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China Approves Xuanyuening (Bireociclib): First Dual-Indication CDK Inhibitor for Advanced Breast Cancer

Drug ApprovalTargeted TherapyOncology
  • China's NMPA has approved Xuanzhu Biopharm's Bireociclib (Xuanyuening®), a novel multi-target CDK inhibitor for HR+/HER2- advanced breast cancer with dual indications.
  • The drug can be used in combination with fulvestrant after endocrine therapy failure and is the only CDK4/6 inhibitor approved in China as monotherapy for heavily pretreated patients.
  • Clinical trials showed impressive efficacy with median PFS of 17.5 months in combination therapy and 11 months as monotherapy, addressing specific needs of Chinese breast cancer patients.

A Phase I/II Study of XZP-3287 in Metastasis Solid Tumors

NCT04539496Unknown StatusPhase 1
Sihuan Pharmaceutical Holdings Group Ltd.
Posted 5/22/2018

A Study of XZP-3287 in Combination With Fulvestrant in Patients With Advanced Breast Cancer

NCT05077449Active, Not RecruitingPhase 3
Xuanzhu Biopharmaceutical Co., Ltd.
Posted 11/16/2021

EU-Wide Health Technology Assessment Regulation Set to Transform Drug Access Across Europe Starting January 2025

Drug Approval
  • The EU Health Technology Assessment Regulation (HTAR) will mandate joint clinical assessments for all new advanced therapeutic products and oncology drugs starting January 2025, with orphan drugs and medical devices following by 2030.
  • The new framework introduces Joint Clinical Assessments (JCAs) and PICO frameworks to replace the current nation-by-nation approach, potentially streamlining market access and reducing duplicated efforts across EU member states.
  • Pharmaceutical companies face significant operational challenges including compressed timelines requiring completed assessments within six months of EMA approval and the need to generate substantial evidence volumes to address multiple country-specific requirements simultaneously.

AbbVie and Gilead Secure EU Approval for Next-Generation Hepatitis C Therapies Targeting Treatment-Resistant Patients

Drug Approval
  • AbbVie's Maviret and Gilead's Vosevi have received EU approval as pan-genotypic hepatitis C treatments covering all six major genotypes with improved dosing schedules.
  • Both therapies target patients who cannot be cured with established regimens, offering 8-12 week treatment courses without the unpleasant side effects of ribavirin.
  • Gilead extended approval for Harvoni to include adolescents aged 12-18 years, making it the first hepatitis C cure approved in the EU for this age group.
  • With an estimated 214,000 people living with hepatitis C in the UK, these approvals address significant unmet medical needs in difficult-to-treat patient populations.

Shilpa Medicare Receives USFDA Clearance for Bengaluru Manufacturing Unit

Drug Approval
  • Shilpa Medicare's Unit VI in Dabaspet, Bengaluru received an Establishment Inspection Report (EIR) with VAI classification from the USFDA following a Good Manufacturing Practices inspection conducted from October 24-30, 2024.
  • The facility specializes in manufacturing complex dosage forms including oral dissolving films and transdermal systems, with current supply operations to the United States and other markets.
  • The company's shares surged over 4% following the announcement, with the stock trading at ₹935.10 against the previous close of ₹892.50 on NSE.
  • The Bengaluru unit has already secured regulatory approvals from multiple international authorities including EMA Europe, MHRA UK, SFDA Saudi Arabia, and TGA Australia.

NICE Approves Capivasertib-Fulvestrant Combination for Advanced Breast Cancer Treatment

Drug Approval
  • NICE has issued guidance approving capivasertib in combination with fulvestrant for treating hormone receptor-positive HER2-negative advanced breast cancer after endocrine treatment.
  • The approval represents a new treatment option for patients with advanced breast cancer who have previously received endocrine therapy.
  • Healthcare professionals are expected to take this guidance into account when making treatment decisions for individual patients with this specific breast cancer subtype.

