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Clinical Trial News

Thailand Achieves Pharmaceutical Independence with First Domestically Produced Targeted Cancer Drugs

Targeted TherapyDrug Approval
  • Thailand has developed its first domestically produced targeted cancer drugs, IMCRANIB 100 and HERDARA, without foreign technology transfer, marking a historic milestone in pharmaceutical independence.
  • IMCRANIB 100 targets multiple cancers including chronic myeloid leukemia and gastrointestinal stromal tumors by inhibiting tyrosine kinase enzyme, while HERDARA serves as a cost-effective alternative to trastuzumab for breast cancer treatment.
  • The breakthrough addresses the financial burden of imported cancer drugs, with trastuzumab previously costing up to 1 million baht per course, significantly improving treatment accessibility under Thailand's universal healthcare system.
  • Production takes place at Thailand's first internationally certified cancer drug manufacturing facility, established in 2020 at the Royal Pharmaceutical Manufacturing Plant in Chonburi Province.

CDSCO Expert Committee Accepts Pfizer's Phase III Data for Abrocitinib in Atopic Dermatitis

  • India's CDSCO expert committee has accepted Pfizer's Phase III clinical trial data for abrocitinib, a selective JAK1 inhibitor for moderate-to-severe atopic dermatitis treatment.
  • The committee reviewed data for both 100 mg and 200 mg tablet formulations during their June 11, 2025 meeting without raising objections or additional conditions.
  • This regulatory milestone follows an earlier SEC recommendation from February 2022 and represents progress toward potential approval in India's systemic therapy market.
  • Abrocitinib targets patients with moderate-to-severe atopic dermatitis who are candidates for systemic therapy, addressing an important unmet medical need.

DRDO and AIIMS-Rishikesh Partner for Clinical Trials of Biomedical Devices in Extreme Environments

  • The Defence Research and Development Organisation (DRDO) and AIIMS-Rishikesh have signed a memorandum of understanding to conduct clinical trials and advanced research in biomedical devices for extreme environments.
  • The collaboration between DRDO's Defence Institute of Physiology and Allied Sciences (DIPAS) and AIIMS-Rishikesh aims to develop products, technologies, and strategies to mitigate adverse effects of extreme environments on human performance.
  • The partnership will focus on formulating biomedical devices and supplements specifically designed to enhance human performance in challenging environmental conditions.

Eli Lilly and Loxo Oncology Advance Phase 3 Trial Testing Pirtobrutinib Combination for Previously Treated CLL/SLL

Oncology
  • Eli Lilly and Loxo Oncology are conducting the BRUIN CLL-322 Phase 3 trial evaluating pirtobrutinib combined with venetoclax and rituximab versus standard venetoclax-rituximab therapy in previously treated chronic lymphocytic leukemia and small lymphocytic lymphoma patients.
  • The randomized, open-label study compares fixed-duration treatment with the experimental three-drug combination against the current two-drug standard of care, with pirtobrutinib and venetoclax administered orally and rituximab given intravenously.
  • The trial, which began in September 2021, is currently active but no longer recruiting participants, with the most recent update submitted in July 2025.
  • Results from this study could significantly impact the companies' market position in the competitive oncology landscape and influence treatment standards for CLL/SLL patients.

Andhra Pradesh Establishes First CDSCO-Notified Medical Device Auditing Body to Streamline Regulatory Compliance

  • Andhra Pradesh becomes home to its first CDSCO-notified auditing body for medical devices, with KIHT Certification Services (KCS) authorized to inspect Class A and Class B manufacturing facilities.
  • KCS operates as the only functional notified body among 14 nationwide in Andhra Pradesh and Telangana, housed within the AMTZ campus in Visakhapatnam.
  • The establishment eliminates the need for out-of-state audits for domestic manufacturers, particularly MSMEs, resulting in significant time and cost savings for regulatory compliance.
  • KCS offers comprehensive services including ISO 13485 certification, quality systems audits, risk management training, and CE-mark consultancy to meet global regulatory standards.

