Latest news with #FDA
Yahoo
an hour ago
- Business
- Yahoo
Perspective Therapeutics Commences Recruitment for [212Pb]VMT-α-NET in the Third Dose Escalation Cohort of its Ongoing Phase 1/2a Clinical Trial
[212Pb]VMT-α-NET Phase 1/2a study is advancing into Cohort 3 with a fixed administered dose that is up to 20% higher (6 mCi) than the dose administered to patients in Cohort 2 Dosimetry sub-study analysis presented at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2025 Annual Meeting to advance utility of dosimetry in clinical development when considered with clinical data On track to submit further clinical updates to scientific congresses in 2H 2025, including longer safety follow-up on all patients who have received at least one treatment of [212Pb]VMT-α-NET and anti-tumor activities in patients dosed to date who have had the opportunity to receive at least one scan after their full treatment SEATTLE, June 21, 2025 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. ("Perspective" or the "Company") (NYSE AMERICAN: CATX), a radiopharmaceutical company pioneering advanced treatments for cancers throughout the body, today announced that alignment was reached with the U.S. Food and Drug Administration (FDA) to open the third dosing cohort (Cohort 3) of its ongoing Phase 1/2a clinical trial for [212Pb]VMT-α-NET in patients with unresectable or metastatic somatostatin receptor 2 (SSTR2)-positive neuroendocrine tumors (NETs) who have not received prior radiopharmaceutical therapies (RPT). "We are excited to start exploring a higher dose level of VMT-α-NET after successfully completing an interaction with the FDA that was agreed prior to commencement of this trial," commented Markus Puhlmann, Chief Medical Officer of Perspective. "We are encouraged by the overall clinical profile observed at the second dose level of VMT-α-NET—including evidence of anti-tumor activity and primarily low-grade adverse events—and we believe it is important to assess whether a higher dose could further improve the therapeutic profile. Meanwhile, we remain committed to engaging with the FDA to evaluate the clinical utility of dosimetry estimates and analyses in the development of our proprietary RPTs." Patients in Cohort 3 will receive up to four fixed administered doses of [212Pb]VMT-α-NET at 6 mCi every eight weeks if they weigh more than 60kg (133lb), or 100μCi/kg of body weight if they weigh less than or equal to 60kg. Observations of dose limiting toxicities (DLTs) in up to eight patients within 42 days of the first treatment cycle will be used to assess whether this cohort of patients have received maximum tolerated dose (MTD) or maximum feasible dose (MFD). Once a safety monitoring committee (SMC) has reviewed the data from these initial patients, it may recommend exploring alternative dosing and/or recruit more patients into Cohort 3. Perspective is notifying sites that Cohort 3 is now open for recruitment. Patients currently being evaluated for entry into the study will enroll into Cohort 3 if they qualify. Pending feedback from sites on operationalizing enrollment into Cohort 3, an update on pace of recruitment will be provided in due course. About [212Pb]VMT-α-NETPerspective designed [212Pb]VMT-α-NET to target and deliver 212Pb to tumor sites expressing SSTR2. The Company is conducting a multi-center, open-label, dose-escalation, dose-expansion study ( identifier NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-positive neuroendocrine tumors who have not received a prior RPT. Interim update with a data cut-off date of April 30, 2025 were reported in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in May 2025. Cohort 2 was reopened in August 2024. During 2H 2025, some of the 33 additional patients enrolled after the cohort reopened and through April 30, 2025 will have had the opportunity for at least 32 weeks of follow-up after their initial doses, sufficient time to receive at least one scan after their full treatment (up to four doses every eight weeks), if they receive all four doses of treatment per protocol. About Perspective Therapeutics, Therapeutics, Inc. is a radiopharmaceutical company pioneering advanced treatments for cancers throughout the body. The Company has proprietary technology that utilizes the alpha-emitting isotope 212Pb to deliver powerful radiation specifically to cancer cells via specialized targeting moieties. The Company is also developing complementary imaging diagnostics that incorporate the same targeting moieties, which provides the opportunity to personalize treatment and optimize patient outcomes. This "theranostic" approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity. The Company's melanoma (VMT01), neuroendocrine tumor (VMT-α-NET), and solid tumor (PSV359) programs are in Phase 1/2a imaging and therapy trials in the U.S. The Company is growing its regional network of drug product finishing facilities, enabled by its proprietary 212Pb generator, to deliver patient-ready products for clinical trials and commercial operations. For more information, please visit the Company's website at Safe Harbor StatementThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include statements concerning, among other things, the Company's ability to pioneer advanced treatments for cancers throughout the body; the Company's belief that it is on track to submit further clinical updates to scientific congresses in 2H 2025 and the planned content of such updates; the Company's ability to explore a higher dose level of VMT-α-NET; the Company's commitment to engage with the FDA to evaluate the clinical utility of dosimetry estimates and analyses in the development of its proprietary RPTs; the Company's expectation that patients currently being evaluated for entry into its VMT-α-NET study will enroll into Cohort 3 if they qualify; the ability of the Company's proprietary technology utilizing the alpha emitting isotope 212Pb to deliver powerful radiation specifically to cancer cells via specialized targeting moieties; the Company's prediction that the use of complementary imaging diagnostics that incorporate the same targeting moieties provides the opportunity