
Ongoing salami salmonella outbreak expands
The expansion of a salami recall due to salmonella leads MedicalWatch for July 15, 2025.

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National Post
2 hours ago
- National Post
Cloudbreak Pharma Inc. Announces Positive Phase 2 Results for CBT-004 in Patients with Vascularized Pinguecula
Article content Novel preservative-free CBT-004 eye drop formulation demonstrates statistically significant improvements in conjunctival hyperemia and patient-reported symptoms with excellent safety profile Article content IRVINE, Calif. — Cloudbreak Pharma Inc. a clinical-stage ophthalmology company developing innovative therapies for ocular surface diseases, today announced positive topline results from its Phase 2 clinical trial evaluating CBT-004 ophthalmic solution in patients with vascularized pinguecula and associated conjunctival hyperemia. Article content Key Phase 2 Results Article content Primary Endpoint Achieved: Article content Both investigated concentrations of CBT-004 demonstrated statistically significant improvements in conjunctival hyperemia compared to vehicle at Day 28, as assessed by an independent reading center using digital imaging. Article content Rapid Onset and Sustained Efficacy: Article content Significant improvements were observed as early as Day 7 with the highest investigated concentration CBT-004 , with benefits persisting through the 28-day treatment period. Article content Significant Symptom Relief: Article content Both CBT-004 concentrations showed statistically significant improvements in five common patient-reported symptoms including burning/stinging, itching, foreign body sensation, eye discomfort, and pain compared to vehicle. Article content Excellent Safety Profile: Article content No treatment-related adverse events were observed. Most adverse events were mild to moderate. No clinically meaningful changes in visual acuity or intraocular pressure were reported. Article content Addressing a Significant Unmet Medical Need Article content Vascularized pinguecula affects millions of Americans and represents a substantial unmet medical need in ophthalmology. This common, benign conjunctival growth can become problematic when it develops abnormal blood vessels and inflammation, which can lead to persistent redness, irritation, pain, and foreign body sensation. Current management options are limited, with many patients relying on off-label corticosteroids or surgical excision, both of which carry significant limitations and potential complications. Article content Study Design and Results Article content The multicenter, randomized, double-masked, vehicle-controlled Phase 2 study enrolled 88 adult patients with vascularized pinguecula and associated conjunctival hyperemia. Participants were randomized to receive one of two concentrations of CBT-004, or vehicle. The primary endpoint was the change from baseline in conjunctival hyperemia at Day 28, as measured by an independent reading center using standardized digital imaging protocols. Article content 'There is a significant unmet need for patients suffering from symptomatic pinguecula, as current therapies are largely off-label and may carry safety concerns with long-term use,' said Dr. John Hovanesian, Clinical Professor of Ophthalmology and recognized key opinion leader in anterior segment disease. 'The results from this trial are exciting, as they demonstrate that a targeted, non- steroidal therapy can meaningfully improve both the clinical signs and symptoms that impact patients' quality of life.' Article content 'As a principal investigator in this study, I was impressed by the consistency and magnitude of improvement in both objective redness and patient-reported discomfort with CBT-004,' commented Dr. Sherif El-Harazi, Medical Director at Global Research Management. 'The safety profile was excellent, and I believe this therapy could represent a meaningful advance for our patients with vascularized pinguecula.' Article content About CBT-004 Article content CBT-004 is a novel, preservative-free topical ophthalmic solution containing a potent and selective inhibitor of vascular endothelial growth factor (VEGF) receptors and platelet-derived growth factor (PDGF) receptors. The formulation is specifically designed to reduce abnormal blood vessel growth and inflammation associated with vascularized pinguecula while minimizing potential ocular surface toxicity through its preservative- free composition. Article content Next Steps and Regulatory Strategy Article content Based on these positive Phase 2 results, Cloudbreak Pharma Inc. plans to advance CBT-004 into Phase 3 development and initiate discussions with the U.S. Food and Drug Administration (FDA) to establish the regulatory pathway toward potential approval. The company anticipates providing updates on Phase 3 study design and timing in the coming months. Article content Market Opportunity Article content The vascularized pinguecula market represents a significant commercial opportunity with limited therapeutic options. The prevalence of pinguecula increases with age and UV exposure, affecting a substantial portion of the aging population. With no FDA-approved treatments specifically indicated for this condition, CBT-004 has the potential to become a category-defining therapy in this underserved market. Article content About Cloudbreak Pharma Inc. Article content Cloudbreak Pharma Inc. is a clinical-stage ophthalmology company dedicated to developing innovative therapies for ocular surface diseases with high unmet medical need. The company's pipeline focuses on novel treatments targeting inflammation, vascularization, and other pathological processes affecting the ocular surface. Cloudbreak is committed to improving outcomes for patients with challenging eye conditions through scientifically-driven therapeutic development. Article content Forward-Looking Statements Article content This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the potential therapeutic benefits of CBT-004, the company's clinical development plans, regulatory strategy, and market opportunity. These forward-looking statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause actual results to differ include, but are not limited to, the uncertainty of clinical trial results, regulatory approval processes, competitive developments, and other risks detailed in the company's filings. The company undertakes no obligation to update these forward-looking statements except as required by law. Article content Article content Article content Contacts Article content Contact Information: Article content Article content Cloudbreak Pharma Inc. Article content Article content

