Theramex purchases Asieris’ innovative cervical lesion treatment for up to...
Asieris, a China-based company, has agreed to pay up to $250 million to get the first-in-class, non-surgical treatment for HPV-associated cervical precancerous lesions in return for its own company’s...
View ArticleMimiVax’s brain cancer vaccine misses phase 2b goal, but CEO sees a path...
MimiVax’s cancer vaccine failed to meet the primary endpoint in a phase 2b trial in newly diagnosed glioblastoma, but the biotech says results in patients 65 and younger still offer a path forward for...
View ArticleCerevance’s Solengepras Meets Phase 3 Goal in Parkinson’s Disease Trial
Cerevance reported positive topline results from its Phase 3 ARISE trial, showing that its oral investigational therapy solengepras reduced motor fluctuations in people with Parkinson’s disease who...
View ArticleFDA Identifies Four Deaths in Newron’s Evenamide Studies as Clinical Hold...
Newron Pharmaceuticals said the U.S. Food and Drug Administration (FDA) has identified four deaths among patients treated with its experimental schizophrenia drug evenamide in feedback provided after...
View ArticleZealand’s obesity medication fails once more in phase 3
Boehringer Ingelheim’s survodutide drug has achieved the co-primary endpoints in a phase 3 trial in adults with obesity and Type 2 diabetes. But as the securities fell by 12% in early trading in...
View ArticleBD Plans Huge U.S. Investment to Expand Medical Manufacturing
BD is preparing a major expansion of its U.S. operations, adding to a growing list of healthcare companies increasing manufacturing commitments to the U.S. Unlike many recent pharmaceutical...
View ArticlePhase 3 Firmonertinib Study Misses Primary Endpoint in EGFR Exon 20 NSCLC
ArriVent BioPharma reported that its phase 3 Furvent trial of firmonertinib in previously untreated patients with non-squamous locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying...
View ArticleHow Healthcare Organizations Are Building AI Centers of Excellence
Executive Summary Artificial intelligence is moving from isolated healthcare experiments toward broader organizational adoption. Hospitals, health systems, pharmaceutical companies, insurers, and...
View ArticleThe Rise of Platform Biotech Companies
Executive Summary Biotechnology companies have traditionally been built around individual drug candidates, therapeutic programs, or specific biological targets. A different model is gaining importance....
View ArticleTop 10 Emerging Modalities Beyond RNA Therapeutics
Executive Summary Pharmaceutical innovation is expanding beyond conventional small molecules and established biologics as researchers pursue new ways to address difficult biological targets. RNA...
View ArticleFDA Warns Fresenius Kabi Over Manufacturing Deviations Linked to Famotidine...
The U.S. Food and Drug Administration (FDA) has issued a warning letter to Fresenius Kabi after identifying deficiencies in the company’s handling of manufacturing deviations associated with reports of...
View ArticleNovartis agrees to pay Abogen $7.8 billion for its in vivo autoimmune T-cell...
Novartis-Abogen Deal & Background Novartis has agreed to pay Abogen Biosciences $575 million up front for an mRNA-encoded T-cell engager (TCE) that demonstrated early clinical potential in the...
View ArticleGrail’s cancer blood test on the brink of receiving groundbreaking FDA approval
An advisory panel to the US Food and Drug Administration handed Grail’s Galleri blood test a milestone win, saying the early cancer detection test’s potential benefits outweigh its risks and bringing...
View ArticlePfizer Reports Phase 3 Results for Litfulo and Phase 2 Atopic Dermatitis Data...
Pfizer has presented detailed results from two phase 3 clinical trials evaluating its oral Janus kinase (JAK) inhibitor Litfulo in patients with nonsegmental vitiligo. The findings were shared at the...
View ArticleTop 10 ESG Priorities for Life Sciences Companies
Executive Summary Environmental, social, and governance (ESG) priorities are becoming increasingly integrated into how life sciences companies manage operations, supply chains, innovation, workforce...
View ArticleContinuous Manufacturing in Pharma Explained
Executive Summary Pharmaceutical manufacturing has traditionally relied on batch production, where materials move through defined production stages and individual batches are completed before the next...
View ArticleWhy Digital Manufacturing Is Becoming Essential
Executive Summary Pharmaceutical manufacturing is entering a period of significant technological change. Manufacturing facilities are generating more data from equipment, sensors, laboratory systems,...
View ArticleTop 10 Technologies Modernizing Trial Monitoring
Executive Summary Clinical trial monitoring is undergoing a significant shift as sponsors move beyond traditional site visits and manual data reviews toward technology-enabled, risk-based approaches....
View ArticleMerck anticipates a significant win for the $3 billion eye disease opportunity
Trial Success & Key Visual Acuity Results Merck & Co.’s Brunello trial has achieved its primary endpoint, offering more clues to the impact of a trio of diabetic macular edema (DME) drugs...
View ArticleWhite House Seeks U.S. Manufacturing Capacity for 86 Essential Medicines
The White House is taking steps to identify domestic and nearshore manufacturing capacity for 86 essential medicines as the administration works to strengthen U.S. pharmaceutical supply chains and...
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