Latest news with #Drug
Yahoo
an hour ago
- Business
- Yahoo
Blue Bell Just Announced a Big Change to Its Ice Cream
Your favorite pint could be affected. On January 15, the United States Food and Drug Administration (FDA) announced a ban on Red No. 3, a move that affects a large number of items across the food and beverage industry. The artificial additive is used in a number of popular grocery items, including candy and desserts, to achieve a bright red color. To be compliant with new federal guidelines, companies must phase it out completely by 2027. Ahead of the deadline, many industry giants have already announced plans to remove not just Red No. 3, but all artificial colors from their products. In June, Kraft Heinz announced that it will not launch any new products containing Federal Food, Drug, and Cosmetic (FD&C) colors in the U.S. Additionally, it will remove all remaining artificial dyes by the 2027 deadline. Hershey and Nestlé have also made recent statements about how their products will be modified to comply with new guidelines. Now, Texas-based creamery Blue Bell is the latest to share its plans for the upcoming transition. Blue Bell Announces Plans To Remove Artificial Colors From Its Products On July 14, the International Dairy Foods Association (IDFA) announced that dozens of U.S. ice cream companies have committed to removing artificial colors in their products. In a recent statement on X, Blue Bell said that it is proud to be part of the IDFA commitment to eliminate certified artificial colors from its products, a list that includes Red No. 3, Red No. 40, Green No. 3, Blues No. 1 and 2, and Yellows No. 5 and 6. The post also contains an image with a list of Blue Bell flavors that are already free from artificial colors, such as Bride's Cake, Java Jolt, and Homemade in the Shade, which recently returned to stores after more than a decade-long hiatus. Many of the ice cream flavors that already meet dye-free guidelines are vanilla or chocolate-based. But what about flavors such as Christmas Cookies and Cotton Candy, which use artificial color blends to achieve their vibrant hue? Blue Bell told Allrecipes that customers can expect the revamped ice cream to maintain the flavor fans love. "The taste, texture, and fun of our ice cream will remain the same—the ingredient list is getting a refresh," the brand wrote in a recent email. At this time, it's not clear which Blue Bell flavors will be introducing a new ingredient label this year, but the brand advises fans to stay up-to-date by following its social media accounts for information on new and returning flavors. Read the original article on ALLRECIPES Solve the daily Crossword
The Hill
2 days ago
- Health
- The Hill
FTC eyes trans youth care providers, seeking input on alleged deceptive practices investigation
The Federal Trade Commission (FTC) on Monday launched a public inquiry into whether providers of gender-affirming health care are violating federal consumer protection laws. In a news release, the FTC said it opened the inquiry 'to better understand how consumers may have been exposed to false or unsupported claims about 'gender-affirming care', especially as it relates to minors, and to gauge the harms consumers may be experiencing.' The agency said it is investigating whether medical professionals who provide transition-related care are violating federal law against deceptive business practices and false advertising by failing to disclose risks associated with treatment or making unsubstantiated claims about its benefits or effectiveness. The request for information issued by the FTC asks for the public's response to four questions about their experience with gender-affirming care and the doctors who administer it. The request, which opens a 60-day comment window, does not specify an exact age range but says the agency is interested in information related to care for minors in particular. Major medical organizations, including the American Medical Association and the American Academy of Pediatrics, say gender-affirming care for transgender adults and minors is medically necessary and can be lifesaving, claims disputed by the Trump administration. In January, President Trump signed an executive order aimed broadly at ending federal support for transition-related care for adolescents under the age of 19, which he called 'a stain on our Nation's history.' He has also pressed Congress to send legislation ' permanently banning and criminalizing' gender-affirming care for minors to his desk. The FTC's announcement follows an earlier memo from the Department of Justice (DOJ) this month that it sent more than 20 subpoenas to doctors and clinics 'involved in performing transgender medical procedures on children' in investigations of 'healthcare fraud, false statements, and more.' Chad Mizelle, the DOJ's chief of staff, said during a July 9 FTC event in Washington that the department also issued subpoenas to major manufacturers of 'the drugs used in trans-related medical interventions' in investigations related to companies' marketing of prescription drugs and the Food, Drug, and Cosmetic Act. The event, a workshop titled 'The Dangers of 'Gender-Affirming Care' for Minors,' featured testimony from doctors, advocates and de-transitioners, individuals who once identified as transgender but have since 'de-transitioned' to live according to their birth sex, who oppose gender-affirming care. 'That testimony indicated that practitioners of 'gender-affirming care' may be actively deceiving consumers,' the FTC said Monday. The agency's workshop did not include testimony from anyone who supports care or said they had benefited from it. Roughly half the nation has banned gender-affirming care for minors since 2021, according to the Movement Advancement Project, a nonprofit tracking LGBTQ laws. In June, the Supreme Court upheld Tennessee's ban, which a group of transgender children and their families had challenged as unconstitutional. In 14 states and Washington, D.C., 'shield laws' protect access to gender-affirming care for youth, though some hospital systems in those states have still suspended or discontinued care because of Trump's order and threats from the administration to their federal funding.