to personalize treatment and optimize patient outcomes; the Company's belief that its "theranostic" approach enables the ability to see a specific tumor and then treat it to potentially improve efficacy and minimize toxicity; the Company's ability to grow its regional network of drug product finishing facilities, enabled by its proprietary 212Pb generator, to deliver patient-ready products for clinical trials and commercial operations; and other statements that are not historical fact. These forward-looking statements involve risks and uncertainties that could cause the Company's actual results to differ materially from the results described in or implied by the forward-looking statements. Certain factors that may cause the Company's actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC"), in the Company's other filings with the SEC, and in the Company's future reports to be filed with the SEC and available at Forward-looking statements contained in this news release are made as of this date. Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Media and Investor Relations Contacts: Perspective Therapeutics IR:Annie J. Cheng, CFAir@ Russo Partners, LLCNic JohnsonPerspectiveIR@
See - Sada Elbalad
3 hours ago
- Entertainment
- See - Sada Elbalad
Find Your Dream Dress from Georges Hobeika's 2026 Bridal Collection
Pasant Elzaitony - Yara Sameh The wedding dress is the most important thing in every woman's life. As brides-to-be carry on an endless search for the perfect dress for their special day, there are important questions that need to be addressed: What is the best wedding dress? And how to combine fashion and elegance in the bridal dress? Find your answers and inspiration from the world-famous Lebanese designer Georges Hobeika's Spring 2026 collection. By Georges Hobeika • While the world keeps a close eye on war, high prices, and tension, fashion designers look to the other side of politics. Therefore, Hobeika's collection captures softness, romanticism, elegance, and sophistication, all removed from the hustle and bustle of embroidery and the exaggerated sparkle of rhinestones. He used lace and guipure embroidery to achieve classic elegance with a modern, youthful perspective while relying on small, repeating units in asymmetrical shapes. By Georges Hobeika • Make sure the wedding dress expresses your personality and fits your body. Don't follow trends and fashion. Choose a modern design that reflects your spirit and personality and suits your height, weight, and skin tone. Also, keep in mind the groom's personality. If he's open-minded, he'll allow you to wear an unconventional dress, perhaps a short or sleeveless gown. If he's a conservative person, he'd opt for a modest dress. It is distasteful to choose a dress that doesn't suit the groom's personality and a risky nasty surprise on your special day. By Georges Hobeika • Focus on simplicity and avoid extravagant embroidery, cuts, and fabrics. Elegance doesn't come from adding many details to the design. Make sure you choose a shade of white, whether it's bright white (which suits white skin) or off-white (which suits wheatish complexion). • Make sure to try on the dress and measure it if you're buying it readymade. If a designer customizes it for you, make sure to try on a similar cut. If you're relying on a private designer, choose a designer whose ideas and style you're confident in. • Make sure to choose a dress that suits the venue where you'll be holding the wedding. If the ceremony is small and the space is cramped, opt for a bodycon dress. If the venue is open and spacious, opt for loose cuts. • Ultimately, your wedding dress and your and your groom's look will be a memory that carries on for decades. By Georges Hobeika read more 15 Ludicrous Cosplay Costumes That Will Blow You Away Watch... Dorra's natural beauty will blow your mind in latest photo session Exercising For As Little As 150 Minutes A Week Will Make You Happier، Study Claims ARIES: Your Horoscope for April 7 FDA Now Considers Vaping A Rising Epidemic In High School Lifestyle How to make Dried salted fish (feseekh) -By Chef El-Sherbini Lifestyle Batarekh Dip & Sardine Dip Lifestyle Best of Easter cookie and cakes Lifestyle ARIES friendship News China Launches Largest Ever Aircraft Carrier Sports Former Al Zamalek Player Ibrahim Shika Passes away after Long Battle with Cancer Lifestyle Get to Know 2025 Eid Al Adha Prayer Times in Egypt Business Fear & Greed Index Plummets to Lowest Level Ever Recorded amid Global Trade War Arts & Culture Zahi Hawass: Claims of Columns Beneath the Pyramid of Khafre Are Lies News Flights suspended at Port Sudan Airport after Drone Attacks Videos & Features Video: Trending Lifestyle TikToker Valeria Márquez Shot Dead during Live Stream News Shell Unveils Cost-Cutting, LNG Growth Plan Technology 50-Year Soviet Spacecraft 'Kosmos 482' Crashes into Indian Ocean News 3 Killed in Shooting Attack in Thailand
Bloomberg
4 hours ago
- Business
- Bloomberg
A Vaping Victory for Big Tobacco Masks the Real Issue
On Friday, the US Supreme Court waded into the confusing, on-again, off-again effort by the Food and Drug Administration to regulate e-cigarettes ... and didn't get too far. In voting 7-2 to allow a suit by RJ Reynolds Vapor Company against the agency to continue, the justices ruled on a tricky procedural issue and, I think, got the answer right. The litigation is far from over, but recent scholarly work suggests that the ban itself might be a mistake. To understand the case, it's useful to review a bit of history. In 2000, the Supreme Court struck down the FDA's efforts to regulate most tobacco products. Nevertheless, in 2008, the agency began seizing e-cigarettes imported into the US. The following year, Congress passed the Family Smoking Prevention and Tobacco Control Act, which, among other things, required FDA approval before the marketing of any 'new' tobacco product. The courts swiftly held that the authority covered vaping devices. But rather than disrupt what had by then become a substantial market, the agency allowed companies to continue selling their e-cigarette products while it processed their applications.
