Jane Koo, head of regulatory affairs at CTMC, plays an important role in accelerating the development and commercialization of innovative cellular therapies.
The FDA decision will enable Antag Therapeutics to initiate the clinical development of its lead candidate drug, a first-in-class treatment for obesity.
The partners are preparing for commercialization of the lung cancer drug limertinib as they await an approval decision from China’s National Drug Administration.
Patient recruitment is a critical and often challenging aspect of clinical trials, particularly for biopharmaceutical companies seeking to accelerate drug development.
Rebekah's father passed on his passion for science and problem solving to her and much her of childhood was spent doing fun hands-on activities from taking apart household mechanics to building rockets.
The proceeds of the financing will support the development of LoQus23’s lead candidate, a small molecule inhibitor that is expected to enter the clinic in 2026.
At this October’s CPHI event being held in Milan, dsm-firmenich, is inviting stakeholders across the pharmaceutical market to immerse themselves in its patient-inspired innovations.
The Barcelona-based startup Sequentia Biotech has raised €10 million ($11 million) in a Series A round to finance the development of its omics-based technology for use in biomedicine, agritech and food.
The US big pharma company Pfizer has voluntarily withdrawn the oral sickle cell disease treatment Oxbryta from the market and halted clinical trials of the drug as data indicate a high risk of severe adverse events.
The small molecule drug arimoclomol (Miplyffa) has got the green light from the U.S. Food and Drug Administration (FDA) for the treatment of the rare disease Niemann-Pick disease type C (NPC), which until now has lacked FDA-approved therapies.
The series A financing will enable Nura Bio to advance its lead drug candidate into the next stage of clinical trials, shortly after successfully completing a first phase 1 clinical trial.
One year after a rejection by the US Food and Drug Administration (FDA), the UK firm F2G has raised $100 million to push its candidate olorofim to the market for the treatment of rare fungal infections in 2026.
Rachel Sha has had a colorful career not without its challenges, but she urges women in the science industry to have confidence and answer hard questions.
Recent investments by major pharmaceutical companies signal a growing confidence in artificial intelligence’s (AI's) potential to transform drug development.
As local and state governments in the US begin to receive and distribute their opioid settlement funds, Sonara Health has developed a comprehensive report analyzing how over $50 billion in national funds can be effectively allocated to address the opioid...
Phastar have implemented an RBQM app within their Clinical Intelligence Data Visualisation Platform, enabling a comprehensive overview of the entire trial across all sites which can be shown in various visualisation graphs, tailored by client.
CluePoints, the leading provider of risk-based quality management (RBQM) and data quality oversight software, has announced the full agenda and speaker line-up for the highly anticipated RBQMLive 2024.
The European Organisation for Research and Treatment of Cancer (EORTC) has renewed and extended its partnership with Medidata, a provider of clinical trial solutions for the life sciences industry.
Slope, a global provider of biospecimen lifecycle software, data, and services for clinical trials, has announced the launch of a new suite of premium services designed to optimize biospecimen operations and data management.
Envision Pharma Group, a global leader in technology solutions for the life sciences industry, has unveiled its latest innovation, EnvisionOne Insights.
Pharmaceutical companies are under increasing pressure to ensure that essential healthcare products are accessible to all, regardless of socioeconomic status or location.
In an in-depth conversation, OSP senior editor, Liza Laws, interviews Adrian Kizewski, associate director at IQVIA, to uncover the transformative impact of the Sub-population Optimization & Modeling Solution (SOMS) on clinical trials.
Seqster and PatientsLikeMe have announced a strategic partnership to integrate real-time electronic health record (EHR) data with patient engagement tools, aiming to significantly improve clinical research and patient outcomes.
Reimagine Care, the leading provider of on-demand cancer care, and Memorial Hermann Health System, one of Texas's largest not-for-profit health systems, have announced an ambitious multi-year expansion of their pioneering partnership.
Global health technology company myTomorrows announced a new partnership on Tuesday (Aug 27) with Pancreatic Cancer Europe (PCE), a multi-stakeholder platform dedicated to improving care for pancreatic cancer patients.
Janssen-Cilag International NV, a Johnson & Johnson company, announced that the European Commission (EC) has approved Balversa (erdafitinib) as a once-daily oral monotherapy for adult patients with unresectable or metastatic urothelial carcinoma (mUC)...
In the rapidly evolving field of drug discovery, Melanie Adams-Cioaba stands at the forefront, leading transformative advancements in cryo-electron microscopy (cryo-EM) at Thermo Fisher Scientific.
Gilead Sciences, Inc. has announced that the US Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC), a rare and chronic autoimmune disease affecting the bile...
The Danish company Bavarian Nordic plans to supply up to 2 million vaccine doses this year in response to the World Health Organization’s declaration of mpox as a Public Health Emergency of International Concern (PHEIC) earlier this month.
Ayvakit, a groundbreaking therapy developed by Blueprint Medicines, has witnessed a remarkable 185% year-over-year revenue growth in the second quarter of this year (2024).
Tonix Pharmaceuticals has announced promising phase 3 trial results for TNX-102 SL (sublingual cyclobenzaprine HCl), a treatment targeting fibromyalgia.
In the rapidly evolving pharmaceutical industry, the process of evaluating outsourcing partners is critical to ensuring quality, efficiency, and innovation.
Driven by personal loss and inspired by the progress in disease management, Elaine has dedicated more than 20 years to the clinical trial technology industry.
In a landmark move for the pharmaceutical industry, PLAIO, a pioneering Icelandic tech firm, has secured €4.3 million in an oversubscribed funding round to accelerate its AI-driven sales and operations planning platform designed specifically for the pharmaceutical...
In a blow to millions of Americans battling post-traumatic stress disorder (PTSD), Lykos Therapeutics announced today that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its new drug application (NDA) for midomafetamine...
In the evolving landscape of precision psychiatry, Universal Brain stands at the forefront, focusing on neuroscience and technology to transform the standard of care for psychiatric conditions.
In an insightful discussion with Outsourcing Pharma and BioPharma Reporter's senior editor, Liza Laws, sat down with Jinesh Patel, an expert in medical equipment maintenance, where he shared his valuable insights on how healthcare facilities can...
