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Eisai Secures Lenvima Patent Protection Through 2036 in US Court Victory

Oncology
  • Eisai has successfully defended its Lenvima patent in a US court case, securing protection against generic competition until 2036.
  • The patent victory represents a significant commercial win for Eisai, extending the exclusivity period for one of its key oncology treatments.
  • This legal success follows broader trends in pharmaceutical patent litigation as companies seek to protect their innovative therapies from generic erosion.

AI Test Identifies Prostate Cancer Patients Who Benefit Most from Life-Saving Drug Abiraterone

AIPrecision MedicineOncologyDrug Approval
  • Researchers developed an AI test that can predict which men with high-risk prostate cancer will benefit most from abiraterone treatment by analyzing tumor images.
  • The AI identified that 25% of men with a specific biomarker saw their five-year death risk cut from 17% to 9% when taking abiraterone alongside standard therapy.
  • Men without the biomarker showed no statistically significant benefit from abiraterone, allowing doctors to spare them unnecessary treatment and side effects.
  • The breakthrough could enable NHS England to reconsider funding abiraterone for newly diagnosed high-risk prostate cancer that hasn't spread, potentially helping 2,100 men annually.

Kenya Slashes Breast Cancer Treatment Costs by 67% Through Roche Partnership

Oncology
  • The Kenyan Ministry of Health has partnered with Roche East Africa to reduce breast cancer treatment costs from Sh120,000 to Sh40,000 per session, representing a 67% cost reduction.
  • The agreement eliminates co-payments for patients at all Social Health Authority-accredited facilities, including public, faith-based, and private hospitals.
  • This initiative addresses a critical need as breast cancer affects 6,799 women annually in Kenya and accounts for 23.3% of all cancer diagnoses among women.
  • The partnership aims to strengthen Kenya's cancer care framework by improving access to essential medicines, enhancing healthcare professional capacity, and expanding screening programs.

Bionical Emas Secures Exclusive Partnership to Address Critical European Fluorouracil Shortage

Oncology
  • Bionical Emas has secured an exclusive global clinical trial supply agreement with German pharmaceutical company Pharma Resources GmbH to distribute EU-marketed oncology injectables, including Fluorouracil.
  • The partnership addresses critical 5-Fluorouracil shortages that are currently disrupting cancer treatments and clinical trials across Europe.
  • Bionical Emas' global infrastructure and agile supply model will reduce delivery times from months to weeks for essential oncology medications.
  • This strategic alliance marks Pharma Resources' entry into the clinical trial supply market while strengthening Bionical Emas' position as a trusted supply partner.

Genor Biopharma Secures NMPA Approval for Lerociclib CDK4/6 Inhibitor in Advanced Breast Cancer

Drug ApprovalTargeted TherapyOncology
  • Genor Biopharma Holdings Ltd. received China National Medical Products Administration (NMPA) approval for Lerociclib (GB491), a novel CDK4/6 inhibitor for advanced breast cancer treatment.
  • The oral bioavailable drug targets hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer in adult patients.
  • Lerociclib will be used in combination with aromatase inhibitors as initial therapy or with fulvestrant following endocrine therapy progression.
  • The approval represents a significant milestone resulting from successful collaboration between Genor Biopharma and G1 Therapeutics Inc.

FDA-Approved Menopause Drug Duavee Shows Promise for Breast Cancer Prevention in Phase 2 Trial

Oncology
  • A multi-center phase 2 clinical trial led by Northwestern Medicine found that Duavee significantly reduced cell growth in breast tissue among 141 postmenopausal women with ductal carcinoma in situ (DCIS).
  • The drug, already FDA-approved for menopausal symptoms, was well tolerated by participants and did not affect quality of life during the four-week treatment period.
  • Duavee may offer a promising alternative for women at elevated breast cancer risk who experience menopausal symptoms but are typically advised against standard hormone therapies.
  • Researchers will present findings at the American Society of Clinical Oncology Annual Meeting, though larger studies with longer follow-up are needed before considering the drug for breast cancer prevention.

The PROMISE Study: Duavee in Women With DCIS

NCT02694809CompletedPhase 2
Northwestern University
Posted 1/1/2017

Javara Secures Series C Funding to Expand Community-Based Clinical Trial Access into Oncology and CNS

Oncology
  • Javara, an integrated research organization, secured Series C funding from community-based investors to expand clinical trial access at the point of care.
  • The funding will enable expansion into new therapeutic areas including Oncology, CNS, and Neurology through localized clinical research collaborations.
  • The company currently provides access to over 5 million patients across 7 states and aims to double both patient and physician reach.
  • Javara pioneers Clinical Research as a Care Option (CRAACO) by partnering with healthcare organizations to deliver trials through integrated research staff and infrastructure.

ProteinQure Secures $11M Series A to Advance First AI-Designed Peptide Therapeutic for Triple-Negative Breast Cancer

Drug DiscoveryAIOncology
  • ProteinQure raised $11 million in Series A funding led by Heron Rock Fund to advance PQ203, a first-in-class AI-designed peptide-drug conjugate targeting triple-negative breast cancer.
  • The lead candidate PQ203 targets the sortilin receptor overexpressed in solid tumors and is designed for tumors resistant to topoisomerase I inhibitors like Trodelvy.
  • A multicenter Phase 1 clinical trial is planned to begin in Q3 2025, enrolling 70-100 patients across renowned cancer centers including Princess Margaret, MD Anderson, and Yale.
  • The financing brings ProteinQure's total funding to $16 million and represents what the company believes to be the first AI-designed peptide therapeutic entering clinical trials.

Monarch Therapeutics and SNAP Biosciences Partner to Advance CAR-NK Cell Therapy with Small Molecule Adaptor Technology

Oncology
  • SNAP Biosciences and Monarch Therapeutics announced a licensing agreement to integrate Monarch's small molecule adaptor technology into SNAP's Snap-Car NK cell therapy platform for oncology applications.
  • The partnership enables simultaneous targeting of multiple tumor antigens and real-time activity modulation, addressing tumor heterogeneity and antigen escape challenges in cancer treatment.
  • Monarch's adaptor technology, developed by scientific co-founders Drs. Jason Lohmueller and Alexander Deiters, enhances precision and flexibility of CAR-based therapies.
  • The collaboration positions both companies to advance more potent and scalable NK therapies for difficult-to-treat cancers with improved manufacturing and regulatory pathways.

Biohaven's Novel ADCs Show Promising Early Clinical Results with TopoIx Payload Technology

Oncology
  • Biohaven's Trop2-directed ADC BHV-1510 demonstrated tumor reduction in all six patients when combined with cemiplimab, including confirmed partial responses and activity in brain metastases.
  • The company initiated first-in-human dosing of BHV-1530, a potential first-in-class FGFR3-directed ADC, marking the only FGFR3 ADC in advanced clinical testing.
  • BHV-1510 showed a favorable safety profile with manageable stomatitis as the main toxicity and notably no cases of interstitial lung disease.
  • The proprietary TopoIx payload demonstrated immunogenic cell death and synergistic efficacy with PD-1/PD-L1 checkpoint inhibitors in preclinical studies.

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