Bio Pharma Dive
SEPTEMBER 18, 2023
Public health officials, as well as drugmakers, are trying to raise awareness of RSV among older adults at risk, and convince them to get an additional respiratory shot alongside those for COVID and flu.
Pharmaceutical Technology
SEPTEMBER 18, 2023
Embattled biotech giant Illumina has led series A funding into genomics mapping company Broken String Biosciences.
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Bio Pharma Dive
SEPTEMBER 18, 2023
With the rise of ChatGPT and artificial intelligence (AI), there are many ways the clinical staffing industry can use AI advantageously while removing the stigma that the rise of technology can be dehumanizing.
Pharmaceutical Technology
SEPTEMBER 18, 2023
The FDA released a draft guidance giving advice on the correct labelling of biosimilar and interchangeable biosimilar products.
Bio Pharma Dive
SEPTEMBER 18, 2023
Three years after gaining European approval, Libmeldy is now under U.S. review with a deadline set for March.
Pharmaceutical Technology
SEPTEMBER 18, 2023
Despite major shifts in the IBD landscape, most approaches that go beyond targeting inflammation remain in the earlier stages of development.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
SEPTEMBER 18, 2023
Experts say a wider diverse pool of patients needs to be given a chance to participate in clinical trials to get rare disease drugs faster to market.
Bio Pharma Dive
SEPTEMBER 18, 2023
As integrated evidence generation takes center stage for driving evidence-based decision making across the product life cycle, automated registries just might be the linchpin that pulls it all together.
Pharmaceutical Technology
SEPTEMBER 18, 2023
Novo Nordisk’s obesity drug Wegovy will soon be available for use from the National Health Service (NHS) of England, despite currently limited stock from manufacturers.
Bio Pharma Dive
SEPTEMBER 18, 2023
Biomedical data analysis without core knowledge = statistically significant nonsense. Be better.
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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
Pharmaceutical Technology
SEPTEMBER 18, 2023
In the functional service provider model, a company can outsource specific functions of clinical research while retaining control and increasing efficiency.
Pharma Times
SEPTEMBER 18, 2023
The treatment is the first oral GPCR receptor antagonist class recommended for NHS use - News - PharmaTimes
Pharmaceutical Technology
SEPTEMBER 18, 2023
Roche’s monoclonal antibody therapy has been approved for treating HER2-positive breast cancer and metastatic gastric cancers.
Outsourcing Pharma
SEPTEMBER 18, 2023
The French-U.S. company Novadiscovery has hailed a âwatershed moment for clinical trial designâ as its trial simulation tool successfully predicted the outcome of a phase 3 oncology trial run by AstraZeneca.
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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
Pharmaceutical Technology
SEPTEMBER 18, 2023
Opill, America’s first OTC oral contraceptive by Perrigo will be available early next year. Is Perrigo’s new drug going to be a hit among American women?
Drug Patent Watch
SEPTEMBER 18, 2023
The article “Maximizing the Value of Drug Patents Before Losing Exclusivity” discusses strategies for biomedical companies to maximize the value of their drug patents before the exclusivity period expires. In… The post Maximizing Drug Patents’ Value: Strategies for Biomedical Companies appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
SEPTEMBER 18, 2023
The CHMP’s opinion, based on three pivotal Phase III trials showing improvement in clear skin, means therapy could be approved within two months.
Pharma Times
SEPTEMBER 18, 2023
The updated vaccines more closely target current circulating variants - News - PharmaTimes
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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.
Pharmaceutical Technology
SEPTEMBER 18, 2023
The ability to detect host-cell proteins in bioprocessing streams is a vital tool in pharmaceutical firms' product purification arsenal
Fierce Pharma
SEPTEMBER 18, 2023
With the loss of elasticity in the skin that accompanies aging, platysma bands can become more apparent, protruding from the neck. | Already approved as an injection to reduce wrinkles in the forehead and around the eyes, AbbVie's Botox is in position to expand its cosmetic uses to the moderate to severe form of platysma prominence, a condition which causes muscle bands to protrude from the neck.
Pharmaceutical Technology
SEPTEMBER 18, 2023
While orphan drug approvals have hit an all-time high, existing incentives need to continue to further support rare disease research.
XTalks
SEPTEMBER 18, 2023
Hooray Foods, a name synonymous with plant-based bacon strips, and Nowadays, known for its plant-based nuggets, are shutting down their operations. Both San Francisco-based ventures recently announced the end of their production journey in separate social media posts. Hooray Foods Hooray Foods made its debut three years ago with plant-based strips designed to sizzle, smell and taste like traditional bacon.
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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.
Pharmaceutical Technology
SEPTEMBER 18, 2023
GSK’s drug is the first treatment approved for intermediate or high-risk myelofibrosis patients who develop anaemia.
BioSpace
SEPTEMBER 18, 2023
Nearly three years after European approval, the U.S. regulator has accepted Orchard Therapeutics’ BLA for its gene therapy OTL-200, being proposed for metachromatic leukodystrophy.
Pharmaceutical Technology
SEPTEMBER 18, 2023
LB-1908 is a gene-modified cell therapy commercialized by Legend Biotech, with a leading Phase I program in Adenocarcinoma Of The Gastroesophageal Junction.
Fierce Pharma
SEPTEMBER 18, 2023
Amid Sanofi’s multi-year effort to simplify its product portfolio, the drugmaker is offloading 11 central nervous system (CNS) meds to lifecycle management company Pharmanovia. | The move falls in line with CEO Paul Hudson's mission to focus Sanofi's efforts on "best-in-class" growth drivers, including the immunology superstar Dupixent.
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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.
Pharmaceutical Technology
SEPTEMBER 18, 2023
LB-1908 is a gene-modified cell therapy commercialized by Legend Biotech, with a leading Phase I program in Adenocarcinoma Of The Gastroesophageal Junction.
Outsourcing Pharma
SEPTEMBER 18, 2023
The small molecule drug Ojjaara (momelotinib), developed by GlaxoSmithKline, has become the first U.S. Food and Drug Administration (FDA)-approved treatment for patients with the blood cancer myelofibrosis and anemia.
Pharmaceutical Technology
SEPTEMBER 18, 2023
Puxitatug Samrotecan is a monoclonal antibody conjugated commercialized by AstraZeneca, with a leading Phase II program in Metastatic Bile Duct Cancer.
Outsourcing Pharma
SEPTEMBER 18, 2023
The Japanese firm Astellas Pharma will apply for planning permission to construct a drug manufacturing facility in Tralee, Co. Kerry, Ireland worth around â330 million ($352 million).
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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