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Fennec Pharmaceuticals Announces Settlement Agreement Resolving PEDMARK Patent Litigation
Globenewswire· 2026-03-16 12:08
Core Insights - Fennec Pharmaceuticals has reached a settlement with Cipla regarding the litigation over Cipla's application to market a generic version of PEDMARK, with Cipla agreeing not to enter the market until September 1, 2033, or earlier under specific conditions [1] Company Overview - Fennec Pharmaceuticals is a specialty pharmaceutical company focused on reducing ototoxicity in cancer patients undergoing cisplatin-based chemotherapy [14] - PEDMARK is the first FDA-approved therapy to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients aged 1 month and older with localized, non-metastatic solid tumors [2][6] Product Details - PEDMARK is a unique formulation of sodium thiosulfate available in single-dose, ready-to-use vials for intravenous use [2] - The product has been endorsed by the National Comprehensive Cancer Network (NCCN) for the adolescent and young adult population with a 2A recommendation [3] Market Context - Approximately 500,000 patients in the U.S. are diagnosed annually with cancers treatable by platinum-based chemotherapy, with many experiencing lifelong hearing loss due to ototoxicity [4] - Prior to PEDMARK's FDA approval, there were no preventative agents for hearing loss resulting from cancer treatment, significantly impacting patients' quality of life [4] Clinical Studies - PEDMARK has been validated through two Phase 3 clinical studies, COG ACCL0431 and SIOPEL 6, demonstrating its efficacy in reducing ototoxicity [5] - The COG ACCL0431 study included various childhood cancers treated with intensive cisplatin therapy, while SIOPEL 6 focused on hepatoblastoma patients [5] Regulatory and Commercialization Status - PEDMARK received FDA approval in September 2022 and has also been approved in Europe and the U.K. under the brand name PEDMARQSI [14][15] - Fennec has entered into an exclusive licensing agreement with Norgine Pharmaceuticals for the commercialization of PEDMARQSI in Europe, the U.K., Australia, and New Zealand [15] - The product has Orphan Drug Exclusivity in the U.S. and Pediatric Use Marketing Authorization in Europe, providing significant market protection [16]
Spyre Announces Acceleration of Expected Topline Readout of SKYWAY Rheumatoid Arthritis Sub-study to Q3 2026
Globenewswire· 2026-03-16 12:00
"Enrollment in the RA sub-study of SKYWAY has exceeded our expectations and reflects both substantial unmet need as well as investigator enthusiasm for the potential of a long-acting anti-TL1A antibody," said Joshua Friedman, M.D., Ph.D., SVP of Clinical Development and SKYWAY study lead. "We look forward to delivering the first proof-of-concept data for this mechanism in rheumatic disease in the third quarter, with the potential to advance to pivotal trials next year. Together with readouts from the SKYLIN ...
Nasus Pharma Announces Positive Top Line Data from Phase 2 Clinical Study of NS002: Achieves Significantly Superior and Faster Epinephrine Delivery Compared to EpiPen® with Accelerated Speed to Therapeutic Threshold
Globenewswire· 2026-03-16 11:30
Core Insights - Nasus Pharma's NS002 demonstrated significantly faster absorption of epinephrine compared to EpiPen®, achieving the critical 100 pg/mL threshold in a median of 1.69 minutes versus 3.42 minutes [1][2][5] - The company plans to initiate a pivotal clinical study for NS002 in the fourth quarter of 2026 [2][4] Group 1: Clinical Study Results - The Phase 2 study enrolled 50 healthy adults, showing NS002's advantages in various administration scenarios during anaphylactic emergencies [3] - At 2.5 minutes, 67.4% of NS002 participants reached the therapeutic threshold compared to 27.1% with EpiPen® [5] - By 10 minutes, approximately 95% of NS002 participants reached the therapeutic threshold, indicating superior performance [5] Group 2: Pharmacokinetic and Pharmacodynamic Advantages - NS002 reached peak concentration in a median of 15 minutes, faster than EpiPen®'s 19.8 minutes [5] - Total epinephrine absorption in the critical 10-minute window was about 50% higher with NS002 compared to EpiPen® [5] - Repeat doses of NS002 maintained pharmacokinetic advantages, crucial for patients needing additional doses during severe anaphylaxis [5][6] Group 3: Safety Profile - NS002 exhibited a favorable safety and tolerability profile, with no serious adverse events reported [6] - The study results suggest NS002 could outperform EpiPen® in real-world conditions, including challenging scenarios [6] Group 4: Company Overview - Nasus Pharma is focused on developing innovative intranasal products, with NS002 as a needle-free alternative for anaphylaxis treatment [8] - The proprietary Nasax® powder platform is designed for rapid and reliable drug delivery, leveraging the nasal cavity's vascular network [8]
Medicus Pharma Announces SkinJect® Phase 2 Principal Investigator and Key Opinion Leader (KOL), Babar K. Rao MD, FAAD, to Provide Clinical Interpretation of Positive Data During Business Update Webcast on March 26
Globenewswire· 2026-03-16 11:30
Phase 2 Study Demonstrated 73% clinical Clearance in the 200-µg Arm suggests that ~3 out of 4 treated lesions may allow patients to avoid immediate surgical intervention. PHILADELPHIA, March 16, 2026 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, today announced that Babar K. Rao, MD, FAAD, an internationally recognized academ ...