National Post
2 days ago
- Business
- National Post
Alpha Cognition Announces Partner China Medical System Has NDA Accepted in China for the Review of ZUNVEYL® (Benzgalantamine) for Alzheimer's Disease
Article content VANCOUVER, British Columbia & DALLAS — Alpha Cognition Inc. (Nasdaq: ACOG) ('Alpha Cognition' [ACI], or the 'Company'), a biopharmaceutical company developing novel therapies for debilitating neurodegenerative disorders, today announced China Medical System Holdings Limited (CMS) New Drug Application (NDA) for ZUNVEYL has been accepted by the National Medical Products Administration of China (NMPA) for review for the treatment of mild-to-moderate Alzheimer's dementia. Article content 'We are pleased to announce the NMPA acceptance of the ZUNVEYL New Drug Application, marking a significant milestone in our mission to bring innovative treatments to patients in need,' said Michael McFadden, Chief Executive Officer of Alpha Cognition. 'This acceptance reflects the strength of our partnership with CMS and the dedication of our team. We look forward to working closely with our partner throughout this important review process as we move one step closer to potentially delivering this important therapy to the Asia market.' Article content Alpha Cognition will rely on successful regulatory and commercial expertise of CMS in the Chinese market and will benefit financially from advances in China and other Asia territories. The Company is eligible to receive regulatory, sales milestones, and royalties should ZUNVEYL be approved for marketing in China and other Asia territories. Article content According to the epidemiological study results published in the Lancet Public Health, there are about 7.93 million patients with mild-to-moderate Alzheimer dementia in China. With the intensifying aging trend, the number of patients and the consequent disease burden will further increase in the future. The Company anticipates additional progress across other countries with regulatory advancement and ZUNVEYL commercial approvals. Article content About Alpha Cognition Inc. Article content Alpha Cognition Inc. is a commercial stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer's disease and cognitive Impairment with mild Traumatic Brain Injury ('mTBI'), for which there are currently no approved treatment options. Article content ALPHA-1062 (benzgalantamine) formulated as a delayed release oral tablet (ZUNVEYL ®), is FDA approved as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer's disease, with expected minimal gastrointestinal side effects. ZUNVEYL's active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer's dementia, and as a sublingual formulation for cognitive Impairment with mTBI. Article content ZUNVEYL is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer's type in adults. Article content IMPORTANT SAFETY INFORMATION Article content CONTRAINDICATIONS Article content ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or to any inactive ingredients in ZUNVEYL. Serious skin reactions have occurred. Article content WARNINGS AND PRECAUTIONS Article content Serious Skin Reactions Article content : Serious skin reactions (Stevens-Johnson syndrome and acute generalized exanthematous pustulosis) have been reported in patients receiving galantamine (the active metabolite of ZUNVEYL tablets). If signs or symptoms suggest a serious skin reaction, use of this drug should not be resumed, and alternative therapy should be considered. Article content Anesthesia Article content : See Drug Interactions Section Article content Cardiovascular Conditions: Article content Cholinesterase inhibitors, including ZUNVEYL, have vagotonic effects on the sinoatrial and atrioventricular nodes, leading to bradycardia and AV block. Bradycardia and all types of heart block have been reported in patients taking cholinesterase inhibitors, both with and without known underlying cardiac conduction abnormalities. Therefore, all patients should be considered at risk for adverse effects on cardiac conduction. Article content Patients treated with galantamine up to 24 mg/day using the recommended dosing schedule showed a dose-related increase in risk of syncope. Article content Gastrointestinal Conditions Article content : Cholinesterase inhibitors, including ZUNVEYL, may increase gastric acid secretion. Patients should be monitored closely for active or occult gastrointestinal bleeding, especially those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical studies of galantamine have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding. Article content Galantamine has been shown to produce nausea, vomiting, diarrhea, anorexia, and weight loss. Monitor the patient's weight during therapy with ZUNVEYL. Article