CTV News
4 hours ago
- CTV News
Drowning deaths: Summer 2025 is expected to be worse than last year
A sign translating to 'risk of drowning' is shown next to the St. Lawrence River in, Montreal, Monday, June 26, 2023. (Graham Hughes/The Canadian Press) In Quebec, 37 people have drowned since the beginning of the year, compared to 31 at the same time last year, with rivers being the main location for drownings. As the construction holidays officially begin, CEO and spokesperson for the Lifesaving Society, Raynold Hawkins, stresses there are ways to prevent these tragedies, which kill about 100 people in Canada per year. This week is the 32nd National Drowning Prevention Week (NDPW). Hawkins's first piece of advice is to never be alone when engaging in activities near, in or on the water, so that someone can call for help if necessary or come to the aid of a person in distress. 'This increases the overall concept of water or nautical safety,' he explains. He says it's crucial to wear a personal flotation device (PFD) when participating in water activities, which 'will make the difference between a (summer) anecdote and a tragedy' in the event of a fall into the water. While he recommends avoiding swimming in rivers, Hawkins urges swimmers to stay away from rapids and not to underestimate deep currents that can't be perceived on the surface. Swimming near a dam is also a bad idea, lest you get sucked into a vortex generated by the opening of a valve. Hawkins recommends that parents of young children always keep their children within arm's reach and under constant supervision, as infant drowning is a 'silent phenomenon' that can occur in 15 to 20 seconds. 'When you're with children, you have a duty to supervise them at all times,' explains Hawkins. According to the Lifesaving Society, 80 per cent of drownings involving children under the age of 5 were due to absent or distracted supervision. For older children and teenagers, there are two practices to avoid: holding your breath for as long as possible in the water, which can cause asphyxiation and make resuscitation more difficult, and diving into shallow areas. In all cases, Hawkins recommends swimming parallel to the shore rather than out to sea. He notes that more and more newcomers are among the drowning victims. How can we prevent this? For Hawkins, there is no doubt that a large part of the population overestimates their swimming ability. According to him, you need to be able to swim about 15-25 metres to consider yourself capable of swimming in deeper water. Otherwise, Hawkins advises staying where the water is no deeper than your armpits. 'Despite what families tell us, our victims overestimate their ability to swim,' says Hawkins. READ MORE: Body found after man goes missing while swimming at Verdun Beach However, there are some tips to follow if you find yourself in trouble. In the case of rivers, Hawkins recommends lying on your back with your feet forward to avoid colliding with any obstacles, then starting to paddle with your hands to move towards the bank. In the case of still water, once you can no longer touch the bottom, Hawkins advises 'spreading your arms and legs' on your back, lifting your face out of the water, then taking a long breath to fill your lungs and float better. He then recommends starting to paddle with your hands to try to reach the shore. Drowning and global warming Hawkins has no doubt that there is a correlation between the number of drownings and global warming. The hotter it gets, the more people want to cool off wherever they are. 'Our concern is that the global warming we are experiencing may bring forward the season for water-related incidents, just as it may also delay it,' he explains. He adds that the summers of 2012, 2017 and 2020 were extremely hot and also the deadliest in terms of drownings. Each year, more than 70 per cent of drownings occur between May and September, with a peak in July. This report by The Canadian Press was first published in French July 20, 2025. Quentin Dufranne, The Canadian Press


CBC
6 hours ago
- CBC
Klinic's workplace in 'distress,' requires transformation, investigation report says
The workplace at Klinic Community Health is in "distress" marked by patterns of "leadership failure," racial harm and unresolved conflict that require a cultural transformation at the organization, according to a report obtained by CBC that Klinic has framed as sobering. The non-profit organization, based in Winnipeg's West Broadway area, hired a third party to conduct an independent review of the organization earlier this year, after its board of directors started receiving letters from staff in January raising concerns about racism, intimidation and bullying at work. The findings of the investigation turned into a 53-page report which was shared with staff on Monday. The report outlines a number of recommendations to address discrimination, diversity and organizational structure at Klinic. "Restoring trust will require more than technical fixes," the report said. "Klinic has been a beacon of light in being responsive to