NeuroThera Labs- Clearmind Medicine Collaboration Leads to Patent Application for Depression Therapy
Thenewswire· 2026-03-16 11:30
Core Viewpoint - NeuroThera Labs Inc. has announced a collaboration with Clearmind Medicine Inc. to file a patent for an innovative combination therapy aimed at treating major depressive disorder (MDD) [1][3] Company Overview - NeuroThera Labs Inc. is a clinical-stage biotech company focused on developing novel therapeutics for central nervous system disorders through collaborations and innovative combinations [4] - Clearmind Medicine Inc. is a clinical-stage pharmaceutical biotech company dedicated to discovering and developing psychedelic-derived therapeutics for various health issues, including alcohol use disorder [5] Patent Filing and Therapy Details - Clearmind has filed a patent application in Hong Kong for a combination therapy that includes Clearmind's proprietary 5-methoxy-2-aminoindane (MEAI) and Palmitoylethanolamide (PEA) sourced from NeuroThera [2][3] - The MEAI-PEA combination is positioned as a non-hallucinogenic neuroplastogen option for treating depression, which affects over 332 million people globally [3] Market Potential and Advantages - The anticipated mechanism of action for the MEAI-PEA therapy suggests it could offer a safer, more accessible, and affordable alternative to existing antidepressants, including SSRIs [3][8] - There is a growing demand for novel treatments for major depressive disorder, highlighting the potential market opportunity for this combination therapy [8]
Alto Neuroscience (NYSE:ANRO) Earnings Call Presentation
2026-03-16 11:00
NYSE: ANRO March 2026 1 Disclaimer No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and our own internal estimates and research. While we believe these third-party studies, publications, surveys and other data to be reliable as of the date of this presentation, we have not indepe ...
Lilly's EBGLYSS (lebrikizumab-lbkz) is the first and only selective IL-13 inhibitor to deliver positive Phase 3 outcomes in patients aged six months to 18 years with moderate-to-severe atopic dermatitis
Prnewswire· 2026-03-16 10:45
Lilly's EBGLYSS (lebrikizumab-lbkz) is the first and only selective IL-13 inhibitor to deliver positive Phase 3 outcomes in patients aged six months to 18 years with moderate-to-severe atopic dermatitis Accessibility StatementSkip Navigation In the Phase 3 ADorable-1 study, 63% of patients achieved meaningful skin improvement (EASI-75) and 44% achieved clear or almost clear skin (IGA 0,1) at Week 16 In key secondary endpoints, 39% of patients achieved a high bar of near-complete skin clearance (EASI-90) and ...
Amphastar Pharmaceuticals, Inc. (AMPH) Presents at Barclays 28th Annual Global Healthcare Conference Transcript
Seeking Alpha· 2026-03-16 08:52
Group 1 - Amphastar Pharmaceuticals is being hosted by Barclays Bank for a presentation, indicating a focus on investor engagement and communication [1] - Bill Peters serves as the CFO of Amphastar Pharmaceuticals, highlighting the company's leadership structure [1] - Dan Dischner is responsible for Corporate Communications at Amphastar, suggesting a strategic emphasis on public relations and stakeholder engagement [1] Group 2 - Glen Santangelo is the analyst at Barclays covering the specialty pharmaceuticals and animal health sectors, indicating the areas of expertise relevant to Amphastar [2] - The event reflects Barclays' commitment to providing insights into the pharmaceutical industry, particularly in the specialty sector [2]
Roche receives CE mark for first IVD immunoassay blood test to identify carriers of ApoE4, a genetic variant present in up to 60% of patients diagnosed with Alzheimer's disease
Prnewswire· 2026-03-16 06:00
Core Insights - Roche has received CE Mark approval for the Elecsys® Apolipoprotein E4 biomarker test, the first in-vitro diagnostic immunoassay to identify the ApoE4 gene variant in blood, which is present in 40-60% of Alzheimer's patients [1][2][5] - The test simplifies the diagnostic process for Alzheimer's disease by allowing quick identification of ApoE4 carriers, thus streamlining patient management and treatment decisions [2][4] - The Elecsys ApoE4 test is part of Roche's broader commitment to improving Alzheimer's care through advanced diagnostic tools and innovative therapies [7][8] Product Details - The Elecsys ApoE4 test uses a minimally-invasive blood sample to determine ApoE4 carrier status, which is clinically significant for guiding disease-modifying therapies (DMTs) [1][4][5] - The test demonstrated 100% concordance with genetic testing, accurately identifying all carriers and non-carriers [6] - It is designed to work alongside other Roche blood-based Alzheimer's biomarkers, enhancing the overall diagnostic journey [2][7] Market Context - Alzheimer's disease accounts for up to 70% of dementia cases globally and is projected to affect nearly 150 million people by 2050 [1][3] - The approval of the Elecsys ApoE4 test aligns with the 2024 Alzheimer's Association criteria, recognizing ApoE4 as a clinically relevant genetic risk factor for Alzheimer's [3][4] - Roche's position as a leader in both pharmaceuticals and diagnostics allows for a comprehensive approach to patient care in Alzheimer's disease [8]
Amphastar Pharmaceuticals: Why I Like Bull Put Options Strategy Here (NASDAQ:AMPH)
Seeking Alpha· 2026-03-16 04:18
Core Insights - Amphastar Pharmaceuticals, Inc. (AMPH) is identified as a small pharmaceutical company with a portfolio that includes both generic and proprietary drugs, which is considered undervalued [1] Investment Strategy - The investment approach combines fundamental analysis with options trading, focusing on various strategies such as income-oriented investments, growth at a reasonable price, deep value, and dividend aristocrats [1] - The company employs 20-25 different options strategies for purposes including hedging, bullish substitutes, neutral trades, trading volatility, and earnings-related trades [1] Teaching and Community Engagement - The company has a passion for teaching and has previously engaged in both formal and informal educational roles, including authoring a free local investing newsletter [1]