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Neurothera Labs Granted U.S. Patent for Cannabinoid Technology to Overcome Antimicrobial Resistance such as MRSA
Thenewswire· 2026-02-02 13:00
Core Viewpoint - Neurothera Labs Inc. has received a U.S. patent for its proprietary combination of antimicrobials and cannabinoids aimed at enhancing the efficacy of existing antibiotics against resistant bacterial strains [1][2]. Company Summary - Neurothera Labs Inc. is a clinical-stage biotech company focused on developing innovative therapeutics, particularly in the area of antimicrobial resistance [10]. - The company is a majority-owned subsidiary of SciSparc Ltd. [1]. Technology and Innovation - The patented technology combines established antibiotics with cannabinoids like THC and CBD, demonstrating enhanced antimicrobial activity against resistant pathogens such as MRSA in preclinical studies [3][5]. - The platform aims to restore the effectiveness of antibiotics that are ineffective as monotherapy against resistant Gram-positive pathogens [3]. Market Context - The global antibiotics market is projected to reach approximately $58 billion in 2026, driven by the rising challenge of antimicrobial resistance [6]. - The emergence of resistant bacterial strains, particularly MRSA, has led to a significant increase in healthcare-acquired infections, with a reported 30% rise in the U.S. [6]. Antimicrobial Resistance Challenge - Prolonged antibiotic use has resulted in the emergence of resistant strains, with MRSA causing approximately 130,000 deaths worldwide in 2021, more than double the 57,000 deaths in 2019 [4]. - Overall, bacterial antimicrobial resistance caused 1.14 million deaths and was associated with 4.71 million deaths globally in 2021 [4]. Industry Dynamics - Pharmaceutical companies are increasingly reluctant to develop new antibiotics due to high costs and lengthy development timelines, leading to a gap in innovation as major firms exit the field [8][9]. - The need for innovative solutions that enhance the efficacy of existing antibiotics while improving safety is critical in the current landscape of antimicrobial resistance [6][7].
US FDA declines to approve Aquestive's oral drug for allergic reactions
Reuters· 2026-02-02 12:10
Core Viewpoint - The U.S. Food and Drug Administration has declined to approve Aquestive Therapeutics' oral drug for severe allergic reactions, indicating a setback for the company in its product development efforts [1] Company Summary - Aquestive Therapeutics has faced a significant regulatory hurdle as the FDA did not approve its oral drug intended for treating severe allergic reactions, which may impact the company's future revenue and market position [1]
What CFOs at Adobe, Dataminr, and Huntington say about scaling AI
Fortune· 2026-02-02 12:04
Core Insights - AI is becoming a critical priority at the board level, with CFOs taking a central role in enterprise AI strategy [1] Group 1: AI Adoption and Strategy - At Dataminr, AI is integral to the annual operating plan and budget decisions, with the CFO acting as a strategic partner to the CEO to drive growth and efficiency [2] - Adobe's AI strategy focuses on increasing "organizational velocity" by embedding AI across operations to enhance responsiveness and effectiveness, emphasizing the importance of culture and continuous learning [3] - Huntington Bancshares is developing a generative AI risk framework to balance speed and risk in a regulated environment, prioritizing use cases by risk level and ensuring human oversight for significant applications [4] Group 2: Challenges in AI Implementation - Many companies face obstacles in scaling AI from pilot projects due to data quality issues, weak governance, infrastructure gaps, talent shortages, and cybersecurity concerns [6] - A KPMG AI Pulse survey indicates that 82% of executives view data quality as the primary barrier to AI success, highlighting the need for finance leaders to establish governance frameworks while business teams manage data accountability [7] Group 3: Future of AI in Finance - Generative AI is now embedded in everyday enterprise tools, aiding finance teams in tasks such as summarizing meetings and analyzing contracts, which can enhance financial performance [8] - By 2026, a shift towards scaled AI agent orchestration is expected, reallocating finance talent towards higher-value analysis and decision-making [9] Group 4: CFO Movements and Strategies - Luca Zaramella of Mondelez International is transitioning to a COO role while retaining his CFO position, with a search underway for a successor [10] - Cassandra Harris of Genesco Inc. will step down as CFO, with the CEO taking on the interim role while a search for a permanent CFO is initiated [11] - Bill Carey has been appointed CFO of OPSWAT, succeeding Simon Ho, who will retire but remain in an advisory capacity [12] Group 5: Financial Strategies for Growth - Gartner research identifies four financial strategies for CFOs to drive efficient growth amid economic volatility, including early supplier payments and zero-based SG&A redesign [13] - The analysis of over 1,500 companies reveals that "efficient growth" firms achieved a 51% total shareholder return premium from 2014 to 2024, defined by simultaneous revenue growth, margin expansion, and capital efficiency [14]
Bioxytran and University of Minnesota Launch Sponsored Research Collaboration to Advance Novel Carbohydrate-Based Therapeutics
Globenewswire· 2026-02-02 12:00
NEEDHAM, Mass., Feb. 02, 2026 (GLOBE NEWSWIRE) -- Bioxytran, Inc. (OTCQB: BIXT) (“Bioxytran” or the “Company”), a clinical-stage biotechnology company developing platform technologies spanning glycovirology, hypoxia, and degenerative diseases, announced the execution of a Sponsored Research Agreement with the University of Minnesota to support advanced biochemical research aimed at improving the understanding and development of novel polysaccharide and oligosaccharide interactions with biologically relevant ...
