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PharmaTher Launches Strategic Initiative to Pursue Health Canada Approval for Generic Semaglutide in Canada, Building on FDA-Approved Ketamine Success
TMX Newsfile· 2026-02-02 14:27
Core Insights - PharmaTher Holdings Ltd. is pursuing Health Canada approval for generic semaglutide, aiming for commercialization following regulatory approval [1][4] - The expiration of regulatory exclusivity for semaglutide in Canada in January 2026 opens the market for generic competition [2] - The Canadian market for semaglutide generated approximately C$2.9 billion in sales in 2025, with potential growth in the broader GLP-1 receptor agonist market estimated at US$6.5 billion by 2033 [3] Company Strategy - PharmaTher's initiative focuses on speed-to-market, reliable supply, and broad dose coverage for generic semaglutide [4][7] - The company plans to leverage its experience from FDA approval of ketamine to execute its strategy for semaglutide [4] - A sterile injectable manufacturing strategy will be employed, utilizing a cost-effective, high-quality manufacturer with regulatory compliance [7] Market Context - The demand for semaglutide is increasing, and affordable access along with reliable supply will be critical in the Canadian market [4] - The transition in Canada's semaglutide market is seen as pivotal, with growing demand for generic options [2][4]
NRx Pharmaceuticals (Nasdaq:NRXP) Announces 70,000 Patient Data on Real World Use of Ketamine for Treatment of Suicidal Depression to be Submitted to the FDA in Support of NRX-100 Approval
Globenewswire· 2026-01-14 12:03
Core Viewpoint - NRx Pharmaceuticals has licensed Real World Evidence (RWE) from over 70,000 patients to support its application for Accelerated Approval of NRX-100, a preservative-free ketamine treatment for suicidal ideation in depression and bipolar depression, addressing a significant unmet medical need [1][4][5] Group 1: Company Overview - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapeutics for central nervous system disorders, including suicidal depression, chronic pain, and PTSD [6] - The company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101 (oral D-cycloserine/lurasidone), with NRX-100 receiving Fast Track Designation for treating suicidal ideation in depression [6][7] Group 2: Real World Evidence and Collaboration - The RWE is provided by Osmind, a neuropsychiatry technology platform, which supplies regulatory-grade data to the FDA to support NRx's application for NRX-100 [2][3] - Osmind's dataset includes nearly one million treatment sessions and hundreds of millions of data points, offering a comprehensive view of ketamine and esketamine's effectiveness and safety [3] Group 3: Clinical Insights and Regulatory Context - Preliminary analysis of a subset of patients indicated a favorable clinical response compared to currently approved products, with optimism for meaningful results from the full dataset [4][7] - The FDA's recent policy change allows the submission of de-identified RWE, facilitating NRx's application process [4] Group 4: Market Need and Access - The company highlights the urgent need for effective treatments, noting that a suicide occurs every 11 minutes in the U.S., and ketamine is increasingly used off-label to reduce suicidal ideation [5] - Current access to ketamine is limited primarily to military and veterans' communities, with broader insurance coverage needed for wider patient access [5]
PharmaTher CEO Publishes Letter to Shareholders
TMX Newsfile· 2026-01-02 13:00
Core Viewpoint - PharmaTher Holdings Ltd. is positioned for significant value creation in 2026 following a year of strategic execution and validation in 2025, focusing on asset monetization and strategic partnerships to enhance revenue and equity value [2][5][16]. Group 1: 2025 Achievements - The company achieved FDA approval for its Ketamine ANDA (217858), marking a pivotal moment that enhances drug development and regulatory confidence [6]. - The sale of the U.S. Ketamine ANDA was completed in December, with potential earnings exceeding US$25 million through an asset purchase agreement that includes upfront payments, sales-based milestones, and profit-sharing [7]. - PharmaTher advanced its asset-driven platform by offering KetaVault™ and KetAImine™, aimed at enabling commercial partnerships [8]. - An Exclusive Evaluation and Option-to-License Agreement was secured with Oakwood Laboratories for a patented long-acting injectable ketamine program targeting neuropsychiatric indications [9]. Group 2: 2026 Objectives - The company plans to realize the economic benefits from the Ketamine ANDA sale, which includes upfront proceeds and profit-sharing tied to cumulative sales [11]. - International expansion for ketamine is a priority, with plans to pursue regulatory and commercial initiatives across multiple geographies [12]. - Strategic partnerships will be sought for ketamine programs, particularly in Parkinson's disease and drug delivery, to improve capital efficiency and accelerate development [13]. - The company aims to crystallize the value of its 49% equity interest in Sairiyo Therapeutics Inc. through various potential transactions [14]. - Development of a next-generation ketamine product will continue, focusing on long-acting injectable formulations and assessing both internal and external opportunities [15]. Group 3: Overall Strategy - PharmaTher's strategy emphasizes acquiring and advancing assets that can be efficiently monetized to generate product revenue, royalty income, and equity value [3][19]. - The company is committed to non-dilutive value creation through disciplined cost control, having reduced cash burn and maintained a lean organization [4].