Abu Dhabi Partners with Children's National Hospital to Advance Pediatric Cell and Gene Therapy

  • The Department of Health – Abu Dhabi has signed a strategic MoU with Children's National Hospital to establish the Abu Dhabi – Children's National Hospital Cell and Gene Therapy Clinical Excellence Programme.
  • The partnership will focus on developing advanced pediatric cell and gene therapies including Virus-Specific T-cell therapies, with plans to establish GMP-compliant manufacturing facilities.
  • The collaboration includes comprehensive fellowship programs for Emirati clinician-scientists and specialized training curricula in pediatric cellular immunotherapy and clinical trial management.
  • The initiative aims to position Abu Dhabi as a global hub for life sciences innovation while ensuring sustainable access to cutting-edge treatments for children.

Spectral Medical Advances PMX Hemoperfusion Device Toward FDA Approval for Septic Shock Treatment

  • Spectral Medical's PMX (Toraymyxin™) hemoperfusion device has received FDA Breakthrough Device Designation for treating endotoxic septic shock, providing expedited regulatory review pathways.
  • The company's Phase III Tigris trial has completed enrollment with 157 patients, with topline results expected in August 2025 and FDA PMA submission planned for October 2025.
  • Spectral secured $10 million in non-dilutive debt financing from partner Vantive US Healthcare to fund FDA submission costs and commercial preparation activities.
  • The target market includes 330,000 North American patients annually with septic shock, representing a significant unmet medical need in critical care medicine.

Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock

NCT01046669CompletedNot Applicable
Spectral Diagnostics (US) Inc.
Posted 6/1/2010

Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized, Open-Label Study

NCT03901807Active, Not RecruitingNot Applicable
Spectral Diagnostics (US) Inc.
Posted 1/9/2020

Viemed Healthcare Completes $28M Acquisition of Lehan's Medical Equipment to Expand Respiratory Care Services

  • Viemed Healthcare has completed the acquisition of Illinois-based Lehan's Medical Equipment for $26 million plus $2.2 million in contingent payments, expanding its post-acute respiratory healthcare footprint.
  • Lehan generated $25.7 million in net revenues and $7.4 million in Adjusted EBITDA in 2024, bringing 80 years of market experience and established payer contracts to Viemed's national platform.
  • The acquisition strengthens Viemed's home medical equipment capabilities, particularly in women's health and respiratory devices including CPAPs, across Northern Illinois and West Chicagoland markets.

Sanofi Advances Multiple Phase 2 Trials Targeting Rare Kidney Diseases and Ulcerative Colitis

Rare Disease
  • Sanofi has initiated a Phase 2a clinical trial evaluating three experimental drugs—Frexalimab, SAR442970, and Rilzabrutinib—for treating primary focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) in patients aged 16 to 75 years.
  • The kidney disease study employs a randomized, double-blind, placebo-controlled design with quadruple masking to assess changes in proteinuria and remission rates of nephrotic syndrome.
  • Separately, Sanofi is conducting a Phase 2 dose-ranging study of SAR441566, an oral tablet, for moderate-to-severe ulcerative colitis to evaluate clinical remission rates.
  • Both studies utilize rigorous randomized, double-blind methodologies with placebo controls and could significantly impact Sanofi's competitive position in treating these challenging conditions.

BTK Inhibitors Show Promise for Progressive MS as Current Therapies Fall Short

Monoclonal Antibody
  • Current therapeutic options for progressive multiple sclerosis remain severely limited, with only ocrelizumab approved for primary progressive MS showing modest efficacy that diminishes after age 53-55.
  • Emerging BTK inhibitors represent a promising new therapeutic class that targets both B cells and myeloid cells while offering crucial CNS penetration to impact microglia underlying progressive MS inflammation.
  • The HERCULES trial demonstrated a 31% reduction in confirmed disability progression over 6 months with BTK inhibitors compared to placebo in patients with nonrelapsing secondary progressive MS.
  • Current phase 3 trials are testing distinct BTK inhibitors in primary progressive MS, with one comparing against placebo and another against ocrelizumab as the gold standard.

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