6 hours ago
- Business
Supreme Court widens court options for vaping companies pushing back against FDA rules
WASHINGTON -- WASHINGTON (AP) — The Supreme Court sided with e-cigarette companies on Friday in a ruling making it easier to sue over Food and Drug Administration decisions blocking their products from the multibillion-dollar vaping market. The 7-2 opinion comes as companies push back against a yearslong federal regulatory crackdown on electronic cigarettes. It's expected to give the companies more control over which judges hear lawsuits filed against the agency. The justices went the other way on vaping in an April decision, siding with the FDA in a ruling upholding a sweeping block on most sweet-flavored vapes instituted after a spike in youth vaping. The current case was filed by R.J. Reynolds Vapor Co., which had sold a line of popular berry and menthol-flavored vaping products before the agency started regulating the market under the Tobacco Control Act in 2016. The agency refused to authorize the company's Vuse Alto products, an order that 'sounded the death knell for a significant portion of the e-cigarette market,' Justice Amy Coney Barrett wrote in the majority opinion. The company is based in North Carolina and typically would have been limited to challenging the FDA in a court there or in the agency's home base of Washington. Instead, it joined forces with Texas businesses that sell the products and sued there. The conservative 5th U.S. Circuit Court of Appeals allowed the lawsuit to go forward, finding that anyone whose business is hurt by the FDA decision can sue. The agency appealed to the Supreme Court, arguing that R.J. Reynolds was attempting to find a court favorable to its arguments, a practice often referred to as 'judge shopping.' The justices, though, found that the law does allow other businesses affected by the FDA decisions, like e-cigarette sellers, to sue in their home states. In a dissent, Justice Ketanji Brown Jackson, joined by Justice Sonia Sotomayor, said she would have sided with the agency and limited where the cases can be filed. The Campaign for Tobacco-Free Kids called the majority decision disappointing, saying it would allow manufacturers to 'judge shop,' though it said the companies will still have to contend with the Supreme Court's April decision. Attorney Ryan Watson, who represented R.J. Reynolds, said that the court recognized that agency decisions can have devastating downstream effects on retailers and other businesses, and the decision 'ensures that the courthouse doors are not closed' to them. ___
Yahoo
6 hours ago
- Health
- Yahoo
Children's cough medicine recalled, may cause food poisoning: FDA
(WJW) – A nationwide recall of a popular children's cough medicine has been announced due to a microbial contamination, which the U.S. Food and Drug Administration warns could cause two types of foodborne illnesses. According to the recall alert, Medtech Products Inc., a Prestige Consumer Healthcare Inc. company, is voluntarily recalling five lots of Little Remedies Honey Cough Syrup due to the presence of Bacillus cereus and loss of shelf-stability. Ready-to-eat meals sold at Walmart and Kroger recalled after multiple deaths The Cleveland Clinic describes Bacillus cereus as a microscopic organism that can cause food poisoning. 'One type is characterized by nausea, vomiting, and stomach cramps that can start 1 to 6 hours after eating or drinking contaminated food. The second type can cause stomach cramps and diarrhea that can start 8 to 16 hours after eating or drinking contaminated food,' states the recall alert. 'Diarrhea may be a small volume or profuse and watery. Although healthy individuals may suffer only short-term illness, exposure to high levels of foodborne B. cereus can cause death.' Browns rookie QB cited for speeding over 100 mph According to the FDA, the affected lots were distributed nationwide through retailers and online from Dec. 14, 2022, through June 4, 2025. Here's what to look for: Item UPC Lot # Exp. Date 7-56184-10737-9 0039 11/2025 0545 01/2026 0640 02/2026 0450 05/2026 1198 12/2026 'All lots of Little Remedies® Honey Cough 4 FL OZ (118 mL) still within expiry are being included in the scope of the recall,' reports the FDA. 'This recall does not include any other Little Remedies® products.' Consumers who have the recalled product are advised to stop using it 'immediately' and should contact their physician or healthcare provider if they experience any problems that may be related to the product. The FDA states that the company will offer reimbursement for consumers who have purchased products from the recalled lots. CLICK HERE to learn more. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