Sagimet Announces Positive 52-Week Data from License Partner Ascletis’ Open-Label Phase 3 Clinical Trial Evaluating the Long-Term Safety of ASC40 (Denifanstat) Tablets in Patients with Moderate to Severe Acne
Globenewswire· 2026-02-02 12:00
Core Insights - Sagimet Biosciences Inc. is collaborating with Ascletis Pharma Inc. on the development of denifanstat (ASC40), a fatty acid synthase (FASN) inhibitor for treating moderate to severe acne, with positive topline results reported from a Phase 3 trial [1][2] Clinical Results - The Phase 3 open-label trial (ASC40-304) involved 240 subjects who received denifanstat 50 mg once daily for up to 40 weeks, following a 12-week double-blind trial [4] - Primary endpoints focused on safety, while secondary endpoints assessed efficacy, showing improvements in all efficacy measures beyond the 12-week mark [5] - Notable efficacy endpoints included a decrease in Investigator's Global Assessment (IGA) scores and reductions in total and inflammatory skin lesion counts [5][6] Safety Profile - Denifanstat was generally well tolerated, with treatment-emergent adverse events (TEAEs) occurring in 5.5% of subjects for dry eye syndrome and 5.2% for dry skin [7] - All adverse events related to denifanstat were mild or moderate, with no serious adverse events linked to the treatment [7] Market Context - Acne affects over 50 million people in the U.S., with a significant number requiring chronic management due to the lack of a definitive cure [9] - The inhibition of FASN is seen as a promising approach to address acne, as it plays a critical role in sebum production and inflammatory pathways [10]
Harrow Reaffirms 2025 Full-Year Revenue Guidance of $270–$280 Million, Marking Another Year of Strong Growth
Globenewswire· 2026-02-02 12:00
Core Insights - Harrow reaffirms its full-year 2025 revenue guidance of $270-280 million, highlighting strong execution across commercial and development programs [1] - The company is on track to double its VEVYE sales force, expand IHEEZO into office-based settings, and double the TRIESENCE sales force in surgical settings [1][2] - Harrow's ImprimisRx has settled regulatory matters with the California Board of Pharmacy and will exit the California market while focusing on other states [1][10] VEVYE Sales Force Expansion - Harrow plans to double the VEVYE sales force from approximately 50 to 100 territories by Memorial Day 2026, driven by recent coverage wins and expected stabilization of net pricing [3] IHEEZO Commercial Expansion - The company is expanding IHEEZO's focus to the office-based setting, targeting over 2.5 million annual procedures, which is expected to accelerate demand and adoption [4] TRIESENCE Sales Force Expansion - Harrow intends to double the surgical sales force for TRIESENCE, responding to positive clinical feedback and increasing demand metrics for the product [6] OneHarrow Initiative - The OneHarrow initiative aims to unify branding and operations under a single organization to enhance patient access, affordability, and clinical outcomes [7] Leadership Changes - Patrick W. Sullivan has been promoted to Chief Commercial Officer, focusing on strengthening Harrow's commercial foundation and aligning with the company's revenue goals [8] MELT-300 and MELT-210 Programs - Harrow is on track to submit New Drug Applications for MELT-300 and MELT-210, with all necessary studies initiated [1][9] ImprimisRx Regulatory Settlement - ImprimisRx has settled with the California Board of Pharmacy, agreeing to a fine of approximately $157,000, and will exit the California market effective February 1, 2026 [10]
Bioxytran and University of Minnesota Launch Sponsored Research Collaboration to Advance Novel Carbohydrate-Based Therapeutics
Globenewswire· 2026-02-02 12:00
NEEDHAM, Mass., Feb. 02, 2026 (GLOBE NEWSWIRE) -- Bioxytran, Inc. (OTCQB: BIXT) (“Bioxytran” or the “Company”), a clinical-stage biotechnology company developing platform technologies spanning glycovirology, hypoxia, and degenerative diseases, announced the execution of a Sponsored Research Agreement with the University of Minnesota to support advanced biochemical research aimed at improving the understanding and development of novel polysaccharide and oligosaccharide interactions with biologically relevant ...