content Genitourinary Conditions: Article content Although this was not observed in clinical trials with galantamine, cholinesterase inhibitors, including ZUNVEYL, may cause bladder outflow obstruction. Article content Neurological Conditions: Article content Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions. Seizure activity may also be a manifestation of Alzheimer's disease. Patients with Alzheimer's disease should be monitored closely for seizures while taking ZUNVEYL. Article content Pulmonary Conditions: Article content Cholinesterase inhibitors, including ZUNVEYL, should be prescribed with care to patients with a history of severe asthma or obstructive pulmonary disease. Monitor for respiratory adverse reactions. Article content ADVERSE REACTIONS Article content The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. Article content DRUG INTERACTIONS Article content Use with Anticholinergics: Article content Galantamine has the potential to interfere with the activity of anticholinergic medications. Article content Use with Cholinomimetics and Other Cholinesterase Inhibitors: Article content A synergistic effect is expected when cholinesterase inhibitors are given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol. Article content USE IN SPECIFIC POPULATIONS Article content Pregnancy: Article content Based on animal data may cause fetal harm. Article content Hepatic Impairment: Article content In patients with moderate hepatic impairment, a decrease in clearance of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with severe hepatic impairment is not recommended. Article content Renal Impairment: Article content In patients with a creatinine clearance of 9 to 59 mL/min, an increase in exposure of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with creatinine clearance less than 9 mL/min is not recommended. Article content These are not all of the possible side effects of ZUNVEYL. You can report side effects to the FDA. Visit or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information. Article content Forward-looking Statements Article content This news release includes forward-looking statements within the meaning of applicable securities laws. Except for statements of historical fact, any information contained in this news release may be a forward‐looking statement that reflects the Company's current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward‐looking statements by the words 'may,' 'might,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'intend,' 'plan,' 'objective,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'target,' 'seek,' 'contemplate,' 'continue' and 'ongoing,' or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward‐looking statements may include statements regarding the potential benefits of the licensing agreement for the development and commercialization of ZUNVEYL in Asia (excluding Japan), Australia and New Zealand, the Company's timing and planned activities to launch ZUNVEYL in the U.S. and China, the timing for the Company's planned corporate update call, the potential timing for the availability of ZUNVEYL in the U.S. and China, the potential future developments of ZUNVEYL in China, the potential market size for ZUNVEYL in China, the Company's business strategy for the launch of ZUNVEYL in China, the market size and demand for ZUNVEYL in China, the Company's potential growth opportunities in China, the timing and results of the Company's milestone payments for China, the Company's regulatory submissions in China, and the potential regulatory approval and commercialization of the Company's products in China. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward-looking statements are subject to certain risks, including risks regarding our ability to raise sufficient capital to implement our plans to commercialize ZUNVEYL, risks regarding the efficacy and tolerability of ZUNVEYL, risks related to ongoing regulatory oversight on the safety of ZUNVEYL, risk related to market adoption of ZUNVEYL, risks related to the Company's intellectual property in relation to ZUNVEYL, risks related to the commercial manufacturing, distribution, marketing and sale of ZUNVEYL, risks related to product liability and other risks as described in the Company's filings with Canadian securities regulatory authorities and available at and the Company's filings with the United States Securities and Exchange Commission (the 'SEC'), including those risk factors under the heading 'Risk Factors' in the Company's Form S-1/A registration statement as filed with the SEC on November 6, 2024 and available at These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future, except as required by law. Article content Article content Article content Article content