Second doctor charged after the death of Matthew Perry
NBC News· 2025-12-17 04:07
Accountability for another former doctor charged after the death of beloved Friends actor Matthew Perry. My heart goes out to the Perry family. Former California doctor Mark Chavez sentenced to eight months of home detention and three years of supervised release.Last year, he pleaded guilty to one count of conspiring to distribute ketamine to Perry, who was found dead from an accidental overdose in 2023. Chavez admitted to selling ketamine from his former clinic to another doctor, Salvador Plasencia, who su ...
Second doctor sentenced in overdose death of 'Friends' star Matthew Perry
NBC News· 2025-12-16 21:44
The second doctor charged in the overdose death of actor Matthew Perry has learned his sentence. >> Mark Chavez will not go to prison. He was sentenced to home detention and supervised release.Chavez pleaded guilty last year to the charge of conspiracy to distribute ketamine. Prosecutors say he sold ketamine to another doctor, Salvador Placencia, who then sold the drugs to Perry. The friend star was found dead at his home back in 2023.Earlier this month, Placencia was sentenced to two and a half years in pr ...
Second doctor sentenced in overdose death of actor Matthew Perry
NBC News· 2025-12-16 21:15
The second doctor charged in the overdose death of actor Matthew Perry has learned his sentence. >> Mark Chavez will not go to prison. He was sentenced to home detention and supervised release.Chavez pleaded guilty last year to the charge of conspiracy to distribute ketamine. Prosecutors say he sold ketamine to another doctor, Salvador Placencia, who then sold the drugs to Perry. The friend star was found dead at his home back in 2023.Earlier this month, Placencia was sentenced to two and a half years in pr ...
Former doctor who prescribed Matthew Perry ketamine sentenced to 30 months
NBC News· 2025-12-04 01:30
Court today, prosecutors called former Dr. . Salvador Placencia a drug dealer in a white coat. Then a judge sentenced him to two and a half years in prison after he pleaded guilty to illegally selling beloved friend star Matthew Perry large amounts of ketamine in the weeks leading up to his overdose.Perry's mother today addressed Placencia, saying he failed to keep the oath he took as a doctor. She also asked him to look at her as a mother. It's a bad thing you did.She said he looked at her and nodded. Plac ...
Doctor sentenced to prison for supplying actor Matthew Perry with ketamine before his death
NBC News· 2025-12-03 23:55
A judge in California today sentencing a doctor who sold ketamine to friendst star Matthew Perry just weeks before his overdose to more than two years in prison. The doctor is Salvador Placencia. And here he is arriving in court in Los Angeles today. He's the first of five people to be sentenced in Perry's death, but he is not accused of selling the dose that killed the actor back in October of 2023. Perry was taking a surgical anesthetic ketamine legally as a treatment for depression. But when his regular ...
X @The Wall Street Journal
The doctor who repeatedly supplied “Friends” star Matthew Perry with the drug ketamine in the weeks before his death was sentenced to 30 months in federal prison https://t.co/R8OfaMQRR2 ...
X @CNN
CNN· 2025-12-03 22:03
A doctor who sold ketamine to "Friends" star Matthew Perry before his overdose death has been sentenced to 2 1/2 years in prison https://t.co/baJGHIAzcf ...