Bio Pharma Dive
JUNE 27, 2022
The regulator suspended testing of Astellas’ Pompe disease treatment after one patient experienced peripheral nerve damage. Both of the pharma’s clinical-stage gene therapies are now on hold.
Pharmaceutical Technology
JUNE 27, 2022
Last Friday, the World Health Organization (WHO) launched updated guidelines for the treatment of hepatitis C , calling for testing and treatment to be delivered in peripheral and community-based facilities and integrating these with available care services. While some countries are making progress in eliminating hepatitis C, many remain challenged in reaching those affected, Dr Philippa Easterbrook, Senior Scientist at WHO’s Department of Global HIV, Hepatitis and Sexually Transmitted Infection
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Bio Pharma Dive
JUNE 27, 2022
Epizyme, which was once worth more than $2 billion, agreed to be bought for $247 million upfront. The biotech has continued to lose money despite winning FDA approval for a drug for rare cancers.
Pharmaceutical Technology
JUNE 27, 2022
Bristol Myers Squibb (BMS) has received approval from the US Food and Drug Administration (FDA) for its CD19-directed chimeric antigen receptor (CAR) T cell therapy Breyanzi (lisocabtagene maraleucel) to treat relapsed or refractory large B-cell lymphoma (LBCL) in adult patients. Breyanzi is given as a defined composition for reducing the variability of the CD8 and CD4 component dose.
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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
Bio Pharma Dive
JUNE 27, 2022
As hospitals have dealt with surging admissions and extended stays with COVID-19, staff and patients alike have still had to contend with another potentially deadly infection from a bacterium called Clostridioides difficile.
Pharmaceutical Technology
JUNE 27, 2022
The proportion of pharmaceutical companies hiring for cybersecurity related positions rose in May 2022 compared with the equivalent month last year, with 46.8% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 39.4% of companies who were hiring for cybersecurity related jobs a year ago and an increase compared to the figure of 43.6% in April 2022.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JUNE 27, 2022
Ipsen has signed a definitive merger agreement to acquire all the outstanding shares of commercial-stage biopharmaceutical company Epizyme, for an initial total consideration of $247m. The company will begin an all-cash tender offer through its subsidiary to buy Epizyme’s all outstanding shares for $1.45 per share in cash along with a contingent value right (CVR) of $1.00 for each share.
Bio Pharma Dive
JUNE 27, 2022
This year's report showed that 47% of physicians feel burned out, compared with 42% the year before.
Pharmaceutical Technology
JUNE 27, 2022
Turning Point Therapeutics has entered a strategic research and development alliance with the University of Texas MD Anderson Cancer Center (MD Anderson) to advance the evaluation of two of its investigational small molecules for precision cancer treatments. The focus of this strategic alliance will be on drug candidates, repotrectinib and elzovantinib (TPX-0022).
Rethinking Clinical Trials
JUNE 27, 2022
Dr. Ted Melnick and Dr. Gail D’Onofrio, co–principal investigators of EMBED. Implementation of a user-centered clinical decision support tool did not increase the rate of patients receiving buprenorphine for treatment of opioid use disorder in the emergency department (ED) when compared to usual care. When the tool was used, it was associated with high rates of buprenorphine initiation, and the tool increased the number of physicians who provided ED-initiated buprenorphine and naloxone pre
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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
BioSpace
JUNE 27, 2022
Danish researchers published a study suggesting that COVID-19 increases the risk of neurodegenerative diseases such as Alzheimer’s and Parkinson’s disease.
Rethinking Clinical Trials
JUNE 27, 2022
A special series of articles addressing pragmatic and virtual trials appears this week in the journal Contemporary Clinical Trials and offers practical approaches to the many challenges clinical trials face. The 14 articles bring together leaders, researchers, biostatisticians, and bioethicists—including members of the NIH Pragmatic Trials Collaboratory—who are rethinking key aspects of the development, conduct, and oversight of clinical trials.
pharmaphorum
JUNE 27, 2022
An antisense drug in development at GSK has shown further activity against hepatitis B virus (HBV) in a mid-stage trial, setting up a phase 3 assessment next year to see if it could offer a “functional cure” for the widespread disease. Interim results from the phase 2b B-Clear showed that bepirovirsen reduced levels of hepatitis B surface antigen (HBsAg) and HBV DNA after 24 weeks’ treatment to below the lower limit of detection in people with chronic hepatitis B, raising hopes
BioPharma Reporter
JUNE 27, 2022
Australian biotech Skin2Neuronâs new form of cell therapy reversed a dementia-like syndrome in dogs, according to results of a veterinary trial.
