Pharmaceutical Technology
JULY 5, 2024
Fucaso, a BCMA CAR T-cell therapy, is co-developed by Innovent and IASO Bio and was approved to treat multiple myeloma in China last month.
pharmaphorum
JULY 5, 2024
Discover how innovative approaches and specialised expertise in peptide API synthesis are increasing efficiency and driving advancements in the manufacturing of Active Pharmaceutical Ingredients (API).
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Pharmaceutical Technology
JULY 5, 2024
Approval is based on positive data from the Phase III FLAURA2 trial where Tagrisso plus chemotherapy showed PFS of 24.4 months.
pharmaphorum
JULY 5, 2024
Explore the vital partnerships and people involved in shaping Labour's policies on the NHS, healthcare, and life sciences during the general election. Learn more about the key areas of focus and priorities.
Pharmaceutical Technology
JULY 5, 2024
HF-158K1 is under clinical development by HighField Biopharmaceuticals and currently in Phase I for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer).
Drug Discovery World
JULY 5, 2024
Newron Pharmaceuticals has reported new findings of mechanism of action that indicate its drug candidate evenamide could be uniquely effective in patients with treatment resistant schizophrenia (TRS). The drug’s unique mechanism of action targets the core abnormalities in patients with schizophrenia and reduces hippocampal dopaminergic activity, improving symptoms of psychosis, social interactions and cognition.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
JULY 5, 2024
The neurodegenerative disease currently affects more than 200,000 people worldwide
Pharmaceutical Technology
JULY 5, 2024
The UK life science industry is crossing its fingers as a Labour government takes the reigns following 14 years of Conservative rule.
pharmaphorum
JULY 5, 2024
Learn about Professor Melanie Bailey's research on single-cell multi-omics and its oncological potential through the company SEISMIC. Discover the groundbreaking work and contributions to the field.
Pharmaceutical Technology
JULY 5, 2024
Whilst Regeneron and Sanofi secured approval in Europe for COPD, the FDA has delayed Dupixent’s application review for the disease in the US.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
pharmaphorum
JULY 5, 2024
Reports indicate that private equity firms Bain Capital and Cinven may be contemplating a bid for the consumer health division of Sanofi.
Pharmaceutical Technology
JULY 5, 2024
The EMA has validated Philogen and Sun Pharmaceutical’s marketing authorisation application (MAA) for Nidlegy, a treatment for melanoma.
Pharma Times
JULY 5, 2024
Pneumococcus is the leading cause of pneumonia, meningitis and sepsis worldwide
Pharmaceutical Technology
JULY 5, 2024
Pendopharm has signed a distribution agreement with Ascendis Pharma to bring the hypoparathyroidism treatment, TransCon PTH, to Canada.
Outsourcing Pharma
JULY 5, 2024
Meg Wilkinson, a resilient cancer survivor, recently sat down with OSP editor Liza Laws to discuss her journey from diagnosis to founding the Omentum Project.
Pharmaceutical Technology
JULY 5, 2024
The UK took to the polls on 4 July 2024 and voted in a new government. How will a Labour government look for the clinical trial sector?
pharmaphorum
JULY 5, 2024
After Labour landslide in UK general election, former shadow health secretary West Streeting sets out his objectives for the NHS.
Pharmaceutical Technology
JULY 5, 2024
LP-184 is under clinical development by Starlight Therapeutics and currently in Phase I for Triple-Negative Breast Cancer (TNBC).
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Drug Discovery World
JULY 5, 2024
The Division of Clinical Neuroscience at Oslo University Hospital (OUS) and the Swedish drug development company TikoMed have signed a research collaboration agreement focused on amyotrophic lateral sclerosis (ALS). TikoMed has previously completed and reported on two successful Phase IIa clinical studies in ALS, one at the Sahlgrenska University Hospital in Sweden and one at the University of Birmingham in the UK, both with promising results.
Pharmaceutical Technology
JULY 5, 2024
As the UK transitions into a Labour party government, the pharma industry urges for boosted investment and talent attraction.
Drug Patent Watch
JULY 5, 2024
Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five NDAs.
Pharmaceutical Technology
JULY 5, 2024
HF-158K1 is under clinical development by HighField Biopharmaceuticals and currently in Phase I for Pancreatic Cancer.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Drug Patent Watch
JULY 5, 2024
Annual Drug Patent Expirations for ORILISSA Orilissa is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug.
Pharmaceutical Technology
JULY 5, 2024
HF-158K1 is under clinical development by HighField Biopharmaceuticals and currently in Phase I for Cervical Cancer.
Drug Patent Watch
JULY 5, 2024
Annual Drug Patent Expirations for LILETTA Liletta is a drug marketed by Medicines360 and is included in one NDA. It is available from one supplier. There are three patents protecting this drug.
Pharmaceutical Technology
JULY 5, 2024
HF-158K1 is under clinical development by HighField Biopharmaceuticals and currently in Phase I for Prostate Cancer.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Drug Discovery World
JULY 5, 2024
AviadoBio has launched its Phase I/II ASPIRE-FTD clinical trial at the Ohio State University in the US. ASPIRE-FTD is evaluating investigational gene therapy AVB-101 in people with frontotemporal dementia (FTD) with progranulin (GRN) gene mutations (FTD-GRN). The study is also recruiting in Europe with study sites in the Netherlands, Poland, and Spain, with additional sites expected to open in multiple countries.
Pharmaceutical Technology
JULY 5, 2024
HF-158K1 is under clinical development by HighField Biopharmaceuticals and currently in Phase I for Bladder Cancer.
Drug Discovery World
JULY 5, 2024
Amgen has reported positive topline results from its randomised, double-blind, multicentre, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of its treatment for Immunoglobulin G4-related disease (IgG4-RD). The company’s MITIGATE study was designed to evaluate the safety and efficacy of UPLINZA compared to placebo in reducing the risk of flares in adults with IgG4-RD.
Pharmaceutical Technology
JULY 5, 2024
HF-158K1 is under clinical development by HighField Biopharmaceuticals and currently in Phase I for Gastric Cancer.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
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