BioPharma Reporter
SEPTEMBER 7, 2020
Venom from honeybees has been found to rapidly destroy triple-negative breast cancer and HER2-enriched breast cancer cells â with minimal effect on healthy cells, according to a study published this month.
pharmaphorum
SEPTEMBER 7, 2020
Laura Morrill from ECI Partners looks at why data and technology are the keys to success in pharma services post-COVID. The pharmaceuticals industry has, for some time, been behind the curve when it comes to the adoption of technology. High barriers to entering the sector and high levels of regulation are just two factors that have meant that there has often been an “innovation lag” when it comes to implementing new technologies and embracing technological and digital change in the pharma indust
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BioPharma Reporter
SEPTEMBER 7, 2020
The Australian Government has made a $1.7bn AUD ($1.34bn USD) supply and production agreement for COVID-19 vaccines: with the first doses set to come from AstraZenecaâs vaccine in January 2021.
BioSpace
SEPTEMBER 7, 2020
For patients with epilepsy, the diagnosis and treatment process can be long, arduous, and filled with lengthy hospital stays. The medical device company NeuroOne Medical Technologies Corporation hopes to change that.
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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
pharmaphorum
SEPTEMBER 7, 2020
A trial of Russia’s Sputnik V coronavirus vaccine has shown the jab produces an immune response, although the study was too small to produce conclusive findings, particularly on safety. Preliminary results published in The Lancet are from a non-randomised phase 1/2 trial of 76 people aged 18-60, which found an antibody response within 21 days and no serious adverse events after 42 days.
BioSpace
SEPTEMBER 7, 2020
The CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Moderna, Novavax, Pfizer, Merck and Sanofi all signed the pledge promising to ensure that any vaccine put forth by one or more of the companies meets the rigorous standards for approval.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
SEPTEMBER 7, 2020
Results from a Phase III open-label extension trial showed that the safety and efficacy profile observed in previous Dupixent trials were maintained for up to three years in adults and adolescents with moderate-to-severe asthma.
NY Times
SEPTEMBER 7, 2020
The problem occurs when drug-induced side effects are viewed as a new ailment and treated with yet another drug that can cause still other side effects.
BioSpace
SEPTEMBER 7, 2020
The U.S. government is putting together the infrastructure for widespread distribution of a COVID-19 vaccine, if and when one is granted emergency use authorization (EUA) or full approval.
Pharma Times
SEPTEMBER 7, 2020
New analysis shows high-dose, once-daily Enerzair Breezhaler cut asthma exacerbation rates by 21% (moderate or severe) and 31% (severe) versus medium-dose
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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
SEPTEMBER 7, 2020
It’s entirely possible that what we will be seeing most from the U.S. Food and Drug Administration for the month of September is related to treatments and vaccines for COVID-19.
Pharma Times
SEPTEMBER 7, 2020
Treatment naïve patients lived longer without disease progression with the Imbruvica-based regimen than those given a chemotherapy-based one
Scienmag
SEPTEMBER 7, 2020
Meta-DNA structures transform the DNA nanotechnology world Credit: Hao Yan A team* of scientists from ASU and Shanghai Jiao Tong University (SJTU) led by Hao Yan, ASU’s Milton Glick Professor in the School of Molecular Sciences, and director of the ASU Biodesign Institute’s Center for Molecular Design and Biomimetics, has just announced the creation of […].
JAMA Internal Medicine
SEPTEMBER 7, 2020
This case-control study estimates the risk of aortic aneurysm or aortic dissection associated with infections and the comparative risk associated with fluoroquinolones vs other antibiotics with similar indication profiles among patients with the same types of infections.
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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.
Scienmag
SEPTEMBER 7, 2020
Credit: Neil Losin When acorn woodpeckers inhabiting high-quality territories die, nearby birds begin a battle royal to win the vacant spot. Researchers used radio tags to understand the immense effort woodpecker warriors expend traveling to and fighting in these dangerous battles. They also found spectator woodpeckers go to great lengths to collect social information, coming […].
JAMA Internal Medicine
SEPTEMBER 7, 2020
This Perspective details the unnecessary restrictions on gay men donating blood and the impact of these restrictions on the critical shortages of blood supply during the COVID-19 pandemic.