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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.
pharmaphorum
JUNE 27, 2022
Almost half (48%) of cancer clinical trials in the US have no Hispanic or Latin American subjects, and 42% have no black patients, according to a diversity analysis focusing on thousands of studies conducted in the past 15 years. The analysis – from a dataset that spans more than half a million patients – reveals once again the lack of inclusivity in clinical research, which undermines the ability of clinical trials to generate results that reflect the real-world situation in US cancer treatmen
BioPharma Reporter
JUNE 27, 2022
The European Medicines Agencyâs Committee for Medicinal Products for Human Use (CHMP) made several recommendations for approval of drugs and therapies at its June 2022 meeting.
Drug Patent Watch
JUNE 27, 2022
Annual Drug Patent Expirations for XYREM Xyrem is a drug marketed by Jazz Pharms and is included in one NDA. It is available from one supplier. There are eight patents…. The post New patent for Jazz Pharms drug XYREM appeared first on DrugPatentWatch - Make Better Decisions.
BioPharma Reporter
JUNE 27, 2022
VIVEbiotech has completed the latest expansion phase of its lentiviral vector manufacturing capabilities; the development is aimed at alleviating the viral vector bottleneck for advanced therapies.
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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.
Scienmag
JUNE 27, 2022
Fossils found at the Sterkfontein Caves in South Africa reveal nearly four million years of hominin and environmental evolution. Since research began at the site in 1936 with the discovery, by Robert Broom, of the first adult hominin of the genus Australopithecus, it has become famous for the hundreds of Australopithecus fossils yielded from excavations of ancient cave […].
XTalks
JUNE 27, 2022
From elevated ketchup and mustard to new takes on ranch, the Whole Foods Market Trends Council revealed its list of best condiments that will be appearing on more barbeque and picnic plates this summer. With the condiment, marinade and dressing category expected to hit $2.9 billion by 2024 according to a Mintel report , the Council noted that consumer desire to experiment will support the sales growth.
pharmaphorum
JUNE 27, 2022
The revamp of French drugmaker Ipsen has continued with a takeover agreement for US counterpart Epizyme and its cancer therapy Tazverik, in a deal valued at a little under $250 million. Ipsen is offering $1.45 per share for Cambridge, Massachusetts-based Epizyme – valuing the US company at around $247 million – and is also promising a further contingent value right (CVR) payment of up to $1 per share if Tazverik (tazemetostat) achieves certain development and sales targets.
Outsourcing Pharma
JUNE 27, 2022
The pharmaceutical company has enlisted the help of the AI and NLP tech specialist to streamline clinical study report generation and submission processes.
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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.
Scienmag
JUNE 27, 2022
TROY, N.Y. — Rensselaer Polytechnic Institute researchers Gaetano Montelione and Christopher Cioffi will use a five-year, $3.5 million grant from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to develop a low-dose, oral COVID antiviral drug that can be administered at home. Dr. Montelione is the […].
BioSpace
JUNE 27, 2022
Ascletis has commenced its Phase II trial in China for its candidate drug ASC22 alongside anti-retroviral therapy for the functional cure and immune restoration of HIV-1 infection.
Scienmag
JUNE 27, 2022
Whether or not a solid can emit light, for instance as a light-emitting diode (LED), depends on the energy levels of the electrons in its crystalline lattice. An international team of researchers led by University of Oldenburg physicists Dr Hangyong Shan and Prof. Dr Christian Schneider has succeeded in manipulating the energy-levels in an ultra-thin […].
ACRP blog
JUNE 27, 2022
Sponsors hoping to increase minority participation in clinical trials might want to cast a wider net when looking for community-based site partners, says Liz Beatty, chief strategy officer at Inato. “Sponsors go to the same sites over and over again, and they are missing out on others” with sturdy local roots in underserved communities, Beatty notes.
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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.
Scienmag
JUNE 27, 2022
Using light-capturing proteins in living microbes, scientists have reconstructed what life was like for some of Earth’s earliest organisms. These efforts could help us recognize signs of life on other planets, whose atmospheres may more closely resemble our pre-oxygen planet. Credit: Sohail Wasif/UCR Using light-capturing proteins in living microbes, scientists have reconstructed what life […].
Pharma Times
JUNE 27, 2022
CHMP returns positive opinion on Rinvoq for the treatment of adults with active non-radiographic axial spondyloarthritis
Scienmag
JUNE 27, 2022
Hormone therapy is successful at keeping metastatic prostate cancer under control, but eventually the tumor cells become resistant to it. An unexpected potential solution has now emerged in medicines not designed to fight cancer, but to target proteins that regulate a cell’s circadian rhythm. Credit: Netherlands Cancer Institute Hormone therapy is successful at keeping metastatic […].
XTalks
JUNE 27, 2022
Leading global medical technology company Becton Dickinson (BD) and Spain’s CerTest Biotec have announced they will be collaborating to develop a molecular diagnostic test for the detection of the monkeypox virus. In a joint press release , the companies said the aim of the partnership is to design a diagnostic test that can help advance understanding of the global spread of the disease.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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