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Clinical Trial News

Novartis and MSN Settle Entresto Patent Dispute, Boosting Divi's Laboratories Outlook

  • Novartis and MSN Laboratories have settled the '659 patent dispute regarding Entresto, a blockbuster heart failure drug generating $6 billion in annual sales for Novartis.
  • The legal battle now moves to the next patent expiring in November 2026, with regulatory exclusivity extending until May 2027, potentially delaying generic competition.
  • Divi's Laboratories, a key API supplier for Entresto, could earn ₹700 crore in FY26 if MSN launches generics in July 2025, or ₹1,000-1,200 crore if the launch is delayed.
  • The settlement could lead to upward revisions in Divi's financial estimates for FY26 and FY27, with shares gaining 1.7% following the news.

FDA Approves First Simultaneous Whole Exome and Transcriptome Cancer Test for Precision Oncology

FDA Approval
  • Caris Life Sciences received FDA approval for MI Cancer Seek, the first simultaneous whole exome and whole transcriptome sequencing-based companion diagnostic test for solid tumors.
  • The test demonstrates over 97% agreement with other FDA-approved diagnostic tools and can analyze both DNA and RNA from minimal tissue samples as small as 50 ng.
  • MI Cancer Seek includes companion diagnostic indications for multiple targeted therapies across breast, lung, colon, melanoma, and endometrial cancers for both adult and pediatric patients.
  • The comprehensive assay detects key biomarkers including PIK3CA, EGFR, BRAF, and KRAS/NRAS mutations while measuring tumor mutational burden and microsatellite instability.

NEC and Chugai Pharmaceutical Develop AI System to Accelerate Cancer Drug Combination Discovery

AIDrug Discovery
  • NEC Corporation and Chugai Pharmaceutical have successfully tested an AI system that can predict effective cancer drug combinations, potentially reducing prediction time by approximately 50% compared to conventional methods.
  • The graph-based AI technology leverages biochemical information and clinical trial data from AACT and ChEMBL databases to quickly suggest candidate drug combinations that could enhance cancer treatment efficacy.
  • In experimental validation using approximately 400 cancer drug combinations, the system demonstrated accurate predictions with highly convincing rationales, showing potential to streamline drug discovery processes.
  • The technology addresses the time-consuming manual research traditionally required for drug combination therapy development, which involves analyzing vast amounts of publications and clinical trial data.

Expanding Innovations Receives FDA Clearance for N-GAGE Lumbar Plate System

  • Expanding Innovations received U.S. FDA 510(k) clearance for its N-GAGE Lumbar Plate System, marking the company's first spinal fixation platform.
  • The modular system offers spine surgeons a flexible fixation solution for lateral and anterolateral lumbar fusions using NON-SCREW-based technology.
  • The N-GAGE Plate uniquely pairs with the X-PAC LLIF Expandable Interbody Cage System via a NON-SCREW-based Polyaxial Coupler.
  • This regulatory milestone represents the company's transition from a product-based technology company to a complete procedural solutions provider.

Applied DNA Sciences Announces Leadership Transition as CEO Dr. James Hayward Retires After 20-Year Tenure

  • Applied DNA Sciences announced the retirement of Chairperson and CEO Dr. James A. Hayward effective June 18, 2025, following a distinguished 20-year term leading the biotechnology company.
  • President and COO Judy Murrah has been appointed as the new Chairperson of the Board of Directors and CEO, bringing over a decade of operational leadership at Applied DNA.
  • The leadership transition comes as Applied DNA focuses on its biotherapeutic manufacturing capabilities and seeks to address manufacturing challenges in the nucleic acid therapeutics industry.
  • Ms. Murrah previously held strategic roles at Symbol Technologies and Motorola, contributing to Symbol's growth to approximately $2 billion in revenue and 5,000 employees.

SaverOne Receives US Patent for Advanced Sensor Fusion Technology to Combat Driver Distraction

  • SaverOne 2014 Ltd. has been granted US Patent 12,326,512 for a sensor fusion system that detects and classifies mobile device usage within vehicle cabins to enhance driver safety.
  • The patented technology combines Radio Frequency-based location detection with non-RF sensor data to distinguish between driver and passenger mobile device usage in real-time.
  • This marks SaverOne's 14th granted patent out of a portfolio of 23 patents and applications, strengthening the company's position in transportation safety technology.
  • The innovation addresses a critical safety issue, as mobile phone-related accidents account for approximately 25% of road incidents and cost the US $870 billion annually according to federal data.

Blue Biofuels Secures Seventh U.S. Patent for Cellulose-to-Sugar Technology

  • Blue Biofuels has been granted its seventh U.S. patent, strengthening its intellectual property portfolio for biofuel technologies with 25 additional patent applications pending.
  • The new patent reinforces protection for the company's proprietary Cellulose-to-Sugar (CTS) technology, which converts plant materials into biofuels including ethanol and sustainable aviation fuel.
  • CEO Ben Slager emphasized that the patent demonstrates the strength of their CTS technology and secures competitive advantage as they scale toward commercial deployment.
  • The CTS process can utilize diverse biomass sources including agricultural waste, grasses, and forestry products, offering a sustainable alternative to food crop-based ethanol production.

Medibank Partners with Emyria to Fund Innovative PTSD Treatment Program in Australian Healthcare First

  • Medibank, Australia's largest private health insurer, has entered a multi-year partnership with Emyria to fund the Empax PTSD care program, marking the first time a major private health insurer has funded an ethics-approved, psychiatrist-led trauma therapy program.
  • Eligible Medibank members can now access the comprehensive trauma care program with no out-of-pocket costs at Perth Clinic, with treatment typically valued between AUD $20,000 and AUD $30,000.
  • The Empax model integrates psychiatrist-supervised therapy, specialist care coordination, and continuous real-world data collection, addressing the urgent need for innovative mental health treatments as PTSD affects approximately one in 11 Australians.
  • Independent evaluation by Professor Paul Fitzgerald from Australian National University will assess clinical effectiveness and health economics to build the case for broader reimbursement and systemic adoption.

OCCAM Immune and Cancer Research Institute Form Strategic Partnership to Advance Personalized Immunotherapy

  • OCCAM Immune, a Mount Sinai initiative, has partnered with the Cancer Research Institute to establish long-term immune monitoring across clinical trials, aiming to identify which patients benefit most from specific immunotherapies.
  • The collaboration will begin with a clinical trial in platinum-resistant high-grade serous ovarian cancer, analyzing 160 blood samples and tumor biopsies using RNA/DNA sequencing and immune cell mapping technologies.
  • This partnership combines CRI's decades of immunotherapy experience and global clinical trial access with OCCAM Immune's advanced immune profiling tools to accelerate personalized cancer treatment development.
  • The initiative addresses the critical challenge that immunotherapy doesn't work for all patients, seeking to understand immune system responses to therapy for more precise treatment matching.

Sartorius Stedim Biotech Completes Major Manufacturing Expansion in France to Meet Growing Bioprocessing Demand

  • Sartorius Stedim Biotech has completed a multi-year capacity expansion project at its Aubagne headquarters, nearly doubling cleanroom space to 9,000 square meters with automated production lines for single-use bioprocessing bags.
  • The expansion includes a new 12,000-square-meter automated warehouse facility and 1,900-square-meter cross-functional lab space for product development and customer training, with total site area quadrupling to 90,000 square meters since 2020.
  • The company has invested significantly in sustainable manufacturing practices, achieving ISCC Plus certification for renewable raw materials and ISO 14001 environmental management standards while doubling its French workforce to 1,400 employees over the past decade.

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