Cision Canada
2 days ago
- Business
- Cision Canada
Oncolytics Biotech® to Engage FDA for Potential Registration-Enabled Study in First-Line Pancreatic Cancer with Goal to Launch Trial Activities by Year-End
Clear regulatory path and strong survival data in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) support accelerated strategy to drive shareholder value and partnership opportunities SAN DIEGO and CALGARY, AB, July 29, 2025 /CNW/ -- Oncolytics Biotech ® Inc. (Nasdaq: ONCY) (TSX: ONC) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, today announced it has initiated regulatory discussions with the U.S. Food and Drug Administration (FDA) for a potential registration-enabled pivotal study in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). Assuming discussions with the FDA go as expected, the Company expects to commence study start-up activities before the end of 2025. This milestone reflects Oncolytics' conviction in pelareorep's differentiated mechanism of action and its encouraging survival signal in one of the most lethal and underserved solid tumors. The FDA interaction will focus on finalizing a clinical trial design that leverages pelareorep's demonstrated synergy with chemotherapy with or without checkpoint inhibition, and overall survival as the primary endpoint. Among the potential options, Oncolytics will consider proposing an adaptive study in collaboration with a third party. "We expect to move quickly and decisively down a clear regulatory path," said Jared Kelly, Chief Executive Officer of Oncolytics. "This is about execution and focus. Our goal is to win on survival—and this pivotal study is how we do it. We believe this program not only creates significant value for shareholders but also positions Oncolytics as a highly attractive partner for pharma companies seeking to break open the immunotherapy landscape in mPDAC and other GI tumors." Oncolytics' recent Key Opinion Leader event reinforced the clinical promise of pelareorep in mPDAC and other gastrointestinal (GI) cancers, including KRAS-mutated colorectal cancer, and validated its ability to transform "cold" tumors into immunologically active ones. Experts emphasized the scarcity of innovation in pancreatic cancer and the urgent demand for new immunotherapies that can deliver a survival benefit in this setting. With Fast Track and Orphan Drug designations in mPDAC and translational data supporting pelareorep's immunologic activity, the Company believes it is well-positioned to engage potential partners seeking to bolster their GI oncology pipelines. The upcoming regulatory discussions and planned trial initiation represent major catalysts for strategic collaboration and long-term value creation. Additional information on the study design, timelines, and next steps will be provided following regulatory feedback. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and early-phase studies in pancreatic and colorectal cancer. It induces anti-cancer immune responses by converting immunologically "cold" tumors "hot" through the activation of innate and adaptive immune responses. The Company is advancing pelareorep in combination with chemotherapy and checkpoint inhibitors in metastatic breast and pancreatic cancers, both of which have received Fast Track designation from the FDA. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: or follow the Company on social media on LinkedIn and on X @ oncolytics. Forward-looking statements This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our plans for a potential registration-enabled pivotal study in first-line mPDAC and the anticipated potential timing of commencement of start-up activities and enrollment in a study, the focus of our discussions with the FDA in respect of the study; the anticipated trial design; our plans to move quickly and decisively down a clear regulatory path; our goals, strategies and objectives; our belief in the clinical promise of pelareorep in mPDAC and other gastrointestinal cancers; our belief that we are well-positioned to engage potential partners seeking to bolster their GI oncology pipelines; and our active pursuit of strategic partnerships. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, and market dynamics. Please refer to Oncolytics' public filings with securities regulators in the U.S. and Canada for more information. The company assumes no obligation to update forward-looking statements, except as required by laws. Company Contact Jon Patton Director of IR & Communication [email protected] Investor Relations for Oncolytics Mike Moyer LifeSci Advisors +1-617-308-4306 [email protected] Media Contact for Oncolytics Owen Blaschak LifeSci Communications [email protected] SOURCE Oncolytics Biotech® Inc.
