Tagged News
Uni-Bio Science Group's Diquafosol Sodium Eye Drops Receives NMPA Approval for Dry Eye Syndrome Treatment in China
• Uni-Bio Science Group has received NMPA marketing approval for 金因康® (Diquafosol Sodium Eye Drops), addressing a market of approximately 360 million individuals with dry eye syndrome in China.
• The novel P2Y2 receptor agonist works by stimulating tear fluid and mucin secretion, offering improved tear layer normalization and corneal epithelial repair for patients with dry eye syndrome.
• China's dry eye syndrome market is projected to reach RMB 42 billion by 2030, growing at a CAGR of 28.4%, positioning 金因康® as a significant player in the rapidly expanding ophthalmology sector.
Genomic Testing Emerges as Critical Tool in Brain Cancer Treatment, Experts Emphasize
• Comprehensive genomic profiling is crucial for brain cancer patients, enabling personalized treatment approaches and identification of actionable mutations like NTRK fusions, according to Dr. Manmeet Ahluwalia.
• The recent FDA approval of vorasidenib (Voranigo) for IDH-mutant gliomas represents a breakthrough in targeted therapy for brain tumors and provides hope for developing additional brain-penetrating drugs.
• Clinical trials remain the optimal treatment option for aggressive brain cancers like glioblastoma, with increasing availability in both academic centers and larger community practices.
Spain Dramatically Reduces Timeframe Between EU Drug Approval and Reimbursement Decisions
• Spain has significantly shortened the waiting period between European drug authorization and national financing decisions, improving patient access to new medications.
• Spanish health authorities emphasize that pharmaceutical companies can further accelerate the reimbursement process by submitting more comprehensive and well-prepared applications.
• The streamlined approval pathway represents Spain's commitment to modernizing its healthcare system while balancing innovation access with fiscal sustainability.
Tempus and Verastem Partner to Develop Companion Diagnostic for First FDA-Approved KRAS-Mutant LGSOC Treatment
• Tempus AI and Verastem Oncology have announced a collaboration to develop a companion diagnostic test for the recently FDA-approved combination therapy of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer.
• The partnership builds on Tempus' confirmatory testing in Verastem's Phase 2 RAMP-201 clinical trial, with their FDA-approved xT CDx assay now being used as an investigational assay in the global Phase 3 RAMP-301 trial.
• Low-grade serous ovarian cancer (LGSOC) is a rare form affecting younger women, accounting for 6-10% of serous ovarian cancers, with historically poor response to chemotherapy and limited treatment options.
FDA Approves Teal Wand: First At-Home HPV Self-Collection Device for Cervical Cancer Screening
• Teal Health's Wand device has received FDA approval as the first prescription device for at-home self-collection of vaginal samples for HPV-based cervical cancer screening.
• The pivotal SELF-CERV study published in JAMA Network Open demonstrated 95% positive agreement for high-risk HPV detection and 96% sensitivity for precancerous lesions, matching clinician-collected samples.
• With an estimated 21 million women under- or unscreened for cervical cancer in the US, the Teal Wand aims to increase screening rates by offering a preferred at-home alternative without compromising clinical accuracy.
New Guidelines and Therapies Reshape Acne Treatment Approach in 2025
• The American Academy of Dermatology's 2024 updated acne guidelines recommend limiting systemic antibiotic use and emphasize treating all four pillars of acne pathogenesis simultaneously.
• Several new FDA-approved acne medications since 2019 have expanded treatment options, including Winlevi (clascoterone), the only topical therapy effective for excessive sebum production.
• Dermatology experts now recommend simpler treatment regimens with fewer products that address multiple pathogenic factors, with a growing focus on early intervention to prevent scarring.
FDA's Approval of MRD as End Point Transforms Multiple Myeloma Research and Treatment
• The FDA's Oncology Drugs Advisory Committee unanimously approved minimal residual disease (MRD) as an end point for accelerated approval of multiple myeloma therapies in April 2024, potentially reducing trial timelines from 10-15 years to just 3 years.
• Pharmaceutical companies have rapidly adapted by implementing MRD as a coprimary end point in new trials and amending existing protocols, with the CEPHEUS trial being the first major study to read out with MRD as a coprimary endpoint.
• Researchers are now exploring MRD applications beyond drug approval, including using MRD status to guide treatment decisions, developing improved blood-based detection technologies, and expanding the approach to other hematologic malignancies.
Related Clinical Trials:
University of Miami
Posted 2/11/2020
Stichting European Myeloma Network
Posted 12/14/2018
Janssen Research & Development, LLC
Posted 11/6/2018
Ionis Reports Positive Phase 3 Results for Olezarsen in Hypertriglyceridemia
• Olezarsen demonstrated significant triglyceride reductions of 61% and 58% at 6 months with 80mg and 50mg monthly doses respectively in patients with moderate hypertriglyceridemia.
• The Phase 3 Essence study met all primary and secondary endpoints, with most participants achieving triglyceride levels within normal range despite already being on standard lipid-lowering therapies.
• Following recent FDA approval of olezarsen (Tryngolza) for familial chylomicronemia syndrome, these results support potential expanded indication for severe hypertriglyceridemia pending upcoming CORE and CORE2 trial data.
Related Clinical Trials:
Ionis Pharmaceuticals, Inc.
Posted 11/21/2022
Ensifentrine Shows Promise as Novel Monotherapy and Add-On Treatment for COPD
• New data from the Phase 3 ENHANCE trials demonstrates that ensifentrine, a dual phosphodiesterase 3 and 4 inhibitor, significantly improves lung function and reduces exacerbations in COPD patients.
• Ensifentrine monotherapy showed meaningful improvements in patient-reported outcomes including dyspnea, COPD symptoms, and health-related quality of life compared to placebo in patients not on long-acting medications.
• As the first nebulized non-steroidal therapy with a novel dual mechanism of action, ensifentrine represents an important addition to the COPD treatment arsenal, offering benefits both as first-line and add-on therapy.
Related Clinical Trials:
Verona Pharma plc
Posted 9/29/2020
Verona Pharma plc
Posted 9/22/2020
FDA Expands Jivi Approval for Hemophilia A Treatment in Children Ages 7-12
• The FDA has approved Bayer's Jivi (antihemophilic factor recombinant, PEGylated-aucl) for pediatric patients aged 7 to 12 years with hemophilia A, expanding treatment options for this age group.
• The approval was based on data from the Alfa-PROTECT and PROTECT Kids studies, which demonstrated the safety and efficacy of Jivi in pediatric patients with severe hemophilia A.
• Jivi was previously approved in 2018 for adults and adolescents aged 12 and older, and can be used for on-demand treatment, perioperative management, and routine prophylaxis to reduce bleeding episodes.
Related Clinical Trials:
Bayer
Posted 5/29/2013
Bayer
Posted 3/23/2022