forum, held on March 25.
Katz—who has led the 11-hospital organization since 2018—said he sees great potential for AI to increase access to breast cancer screening. Hospitals could potentially produce “major savings” by letting the technology handle first reads, with radiologists then double-checking any abnormal screenings.
Fellow panelist David Lubarsky, MD, MBA, president and CEO of the Westchester Medical Center Health Network, said his system is already seeing great success in deploying such technology. The AI Westchester uses misses very few breast cancers and is “actually better than human beings,” he told the audience.
“For women who aren’t considered high risk, if the test comes back negative, it’s wrong only about 3 times out of 10,000,” Lubarsky said.
Katz asked fellow hospital CEOs if there is any reason why they shouldn’t be pushing for changes to New York state regulations, allowing AI to read images “without a radiologist,” Crain’s reported. In this scenario, rads could then provide second opinions, if AI flags any images as abnormal. Sandra Scott, MD, CEO of the One Brooklyn Health, a small hospital facing tight margins, agreed with this line of thinking, according to Crain’s.
“I mean, I’m in charge of a safety-net institution. It would be a game-changer,” Scott said about AI being used to replace rads.
The discussion comes after Dario Amodei, PhD, CEO of Anthropic, recently made similar statements about artificial intelligence replacing rads. In a podcast interview, he falsely stated that AI has taken over the specialty’s core function, allowing doctors to focus more on the human side of the job. Radiologists roundly criticized Amodei’s remarks. Mohammed Suhail, MD, a San Diego-based rad with North Coast Imaging, said the same about Katz’s comments on Monday.
“Undeniable proof that confidently uninformed hospital administrators are a danger to patients: easily duped by AI companies that are nowhere near capable of providing patient care,” Suhail told Radiology Business. “Any attempt to implement AI-only reads would immediately result in patient harm and death, and only someone with zero understanding of radiology would say something so naive. But in some sense, they’re correct: Hospitals are happy to cut costs even if it means patient harm, as long as it’s legal.”
United States President Donald Trump and Saudi Arabia's Crown Prince Mohammed bin Salman (MbS) held a telephone call on Wednesday to discuss the current situation regarding the war with Iran, Axios correspondent Barak Ravid reported, citing two unnamed sources with knowledge of the matter.
Trump briefed the crown prince on the alleged talks with Tehran and the possibility of reaching a ceasefire. The US president previously said he could agree to end hostilities if Iran unblocked the Strait of Hormuz, but the Iranian authorities denied any negotiations were taking place.
During the course of the war, Iranian attacks also struck US military bases on Saudi territory, though Tehran maintained that its retaliation was not directed at Riyadh. On the other hand, the media speculated that Saudi Arabia pressured Trump to continue the conflict to further weaken the government in Tehran.
https://breakingthenews.net/Article/Trump-MbS-said-to-discuss-Iran-truce-over-phone/65999656
Russian State Atomic Energy Corporation (Rosatom) Director General Alexey Likhachev (pictured) announced on Wednesday that over 200 staff members will leave the Bushehr nuclear power plant this week.
"Only volunteers will remain there, including the guys from our security unit. But this is the kind of work - you cannot completely ignore the nuclear facility," Likhachev told reporters.
He also added that around 50 people will stay in Iran to ensure the "operability of construction development."
https://breakingthenews.net/Article/Rosatom-to-evacuate-over-200-people-from-Bushehr/65999834
Space Exploration Technologies Corporation, better known as SpaceX, has confidentially filed for an initial public offering (IPO) with the United States Securities and Exchange Commission (SEC), The Wall Street Journal (WSJ) reported on Wednesday, citing people familiar with the matter.
Allegedly, SpaceX's shares would likely be listed by July. Given the IPO's reported confidentiality status, investors will have to wait until a date closer to the IPO to receive an update on SpaceX's financial performance.
In the second half of March, it was alleged that SpaceX could file to go public within next weeks. Meanwhile, The Wall Street Journal reported that the space exploration company of the world's richest man, Elon Musk, was aiming to raise between $40 billion and $80 billion on the occassion, which would make it one of the biggest IPOs in history.
https://breakingthenews.net/Article/SpaceX-said-to-have-filed-for-IPO/65999522
Agios is planning to file its sickle cell disease (SCD) candidate mitapivat with the FDA under the accelerated pathway, based on feedback from the US regulator at a recent meeting.
The decision has come despite mixed results in the phase 3 RISE UP trial of the orally-active pyruvate kinase (PKR) activator, reported last November, which led to a big fall in the company's share price.
Agios said it has submitted the protocol for a proposed confirmatory trial of mitapivat for consideration by the FDA as it works towards an accelerated approval application "in the coming months."
Shares in the company rose around 20% to more than $34 after the announcement, regaining a sizeable chunk of the territory last after the RISE UP data reveal, when it was trading above $45.
In the phase 3 trial, mitapivat was shown to achieve a significant improvement compared to placebo on the haemoglobin response, a primary endpoint, but was unable to improve the annualised rate of sickle cell vaso-occlusive crises (VOCs) – the excruciatingly painful attacks that occur when red blood cells become misshapen and block blood vessels.
Agios presented the RISE UP results and data from its phase 3 programme for mitapivat at the FDA meeting, according to the company, adding that, "based on the discussion, the FDA recommended submission of a proposal for a confirmatory clinical trial to support US accelerated approval."
The US regulator has been talking a lot about exercising regulatory flexibility to make potentially clinically important new drugs available more quickly to patients, particularly for rare diseases, whilst still adhering to its obligation to approve drugs based on "substantial evidence" of effectiveness.
"Our engagements with the FDA continue to underscore both the unmet need in sickle cell disease and the importance of expeditiously advancing new treatment options for patients living with this complex, debilitating, and deadly disease," said Agios' chief medical officer, Sarah Gheuens.
The company said it has proposed a primary endpoint that is different from the one used in the RISE UP clinical programme, and it remains to be seen whether its suggestion will be accepted by the regulator.
Mitapivat has been approved in the US under the Pyrukynd trade name since 2022 as a treatment for haemolytic anaemia in adults with pyruvate kinase (PK) deficiency, and late last year claimed another approval – as Aqvesme – for anaemia associated with alpha- or beta-thalassaemia.
An approval in SCD would transform the sales potential for the drug, as around 100,000 people are living with SCD in the US, compared to around 4,000 with thalassaemia and an estimated 1,000 to 2,000 with PK deficiency.
Agios reported $54 million in revenues from Pyrukynd last year, up 48% on the prior year.
https://pharmaphorum.com/news/agios-mulls-early-fda-filing-sickle-cell-therapy