Time Business News
21-07-2025
- Health
- Time Business News
Why Employers Choose the DrugWipe 6S Saliva Drug Testing Kit
When it comes to keeping your workplace safe, fast and accurate drug screening is essential. The DrugWipe 6S Saliva Drug Testing Kit makes that easier than ever. Trusted by law enforcement and employers across Australia, this compact device is designed for quick, on-the-spot saliva drug testing—without the need for lab instruments or complicated procedures. If you're looking for a reliable testing kit that meets national standards and delivers consistent results, here's why the DrugWipe 6S Saliva Drug Testing Kit deserves your attention. Let's start with the basics. The DrugWipe 6S Saliva Drug test offers: Fast results – Get answers in just 8 minutes No lab tools required – All results are visually read Zero saliva handling – More hygienic and less invasive Point-of-incident ready – Ideal for on-site or random testing AS/NZS 4760:2019 compliant – Fully meets Australian standards The test detects six commonly abused drug groups: Methamphetamines (including ecstasy) With broad detection coverage and fast results, this kit helps you act quickly when workplace safety is at risk. In high-risk environments like construction or mining, time matters most. The DrugWipe 6S Saliva Drug Testing Kit gives you quick answers when every second counts—helping you take the right action at the right time. In Australia, workplace drug testing must be both effective and legally defensible. That's why using a kit certified to AS/NZS 4760:2019 is so important. The DrugWipe 6S Saliva Drug Testing Kit from Australia Drug Testing meets this exact standard. What does that mean for you? Accurate test performance Credible results in legal or HR matters Confidence in compliance during audits or reviews When you use a testing device that meets the national benchmark, you can feel confident you're doing it right. Using the DrugWipe 6S Saliva Drug test is straightforward. Here's a simplified version of the process: Open the kit and check the three weak blue control lines. Instruct the donor to move their tongue around their mouth. Hand them the blue sample collector and have them wipe it down their tongue once. Make sure the sample pads change from pink to yellow. Reattach the collector to the detection unit and press until it clicks. Crack the buffer ampoule by pressing the 'PRESS' mark. Set the kit upright for 10 seconds, then lay it flat. Wait 8 minutes—then read the result. It's that simple. No mess. No guesswork. While reading the results, here's what to look for: Negative result = Only control lines appear Non-negative result = A control line plus any faint or bold test line appears If drugs are detected, you can follow up with a confirmatory lab test. Each method has its place, but here's how they compare: Saliva Testing (like DrugWipe 6S): Detects recent drug use (2–4 hours) Best for on-the-spot impairment checks Less invasive and faster to administer Urine Testing: Detects drug use over a longer time More suitable for pre-employment screening Often more cost-effective for large batches If your priority is identifying recent drug use and impairment, saliva testing is the better option—and the DrugWipe 6S Saliva Drug Testing Kit is built for it. Need alternative options? Australia Drug Testing also offers: First Step Oral Fluid Drug Screen Device Verified to AS/NZS 4760:2019 Includes saturation indicator Easy to use and non-invasive First Sign Saliva Drug Testing Kit Screens for Δ9 THC (not just metabolites) Quick, 1-step test with swab and test in one Results in under 5 minutes While these are great choices too, the DrugWipe 6S Saliva Drug test remains a robust option for on-site testing in many Australian workplaces. If you're serious about maintaining a safe, drug-free work environment, you need a test that delivers reliable results—fast. The DrugWipe 6S Saliva Drug Testing Kit offers everything you need: compliance, convenience, and confidence. Ready to upgrade your workplace drug tests? Browse the DrugWipe 6S Saliva Drug Testing Kit and other certified solutions at Australia Drug Testing—and make safety your workplace standard. TIME BUSINESS NEWS
