Bio Pharma Dive
MAY 2, 2023
Fresh off its success with the multiple myeloma treatment Carvykti, J&J is paying Cellular Biomedicine Group $245 million upfront for rights to two experimental cell therapies for blood cancer.
Pharmaceutical Technology
MAY 2, 2023
The US Food and Drug Administration (FDA) has accepted the supplemental biologics licence application submitted by Bristol Myers Squibb for Reblozyl (luspatercept-aamt) as a first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes (MDS). The regulatory body has also granted priority review to the application and set 28 August 2023 as a target date for the prescription drug user fee act (PDUFA).
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Bio Pharma Dive
MAY 2, 2023
The drugmaker beat Wall Street’s first quarter forecasts despite a sales drop that puts pressure on it to succeed with upcoming market launches.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 2, 2023
Scientists have caught a type of immune cell invading nerve cells, discovering a possible cause of fibromyalgia in an animal model of the disease. Fibromyalgia is characterized by chronic, widespread, and debilitating pain, thought to be triggered by a process known as central sensitization.
Bio Pharma Dive
MAY 2, 2023
Shares in the biotech, formerly Retrophin, sank after the company disclosed its newly approved drug sparsentan failed a study meant to expand its use.
Pharmaceutical Technology
MAY 2, 2023
ODAIA, a life sciences predictive analytics and commercial insights provider, has secured an investment of $25m in its Series B funding round. The round was led by Threshold Ventures and co-led by Monograph Capital. Another new investor to take part in Series B round was Wittington Ventures. Existing investors including Flint Capital, StandUp Ventures, Graphite Ventures and BDC Capital’s Women in Technology Venture Fund, also participated in this round.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
MAY 2, 2023
Marker Therapeutics has reached a non-dilutive agreement to sell cell manufacturing assets to CellReady for $19m in cash. CellReady is a newly created contract development and manufacturing organisation (CDMO) founded by Marker board member and co-founder John Wilson. CellReady will minimise Marker’s overhead by $11m per year, using Marker’s manufacturing, development, quality and regulatory affairs team.
Medical Xpress
MAY 2, 2023
Rumors of artificial intelligence becoming sentient abound. In July of 2022, a Google engineer claimed that an AI chatbot he was working with had become self-aware. The same AI recently passed the Turing Test, once considered the gold standard for determining if something was human.
Pharmaceutical Technology
MAY 2, 2023
Soligenix has signed an exclusive option agreement with Silk Road Therapeutics for the right to acquire Pentoxifylline (PTX) topical formulation intended to treat mucocutaneous ulcers in Behçet’s disease (BD) patients. The firms did not divulge the terms of the deal. BD is a rare multisystem inflammatory vasculitis, which currently has no treatment.
Medical Xpress
MAY 2, 2023
A recent study published in Pulmonary Circulation assesses changes in oxygen extraction following post-acute sequelae of SARS-Cov-2 infection (PASC) syndrome, or "long COVID." PASC may affect half of patients who recover from COVID-19. One debilitating hallmark is a persistent decrease in exercise tolerance.
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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
MAY 2, 2023
Plus Therapeutics has expanded its partnership with Piramal Pharma Solutions (PPS) to produce additional cGMP liposome intermediate drug products. This will help to meet the rising demand for Plus Therapeutics’ lead investigational targeted radiotherapeutic, rhenium (186Re) obisbemeda, for clinical trials that are underway and planned. The latest supply agreement builds on the master services agreement signed by Plus Therapeutics and PPS in 2021 to develop, manufacture and supply rhenium (186Re)
Medical Xpress
MAY 2, 2023
Medicinal cannabis can safely relieve cancer pain, while curbing the total number of meds and opioids taken, suggest the results of a multicentre registry study, published online in BMJ Supportive & Palliative Care.
Pharmaceutical Technology
MAY 2, 2023
FibroGen is set to receive a non-dilutive term loan facility worth up to $150m from funds managed by Morgan Stanley Tactical Value (MSTV) to advance pamrevlumab towards commercialisation. The loan also provides capital to sustain the development of the company’s pre-clinical pipeline and will be made accessible to the company in three tranches. FibroGen will receive an initial tranche of $75m in May 2023.
XTalks
MAY 2, 2023
World Asthma Day 2023 is on May 2. This annual event is marked on the first Tuesday of May to boost awareness about asthma and help improve asthma care all over the world. The day was first organized in 1998 by the Global Initiative for Asthma (GINA) , a collaboration between healthcare professionals and public health officials, and has since been observed every year.
