Pharmaceutical Technology

JUNE 26, 2022

Concept: German company TK Elevator has rolled out a cloud-based, real-time monitoring and predictive maintenance platform called MAX. It collects data on components, systems, and performance to assist building owners and managers in increasing elevator and escalator uptime. MAX also assists facility staff in monitoring and controlling their equipment, as well as improving passenger safety using digital emergency services.

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BioSpace

JUNE 26, 2022

BioSpace spoke with three CEOs: Alto Neuroscience’s Dr. Amit Etkin, Omega Therapeutics’ Mahesh Karande and Rain Therapeutics’ Avanish Vellanki about their companies' employment growth.

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Scienmag

JUNE 26, 2022

The monumental global task to restore degraded ecosystems will need to include sophisticated technologies such as environmental DNA monitoring to understand and support the recovery of complex biospheres, international researchers say. Credit: Flinders University The monumental global task to restore degraded ecosystems will need to include sophisticated technologies such as environmental DNA monitoring to understand […].

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BioSpace

JUNE 26, 2022

A report by CBRE shows that finding life sciences research talent may prove extremely difficult for employers. However, there are steps you can take to find top talent for these roles.

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Life Science Research 98

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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

Clinical Research

Scienmag

JUNE 26, 2022

June 27, 2022–The first high-quality genome of the desert locust—those voracious feeders of plague and devastation infamy and the most destructive migratory insect in the world—has been produced by U.S. Department of Agriculture Agricultural Research Service scientists. Credit: Photo by Brandon Woo. June 27, 2022–The first high-quality genome of the desert locust—those voracious feeders of […].

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BioSpace

JUNE 26, 2022

The current vaccinations still offer significant protection against severe diseases. Meanwhile, vaccine companies are progressing in designing and testing Omicron-specific booster shots.

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Vaccination Vaccine 98

BioSpace

JUNE 26, 2022

Researchers have developed a graphene-based e-tattoo that measures blood pressure continuously and has several advantages over the traditional blood pressure cuff.

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Scienmag

JUNE 26, 2022

Even if global temperatures begin to decline after peaking this century because of climate change, the risks to biodiversity could persist for decades after, finds a new study by UCL and University of Cape Town researchers. The paper, published in Philosophical Transactions of the Royal Society B: Biological Sciences, models the potential impacts on global […].

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Research 77

BioSpace

JUNE 26, 2022

Researchers and drug developers have searched for a way to deliver IL-12 to patients. Researchers at the University of Chicago’s Pritzker School of Molecular Engineering may have found one.

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Engineer Research Development Drugs 98

Scienmag

JUNE 26, 2022

Late-life dementia is becoming increasingly common in people after 80 years of age. Credit: Getty Late-life dementia is becoming increasingly common in people after 80 years of age. A new long-term study has shown a simple and common scan can reveal if people are at increased risk of developing the condition late in life. Late-life […].

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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

Clinical Trials

BioSpace

JUNE 26, 2022

Ipsen announced it is acquiring the company and its cancer drugs, including Tazverik, which were approved for two different indications by the FDA in 2020.

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JAMA Internal Medicine

JUNE 26, 2022

This genetic association study assesses the association of sickle cell trait with prepandemic health conditions in Million Veteran Program participants and assesses the severity and sequelae of COVID-19.

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Genetics 73

BioSpace

JUNE 26, 2022

Collectively, the data set found that 5.1% of vaccinated patients went on to develop AD, while 8.5% of unvaccinated patients developed the disease.

Vaccination 101

Vaccination Vaccine Development 101

NY Times

JUNE 26, 2022

Demand for medication abortion is surging, setting the stage for new legal battles.

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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.

Clinical Supply

BioSpace

JUNE 26, 2022

While it was a relatively quiet week for clinical trial announcements overall, BioSpace takes a look at some of the more intriguing ones.