Telisotuzumab Vedotin Plus Osimertinib Shows Promise in TKI-Resistant NSCLC with c-MET Overexpression

OncologyTargeted TherapyDrug Approval
  • The combination of telisotuzumab vedotin and osimertinib demonstrated a 50% objective response rate in patients with EGFR-mutant NSCLC who had progressed after prior osimertinib treatment.
  • All patients experienced at least one treatment-emergent adverse event, with peripheral sensory neuropathy (50%) and peripheral edema (32%) being most common, though no dose-limiting toxicities were reported.
  • The promising efficacy data, including a median progression-free survival of 7.4 months, suggests this combination could address an unmet medical need in patients with c-MET protein overexpression-mediated resistance to EGFR TKIs.

Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer

NCT03539536Active, Not RecruitingPhase 2
AbbVie
Posted 10/10/2018

A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors

NCT02099058Active, Not RecruitingPhase 1
AbbVie
Posted 1/15/2014

Sun Pharma Increases Investment in US-Based Pharmazz to Expand Specialty Therapeutics Portfolio

Drug Approval
  • Sun Pharma has signed an agreement to invest up to $25 million in US-based Pharmazz, increasing its stake to approximately 22.7% on a fully diluted basis.
  • Pharmazz specializes in developing drugs for stroke and hypovolemic shock that have already received approval in India.
  • The strategic investment aligns with Sun Pharma's expansion into specialty therapeutics and strengthens its presence in critical care medicine.
  • Despite the significant investment announcement, Sun Pharma's stock remained flat following the news.

First Oral Treatment for Deadly Rhodesiense Sleeping Sickness Now Available in Three African Countries

Drug Approval
  • Fexinidazole Winthrop, the first all-oral treatment for Trypanosoma brucei rhodesiense sleeping sickness, is now available free of charge in Ethiopia, Malawi, and Zimbabwe.
  • The breakthrough treatment replaces toxic intravenous drugs requiring hospitalization with a simple oral therapy that can be taken at home with minimal observation.
  • Clinical trials led by DNDi demonstrated the treatment's superiority over existing drugs, leading to European Medicines Agency approval in December 2023 and WHO guideline inclusion in June 2024.
  • The drug is approved for patients aged six years and older weighing at least 20 kg, addressing a disease that is almost always fatal if untreated.

FDA Approves Tzield as First Disease-Modifying Therapy for Type 1 Diabetes Prevention

Drug ApprovalMonoclonal Antibody
  • Provention Bio received FDA approval for teplizumab (Tzield), marking the first disease-modifying therapy to delay onset of stage 3 type 1 diabetes in at-risk patients aged eight and older.
  • Clinical trial data showed Tzield delayed progression to stage 3 disease by 25 months compared to placebo, with only 45% of treated patients progressing versus 72% on placebo after 51 months median follow-up.
  • The approval comes after an initial FDA rejection in July 2021 due to pharmacokinetic concerns, which Provention addressed through resubmission with modified dosing data.
  • Sanofi has partnered with Provention for US co-promotion, providing $20 million upfront with an additional $35 million equity investment following approval.

Next-Generation Vaccine Adjuvants Transform Immunotherapy with Targeted Immune Activation

Drug Approval
  • Novel adjuvants including ARNAX, CpG oligodeoxynucleotides, and STING agonists overcome traditional adjuvant limitations by targeting specific immune pathways like TLR3, TLR9, and STING for enhanced cellular immunity.
  • These emerging adjuvants demonstrate superior ability to induce Th1 and Th17 responses critical for cancer immunotherapy and intracellular pathogen defense, while traditional adjuvants primarily favor Th2-biased humoral immunity.
  • Advanced adjuvant systems like AS01, AS03, and AS04 combine multiple mechanisms through liposomal delivery and synergistic immunostimulants, achieving up to 97.2% efficacy in approved vaccines like Shingrix.
  • Despite promising therapeutic potential, next-generation adjuvants face challenges including safety concerns from potent immune activation, manufacturing complexity, and the need for personalized approaches to address population-specific immune variability.

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