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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
MAY 2, 2023
Immuno-oncology (IO) agents have transformed the cancer therapeutics landscape, driving long-term remissions in a subset of patients who historically had limited options. IO agents include the classes of immune checkpoint modulators, cell therapies, bispecific antibodies, oncolytic viruses, therapeutic vaccines, and cytokines. The most widely utilised IO class is immune checkpoint inhibitors (ICIs), which work by blocking the inhibitory interactions between tumour cells and T-cells, facilitating
Medical Xpress
MAY 2, 2023
A major impediment to treating the deadly brain cancer glioblastoma has been that the most potent chemotherapy can't permeate the blood-brain barrier to reach the aggressive brain tumor.
Pharmaceutical Technology
MAY 2, 2023
Erasca has received the US Food and Drug Administration’s (FDA) fast track designation (FTD) for ERAS-801 to treat adults with glioblastoma (GBM) with epidermal growth factor receptor (EGFR) gene alterations. The orally bioavailable small molecule EGFR inhibitor ERAS-801 demonstrated significant central nervous system (CNS) penetration in animal trials.
Medical Xpress
MAY 2, 2023
Neuroscience Research Australia and the University of New South Wales, Australia, research has examined the sociodemographic, psychosocial, cognitive and life event predictors of well-being. The study, published in Scientific Reports is titled "Predicting well-being over one year using sociodemographic factors, personality, health behaviors, cognition, and life events.
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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.
BioPharma Reporter
MAY 2, 2023
Cytiva and the life sciences business of Pall Corporation are now united as one business under the Cytiva brand, with the completion of the integration announced this morning. Emmanuel Ligner, Danaher Group Executive, President and CEO of Cytiva, tells us how the company will focus its efforts moving forward to support long-term growth of the biotech industry.
Medical Xpress
MAY 2, 2023
Incorrect advice by an AI-based decision support system could seriously impair the performance of radiologists at every level of expertise when reading mammograms, according to a new study published in Radiology.
Fierce Pharma
MAY 2, 2023
Pfizer pulls off Q1 surprise with strong sales even as COVID vaccine demand plummets kdunleavy Tue, 05/02/2023 - 09:27
Medical Xpress
MAY 2, 2023
Long-term sufferers of chronic back pain experienced dramatic reductions in pain and related disability that remained at their one-year follow-up after taking part in a new treatment tested by Curtin-Macquarie-Monash University research.
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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.
Fierce Pharma
MAY 2, 2023
GSK staffers kick off series of strikes in UK for the first time in drugmaker's history aliu Tue, 05/02/2023 - 14:22
Medical Xpress
MAY 2, 2023
Exercise decreases the risk of cancer and reduces side effects of cancer treatments. In addition, it improves patients' quality of life and the prognosis of cancer patients. This is according to two new Finnish studies.
Fierce Pharma
MAY 2, 2023
Poland takes its COVID-19 vaccine fight to Pfizer's shareholders, urging the company to be a good corporate citizen zbecker Tue, 05/02/2023 - 16:34
Medical Xpress
MAY 2, 2023
Scientists at UMass Chan Medical School have developed a technology to deliver gene therapy directly to lung tissue through intranasal administration, a development that could potentially create a new class of treatments for lung disease.
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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 Channels
MAY 2, 2023
In my most recent video webinar , I explored how the rapid expansion of patient-paid prescriptions—via cash-pay pharmacies and discount card vendors—is transforming the prescription market. Below, I follow the dollar when a patient uses a discount card to pay for a generic drug prescription. As you’ll see, a discount card can save money for consumers by leveraging several quirks of U.S. retail pharmacy pricing.
Medical Xpress
MAY 2, 2023
Humans have consciousness. However, is it just a result of evolution or does it serve a crucial purpose? Professors Albert Newen from Ruhr University Bochum, Germany, and Carlos Montemayor from San Francisco State University, U.S., propose a fresh theory to address this issue. They identify two tiers of consciousness, each with two distinct roles, in the January 1, 2023 edition of the Journal of Consciousness Studies.
Fierce Pharma
MAY 2, 2023
Gilead, US government set for courtroom showdown over PrEP drug patents esagonowsky Tue, 05/02/2023 - 08:50
Medical Xpress
MAY 2, 2023
The accepted clinical practice of using beta blockers over the long term to curb the risk of further heart attacks or death doesn't seem to be warranted in patients who don't have heart failure, suggests a large study published in the journal Heart.
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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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