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Agilent's MMR IHC Panel PharmDx Receives FDA Approval as Companion Diagnostic for Colorectal Cancer Immunotherapy

FDA ApprovalPrecision Medicine
  • Agilent Technologies received FDA approval for its MMR IHC Panel pharmDx (Dako Omnis) as a companion diagnostic test to identify mismatch repair deficient colorectal cancer patients eligible for Bristol Myers Squibb's Opdivo immunotherapy treatments.
  • The test detects loss of function in four key mismatch repair proteins (MLH1, PMS2, MSH2, and MSH6) in colorectal cancer tissue, making it the only FDA-approved companion diagnostic IHC panel for this specific indication.
  • This diagnostic tool enhances healthcare providers' ability to tailor immunotherapy treatments for colorectal cancer patients, potentially improving tumor control and progression-free survival outcomes.

A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread

NCT02060188CompletedPhase 2
Bristol-Myers Squibb
Posted 3/12/2014

A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

NCT04008030Active, Not RecruitingPhase 3
Bristol-Myers Squibb
Posted 8/5/2019

Dana-Farber Researchers Launch Phase 1 Trial of Novel Cyclin Inhibitor for Small Cell Lung Cancer

OncologyPrecision Medicine
  • Dana-Farber Cancer Institute researchers have developed a first-in-class direct cyclin inhibitor that selectively kills cancer cells with disabled G1/S checkpoints, showing 100-1000 fold greater sensitivity in cancer cells compared to normal cells.
  • The novel drug class targets cyclins A and B through a two-step mechanism that causes DNA damage and mitotic cell death specifically in cancers with elevated E2F activity, including small cell lung cancer and triple negative breast cancer.
  • A nationwide phase 1 clinical trial testing compound CID-078 is now open for patients with small cell lung cancer, triple negative breast cancer, and other cancers, marking the first clinical application of direct cyclin inhibition.
  • Preclinical studies demonstrated that patient-derived xenografts of small cell lung cancer stopped growing when treated with the drug, providing strong mechanistic evidence published in Nature to support human testing.

Eli Lilly Neuroscience Chief Anne White to Retire After Leading Alzheimer's Drug Launch

  • Eli Lilly announced that Anne White, head of its neuroscience division, will retire in December after a 30-year career at the company.
  • White oversaw the regulatory submission and launch of Kisunla, Lilly's Alzheimer's drug that represents the culmination of decades of research into treatments for the memory-robbing condition.
  • The company is searching for internal and external candidates to replace White, who previously led Lilly's oncology unit and helped integrate the Loxo Oncology acquisition.
  • Kisunla recorded $49 million in sales during the April-June quarter, performing modestly since its launch despite analyst expectations for eventual blockbuster status.

First Nations Launch Comparative Drug Trial to Combat Psoroptic Mange in Declining Bighorn Sheep Population

  • The Okanagan Nation Alliance is leading a drug trial testing fluralaner and moxidectin to treat psoroptic mange in bighorn sheep, with research running from February 2025 to July 2026.
  • Psoroptic mange has caused a 60% decline in bighorn sheep populations in South Okanagan since 2011, with the parasitic disease causing fatal hair loss and hearing impairment.
  • Researchers traced the mange outbreak to a domestic rabbit farm through genetic testing, highlighting the risk of cross-species transmission.
  • The comparative trial builds on successful 2016 research using fluralaner and aims to treat all affected bighorn sheep in the region if proven effective.

AlzeCure Pharma Strengthens Clinical Development Team with Appointment of Cecilia Wadell as Head of Development

  • AlzeCure Pharma has appointed Cecilia Wadell, MScPharm, Ph.D., as Head of Development to lead the clinical development organization effective August 20, 2025.
  • Wadell brings over 25 years of pharmaceutical industry experience from major companies including AstraZeneca, Wilson Therapeutics, Medivir, and World Wide Clinical Trials.
  • The appointment strengthens AlzeCure's clinical capacity as the company advances multiple drug candidates for Alzheimer's disease and pain through clinical development phases.
  • Dr. Märta Segerdahl will continue in her role as Chief Medical Officer while Wadell takes over development leadership responsibilities.

