Bio Pharma Dive
JANUARY 20, 2021
Results from a clinical trial in nursing home residents and staff offered the first evidence Lilly's bamlanivimab could protect against, as well as treat, COVID-19
pharmaphorum
JANUARY 20, 2021
Ella Balasa says she owes her life to the experimental phage therapy she was able access in no small part thanks to her scientific background. Her mission, she told pharmaphorum, is to ensure everyone has the knowledge and power they need to navigate their own healthcare journey, no matter where they are from or what they do. Ella, 28, was diagnosed with cystic fibrosis – a rare genetic disease which causes a build-up of thick, sticky mucus in the lungs, digestive tract, and sinuses – at 18 mont
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Bio Pharma Dive
JANUARY 20, 2021
BioNTech's CEO has also promised data will soon be available on the shot's protection against a South African variant that's worried public health experts.
BioPharma Reporter
JANUARY 20, 2021
We take a look at some of the COVID-19 vaccine candidates moving through Phase 1 and 2 clinical trials - and how they could offer a point of difference to authorized vaccines.
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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
JANUARY 20, 2021
Many officials in the administration will be focused on the U.S. response to the COVID-19 pandemic, which Biden has named as his top priority as cases and deaths remain near record highs.
BioPharma Reporter
JANUARY 20, 2021
Pfizer and BioNTech have re-iterated that their COVID-19 vaccine appears to be effective against the UK strain, with the publication of new data today.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
JANUARY 20, 2021
Project managers in the biotech industry play an especially important role on a daily basis.
pharmaphorum
JANUARY 20, 2021
Laboratory studies have confirmed that antibodies stimulated by Pfizer and BioNTech’s COVID-19 vaccine can neutralise the new, more transmissible variant of SARS-CoV-2 identified in the UK. The results of the study – published online prior to peer review – are among the first data to indicate that any of the approved coronavirus vaccines can effectively target the mutated spike protein in the UK strain, known as B.1.1.7 lineage or VOC 202012/01.
XTalks
JANUARY 20, 2021
San Diego’s IconOVir Bio has raised $77 million in Series A financing to develop differentiated oncolytic virus candidates which the company believes could be tumor-selective to infect and destroy tumor cells. The financing was co-led by Nextech and Vida Ventures. IconOVir was founded by Two River Group and is chaired by Dr. Arie Bellegrum who founded Kite Pharma, Allogene Therapeutics and Kronos Bio.
BioSpace
JANUARY 20, 2021
The decision was made based on an Independent Data Monitoring Committee recommendation which indicated the study was unlikely to meet its specified primary efficacy endpoint of progression-free survival.
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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
Scienmag
JANUARY 20, 2021
Credit: Jan Zrimec/Chalmers University of Technology Pathogenic bacteria in humans are developing resistance to antibiotics much faster than expected. Now, computational research at Chalmers University of Technology, Sweden, shows that one reason could be significant genetic transfer between bacteria in our ecosystems and to humans. This work has also led to new tools for resistance […].
BioSpace
JANUARY 20, 2021
The U.S. FDA has accepted Genentech’s supplemental New Drug Application and has granted Priority Review for the company’s unclassifiable interstitial lung disease (UILD) treatment Esbriet® (pirfenidone).
Pharma Times
JANUARY 20, 2021
UK biotech company will collaborate with Lawrence Livermore National Laboratory
BioSpace
JANUARY 20, 2021
Protecting the most vulnerable, Eli Lilly’s bamlanivimab significantly reduced COVID-19 risk for nursing home residents in a Phase III 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.
Pharma Times
JANUARY 20, 2021
Approximately one in five breast cancer cases in the EU are HER2-positive
BioSpace
JANUARY 20, 2021
Servier and MiNA Therapeutics are partnering on small activating RNA (saRNA) therapies to treat neurological diseases. saRNA is an entirely new class of drugs.
Scienmag
JANUARY 20, 2021
NIH-supported study finds biggest increase among American Indians and Alaska Natives Credit: National Institute on Drug Abuse Methamphetamine overdose deaths surged in an eight-year period in the United States, according to a study published today in JAMA Psychiatry. The analysis revealed rapid rises across all racial and ethnic groups, but American Indians and Alaska Natives […].
BioSpace
JANUARY 20, 2021
Less than a year after taking over the reins, Biotechnology Innovation Organization Chief Executive Officer Michelle McMurry-Heath is reorganizing the organization's leadership structure.
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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
JANUARY 20, 2021
US government non-dilutive funding has played a key role in the accelerated development of the COVID-19 vaccine.
BioSpace
JANUARY 20, 2021
Northway Biotech, which was previously Northway Biotechpharma, has opened a new $40 million 30,000-square-foot process development and Current Good Manufacturing Practice (cGMP) manufacturing site in Waltham, Mass.
Scienmag
JANUARY 20, 2021
Boston, Mass. — Renal cell carcinoma (RCC) is the most common form of cancer of the kidney. In 2018, there were an estimated 403,000 new cases of RCC and 175,000 deaths due to kidney cancer worldwide. Currently, the 5-year survival rate for patients with metastatic RCC is only about 12 percent. Current treatments include inhibitors […].
BioSpace
JANUARY 20, 2021
California-based Avidity Biosciences has a goal of disrupting the way RNA-based therapies are delivered to patients through its Antibody-Oligonucleotide Conjugates (AOCs) platform.
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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
JANUARY 20, 2021
MINNEAPOLIS – A new study shows that intense immunosuppression followed by a hematopoietic stem cell transplant may prevent disability associated with multiple sclerosis (MS) from getting worse in 71% of people with relapsing-remitting MS for up to 10 years after the treatment. The research is published in the January 20, 2021, online issue of Neurology®, […].
BioSpace
JANUARY 20, 2021
Hours after being sworn in as the 46th President of the United States, Joe Biden signed 10 executive orders that are aimed at combating the ongoing COVID-19 crisis.
Scienmag
JANUARY 20, 2021
Over the past 20 years, scientists have been developing metamaterials, or materials that don’t occur naturally and whose mechanical properties result from their designed structure rather than their chemical composition. They allow researchers to create materials with specific properties and shapes. Metamaterials are still not widely used in everyday objects, but that could soon change. […].
BioSpace
JANUARY 20, 2021
The jury is still out on whether Roche’s arthritis drug, Actemra/RoActemra (tocilizumab), is helpful for the most severe cases of COVID-19.
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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
JANUARY 20, 2021
Successful precision cancer diagnosis through an AI analysis of multiple factors of prostate cancer. Potential application of the precise diagnoses of other cancers by utilizing a urine test Credit: Korea Institute of Science and Technology(KIST) Prostate cancer is one of the most common cancers among men. Patients are determined to have prostate cancer primarily based […].
BioSpace
JANUARY 20, 2021
Biopharma and life sciences companies from across the globe provide updates on their pipelines and businesses.
Scienmag
JANUARY 20, 2021
Renewable energy sources, such as wind and solar power, could help decrease the world’s reliance on fossil fuels. But first, power companies need a safe, cost-effective way to store the energy for later use. Massive lithium-ion batteries can do the job, but they suffer from safety issues and limited lithium availability. Now, researchers reporting in […].
Pharma Times
JANUARY 20, 2021
PIM status was awarded on the basis of Phase IIb results of nirsevimab
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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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