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Clinical Trial News

Federal Circuit Transfers $66 Million Patent Dispute Between Alkermes and Acorda Therapeutics

  • The Federal Circuit ruled that Acorda Therapeutics' appeal of a patent arbitration award belongs in the Second Circuit, not under Federal Circuit jurisdiction.
  • Alkermes PLC was allowed to retain $65.6 million in royalty payments from an $82 million licensing dispute over an expired patent.
  • The case involves U.S. Patent No. 5,540,938, where Acorda paid royalties for two years after the patent had expired.
  • Judge Richard G. Taranto issued a precedential opinion stating the appeal "is not within our jurisdiction" despite the Federal Circuit's exclusive appellate jurisdiction over patent infringement cases.

BioNet and Bio Farma Partner to Accelerate TdaP Vaccine Access Across Southeast Asia

  • BioNet and PT Bio Farma have signed a strategic MoU to develop and distribute a combined TdaP vaccine targeting tetanus, diphtheria, and acellular recombinant pertussis across ASEAN markets.
  • The partnership aims to reduce vaccine introduction timelines from 10-15 years to less than five years through combined clinical development and regulatory alignment strategies.
  • The collaboration targets an estimated 10-15 million doses annually in the ASEAN market, valued at approximately USD 200 million, focusing on adolescents, pregnant women, and elderly populations.
  • Bio Farma will lead clinical trials and regulatory submissions in Indonesia while BioNet handles other ASEAN countries, leveraging each company's regional expertise and manufacturing capabilities.

Major PBMs Exclude Humira Biosimilars from 2025 Formularies, Favor Private-Label Products

  • The three largest U.S. pharmacy benefit managers have excluded nearly all marketed Humira biosimilars from their 2025 standard formularies, marking a dramatic shift from 2024 when eight products were covered.
  • PBMs are prioritizing their own private-label biosimilars through subsidiaries like Cordavis, Quallent, and Nuvaila, offering plan sponsors high-list-price and low-list-price options while excluding manufacturer-branded competitors.
  • Industry experts warn this formulary strategy may discourage future biosimilar market entry and manufacturer investment, potentially reducing long-term competition despite current cost benefits for payers.

FDA Accepts Kura Oncology's NDA for Ziftomenib in NPM1-Mutant AML with Priority Review

Drug Approval
  • The FDA has accepted Kura Oncology's new drug application for ziftomenib, an oral menin inhibitor for treating relapsed or refractory acute myeloid leukemia with NPM1 mutations.
  • The agency granted priority review with a decision expected by November 30, 2025, potentially making ziftomenib the first approved menin inhibitor for this indication.
  • The NDA was based on positive results from the phase II KOMET-001 study, which met its primary endpoint of complete remission with statistical significance.
  • Kura Oncology's stock surged 15.5% following the FDA acceptance, reflecting investor confidence in the drug's approval prospects.

AI Integration and Advanced Drug Delivery Systems Reshape Pharmaceutical Outsourcing Models

AI
  • Recent developments in drug delivery methods and artificial intelligence advancements are influencing the dynamics of outsourcing models within the pharmaceutical industry.
  • Emerging trends in drug delivery systems have prompted companies to reevaluate their approaches to outsourcing with a focus on innovation and efficiency.
  • AI is playing an increasingly significant role by streamlining processes and enhancing decision-making capabilities in pharmaceutical partnerships.
  • Novel partnership models are emerging that reflect changing market demands and operational strategies as companies adapt to innovation-driven opportunities.

Transcatheter PDA Closure Shows Comparable Respiratory Outcomes to Surgery in Preterm Infants

  • A retrospective study of 561 extremely preterm infants found that transcatheter patent ductus arteriosus closure produced similar respiratory outcomes compared to surgical ligation, with no significant difference in total mechanical ventilation days.
  • Research from Riley Hospital demonstrated that 59% of preterm infants showed improved chest X-ray appearance after transcatheter closure, with 16% experiencing clinically significant reductions in pulmonary edema.
  • Infants with hemodynamically significant PDAs showed the greatest benefit from transcatheter closure, with younger and smaller infants demonstrating more pronounced improvements in radiographic findings and respiratory support requirements.

FDA Grants Phathom Pharmaceuticals 10-Year Market Exclusivity for VOQUEZNA Through 2032

Drug Approval
  • The FDA has approved Phathom Pharmaceuticals' Citizen Petition and will correct the Orange Book to recognize 10 years of New Chemical Entity exclusivity for VOQUEZNA (vonoprazan) tablets, extending through May 3, 2032.
  • VOQUEZNA is a first-in-class potassium-competitive acid blocker (PCAB) currently marketed for treating heartburn associated with Non-Erosive GERD, healing and maintenance of Erosive GERD, and H. pylori infection in adults.
  • The regulatory exclusivity provides Phathom with significant market protection for their gastrointestinal disease treatment portfolio, including VOQUEZNA TRIPLE PAK and DUAL PAK formulations.
  • This FDA decision strengthens Phathom's competitive position in the acid-blocking therapy market and supports their commercialization strategy for vonoprazan-based treatments.

Kelun-Biotech Raises $250 Million in Largest Hong Kong Biopharma Follow-On Offering in 12 Months

Oncology
  • Kelun-Biotech successfully completed a $250 million share placement on June 5, 2025, representing the largest follow-on offering in Hong Kong's biopharma sector over the past 12 months.
  • The offering was multiple times oversubscribed with strong participation from global institutional investors, leading to an upsize from the initially targeted $200 million.
  • Proceeds will fund R&D, clinical trials, manufacturing and commercialization of the company's innovative drug pipeline, which includes over 30 ongoing projects and a leading ADC platform.
  • The company focuses on solid tumors, autoimmune, inflammatory and metabolic diseases, with 3 approved products, 1 in NDA stage, and over 10 in clinical development.

Otsuka's Sibeprenlimab Achieves 51% Reduction in Proteinuria for IgA Nephropathy, Intensifying Competition with Vera Therapeutics

  • Otsuka's experimental therapy sibeprenlimab demonstrated a 51.2% reduction in proteinuria levels in patients with IgA Nephropathy at nine months in a late-stage trial.
  • The results come days after competitor Vera Therapeutics reported a 46% reduction with its drug atacicept, intensifying competition in the potentially $10 billion market.
  • Despite the superior numerical results, analysts suggest the clinical difference may not significantly impact demand for Vera's therapy.
  • Otsuka has already applied for FDA accelerated approval while planning additional studies to evaluate kidney function preservation through 2026.

Fidaxomicin Demonstrates Superior Efficacy in Reducing C. difficile Recurrence Among High-Risk Patients

  • Multiple studies presented at MAD-ID 2025 demonstrate fidaxomicin's superior efficacy over vancomycin in preventing C. difficile infection recurrence among high-risk patient populations.
  • A multicenter retrospective study of 176 hospitalized adults showed fidaxomicin reduced 90-day recurrence rates by 68.3% compared to vancomycin (7.9% vs 19%).
  • Immunocompromised patients, including solid organ transplant recipients and chemotherapy patients, experienced significantly lower 28-day recurrence rates with fidaxomicin (5% vs 30%).
  • Despite clinical benefits and updated guidelines recommending fidaxomicin, adoption remains limited due to cost barriers and formulary restrictions.

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