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Clinical Trial News

Kexing Biopharm Partners with IQVIA to Accelerate Global Drug Development and Market Access

  • Kexing Biopharm has entered a strategic partnership with IQVIA in August 2025 to accelerate global clinical development and regulatory approval of its innovative drugs and biosimilars, particularly targeting Europe and other regulated international markets.
  • The collaboration combines Kexing's R&D pipeline in antiviral, antitumor, immunosuppressant, and metabolic disease treatments with IQVIA's global operational infrastructure and regulatory expertise.
  • IQVIA's Connected Intelligence platform and data-driven insights are expected to enhance trial efficiency and reduce time-to-market for Kexing's therapeutic candidates.
  • The partnership addresses critical industry challenges including regulatory complexity and market fragmentation, positioning Kexing to capitalize on the growing trend of emerging biopharma companies driving innovation.

Zydus Lifesciences Secures FDA Approval for Generic Diltiazem Tablets to Treat Angina and Hypertension

Drug Approval
  • Zydus Lifesciences received final FDA approval for Diltiazem Hydrochloride tablets in four strengths (30 mg, 60 mg, 90 mg, and 120 mg) for treating chronic stable angina and coronary artery spasm.
  • The calcium-channel blocker works by relaxing blood vessels to reduce cardiac workload and improve blood and oxygen supply to heart muscle.
  • The approved generic formulation targets a US market worth $13.9 million annually according to IQVIA data, with production planned at the company's Baddi facility in India.

Amphastar Receives FDA Approval for Generic Iron Sucrose Injection to Treat Anemia in Chronic Kidney Disease Patients

Drug Approval
  • Amphastar Pharmaceuticals received FDA approval for its generic iron sucrose injection (AMP-002) in three dosage strengths for treating iron deficiency anemia in chronic kidney disease patients.
  • The FDA determined that Amphastar's iron sucrose injection meets bioequivalence and therapeutic equivalence criteria to the reference drug Venofer®, which generated approximately $513 million in U.S. sales over the past 12 months.
  • The company plans to launch the generic iron sucrose injection in the third quarter of 2025, adding to its pipeline of complex generic and biosimilar products targeting markets worth over $9.5 billion combined.

Kamada Receives FDA Approval for Houston Plasma Collection Center, Expanding Specialty Plasma Operations

Drug Approval
  • Kamada Ltd. received FDA approval for its Houston plasma collection center following a second quarter 2025 inspection, clearing the facility to commence commercial sales of normal source plasma.
  • The 12,000 square foot facility features 50 donor beds with an annual collection capacity of approximately 50,000 liters and projected revenue contribution of $8-10 million at full capacity.
  • The Houston center is anticipated to become one of the largest specialty plasma collection sites in the U.S., collecting both normal source plasma and specialty plasma including anti-rabies and anti-D products.
  • Combined with existing facilities in Beaumont and San Antonio, Texas, Kamada now operates three plasma collection centers to support its portfolio of FDA-approved plasma-derived therapies for rare conditions.

AMI Pharm's AYP-101 Enters Phase 3 Trial for Non-Inflammatory Fat Reduction

  • AMI Pharm has advanced AYP-101, a novel non-cytolytic injectable drug, to Phase 3 clinical trials for treating submental fat with reduced pain and swelling.
  • The drug utilizes apoptosis rather than necrosis to eliminate fat cells, potentially avoiding the inflammation associated with current deoxycholic acid-based treatments.
  • Phase 2 results showed over 70% of patients achieved at least 1-grade improvement on the Evaluator-Reported Submental Fat Rating Scale in the per-protocol population.
  • The ongoing Phase 3 trial involves 252 participants across multiple sites in South Korea and is expected to complete by the end of 2025.

BioNxt Solutions Completes $1.25M Oversubscribed Funding Round to Advance Drug Delivery Platform Development

  • BioNxt Solutions successfully closed an oversubscribed $1.25 million convertible debenture private placement across two tranches, demonstrating strong investor confidence in the company's drug delivery technologies.
  • The bioscience company focuses on next-generation drug delivery platforms including sublingual thin-film, transdermal patches, and oral enteric-coated tablets targeting autoimmune diseases, neurological disorders, and longevity applications.
  • Proceeds will fund product development and commercialization efforts, intellectual property filings, and general working capital as the company advances regulatory approvals primarily in European markets.
  • The funding structure includes 8% convertible debentures and warrants, providing flexible financing terms while the company develops its proprietary therapeutic delivery platforms.

Truemeds Raises $85M to Expand Generic Drug Platform Serving India's 400 Million Chronic Patients

  • Truemeds secured $85 million in funding led by Accel, boosting its valuation to over $400 million from $110 million two years ago.
  • The Mumbai-based startup focuses on recommending generic alternatives to branded medicines, achieving 66% year-over-year revenue growth to ₹5 billion ($57 million).
  • The platform serves 500,000 customers monthly across 20,000 postal codes, with over 75% of customers from tier-2 cities and beyond.
  • Truemeds offers average discounts of 32% and up to 47% savings for customers who switch to generic alternatives compared to branded drugs.

Syntara Receives FDA Guidance for Amsulostat Phase 2 Trial in Myelofibrosis

Oncology
  • Syntara Limited received FDA guidance recommending a Phase 2 controlled trial for amsulostat in myelofibrosis to gather additional safety and efficacy data.
  • The FDA reviewed data from the ongoing MF-101 trial combining amsulostat with ruxolitinib and a proposal for a pivotal registrational study during a Type C meeting.
  • The Phase 2 trial will focus on symptom improvements and spleen volume reductions to optimize the design of a subsequent Phase 3 trial.
  • Syntara expects to report top-line Phase 1c/2 data for amsulostat in myelofibrosis in Q3 2025, with strong financial runway extending into 2027.

King's College London Develops KCL-HO-1i, Novel Oral Drug to Overcome Chemotherapy Resistance

  • Researchers at King's College London have developed KCL-HO-1i, an oral tablet designed to enhance chemotherapy effectiveness by targeting the heme oxygenase-1 protein that helps tumors resist treatment.
  • Preclinical studies in mice demonstrated that the drug successfully made chemotherapy-resistant breast cancer tumors responsive to various chemotherapy regimens.
  • The drug is designed for at-home administration between chemotherapy sessions, with human trials potentially beginning within two years.
  • KCL-HO-1i works by dismantling tumor defense mechanisms created by macrophages that produce protective proteins, allowing both immune cells and chemotherapy drugs to become more effective.

IO Biotech's Cylembio Narrowly Misses Primary Endpoint in Phase 3 Melanoma Trial Despite Progression-Free Survival Benefit

  • IO Biotech's Phase 3 trial of cancer vaccine Cylembio combined with pembrolizumab showed over 8 months median progression-free survival benefit in advanced melanoma patients but narrowly missed statistical significance for the primary endpoint.
  • The company's stock plunged 34.25% to $1.19 following the announcement, with CEO Mai-Britt Zocca stating the trial missed the primary endpoint "by a hair."
  • Despite mixed results, H.C. Wainwright analyst Emily Bodnar maintains a Buy rating with $14.00 price target, citing the significant survival benefit and comparable safety profile.
  • IO Biotech plans to engage with the FDA this fall to discuss the data package and potential regulatory pathways forward.

IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)

NCT05155254Active, Not RecruitingPhase 3
IO Biotech
Posted 5/17/2022

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