Tagged News
UPC Issues Landmark Ruling on Second Medical Use Patents in Cholesterol Drug Dispute
• The Unified Patent Court's Düsseldorf Local Division has issued its first-ever ruling on second medical use patent infringement in a dispute between Sanofi/Regeneron and Amgen over PCSK9 inhibitor drugs.
• The court established a two-part test for infringement: the product must be marketed in a way that leads to the patented use, and the alleged infringer must know or should have known about such use.
• While upholding the validity of Sanofi/Regeneron's patent for using PCSK9 inhibitors to reduce lipoprotein(a) levels, the court ruled Amgen's Repatha did not infringe as there was insufficient evidence of it being prescribed for this purpose.
ATS 2025 Conference to Showcase Groundbreaking Pulmonary Research and Patient-Centered Initiatives
• The American Thoracic Society (ATS) 2025 International Conference in San Francisco will feature cutting-edge research across pulmonary, critical care, and sleep medicine, drawing over 10,000 attendees from 85 countries.
• Key clinical trials to be presented include studies on tezepelumab for asthma and chronic rhinosinusitis, mepolizumab for COPD, sotatercept for pulmonary arterial hypertension, and tirzepatide for obstructive sleep apnea.
• The conference will emphasize patient advocacy through dedicated panels and introduce the Respiratory Innovation Summit, fostering collaboration between scientific leaders and industry partners to advance therapeutic development.
Syndax Pharmaceuticals Appoints Dr. Nicholas Botwood as New R&D Head and Chief Medical Officer
• Dr. Nicholas Botwood joins Syndax Pharmaceuticals from Bristol Myers Squibb, bringing 25 years of oncology drug development and commercialization experience to accelerate the company's cancer therapy pipeline.
• The appointment comes as Syndax continues to expand its portfolio, which includes FDA-approved Revuforj (menin inhibitor) and Niktimvo (axatilimab-csfr), a monoclonal antibody targeting the CSF-1 receptor.
• Dr. Botwood succeeds Dr. Neil Gallagher, who oversaw multiple positive data readouts, two product approvals, and the recent submission of Revuforj's supplemental New Drug Application for relapsed or refractory mNPM1 acute myeloid leukemia.
Dupilumab Shows 31% Greater Likelihood of Avoiding Negative Outcomes in COPD Patients with Type 2 Inflammation
• Patients with COPD and type 2 inflammation treated with dupilumab were 31% more likely to avoid a combination of negative outcomes including death, hospitalization, exacerbations, and lung function decline.
• The win ratio analysis of BOREAS and NOTUS phase 3 trials demonstrated dupilumab's superiority over placebo across all individual clinically important outcomes, with researchers noting that every 16th patient treated completely stopped having exacerbations.
• Dupilumab (Dupixent), already approved for eligible patients with uncontrolled COPD, showed significant benefits in preventing hospitalizations, moderate exacerbations, lung function deterioration, and symptom worsening compared to placebo.
Taiwan's Formosa Pharmaceuticals Signs Exclusive Licensing Deal with Almac Discovery for ADC Development
• Taiwan-based Formosa Pharmaceuticals has entered into an exclusive licensing agreement with Northern Ireland's Almac Discovery to develop novel antibody-drug conjugates for cancer treatment.
• The partnership combines Formosa's antibody expertise with Almac's proprietary drug-linker technology, aiming to address unmet needs in oncology with more targeted therapeutic approaches.
• This collaboration represents a significant expansion of Taiwan's growing presence in the global biopharmaceutical sector, particularly in the rapidly evolving ADC market.
Biogen Advances LEQEMBI Treatment with Subcutaneous Formulation for Alzheimer's Disease
• Biogen is developing a subcutaneous formulation of LEQEMBI for maintenance therapy, which could simplify treatment for Alzheimer's patients after 18 months of biweekly infusions.
• The subcutaneous administration option may increase patient adherence, reduce burden on infusion centers, and provide better accessibility for patients in rural settings.
• Fujirebio's in-vitro diagnostic tool is expected to facilitate earlier diagnosis of Alzheimer's disease, allowing treatment before significant neuronal damage occurs.
Federal Court Dismisses Sanofi's Appeal, Orders Amgen's Repatha Patent Applications to Proceed in Australia
• The Federal Court of Australia has dismissed Sanofi's appeal against Amgen's PCSK9 antibody patents, ordering that Amgen's Repatha patent applications proceed to grant under Australia's pre-2013 patent laws.
• This Australian ruling contrasts with decisions in the US, where the Supreme Court invalidated similar Amgen patents for lack of enablement, highlighting significant jurisdictional differences in antibody patent protection.
• The case provides important precedent for other valuable antibody patents approaching the end of their term that are still subject to Australia's old Patent Act as biosimilars seek market entry.
ZyVersa's IC 100 Shows Promise as Disease-Modifying Treatment for Parkinson's Disease
• New research validates that microglia-driven inflammation plays a pivotal role in Parkinson's disease progression, with studies showing IC 100 can block NLRP1 inflammasome activation and reduce toxic alpha-synuclein accumulation.
• ZyVersa Therapeutics' Inflammasome ASC Inhibitor IC 100 demonstrates potential as a disease-modifying therapy by targeting both inflammasome formation and protein aggregation, addressing underlying disease mechanisms rather than just symptoms.
• The findings, supported by the Michael J. Fox Foundation, could represent a significant advancement for the 10 million Parkinson's patients worldwide, with ZyVersa preparing to initiate proof-of-concept studies in animal models later this year.
City of Hope to Present Groundbreaking Cancer Research at AACR Annual Meeting 2025
• City of Hope researchers will present over 74 sessions at the AACR Annual Meeting 2025, showcasing innovative work in AI, precision medicine, and immunotherapies for various cancers.
• A phase 3 clinical trial led by Dr. Aditya Shreenivas demonstrated that penpulimab combined with chemotherapy significantly improved progression-free survival in patients with recurrent or metastatic nasopharyngeal carcinoma.
• Novel AI tools and spatial transcriptomic technologies developed at City of Hope are advancing precision medicine approaches and revealing unique genetic changes in early-onset colorectal cancer among Hispanic and Latino patients.
CatalYm's Visugromab Shows Promise in Enhancing Antibody-Drug Conjugate Efficacy by Blocking GDF-15
• New preclinical data reveals that visugromab, CatalYm's GDF-15-neutralizing antibody, significantly enhances the anti-tumor activity of antibody-drug conjugates (ADCs) in multiple solid tumor models.
• Research demonstrates that ADC treatment triggers GDF-15 expression as a potential resistance mechanism, which visugromab effectively counteracts by improving immune cell infiltration and activation in the tumor microenvironment.
• These findings build on CatalYm's previous clinical evidence showing visugromab's ability to induce durable responses in relapsed/refractory solid tumors and mitigate cancer-associated cachexia.
Related Clinical Trials:
CatalYm GmbH
Posted 12/9/2020