Health Canada
🇨🇦Canada
- Country
- 🇨🇦Canada
- Ownership
- Private, Subsidiary
- Established
- 2010-11-01
- Employees
- 10K
- Market Cap
- -
- Website
- http://www.hc-sc.gc.ca
Zetagen Therapeutics Completes Enrollment in Phase 2a Trial for Novel Metastatic Breast Cancer Bone Lesion Treatment
• Zetagen Therapeutics has completed enrollment in a Phase 2a clinical trial evaluating ZetaMet™ (Zeta-BC-003) for treating spinal metastatic lytic breast cancer lesions, with results expected in Q4 2025.
• ZetaMet™ is a first-of-its-kind synthetic small molecule designed to eliminate cancer cells responsible for bone destruction, reduce pain, regenerate bone, and potentially improve survival rates in Stage IV breast cancer patients.
• The 26-week study at the University of British Columbia will assess the treatment's safety and efficacy by measuring reduction in skeletal-related events, pain levels, vertebral defect size changes, and postoperative opioid use.
Theralase's Light-Activated Ruvidar Shows Promising Results in BCG-Unresponsive Bladder Cancer Clinical Trial
• Theralase's Phase II clinical trial for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) shows 62.5% complete response rate with its light-activated small molecule Ruvidar.
• The therapy demonstrates impressive durability with 45% of complete responders maintaining cancer-free status for at least 12 months, and some patients showing responses lasting over 7 years.
• Theralase plans to complete trial enrollment by mid-2025, submit regulatory applications to Health Canada and FDA in late 2026, with potential market approval by early 2027.
FDA Warns of Serious Side Effects from Unapproved Topical Finasteride Hair Loss Treatments
• The FDA has issued a warning about unapproved topical formulations of finasteride (generic Propecia) sold through telehealth companies, citing 32 reports of serious adverse events including suicidal thoughts and erectile dysfunction.
• Unlike FDA-approved oral finasteride (Propecia and Proscar), these compounded topical versions lack comprehensive safety data and regulatory scrutiny, yet are widely promoted on social media with minimal risk disclosure.
• Medical experts have raised concerns that telehealth companies may prioritize prescription volume over patient safety, with some patients reporting they weren't adequately informed about potential severe side effects.
FDA Approves Genus PIC's Gene-Edited PRRS-Resistant Pigs in Landmark Decision
• The U.S. Food and Drug Administration has granted approval for Genus PIC's gene-edited pigs resistant to Porcine Reproductive and Respiratory Syndrome (PRRS), marking a significant milestone in agricultural biotechnology.
• Despite FDA approval, Genus plans to delay broad U.S. commercialization until key export markets including Mexico, Canada, Japan, and China also grant regulatory clearance to ensure market viability.
• PRRS costs the global pork industry approximately $2 billion annually, with the gene-edited solution potentially reducing antibiotic use by over 200% while improving animal welfare and farm economics.
Australia Approves IFINWIL (Eflornithine) for High-Risk Neuroblastoma Treatment
• The Australian Therapeutic Goods Administration has approved IFINWIL® (eflornithine) for treating adults and children with high-risk neuroblastoma who have responded to prior multimodality therapy.
• High-risk neuroblastoma predominantly affects young children with an average survival rate of only 50%, and approximately 25 Australian children are diagnosed with this aggressive form annually.
• The approval comes through Project Orbis, an FDA initiative facilitating collaborative international regulatory reviews to expedite patient access to innovative cancer therapies worldwide.
Health Canada Expands HyQvia Authorization for CIDP Maintenance Therapy
• Health Canada has expanded marketing authorization for Takeda's HyQvia as a maintenance therapy for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults after stabilization with intravenous immunoglobulin.
• HyQvia is now the only subcutaneous immunoglobulin treatment in Canada that can be administered as infrequently as once monthly and can be self-administered at home after proper training, reducing hospital visits.
• The approval is based on the Phase 3 ADVANCE-1 trial, which demonstrated a significant reduction in CIDP relapse rates with HyQvia compared to placebo (15.5% vs 31.7%), with an estimated treatment difference of -16.2%.
AEON Biopharma Appoints Rob Bancroft as New CEO to Lead ABP-450 Therapeutic Development
• AEON Biopharma has appointed industry veteran Rob Bancroft as Chief Executive Officer to lead the company's development of ABP-450 for therapeutic applications.
