Bio Pharma Dive
NOVEMBER 16, 2022
Tricida, Harpoon, Freeline and three other small drug developers have this week announced plans to cut staff or to reprioritize their drug development.
Pharmaceutical Technology
NOVEMBER 16, 2022
ElevateBio has entered a partnership with Affini-T Therapeutics to progress the latter’s engineered TCR-T therapies focused on Kirsten rat sarcoma viral oncogene homolog (KRAS), a dominant oncogenic driver mutation in solid tumours. Under the deal, the LentiPeak lentiviral vector technology platform and cell therapy production expertise of ElevateBio BaseCamp will be used by Affini-T to develop its investigational oncogenic driver programmes in the clinic.
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Bio Pharma Dive
NOVEMBER 16, 2022
The U.K. biotech will sell its German unit and lay off staff to save cash as it focuses on therapies for Gaucher and Fabry diseases.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 16, 2022
Electric shocks to the brain took away the cravings of two patients with binge eating disorder for at least six months, a small study said. The two patients were fitted with a brain implant to zap the part of the brain linked to cravings. They told The New York Times that after the surgery they […].
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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
Rethinking Clinical Trials
NOVEMBER 16, 2022
? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?. Speakers. Stephanie Morain, PhD, MPH. Assistant Professor. Berman Institute of Bioethics & Johns Hopkins Bloomberg School of Public Health. Kayte Spector-Bagdady, JD, MBioethics. Associate Director, Center for Bioethics & Social Sciences in Medicine. Assistant Professor of Obstetrics & Gynecology.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 16, 2022
In a bid to bring transparency in clinical trial costs which will in turn increase equity in the biomedical R&D ecosystem, Médecins Sans Frontières (MSF), a global medical non-governmental organization, has approved and published its first Clinical Trial Transparency Policy (CTTP). This policy is a commitment to publishing research protocols, registering clinical trials on appropriate […].
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Rethinking Clinical Trials
NOVEMBER 16, 2022
In this Friday’s PCT Grand Rounds, Dr. Padmanabhan Ramnarayan of Imperial College London will present “The FIRST-ABC Pragmatic Trials of Non-Invasive Respiratory Support in Children.” The Grand Rounds session will be held on Friday, November 18, 2022, at 1:00 pm eastern. Ramnarayan is a reader in pediatric critical care at Imperial College London.
Pharmaceutical Technology
NOVEMBER 16, 2022
Each year at the annual UN climate summits, many businesses set up pavilions at the event and have high-level meetings with policymakers. The number of companies at the COPs has been increasing each year. For some, this is a worrying sign of corporate capture. For others, it is a sign of the business community seriously engaging with the issue of climate change and telling policymakers what they need to create a stable landscape for clean investment.
Bio Pharma Dive
NOVEMBER 16, 2022
The agency is focused on implementing drug price negotiation in Medicare and surprise billing regulations, according to the secretary.
Pharmaceutical Technology
NOVEMBER 16, 2022
Clinical-stage biopharmaceutical companies NextCure and LegoChem Biosciences have signed a collaboration and co-development agreement to develop a B7-H4 antibody drug conjugate (ADC), and features options for two further targets. The B7-H4 ADC will leverage South Korea-based LCB’s ConjuAll ADC technology and US-based NextCure’s B7-H4 antibody. As per the agreement, the two firms will not only share the costs equally in developing the molecules but also the profits from the marketed products.
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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
NPR Health - Shots
NOVEMBER 16, 2022
NPR spoke with 26 people who were involved with more than 200 executions across the country. Most said their health suffered and they had little support to help them cope with their unusual jobs.
STAT News
NOVEMBER 16, 2022
BOSTON — The U.S. government’s top addiction researcher is calling for broad deregulation of methadone , a key drug used to treat opioid use disorder. American doctors should “absolutely” be allowed to prescribe methadone directly to patients, Nora Volkow, the director of the National Institute on Drug Abuse, said Wednesday.
pharmaphorum
NOVEMBER 16, 2022
Novartis has already spun out its eyecare business Alcon, and is now considering the sale of its ophthalmology and respiratory medicines businesses as it continues a narrowing of its focus, according to media reports. A Bloomberg article citing people close to the matter claims that Novartis is engaged in early discussions about the sale of the two units, which could raise billions of dollars in capital that could be reinvested into the pharma group’s pipeline.
STAT News
NOVEMBER 16, 2022
The World Health Organization and the government of Uganda plan to test three candidate Ebola vaccines in a clinical trial during the ongoing outbreak in the East African nation, Director-General Tedros Adhanom Ghebreyesus announced Wednesday, acting on the advice of experts convened by the global health agency. The first doses of vaccine should arrive in Uganda next week, Tedros said, though the WHO has not yet indicated a start date for the 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.
NPR Health - Shots
NOVEMBER 16, 2022
New research points to a surprising way to stop spillovers of Hendra virus, which is harbored by bats. It's not often that it jumps to horses, then humans, but when it does, the result are brutal.
