Bio Pharma Dive
AUGUST 3, 2023
One patient received its Duchenne gene therapy, Elevidys, this week and a handful more could follow shortly, surprising some analysts and raising near-term sales expectations.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 3, 2023
An experimental vaccine that aims to slow down or prevent the progression of Alzheimer’s disease has been trialed in mice with promising early results. Mice engineered with genes that put them at greater risk of an Alzheimer’s-like disease had fewer amyloid plaques following the vaccine.
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Bio Pharma Dive
AUGUST 3, 2023
The company disclosed the study result alongside second quarter earnings showing Lumakras sales were flat versus the same period one year prior.
Pharmaceutical Technology
AUGUST 3, 2023
The impact of artificial intelligence has been profoundly felt in the drug discovery space, with increased interest in AI in recent years.
Bio Pharma Dive
AUGUST 3, 2023
Sales of the company’s COVID-19 vaccine plummeted 94% year over year. But executives believe newer products can help revenue rebound.
Pharmaceutical Technology
AUGUST 3, 2023
AAHI is developing a novel RNA vaccine that overcomes manufacturing and storage limitations to increase accessibility.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
AUGUST 3, 2023
ABM Therapeutics has received ODD from the US FDA for ABM-1310 to treat patients with glioblastoma (GBM) harbouring the BRAF V600 mutation.
Bio Pharma Dive
AUGUST 3, 2023
A treatment licensed from the NIH and in clinical testing for lupus is the startup’s lead program, while its founding “Treg” cell therapy research matures, according to CEO Peter Maag.
Rethinking Clinical Trials
AUGUST 3, 2023
This year’s Annual Steering Committee Meeting for the NIH Pragmatic Trials Collaboratory featured implementation science as one of the topics of focus. In an interview after his keynote presentation, Dr. David Chambers, deputy director for implementation science at the National Cancer Institute, shared his thoughts on opportunities for implementation science in the context of pragmatic trials.
Bio Pharma Dive
AUGUST 3, 2023
The biotech is acquiring rights to an RNA interference medicine Alnylam invented for a rare blood disorder, continuing a corporate makeover that began in 2020.
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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
AUGUST 3, 2023
In this issue: Drug shortages force clinics to ration supplies, AMR drug discovery using a subscription model, AI revolutionizes pharma sales.
Rethinking Clinical Trials
AUGUST 3, 2023
Speaker Carl T. Bergstrom, PhD Professor, Department of Biology University of Washington Slides Keywords Research, Misinformation, Media, Social Media Key Points Misinformation abounds in medicine and about medicine. As researchers, we are producers and consumers of the medical literature. It is important to know and understand the information landscape into which your research is going out.
Pharmaceutical Technology
AUGUST 3, 2023
Ionis has signed a licence agreement with Novartis to advance a programme targeting lipoprotein(a) (Lp(a)) for cardiovascular disease (CVD).
XTalks
AUGUST 3, 2023
Johnson & Johnson’s latest bankruptcy attempt, tied to its proposed $8.9 billion settlement for talc litigations, has been shot down by the United States Bankruptcy Court for the District of New Jersey. Last week, Bankruptcy Court Judge Michael Kaplan decided that Johnson & Johnson’s subsidiary LTL Management didn’t meet certain requirements to qualify as a good faith bankruptcy attempt.
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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
AUGUST 3, 2023
This new grant extends Addex’s collaboration agreement with Indivior until June 2024 for research into GABAB positive PAM drug candidates.
Outsourcing Pharma
AUGUST 3, 2023
At-risk families of patients diagnosed with motor neurone disease (MND), better known in the US as amyotrophic lateral sclerosis (ALS) will now have access to genetic sequencing thanks to a financial award from Innovate UK.
Pharmaceutical Technology
AUGUST 3, 2023
Oramed Pharmaceuticals and Hefei Tianhui Biotech (HTIT) have entered an agreement to form a joint venture to advance oral drug products.
ProRelix Research
AUGUST 3, 2023
Although the United States Food and Drug Administration (FDA) has always supported and advocated the idea of decentralized trials, the real adoption and application of decentralized aspects in trials has […] The post FDA Guidance on Advancement of Decentralized Clinical Trials appeared first on ProRelix Research.
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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
AUGUST 3, 2023
Mithra has received €1.25m ($1.37m) from Fuji Pharma as part of a 2016 licence agreement involving Estelle for Japan and ASEAN regions.
XTalks
AUGUST 3, 2023
In a further testament to the growing popularity of plant-based seafood, Konscious Foods, a frozen vegan sushi brand based in Vancouver, Canada, has successfully raised $26 million in a seed funding round. The innovative brand is the brainchild of French chef Yves Potvin, known for founding Yves Veggie Cuisine and Gardein. The funding round attracted notable investors, including Protein Industries Canada, Zynik Capital and the Walter Group.
Pharmaceutical Technology
AUGUST 3, 2023
Taiho Oncology and Taiho Pharmaceutical have received approval from the US FDA for Lonsurf to treat adult patients with mCRC.
XTalks
AUGUST 3, 2023
Pharmacovigilance is an essential and dynamic clinical discipline that holds tremendous importance in supporting public health. Pharmacovigilance activities ensure optimal use of drugs, early detection of safety signals and inform updates to product labeling or regulatory status. While most post-marketing activities are typically oriented towards marketing, sales, and commercialization of the drug, pharmacovigilance is fundamentally patient-centric, focusing on the safety and efficacy of pharmac
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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
AUGUST 3, 2023
Biogen's $7.3bn acquisition of Reata gives the company access to the only approved drug for Friedreich's Ataxia.
Fierce Pharma
AUGUST 3, 2023
Even as Moderna chugs through another post-pandemic year, the biotech has raised its COVID-19 vaccine revenue projection in the expectation that it can deliver a strong showing in the private marke | The company raised its forecast for COVID-19 sales to between $6 billion and $8 billion, up from a prior estimate of $5 billion. Elsewhere, an RSV clash with pharma giants nears.
Pharmaceutical Technology
AUGUST 3, 2023
CG Oncology has secured $105m in a crossover funding round to advance its clinical-stage bladder cancer programmes.
BioPharma Reporter
AUGUST 3, 2023
NK:IO, a leader in natural killer (NK) cell biology applied to the development of potent, off-the-shelf cell therapies targeting solid tumors, has raised Â1.2m.
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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
AUGUST 3, 2023
The round extension pushes the Series B total to $145m, with plans for the first clinical data readout in H2 2023.
Fierce Pharma
AUGUST 3, 2023
As Novo Nordisk and Eli Lilly rack up significant sales from their GLP-1 diabetes and obesity drugs, the companies also must gear up for defense against lawsuits from new users. | A Louisiana woman is suing Novo Nordisk and Eli Lilly, alleging that her use of Ozempic and Mounjaro caused her to vomit so much that some of her teeth have fallen out. Jaclyn Bjorklund, 44, says that she also has been hospitalized on "several" occasions and that the companies failed to warn patients of “seve
Pharmaceutical Technology
AUGUST 3, 2023
GlobalData has revealed the top 20 global M&A financial advisers for H1 2023 in its latest league tables.
Fierce Pharma
AUGUST 3, 2023
After coming to the rescue during the mpox outbreak in 2022, vaccine maker Bavarian Nordic has agreed to help replenish U.S. stores of its smallpox/mpox shot. | The U.S. Biomedical Advanced Research and Development Authority is handing Bavarian Nordic a new $120 million contract, primarily to cover the production of new bulk vaccine product.
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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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