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Biotechnology
Taiwanese biotech PharmaEssentia is preparing to seek an expanded US label for its long-acting interferon Besremi (ropeginterferon alfa-2b) following new late-stage data that show the therapy outperforms anagrelide in treating essential thrombocythaemia (ET) after hydroxyurea failure. 3 June 2025
Pharmaceutical
Detailed results from the Phase III OASIS-4 study have found that Bayer’s elinzanetant showed a statistically significant reduction in the frequency of moderate to severe vasomotor symptoms (VMS, also known as hot flushes) from baseline to week four and 12 compared to placebo, in women taking endocrine therapy to prevent hormone receptor (HR+) breast cancer. 2 June 2025
Pharmaceutical
Positive results from the SERENA-6 Phase III trial have shown that AstraZeneca’s camizestrant alongside a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) led to a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS). 2 June 2025
Biotechnology
The Alliance for Clinical Trials in Oncology has announced results from ATOMIC, a Phase III trial evaluating standard chemotherapy alone or combined with Roche’s Tecentriq (atezolizumab) in patients who have surgically resected stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair (dMMR). 2 June 2025
Biotechnology
With ASCO 2025 drawing toward its close in Chicago, Amsterdam-based biotech Avidicure is entering the spotlight with its first public data on a new class of cancer immunotherapies. The company’s lead program, AVC-S-101, is designed to target TROP2 in non-small cell lung cancer (NSCLC) and other solid tumors. 2 June 2025
Biotechnology
US biotech Regeneron Pharmaceuticals has announced detailed analyses from the Phase III C-POST trial, which evaluated PD-1 inhibitor Libtayo (cemiplimab) in patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery. 2 June 2025
Biotechnology
AstraZeneca has reported positive findings from its Phase III MATTERHORN trial, spotlighting the potential of its immunotherapy Imfinzi (durvalumab) to significantly delay disease progression in patients with early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers. 2 June 2025
Pharmaceutical
Arcus Biosciences is setting the stage for a high-stakes Phase III showdown in kidney cancer, after early results showed that nearly half of patients treated with its experimental therapy had a confirmed response. 2 June 2025
Pharmaceutical
US drugmaker Protagonist Therapeutics and Japan’s Takeda Pharma announced detailed results from the Phase III, randomized, placebo-controlled VERIFY study evaluating rusfertide in patients with polycythemia vera (PV), which met the primary and all key secondary endpoints. 2 June 2025
Pharmaceutical
Arvinas and Pfizer today announced detailed results from the Phase III VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant monotherapy versus fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer (MBC) whose disease progressed following prior treatment with cyclin-dependent kinase (CDK) 4/6 inhibitors and endocrine therapy. 2 June 2025
Pharmaceutical
US pharma giant Pfizer on Saturday announced statistically-significant and clinically-meaningful survival results from the Phase III BREAKWATER trial evaluating Braftovi (encorafenib) in combination with cetuximab (marketed as Erbitux) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) in patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. 2 June 2025
Biotechnology
Daiichi Sankyo and AstraZeneca have released detailed Phase III results that could help position their HER2-targeting drug Enhertu (trastuzumab deruxtecan) as the second-line standard of care for advanced gastric cancer. 2 June 2025
Biotechnology
In the run up to the 2025 annual ASCO meeting, IMUNON (Nasdaq: IMNN) is moving into a Phase III trial with its lead candidate IMNN-001. We interviewed president and chief executive Stacy Lindborg on the long path to this moment—and what may lie ahead in the evolving ovarian cancer treatment landscape. 28 May 2025
Pharmaceutical
Germany’s Merck KGaA today announced the presentation of detailed positive results from Part 1 of the global Phase III MANEUVER trial evaluating pimicotinib, a potentially best-in-class investigational colony stimulating factor-1 receptor (CSF-1R) inhibitor in development by Abbisko Therapeutics, in the treatment of patients with tenosynovial giant cell tumor (TGCT). 28 May 2025
Biotechnology
French biotech ImCheck Therapeutics is preparing to showcase encouraging interim results for its investigational monoclonal antibody ICT01 at the 2025 ASCO Annual Meeting, highlighting the compound’s potential to improve outcomes in acute myeloid leukemia (AML) patients not eligible for intensive chemotherapy. 27 May 2025
Pharmaceutical
US biotech Syndeio Biosciences has launched with over $90 million in funding and a pipeline of synapse-targeting neurotherapies aimed at treating major depressive disorder, Alzheimer’s disease, and other central nervous system (CNS) conditions. 27 May 2025
Pharmaceutical
Verastem Oncology has unveiled updated early-stage data from its RAMP 205 trial in metastatic pancreatic cancer, bolstering its efforts to broaden use of its dual-drug regimen, Avmapki Fakzynja Co-Pack, beyond its recently approved indication in a rare form of ovarian cancer. 23 May 2025