STAT News
NOVEMBER 16, 2022
When I was seven years old, I watched as police carted my father out of the house and took him away. He had severe bipolar disorder and was experiencing what I know now to be an “episode” of this mental illness. What I learned over the 40 years that my dad was alive is that he could foster a loving relationship despite not ever mastering his recurrent episodes.
NPR Health - Shots
NOVEMBER 16, 2022
Researchers compiled data from previous studies and found that recreational listening, such as on devices and at entertainment venues, posed a threat for those aged 12 to 35.
STAT News
NOVEMBER 16, 2022
Doctors are reporting a troubling trend when it comes to fentanyl. The powerful drug, they say, isn’t just causing overdoses — it’s also making it more difficult to begin addiction treatment. In particular, fentanyl appears more likely to cause severe withdrawal symptoms for patients put on buprenorphine, a key medication used to treat opioid use disorder.
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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.
Medical Xpress
NOVEMBER 16, 2022
People who have a COVID-19 infection are more likely to develop seizures or epilepsy within the next six months than people who have an influenza infection, according to a study published in the November 16, 2022, online issue of Neurology. The increased risk was more noticeable in children than adults. It was also more noticeable in people who did not need hospitalization for COVID-19 infections.
STAT News
NOVEMBER 16, 2022
The increased stress doctors have faced throughout the Covid-19 pandemic is making some feel like they are providing worse patient care, according to a new survey of primary care physicians from 10 wealthy countries. Younger doctors also reported higher rates of feeling distressed and burned out — a finding that was broadly consistent across the countries included.
Medical Xpress
NOVEMBER 16, 2022
Fungi in the soil cause a significant number of serious lung infections in 48 out of 50 states and the District of Columbia, including many areas long thought to be free of deadly environmental fungi, according to a study by researchers at Washington University School of Medicine in St. Louis.
STAT News
NOVEMBER 16, 2022
BOSTON — Even after leading the charge combating the worst pandemic in a century, vaccine researcher Kathrin Jansen doesn’t feel that she can relax. Another pandemic — this one based on an influenza virus — is inevitable, Jansen said at the annual STAT Summit on Tuesday. “Before SARS-CoV-2, we had worried about pandemic flu.
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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.
Medical Xpress
NOVEMBER 16, 2022
COVID-19 vaccines and drugs were developed at "warp speed" and now experts are concerned about the US Food and Drug Administration's (FDA) inadequate surveillance of clinical trial sites, reports an investigation published by The BMJ today.
STAT News
NOVEMBER 16, 2022
Amid a bumpy few years for development in Boston, the business of building lab space has been a gleaming bright spot, with billions upon billions of dollars pouring in to house the region’s booming life science industry. Now, though, even the lab boom is slowing amid a rocky economy, rising interest rates, and soaring construction costs.
Medical Xpress
NOVEMBER 16, 2022
Researchers at Karolinska Institutet in Sweden have shown that patients with acute COVID-19 infection have increased levels of the cytokine IL-26 in their blood. Moreover, high IL-26 levels correlate with an exaggerated inflammatory response that signifies severe cases of the disease. The findings, which are presented in Frontiers in Immunology, indicate that IL-26 is a potential biomarker for severe COVID-19. ?.
pharmaphorum
NOVEMBER 16, 2022
The 2022 edition of the Access to Medicine Index (ATMI) – which places the top 20 pharma companies for their efforts to improve delivery of medicines to lower income countries – sees GSK retain the number one position, newly joined by Johnson & Johnson in second and AstraZeneca in third. GSK scored highly as its R&D programmes encompass a sizeable chunk of the 83 high burden priority diseases covered in the assessment, an integrated access to medicine strategy in its governance, and robu
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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.
NPR Health - Shots
NOVEMBER 16, 2022
In a new book, writer Alison Mariella Désir shares her journey into long distance running, reveals the hidden contributions of Black runners and calls for the sport to become more inclusive.
pharmaphorum
NOVEMBER 16, 2022
Last month, pharmaphorum spoke with Dr Charles C. Wykoff about the results from Apellis Pharmaceuticals’ OAKS study on intravitreal pegcetacoplan for geographic atrophy (GA), otherwise known as atrophic or dry age-related macular degeneration (AMD), a leading cause of blindness worldwide. Having presented the data from the 24-month phase 3 trial at the American Academy of Ophthalmology (AAO) annual meeting, Dr Wykoff set aside some time to go into further detail with pharmaphorum about how the r
BioSpace
NOVEMBER 16, 2022
According to a BIO report, less than a third of executive team members are women. BioSpace spoke with three influential women in biopharma to get their advice on breaking the executive barrier.
Medical Xpress
NOVEMBER 16, 2022
Memory loss is often the first sign of Alzheimer's disease, followed by confusion and difficulty thinking. These symptoms reflect the typical pattern of worsening damage to brain tissues. Toxic clusters of proteins first concentrate in the temporal lobes of the brain—the memory area—before spreading to parts of the brain important for thinking and planning.
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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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