Aquestive Therapeutics Announces FDA Issuance of Complete Response Letter for Anaphylm™
Globenewswire· 2026-02-02 12:00
Core Viewpoint - Aquestive Therapeutics received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for Anaphylm™ (dibutepinephrine) Sublingual Film, which is intended for treating Type I allergic reactions, including anaphylaxis, in patients weighing 30kg or more [1][2] Group 1: FDA Response and Company Actions - The CRL highlighted deficiencies related to human factors in the Anaphylm validation study, specifically issues with pouch opening and film placement that could pose safety risks [2][3] - The company plans to modify the pouch design and labeling, and conduct a new human factors validation study to address the FDA's concerns [2][4] - No additional studies were requested by the FDA, and the company believes it can resolve the identified deficiencies quickly, aiming for resubmission in Q3 2026 [3][6] Group 2: Clinical Development and Market Strategy - The original NDA submission for Anaphylm is supported by a comprehensive clinical program involving 11 studies with approximately 967 administrations across 411 subjects, demonstrating a comparable pharmacokinetic profile to leading epinephrine auto-injectors [7][8] - The company is advancing its global expansion strategy for Anaphylm, with regulatory engagements initiated in Canada, Europe, and the UK, expecting to submit applications in the second half of 2026 [5][6] Group 3: Financial Position and Future Outlook - The company remains well-capitalized and anticipates ending 2026 with significant cash reserves, which will support the Anaphylm approval and pre-launch processes in the U.S. and other key markets [6][9] - The company is committed to bringing Anaphylm to the allergy community and believes in its potential as a non-invasive treatment option for severe allergic reactions [2][8]
Eli Lilly and Company (LLY) Forms Strategic Collaboration with Repertoire Immune Medicines
Yahoo Finance· 2026-02-02 11:55
Core Insights - Eli Lilly and Company (NYSE: LLY) is forming a strategic collaboration with Repertoire Immune Medicines, potentially worth up to $1.93 billion, aimed at developing new treatments for multiple autoimmune diseases [2][3]. Group 1: Collaboration Details - Under the agreement, Repertoire will receive an upfront payment of $85 million, with an additional $1.84 billion contingent on development and commercial milestones [3]. - The collaboration includes tiered royalties on future net sales, focusing on therapies that restore the immune system without broad immune suppression [3]. Group 2: Access to Technology - As part of the collaboration, Eli Lilly will gain access to Repertoire's Decode platform, which studies T cell recognition and binding to specific targets on diseased cells [4]. - Repertoire will handle early discovery work, after which Eli Lilly will take over clinical development, manufacturing, regulatory activities, and commercialization [4]. Group 3: Strategic Expansion - Eli Lilly is actively expanding its immunology business through various deals and acquisitions, including the $3.2 billion acquisition of Morphic Holding in 2024 to enhance its inflammatory bowel disease pipeline [5]. - The current immunology portfolio of Eli Lilly includes treatments such as Olumiant, Taltz, and Omvoh, addressing conditions like arthritis, immune-related hair loss, psoriasis, and chronic bowel disorders [6].
3 Headwinds Facing Pfizer in 2026
Yahoo Finance· 2026-02-02 11:52
Core Viewpoint - Pfizer is facing significant challenges that could impact its attractiveness as an investment, particularly in relation to its dividend yield and upcoming patent expirations [1] Group 1: GLP-1 Drug Development - Pfizer's stock has fallen over 50% from its 2021 highs, partly due to its lack of a GLP-1 drug, which is crucial for diabetes management and weight loss [2] - The company previously had an internal GLP-1 candidate that was dropped, leaving it behind competitors like Eli Lilly and Novo Nordisk, which have successful GLP-1 drugs on the market [3] - Pfizer is attempting to catch up by acquiring a company with a promising GLP-1 pipeline and has agreed to distribute a GLP-1 pill for a Chinese company pending approval [3][4] Group 2: Patent Expirations - Pfizer is approaching key patent cliffs, with its oncology drug Ibrance expected to face generic competition in 2027, followed by cardiovascular drugs Eliquis and Vyndaqel in 2028 [5] - The timing of new drug development and patent expirations does not always align, but 2026 is critical as it is the last year before revenues from key drugs may start to decline [6] Group 3: Dividend Concerns - Pfizer's dividend payout ratio is around 100%, raising concerns about its ability to sustain dividends amidst setbacks in GLP-1 development and upcoming patent cliffs [7] - Although dividends are paid from cash flow rather than earnings, the high payout ratio, combined with recent acquisitions and the capital-intensive nature of the pharmaceutical sector, adds to the worry [8]