Pharmaceutical
Japanese drugmaker Astellas and US pharma giant Pfizer have announced longer-term follow-up results from an open-label extension of the Phase III ARCHES study. 23 May 2025
Biotechnology
Swiss pharma major Roche has reported updated results from its Phase III STARGLO trial, showing that a fixed-duration regimen of Columvi (glofitamab) combined with gemcitabine and oxaliplatin (GemOx) continues to deliver a notable survival benefit for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). 23 May 2025
Pharmaceutical
The oncology community’s biggest gathering returns to Chicago from May 30 to June 3, and all signs suggest the 2025 ASCO Annual Meeting will be a watershed moment. 23 May 2025
Biotechnology
Anthos Therapeutics has reported a new analysis from the landmark AZALEA-TIMI 71 study, demonstrated that the investigational Factor XI inhibitor abelacimab was associated with remarkably low levels of periprocedural bleeding in patients with atrial fibrillation (AFib). 3 September 2024
Pharmaceutical
Germany’s Bayer (BAYN: DE) has presented detailed results from its Phase III OCEANIC-AF trial for the blood thinner asundexian at the annual meeting of the European Society of Cardiology (ESC). 3 September 2024
Pharmaceutical
UK-based George Medicines has announced the presentation of results from its two pivotal Phase III trials at a Hot Line session of the European Society of Cardiology (ESC) Annual Meeting in London. 2 September 2024
Biotechnology
US biotech Arrowhead Pharmaceuticals has unveiled highly anticipated pancreatitis results from a late-stage trial of plozasiran, several months after reporting top-line data. 2 September 2024
Pharmaceutical
Cytokinetics (Nasdaq: CYTK) has presented new data on aficamten, its experimental cardiac myosin inhibitor, at the European Society of Cardiology Congress 2024. 2 September 2024
Pharmaceutical
The European subsidiary of Japanese drugmaker Daiichi Sankyo announced its reinforced commitment to addressing key unmet needs and barriers in cardiovascular (CV) care, by shining a light on inequalities in treatment and outcomes experienced by various patient groups. 2 September 2024
Pharmaceutical
The potential benefits for GLP-1 agonists appear unlimited, with new data at a leading Alzheimer’s conference suggesting a possible benefit for people taking an earlier generation option from Novo Nordisk (NOV: N). 31 July 2024
Biotechnology
Eisai (Tokyo: 4523) and Biogen (Nasdaq: BIIB) have shared new findings on Leqembi (lecanemab), the star of the show at the Alzheimer’s Association International Conference (AAIC) 2024. 31 July 2024
Pharmaceutical
Cognition Therapeutics (Nasdaq: CGTX) has announced disappointing results from its Phase II SHINE study for the drug CT1812, aimed at treating Alzheimer's disease. 30 July 2024
Biotechnology
OnabotulinumtoxinA (BoNT-A) and monoclonal antibodies against the calcitonin gene-related protein (anti-CGRP MAbs) have emerged as the first disease-specific preventative treatments to be approved for chronic migraine. 8 July 2024
Biotechnology
Work on FcRn inhibition continues apace at Johnson & Johnson (NYSE: JNJ), with more success for nipocalimab. 1 July 2024
Pharmaceutical
Oncology small molecule specialist Redx Pharma (JPJ: REDX) has announced positive mid-stage results from the Phase II PORCUPINE and PORCUPINE2 studies of zamaporvint. 1 July 2024
Biotechnology
Johnson & Johnson has announced that its drug nipocalimab demonstrated statistically significant and clinically meaningful improvements in a Phase II study for Sjögren’s disease (SjD). 18 June 2024
Pharmaceutical
The US unit of Japan’s Mitsubishi Tanabe Pharma has announced results from two studies of its already marketed Radicava (edaravone) for amyotrophic lateral sclerosis (ALS) at the European Network to Cure Amyotrophic Lateral Sclerosis (ENCALS) 2024 meeting. 18 June 2024
Biotechnology
Boston, USA-based Vertex Pharmaceuticals has announced longer-term data for Casgevy (exagamglogene autotemcel [exa-cel]) from global clinical trials in people with severe sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT). 17 June 2024
Biotechnology
Johnson & Johnson has released long-term data from the Phase I/II MonumenTAL-1 study of Talvey (talquetamab-tgvs). 17 June 2024
Biotechnology
Swiss pharma giant Roche presented strong new overall survival data at the European Hematology Association (EHA) 2024 Congress over the weekend on its Columvi (glofitamab). 17 June 2024
Biotechnology
Overall survival (OS) results from the Phase II MagnetisMM-3 study of Pfizer’s Elrexfio (elranatamab-bcmm) in patients with heavily pre-treated relapsed or refractory multiple myeloma (RRMM), demonstrated a median OS of 24.6 (95% CI, 13.4, NE) months in cohort A (n=123) of the pivotal single arm trial. 14 June 2024
Biosimilars
Celltrion has announced positive Phase III data for CT-P47, a biosimilar referencing Actemra (tocilizumab). 14 June 2024
Biotechnology
Kite, a Gilead Sciences company, has unveiled new analyses for Yescarta (axicabtagene ciloleucel) in relapsed/refractory large B-cell lymphoma (LBCL). 14 June 2024
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