• ABP-450 (prabotulinumtoxinA) is the same botulinum toxin complex marketed for cosmetic use as Jeuveau, with AEON focusing on its potential for debilitating medical conditions in neurosciences.
• The company is pursuing a 351(k) biosimilar pathway with the FDA, aiming to position ABP-450 as a biosimilar to BOTOX for both current and future therapeutic indications.
Health Canada Approves Arjuna's Shoden® Ashwagandha Extract as Natural Health Product
• Health Canada has granted Natural Health Product status to Arjuna Natural's Shoden® ashwagandha extract, validating its safety and efficacy claims for stress reduction and sleep improvement.
• The highly bioactive extract is standardized to contain over 35% withanolide glycosides and has demonstrated clinical efficacy at low doses (60-120mg), supported by 11 clinical studies and 23 patents.
• This regulatory approval enables Arjuna to make authorized health claims in Canada and potentially accelerate market expansion in the US, Europe, and Asia where Health Canada certification is highly regarded.
Health Canada Approves Hikma's KLOXXADO® 8 mg Nasal Spray for Opioid Overdose Treatment
• Health Canada has approved KLOXXADO® (naloxone HCl) Nasal Spray 8 mg for treating known or suspected opioid overdoses in adults, providing a higher-dose alternative to existing treatments.
• Emergent BioSolutions will lead commercial efforts in Canada under a six-year agreement with Hikma, with the product expected to be available by prescription as early as 2026.
• The approval comes as Canada faces an ongoing opioid crisis with 22 lives lost daily to overdoses in 2023, though expanded naloxone distribution has contributed to decreasing death rates in recent years.
Cytrellis Expands Global Reach: ellacor® with Micro-Coring® Technology Receives Regulatory Approval in Canada and Saudi Arabia
• Health Canada and Saudi Food and Drug Authority have approved Cytrellis Biosystems' ellacor® with Micro-Coring® technology, marking a significant expansion of the company's global footprint beyond the United States.
• The minimally invasive aesthetic device, which removes micro-cores of skin tissue to treat moderate to severe wrinkles without surgery or thermal energy, has already been used in over 10,000 procedures in the U.S. since FDA clearance in 2021.
• Cytrellis is immediately commercializing in Canada and has partnered with a local distributor in Saudi Arabia, targeting aesthetic procedure markets projected to reach $7.2 billion and $1.8 billion respectively by 2030.
RetinaLogik Secures $1.1M Funding and Health Canada Approval for VR-AI Eye Care Platform
• RetinaLogik Inc. has raised $1.1 million in funding and received Health Canada Class II medical device approval for its VR-AI-powered eye care platform, enabling more efficient visual field exams.
• The Calgary-based startup's technology reduces equipment costs by up to 90% compared to traditional systems while offering enhanced patient comfort through a portable headset design.
• The ISO-13485 and MDSAP certified device, which is also FDA registered, features multilingual support and aims to expand across North America to improve early detection of vision-threatening conditions.
Health Canada Approves Spark Biomedical's Drug-Free Neurostimulation Device for Opioid Withdrawal
• Spark Biomedical has received Health Canada's Medical Device License for Sparrow Ascent™, a wearable neurostimulation device providing drug-free relief from opioid withdrawal symptoms.
• The FDA-cleared device will be distributed exclusively through Safe Science Solutions across Canada, offering a new treatment option for patients with opioid use disorder.
• This regulatory milestone expands access to innovative bioelectronic medicine, potentially transforming opioid dependence treatment in a country facing significant challenges with opioid addiction.
Esperion Expands Global Reach: New Partnerships with CSL Seqirus and HLS Therapeutics for NEXLETOL and NEXLIZET
• Esperion Therapeutics has secured exclusive commercialization agreements with CSL Seqirus for Australia/New Zealand and HLS Therapeutics for Canada, expanding global access to its cholesterol-lowering medications NEXLETOL and NEXLIZET.
• The partnerships include upfront payments and milestone-based compensation, with CSL Seqirus deal worth up to $5 million plus transfer pricing and HLS agreement including royalties on future Canadian sales.
• Both medications are indicated to reduce cardiovascular risk and lower LDL-C in patients unable to take statins, addressing significant unmet needs in regions where cardiovascular disease affects millions.