India Advances Rare Disease Treatment Pipeline with Nine New Medications

Drug Approval
  • India has successfully launched five medications for seven rare diseases including Thalassemia, Wilson's disease, and Cystic Fibrosis, with four additional drugs expected to reach market soon.
  • The National Policy for Rare Diseases currently covers 63 rare conditions, with NITI Aayog prioritizing 13 disorders for accelerated development in 2023.
  • Generic medications from local companies are providing significant cost savings for rare disease patients, while the government's PLI scheme supports production of treatments for eight rare diseases.
  • With 70-90 million Indians affected by rare diseases out of 300 million globally, industry leaders emphasize the need for improved R&D ecosystems and faster regulatory processes.

Natco Pharma Launches Generic Bosentan for Pediatric Pulmonary Arterial Hypertension with 180-Day US Market Exclusivity

Drug Approval
  • Natco Pharma has launched generic Bosentan tablets (32 mg) for oral suspension in the US, securing 180-day market exclusivity as the first-to-file generic manufacturer.
  • The drug treats pulmonary arterial hypertension in pediatric patients aged 3 years and older, serving as a generic equivalent to Actelion's Tracleer tablets.
  • Lupin Ltd serves as the marketing partner for this product, which had estimated annual sales of USD 10 million in the US market according to recent industry data.
  • The launch represents a significant opportunity in the specialized pediatric PAH treatment market, addressing an important unmet need for affordable therapy options.

FDA Approves First Continuous Glucose Monitor for Weight Management Beyond Diabetes

Drug Approval
  • The FDA has approved Signos's continuous glucose monitoring system as the first-ever CGM specifically designed for weight management, extending access beyond traditional diabetes care to any consumer seeking weight loss support.
  • The system combines an AI platform with Dexcom's off-the-shelf CGM technology to provide real-time glucose data and personalized lifestyle recommendations, costing $129-139 for multi-month plans compared to roughly $1,000 monthly for GLP-1 medications.
  • With nearly 74% of Americans classified as overweight or obese and obesity costing the U.S. healthcare system over $170 billion annually, this approval represents a significant shift toward accessible, personalized weight management technology.
  • The device can be used independently or in combination with existing treatments like GLP-1 drugs or bariatric surgery, offering support for individuals across the weight loss spectrum from five to 100 pounds.

NICE Recommends Major Shift in Type 2 Diabetes Treatment with Earlier Access to SGLT-2 Inhibitors and Weight Loss Drugs

  • The National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending SGLT-2 inhibitors as first-line treatment for type 2 diabetes patients, potentially saving 22,000 lives once 90% uptake is achieved.
  • The new personalized approach moves away from one-size-fits-all treatment, offering earlier access to GLP-1 receptor agonists like semaglutide for specific patient groups including those with cardiovascular disease.
  • Analysis of 590,000 patient records revealed significant under-prescribing of SGLT-2 inhibitors, particularly among women, older people, and Black patients, highlighting existing health inequalities.
  • The guidance represents the biggest shake-up in type 2 diabetes care in a decade, affecting treatment for millions of the 4.6 million people diagnosed with diabetes in the UK.

Invion's INV043 Receives FDA Orphan Drug Designation for Anal Cancer Treatment

OncologyRare Disease
  • Invion Limited has secured FDA Orphan Drug Designation for INV043, its lead cancer drug candidate targeting anal cancer treatment.
  • The designation provides seven years of exclusive marketing rights in the US, financial incentives including tax credits, and potential for accelerated approval pathways.
  • Preclinical data demonstrated approximately 80% tumor control in mouse models when INV043 was combined with immune checkpoint inhibitors.
  • Invion plans to conduct clinical trials in collaboration with Peter MacCallum Cancer Centre for anogenital cancers including anal, vulvar, and penile cancers.

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