the needs of diverse and poorly served groups of people," the report said. "The goal is to live those values with one another, not only community members." The independent review included interviews with 75 people and a survey that was filled by 128 members of staff and volunteers. Most of them indicate that despite the ongoing concerns about senior management, they love working at the organization because of their supportive coworkers and meaningful community work. But the review found there are issues with the leadership style of some managers and directors. Some members of staff believe leadership's decision-making doesn't align with the day-to-day realities of the services the organization provides. Meanwhile, the structure of the organization was found to be "top heavy," with more management positions than necessary. And while there is no rampant racism, when incidents of discrimination happen they are not dealt with quickly or effectively to the satisfaction of those being affected, resulting in unresolved conflict building up into polarization and blaming, the report said. In an email to staff on behalf of the board of directors, Chairperson Kathy Majowski said the findings are "difficult and sobering." She said the organization will be working with staff, unions and leadership to develop "a concrete, inclusive action plan" based on the recommendations. "We know this won't be easy. But we also know that Klinic's strength has always come from the people who care deeply about its mission." On Thursday, three days after the report was shared, the role of three directors at Klinic were eliminated and their employment terminated, Debra Radi, Klinic's executive director said in an email to staff obtained by CBC. "These were difficult decisions, and they were not taken lightly," the email said. CBC has reached to Klinic and its board of directors for comment. Staff frustration A spokesperson for Manitoba's health minister, which offers some funding to Klinic, didn't directly comment on the report findings but said the province expects all of its partners to provide a safe and respectful workplace for all staff, that's free of discrimination, harassment and toxicity. The review found there's lack of a process to deal with inappropriate remarks or misgendering, which has led to divisions, the report said. With little satisfaction on how complaints are handled, staff reported they are more likely to file grievances with the union, but the process is time-consuming and union staff are "not always available to help." The situation is frustrating, the report said, to members of staff and volunteers from diverse communities "who have spent years dealing with racism, homophobia or transphobia" in a place "that should be a positive environment." Some staff who witnessed others being harassed or disrespected feared speaking out about it or becoming a target, counter to how Klinic has "prided itself in being on the forefront of change" for those without a voice, the report said. Other members of staff reported fear about being terminated and most wouldn't recommend Klinic as a workplace because it would be "harmful to their mental health and well-being." With the organization's growth in recent years, staff told the third-party reviewer they have seen a change in how Klinic deals with issues in a more "top-down manner." Those interviewed said decisions are made at a higher level, and the input of staff is not encouraged while opposing views are met with abuse or intimidation. "Klinic has highly knowledgeable staff who expect their knowledge and experience to be recognized and valued. That is not happening," the report said. Part of a bigger issue The review also found more resources are needed for middle and front-line staff. While some directors have two to three people reporting directly to them, middle managers have sometimes between 24 to 68 people under their wing — making it "impossible" to give people feedback or monitor their progress. The report said the addition of more services may be a reason for this issue and a review of the organization's structure is needed with more teams working together. The report also examines questions around Klinic offering drop-in services, explaining there is a need in the community for a low-barrier inclusive service provider, especially after the drop-in centre at the West Broadway Community Ministry closed in 2019, At the moment, the organization does not have capacity to operate a full drop-in centre safely and effectively, the report recommended. Klinic could explore the possibility of creating a separate facility with another organization, the report said. But "without clear and immediate action, Klinic Community Health risks deepening internal dysfunction and potentially creating unsafe conditions for staff and vulnerable community members alike," the report said. Jason Linklater, president of the Manitoba Association of Health Care Professionals, said the report matches the feedback the union representing over 150 workers at the Klinic has seen over the years, and some employees have expressed feeling validated. He is also happy to see the response from Klinic, inviting the union and staff to work with leadership on the recommendations. But the report speaks to a bigger problem in the health-care system and "it is time to get serious about the cultural issues," he said. The NDP government, which ran on a promise to fix the health-care system, has talked about changing the culture in the system, but front-line workers have yet to see a transformation, he said. Adequate staffing levels — a focus of the current government — are important to usher in that change, but systemic problems are born out of poor management as well, Linklater said, "Leadership really matters," he said. "The ones that are not good drive severe problems, and we need those rooted out and we need them to be exited."