BioPharma Reporter
SEPTEMBER 7, 2020
Rocheâs new test will allow healthcare professionals to differentiate between SARS-CoV-2, Influenza A and Influenza B.
pharmaphorum
SEPTEMBER 7, 2020
AbbVie has claimed rights to an immuno-oncology antibody from I-Mab in what is thought to be a record licensing deal involving a Chinese biotech. The US drugmaker is paying $200 million upfront for lemzoparlimab, which targets CD47 – an immune checkpoint on malignant cells that helps them evade being destroyed by immune cells such as macrophages. It has also pledged another $1.74 billion in payments due if the drug achieves development and sales objectives. $20 million of the upfront fee is tied
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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
SEPTEMBER 7, 2020
Credit: Elissa Newport WASHINGTON — Infants and young children have brains with a superpower, of sorts, say Georgetown University Medical Center neuroscientists. Whereas adults process most discrete neural tasks in specific areas in one or the other of their brain’s two hemispheres, youngsters use both the right and left hemispheres to do the same task. […].
Pharma Times
SEPTEMBER 7, 2020
The personalised cancer treatment has received conditional approval in the US
pharmaphorum
SEPTEMBER 7, 2020
NHS patients with treatment-resistant depression in Scotland will be able to access Johnson & Johnson’s Spravato, a drug that has been turned down twice by NICE for patients in England. The Scottish Medicines Consortium – NICE’s equivalent north of the border – backed the use of Spravato (esketamine) nasal spray at its meeting this week, giving it the go-ahead for people with major depression who haven’t responded to at least two different antidepressants.
Scienmag
SEPTEMBER 7, 2020
Credit: Felix Petermann, MDC Hundreds of innovators, research pioneers, clinicians, industry leaders and policy makers from all around Europe are united by a vision of how to revolutionize healthcare. In two publications – a perspective article in the journal Nature and the LifeTime Strategic Research Agenda – they now present a detailed roadmap of how […].
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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
SEPTEMBER 7, 2020
It was a busy week for both COVID-19-related clinical trial news and the rest of the industry. Here’s a look.
Scienmag
SEPTEMBER 7, 2020
Drastically shifting agricultural production from animals to plant-sourced foods could remove more than a decade of our carbon dioxide emissions from the atmosphere Plant protein foods–like lentils, beans, and nuts–can provide vital nutrients using a small fraction of the land required to produce meat and dairy. By shifting to these foods, much of the remaining […].
Pharma Times
SEPTEMBER 7, 2020
Development of SPOR-COV is supported by a grant from Innovate UK
Scienmag
SEPTEMBER 7, 2020
Credit: Dr Jie Zheng An innovative genetic study of blood protein levels, led by researchers in the MRC Integrative Epidemiology Unit (MRC-IEU) at the University of Bristol, has demonstrated how genetic data can be used to support drug target prioritisation by identifying the causal effects of proteins on diseases. Working in collaboration with pharmaceutical companies, […].
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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.
The Pharma Data
SEPTEMBER 7, 2020
Inhaled ensifentrine will be assessed in hospitalised patients. Verona Pharma has kicked off a pilot study to investigate the efficacy and safety of ensifentrine delivered via pressurised metered-dose inhaler (pMDI) formulation in patients hospitalised with COVID-19. The US study will evaluate the effect of ensifentrine on key outcomes in patients hospitalised with COVID-19, including facilitation of recovery from the viral infection, clinical status improvement and reduction i
Scienmag
SEPTEMBER 7, 2020
Study says endogenous retroviruses help promote genetic diversity and speciation Credit: Cincinnati Children’s CINCINNATI – As the world scrambles to control the growing COVID-19 coronavirus pandemic, new research in Nature Structural & Molecular Biology shows viruses also play a key evolutionary role in mammals’ ability to reproduce and survive.
The Pharma Data
SEPTEMBER 7, 2020
Novartis will present 48 abstracts from its leading MS portfolio, including new data on recently FDA-approved Kesimpta ® (ofatumumab) — the first and only self-administered, targeted B-cell therapy for relapsing forms of MS (RMS )— Mayzent ® (siponimod) and Gilenya ® (fingolimod) . New pivotal data from ASCLEPIOS trials evaluating the efficacy and safety of Kesimpta in a subgroup of treatment-naïve RMS patients will be presented for the first time 1 .
Scienmag
SEPTEMBER 7, 2020
New study suggests that high-intensity focused ultrasound ablation is effective against prostate cancer with decreased side effects and improved recovery time Credit: Ricardo Carrasco III, Keck Medicine USC LOS ANGELES — For some prostate cancer patients, radical treatment (surgery or radiation) are treatment standards. However, these procedures may cause side effects including urinary incontinence or […].
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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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