Articles by Dr. Laura Bennett
Takeda's TAK-881 Shows Positive Phase 2/3 Results for Primary Immunodeficiency Disease Treatment
Takeda announces positive topline results for TAK-881 in pivotal Phase 2/3 trial, showing comparable efficacy to HYQVIA with reduced infusion time for PID patients.
Alpha Tau's Alpha DaRT Achieves 100% Local Disease Control in Pancreatic Cancer Trials at DDW 2026
Alpha Tau reports 100% local disease control with Alpha DaRT device in heavily pre-treated pancreatic cancer patients with favorable safety profile.
InflaRx Izicopan Shows Low Reactive Metabolite Formation in Liver Safety Study
InflaRx reports favorable safety data for Izicopan showing low reactive metabolite formation in human liver microsomes, reducing bioactivation risks.
MacroGenics Expands ZYNYZ Royalty Agreement with Sagard Healthcare Partners for Cancer Drug
MacroGenics expands its ZYNYZ royalty purchase agreement with Sagard Healthcare Partners, providing additional funding for the cancer immunotherapy drug.
Arvinas VEPPANU (Vepdegestrant) Receives FDA Approval as First PROTAC Drug for ESR1-Mutated Breast Cancer
Arvinas' VEPPANU becomes the first FDA-approved PROTAC drug for ESR1-mutated, ER+/HER2- advanced breast cancer, marking a breakthrough in protein degradation therapy.
NMPA Clinical Trial Regulations: Impact on Multinational Pharma Data & Inspections
This article delves into the NMPA clinical trial regulations and their significant impact on multinational pharmaceutical data management and inspection processes.
CAR-T Cell Therapy Europe: Clinical Trials, Safety & Market Access Insights
Discover the latest insights on CAR-T Cell Therapy in Europe, focusing on clinical trials, safety profiles, and market access for hematologic cancers.
ARCHIMED Acquires Esperion Therapeutics in Strategic Cardiometabolic Deal
Healthcare investment firm ARCHIMED announces definitive agreement to acquire Esperion Therapeutics, maker of cholesterol drugs NEXLETOL and NEXLIZET.
FDA Approves Incyte's Jakafi XR Extended-Release Tablets for Myelofibrosis, Polycythemia Vera, and GVHD Treatment
Incyte receives FDA approval for Jakafi XR (ruxolitinib) extended-release tablets, offering improved dosing convenience for rare blood disorders and GVHD patients.
Plozasiran TGA Approval: REDEMPLO® Approved in Australia for FCS
Arrowhead Pharmaceuticals announced the TGA approval of REDEMPLO® (plozasiran) in Australia for the treatment of Familial Chylomicronemia Syndrome (FCS). This significant milestone expands global access to a novel therapy for patients with this rare genetic disorder.
Addex Advances Dipraglurant for Brain Injury Recovery, Reports 2025 Financial Results
Addex repositions dipraglurant mGlu5 NAM for brain injury recovery while advancing GABAB PAM chronic cough candidate toward clinical trials in 2025 update.
FDA Guidance on Decentralized Clinical Trials: What You Need to Know
This article covers essential FDA guidance on decentralized clinical trials, focusing on their impact on drug development and patient engagement.
Teva's PONLIMSI Biosimilar Receives FDA Approval for All Prolia Indications as Q1 2026 Results Show Strong Growth
Teva's PONLIMSI biosimilar gains FDA approval for all Prolia indications while duvakitug shows promising Phase 2b results in inflammatory bowel disease.
EU Clinical Trial Ethics Committees: Analysis of Decision Patterns & Timelines
This article analyzes the decision-making patterns and timelines of EU Clinical Trial Ethics Committees, focusing on their impact on drug development in oncology.
Saudi Arabia National Cancer Registry: Trends & Oncology Treatment Insights
The Saudi Arabia National Cancer Registry reveals significant trends in cancer incidence and treatment, highlighting advancements in therapies such as Pembrolizumab for improved patient outcomes.
![ANVISA Approval Immunotherapy [Drug Name] for Melanoma: Key Insights 2024](/uploads/articles/anvisa-approval-novel-immunotherapy-melanoma-2024.webp)
ANVISA Approval Immunotherapy [Drug Name] for Melanoma: Key Insights 2024
ANVISA has approved Immunotherapy [Drug Name] for melanoma, marking a significant advancement in cancer treatment and offering new hope for patients in 2024.
Clinical Trial Quality Management Systems: New APAC Standards & Challenges
This article delves into the latest APAC standards for clinical trial quality management systems, highlighting challenges in ensuring drug efficacy and patient safety.
ANVISA Approves MagicTouch Sirolimus-Coated Balloon: Market Impact in Brazil
The recent approval of MagicTouch Sirolimus-Coated Balloon by ANVISA is set to transform the treatment landscape for coronary artery disease in Brazil.
Orca Bio's Orca-Q Receives FDA RMAT Designation for High-Risk Blood Cancers Treatment
Orca Bio's Orca-Q therapy gains FDA RMAT designation for high-risk hematologic malignancies based on promising Phase 1 survival and safety data.
Wave Life Sciences WVE-007 Phase 2a Trial Gets FDA Approval for Obesity and Type 2 Diabetes Treatment
Wave Life Sciences receives FDA acceptance for WVE-007 Phase 2a multidose trial targeting obesity and type 2 diabetes, set to begin Q2 2026.