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Clinical Trials Clinical Trials Trials 98

Drug Patent Watch

JUNE 26, 2022

Annual Drug Patent Expirations for CAPRELSA Caprelsa is a drug marketed by Genzyme Corp and is included in one NDA. It is available from one supplier. There are three patents…. The post New patent expiration for Genzyme Corp drug CAPRELSA appeared first on DrugPatentWatch - Make Better Decisions.

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BioSpace

JUNE 26, 2022

Another C-suite change at Zymeworks was announced Monday, with the appointment of Paul Moore, Ph.D. as chief scientific officer.

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Pharma in Brief

JUNE 26, 2022

On June 22, 2022, the Canadian Institutes of Health Research ( CIHR ) announced the launch of the Clinical Trials Fund ( CTF ), which will inject funding into Canada’s clinical trials environment. The government’s goals include reinforcing Canada’s clinical trials infrastructure so as to improve the health and safety of all Canadians while also ensuring that Canada is well-positioned to respond to any future pandemics or other health crises by having the best available treatments.

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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.

Clinical Trials

BioSpace

JUNE 26, 2022

Otsuka Pharmaceutical and Lundbeck announced positive Phase III clinical trial results Monday regarding brexpiprazole (Rexulti) as a treatment for agitation in patients with Alzheimer’s dementia.

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Scienmag

JUNE 26, 2022

Compared with other G10 countries, Canada handled the first 2 years of the COVID-19 pandemic well by most measures, according to an analysis in CMAJ (Canadian Medical Association Journal) [link] Canada had some of the most stringent policies to help contain the spread of SARS-CoV-2, such as restrictions on movement and public gatherings, workplace closures, event […].

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Containment 57

BioSpace

JUNE 26, 2022

???????GSK and Ionis released promising trial data showing their investigational antisense oligonucleotide, bepirovirsen, could significantly reduce HBsAg and viral DNA levels in patients with CHB.

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DNA Trials 75

Drug Patent Watch

JUNE 26, 2022

PRADAXA (dabigatran etexilate mesylate) Boehringer ingelheim Patent: 6,087,380 Expiration: Jun 28, 2022 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact…. The post Drug Patent Expirations for the Week of June 26, 2022 appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs 40

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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.

Clinical Supply

BioSpace

JUNE 26, 2022

BMS’ CAR-T therapy Breyanzi picked up a second approval from the FDA. The cancer drug was approved for the treatment of adult patients with large B-cell lymphoma.

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FDA Approval Drugs 75

JAMA Internal Medicine

JUNE 26, 2022

This randomized clinical trial compares health system–based smoking cessation treatment with referral to community-based quitline services after hospital discharge.

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Clinical Trials Clinical Trials Trials 40

BioSpace

JUNE 26, 2022

For the first time in two years, the European Association for the Study of the Liver’s International Liver Congress was back on-site with cutting-edge research in hepatology and other sectors.

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Drug Patent Watch

JUNE 26, 2022

This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Ireland. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating…. The post Which pharmaceutical companies have the most SPCs in Ireland? appeared first on DrugPatentWatch - Make Better Decisions.

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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.

Clinical Trials

BioSpace

JUNE 26, 2022

The FDA has placed Astellas Pharma's Phase I/II FORTIS trial on clinical hold after one of its study participants experienced a serious adverse event.

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Pharmaceutical Technology

JUNE 26, 2022

Drug substance plays a key part in ensuring a drug program achieves its major milestones, keeps to budget and delivers on its corporate goals. As every molecule and development program is unique, there is no single drug substance synthesis and manufacturing solution, so understanding what processes and technologies are available, what strategy is best, and who to partner with is key. .

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BioSpace

JUNE 26, 2022

Monday morning, Nuvation Bio announced that the U.S. Food and Drug Administration placed a partial clinical hold on its Phase I dose escalation study of NUV-422.

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BioTech 365

JUNE 26, 2022

Nanostics is focused on development and commercialization of novel, non-invasive diagnostic tests for cancer. Its core technology is an advanced liquid biopsy platform that can accurately diagnose cancer from a single drop of blood.

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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.

Clinical Trials