Bio Pharma Dive
JUNE 28, 2021
A study of Gilead's Yescarta found the cell therapy dramatically outperformed chemotherapy and stem cell transplant in treating lymphoma, a result that could support much broader use of the drug.
World of DTC Marketing
JUNE 28, 2021
SUMMARY: The debate around Biogen’s Alzheimer’s drug continues to rage. The clinical evidence supporting the approval of the drug is at best “weak.” How could the FDA approve a drug with such poor clinical data? How can Biogen’s employees continue to work for a company that is raping taxpayers for a drug that doesn’t work?
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Bio Pharma Dive
JUNE 28, 2021
The agency's decision-making process as well as Biogen's pricing of Aduhelm at $56,000 per year are both under the microscope as the repercussions of the controversial OK continue to be felt.
BioPharma Reporter
JUNE 28, 2021
Live biotherapeutic product (LBP) developer, 4D Pharma, says it is building a âstrong body of evidenceâ for its portfolio of bacterial strains in relation to cancer, asthma, and neurodegenerative diseases, while the company also calls its recent dual listing a âtransformational milestoneâ.
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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 28, 2021
Wearables can minimize trips to clinic sites and may provide study participants and cancer patients with a feeling of having more control over how they manage their own illness.
BioSpace
JUNE 28, 2021
Tofersen is the furthest along of four ASOs currently in clinical development for ALS and as such, there is quite a bit riding on the results of the VALOR trial which has an estimated completion date of August 31st, 2021.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
JUNE 28, 2021
The groundbreaking success of the mRNA vaccines for COVID-19 by Pfizer-BioNTech and Moderna has led the way for other companies with a vested interest in vaccine development.
Bio Pharma Dive
JUNE 28, 2021
Optimizing your insights into HCP/thought leader networks is critical for promoting new treatments.
BioSpace
JUNE 28, 2021
A new study published in Nature offers good news for those who recovered from COVID-19 and were then vaccinated with a mRNA vaccine – a booster may not be needed.
Bio Pharma Dive
JUNE 28, 2021
The U.S. government has stopped distributing the drugmaker's COVID-19 antibody combination nationwide, just two months after the FDA pulled its other antibody treatment from the market.
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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 28, 2021
Orphazyme said that its OLE trial, which has been running for the past 24 months, showed that arimoclomol could be an effective and safe option in treating Niemann-Pick disease type C.
Bio Pharma Dive
JUNE 28, 2021
Discover the bioservices and manufacturing efforts that have made an impact within the biological manufacturing field.
BioSpace
JUNE 28, 2021
Major players in the biotech industry are targeting Ohio for their new facilities, including Amgen, which recently dropped $365 million on a “digitally advanced” smart facility just 15 miles outside the state’s capital.
Scienmag
JUNE 28, 2021
A new alternative seawater desalination membrane to produce drinking water Credit: Elsevier According to the World Health Organization, about 785 million people around the world lack a clean source of drinking water. Despite the vast amount of water on Earth, most of it is seawater and freshwater accounts for only about 2.5% of the total. […].
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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.
BioPharma Reporter
JUNE 28, 2021
The University of Oxford in partnership with AstraZeneca began vaccinations yesterday for a new phase in human trials to test a COVID-19 vaccine âAZD2816â in volunteers against the Beta [South African] variant.
Scienmag
JUNE 28, 2021
Credit: Jungeun Won Middle ear infections, also known as otitis media, affect more than 80% of the children in the U.S. In a new study, researchers have designed a miniaturized 3D-printed device to inactivate Pseudomonas aeruginosa, a common bacterium that causes the infection. The device–a microplasma jet array–generates plasma, which is composed of charged particles […].
Outsourcing Pharma
JUNE 28, 2021
The companyâs Ryze technology combines a clinical MDR and study automation platform, designed to accelerate and optimize design and execution of trials.
Scienmag
JUNE 28, 2021
UMass Amherst researcher: ‘Who the therapist is matters’ Credit: UMass Amherst In first-of-its kind research led by a University of Massachusetts Amherst psychotherapy researcher, mental health care patients matched with therapists who had a strong track record of treating the patients’ primary concerns had better results than patients who were not so matched.
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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.
pharmaphorum
JUNE 28, 2021
Exelixis has suffered a blow to its efforts to expand the use of Cabometyx into additional indications after reporting mixed results in a phase 3 trial in liver cancer. The COSMIC-312 study is comparing Cabometyx (cabozantinib) given alongside Roche’s cancer immunotherapy Tecentriq (atezolizumab) to Bayer’s Nexavar (sorafenib) as a first-line treatment for hepatocellular carcinoma (HCC), the most common form of liver cancer.
Scienmag
JUNE 28, 2021
Credit: Balázs Major The invention of the laser has opened the era of nonlinear optics, which today plays an important role in many scientific, industrial and medical applications. These applications all benefit from the availability of compact lasers in the visible range of the electromagnetic spectrum. The situation is different at XUV wavelengths, where very […].
BioSpace
JUNE 28, 2021
The two companies studying the regimen for HCC, Exelixis and Ipsen, suggest the probability of reaching significance at the final analysis is low.
Scienmag
JUNE 28, 2021
Inaugural faculty fellows have been named to lead the collaborative effort Credit: WVU Photo In 2014, around 10,000 gallons of a coal-washing chemical called MCHM spilled into the Elk River near Charleston, affecting 30,000 residents in nine counties. Two years later, floods ravaged central and southeastern West Virginia, claiming 23 lives. These incidents and others, […].
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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.
BioSpace
JUNE 28, 2021
If approved, lenacapavir would be offered to HIV patients who have been heavily treated for the disease and have multi-drug-resistant HIV.
Scienmag
JUNE 28, 2021
Credit: Anne Devan-Song CORVALLIS, Ore. – Research by a graduate student in Oregon State University’s College of Science has upended the conventional wisdom that for a century has incorrectly guided the study of a toad listed as endangered in part of its range. Anne Devan-Song used spotlighting – shining a light in a dark spot […].
BioSpace
JUNE 28, 2021
The company said more patients treated with Rinvoq in the 52-week study achieved clinical remission compared to placebo.
Scienmag
JUNE 28, 2021
Traditional folk remedies in rural Italy inspired the research Credit: Quave Lab Scientists isolated a molecule, extracted from the leaves of the European chestnut tree, with the power to neutralize dangerous, drug-resistant staph bacteria. Frontiers in Pharmacology published the finding, led by scientists at Emory University. The researchers dubbed the molecule Castaneroxy A, after the […].
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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.
BioSpace
JUNE 28, 2021
On Monday, the House passed a bipartisan bill designed to reportedly boost scientific research and increase the scientific competitiveness of the U.S. to that of China.
Scienmag
JUNE 28, 2021
Papers by Eric Pietras, Ph.D., and James DeGregori, Ph.D., touch on topics of chronic inflammation, aging, and increased blood cancer risk Credit: CU Cancer Center Two recent collaborative publications by CU Cancer Center members provide insights into how chronic inflammation can serve as a key factor in the development of leukemia and other blood cancers. […].
NY Times
JUNE 28, 2021
A new workshop explores the right of Indigenous people to govern the collection, ownership and use of their biological and cultural data.
Scienmag
JUNE 28, 2021
Credit: Michael Holahan, Augusta University Dr. Richard A. McIndoe, bioinformatics expert and associate director of the Center for Biotechnology and Genomic Medicine at the Medical College of Georgia, is leading a dynamic, new $6.2 million federally funded initiative to support highly innovative research ideas in three areas with tremendous impact on health.
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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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