Ipsen's Sohonos Becomes First Approved Treatment for FOP in Canada
• Health Canada has approved Sohonos (palovarotene), making it the first-ever treatment for fibrodysplasia ossificans progressiva (FOP), a rare genetic disorder that turns soft tissue into bone.
• The approval follows regulatory challenges in the US, where Ipsen withdrew its marketing application in 2022 after the FDA requested additional phase 3 trial data.
• The drug is approved for both chronic use and flare-ups in patients aged 8+ (females) and 10+ (males), marking a significant milestone following Ipsen's $1.3 billion acquisition of Clementia Pharma.
UK MHRA Approves Winlevi®, First Novel Acne Treatment in 40 Years
• Winlevi® (clascoterone cream 1%), the first topical androgen receptor inhibitor for acne, receives MHRA approval for patients 12 years and older in the United Kingdom.
• Phase III studies demonstrated superior efficacy of Winlevi® over vehicle cream in reducing both inflammatory and non-inflammatory acne lesions, with a favorable safety profile.
• The approval represents a significant advancement in acne treatment, offering a new mechanism of action that targets sebum production without systemic anti-androgen effects.
FDA Approves ORLYNVAH™: First New Oral Treatment for Uncomplicated UTIs in 25 Years
• Iterum Therapeutics receives FDA approval for ORLYNVAH™, marking the first branded uncomplicated UTI treatment to enter the U.S. market in over 25 years and the first oral penem antibiotic approved in the country.
• The drug demonstrates significant potential against multi-drug resistant pathogens, specifically targeting Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis in adult women with limited treatment options.
• Iterum reports $24.1 million in cash reserves as of December 2024, with funding projected to sustain operations into the second half of 2025 while pursuing pre-commercialization activities.
Nivolumab Plus Ipilimumab Shows Promise in Advanced Hepatocellular Carcinoma
• The combination of nivolumab and ipilimumab has shown significantly improved overall survival in patients with unresectable hepatocellular carcinoma (HCC).
• The CheckMate 9DW trial demonstrated a median overall survival of 23.7 months with nivolumab/ipilimumab compared to 20.6 months with lenvatinib or sorafenib.
• The combination therapy also resulted in a higher objective response rate of 36% versus 13% with lenvatinib/sorafenib, indicating better tumor control.
• The FDA has accepted the application for nivolumab plus ipilimumab as a first-line treatment for unresectable HCC, with a decision expected by April 2025.
Scilex Seeks FDA Approval for ELYXYB in Acute Pain Management
• Scilex Holding Company has submitted a Supplemental New Drug Application (SNDA) to the FDA for ELYXYB in acute pain management.
• ELYXYB, an oral solution of celecoxib, has demonstrated significant pain relief in a study involving post-dental surgery patients.
• The company aims to provide a non-opioid alternative for acute pain, addressing the need for opioid-sparing pain management.
• The FDA's decision on the SNDA will determine ELYXYB's role in the $3 billion U.S. acute pain market.
Valneva's IXCHIQ Shows Sustained Immune Response in Adolescents and Positive Phase 2 Results in Children
• Valneva's IXCHIQ vaccine demonstrates a sustained 98.3% sero-response rate one year after single vaccination in adolescents, supporting potential label extension.
• Phase 2 trial data in children aged 1-11 years shows the vaccine is well-tolerated and highly immunogenic, paving the way for a Phase 3 study.
• The UK's MHRA has granted marketing authorization for IXCHIQ, making it available for adults, with plans for label extension applications.
• Valneva partners with CEPI and SII to expand access to the vaccine in low- and middle-income countries, addressing a significant unmet need.
Telix's Illuccix Receives Approvals in Europe and Denmark for Prostate Cancer Imaging
• Telix Pharmaceuticals' Illuccix receives European marketing authorization for prostate cancer imaging, following a positive decision via decentralized procedure.
• Illuccix is now approved in Denmark for detecting PSMA-positive lesions in adults with prostate cancer across multiple clinical settings.
• PSMA-PET imaging with Illuccix offers superior accuracy for staging primary disease and evaluating biochemical recurrence, replacing conventional methods.
• The approvals set the stage for commercial launches in Europe and Denmark, enhancing access to advanced prostate cancer diagnostics.
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