Mon.Jan 17, 2022

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Horizon pharma’s bad DTC decision

World of DTC Marketing

Thyroid eye disease affects more women than men, although men are more likely to have severe illnesses. The exact prevalence of thyroid eye disease is not known, but is estimated to be 16 per 100,000 women in the general population, and 2.9 per 100,000 men in the general population. So why in the hell is Tepezza running TV ads? Do Millennials know how to market to older consumers?

Marketing 223
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Botanical Solution Inc. (BSI) Secures $6.1 Million in Series A First Closing

Pharma Mirror

January 17, 2022 (Davis, CA) – Botanical Solution Inc. (BSI), innovator of sustainable, consistent, and cost-effective Advanced Botanical Materials for agricultural and pharmaceutical applications, has successfully closed $6.1 million in a Series A round led by Palo Alto based VC Firm, Otter Capital. This round of funding will enhance BSI’s value proposition by facilitating the geographic expansion of its current botanical-based products and the development of a new product pipeline derive

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Vir Biotechnology and Bill & Melinda Gates Foundation to develop vaccinal antibody tech for tackling HIV and malaria

BioPharma Reporter

Vir Biotechnology and the Bill & Melinda Gates Foundation have partnered up to develop broadly neutralizing antibodies designed to provide a âvaccinal effectâ for the treatment of HIV and prevention of malaria.

Antibody 143
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Novo Nordisk moves to strengthen obesity efforts

pharmaphorum

After securing FDA approval for Wegovy last year, Novo Nordisk is strengthening its position in the obesity space through a collaboration with EraCal Therapeutics. Under the joint research plan, the Danish giant will work with EraCal to identify novel drug targets relevant for food intake regulation and additional metabolic phenotypes. Although specific details of the collaboration are yet to be released, EraCal has confirmed that the duo will utilise its phenotypic drug discovery platform to id

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Abbott’s New Cardiac Mapping System Gets FDA Clearance for Treatment of Cardiac Arrhythmias

XTalks

Abbott’s new cardiac mapping platform, EnSite X EP System, has received clearance from the US Food and Drug Administration (FDA) for the treatment of cardiac arrhythmias. The cardiac mapping system incorporates Abbott’s proprietary EnSite Omnipolar Technology (OT), which allows for 360° mapping to generate better and “true” electrograms (EGM) using the Advisor HD Grid Catheter.

Doctors 110
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GSK rejects $68.4bn Unilever bid for consumer health

pharmaphorum

GlaxoSmithKline (GSK) claims it has rejected three unsolicited, conditional and non-binding proposals from Unilever to acquire GSK Consumer Healthcare in a deal worth approximately $68.4 billion (£50 billion). The Consumer Healthcare business is a Joint Venture between GSK and Pfizer, with GSK holding a majority controlling interest of 68% and Pfizer 32%.

Marketing 117

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Two new drugs added to WHO list of COVID-19 therapies

pharmaphorum

A World Health Organization (WHO) panel has given the green light to two new drugs to treat COVID-19. US-based Eli Lilly’s baricitinib (Olumiant), a Janus kinase inhibitor, and GlaxoSmithKline and Vir Biotechnology’s sotrovimab, a monoclonal antibody, were recommended in new WHO guidelines, published in the British Medical Journal. . Baricitinib, administered with corticosteroids, was strongly recommended as a treatment for patients with severe or critical illness.

Drugs 115
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Scientists find potential diagnostic and therapeutic target for lung cancer

Scienmag

Chinese scientists recently reported the key role of histone acetylation-regulated long noncoding RNA termed as lysosome cell death regulator (LCDR) in tumor survival, providing a potential diagnostic and therapeutic target for lung cancer. Credit: GAO Shan Chinese scientists recently reported the key role of histone acetylation-regulated long noncoding RNA termed as lysosome cell death regulator […].

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Decentralised trials: beyond the pandemic

pharmaphorum

The adoption of decentralised activities was a major factor in allowing clinical trials to continue during the early stages of the pandemic. Ben Hargreaves examines whether this adoption looks set to become a permanent feature of clinical trials moving into the future, rather than just supplying the tools to a temporary need. Decentralised clinical trials (DCTs) have become a major talking point due to their ability to ensure that drug development can continue efficiently through the current pan

Trials 105
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Introducing lifestyle interventions in preschool lowers heart disease risk

Scienmag

Implementing school-based programs aimed at teaching healthy cardiovascular health habits as early as preschool can achieve lasting lifestyle changes in children, according to a review published today in the Journal of the American College of Cardiology. Previous studies have found that unhealthy lifestyle habits such as a nutritionally poor diet, sedentary lifestyle and smoking, all […].

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Vanderbilt discovery offers hope for colorectal cancer patients

Outsourcing Pharma

The researchers, in studying how polyps morph into colorectal cancer, have set a path for improved surveillance of the disease, harnessing precision medicine.

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Earth BioGenome Project begins genome sequencing in earnest

Scienmag

A global effort to map the genomes of all plants, animals, fungi and other microbial life on Earth, is entering a new phase as it moves from pilot projects to full-scale production sequencing. This new phase of the The Earth BioGenome Project, or EBP, is marked with a collection of papers published this week (Jan. […].

Genome 84
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Detainees Sue Arkansas Jail That Gave Them Ivermectin to Treat Covid

NY Times

For months, the jail’s doctor has promoted the drug, which health experts say should not be used to treat or prevent Covid-19.

Doctors 98
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The brain pays attention to unfamiliar voices during sleep

Scienmag

A good night’s sleep is not as simple as it appears. While you snooze, your brain continues to monitor the environment, balancing the need to protect sleep with the need to wake up. One example of how the brain accomplishes this is by selectively responding to unfamiliar voices over familiar ones, according to new research […].

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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AML digital therapeutic lands Breakthrough Device Designation from FDA

Outsourcing Pharma

Blue Note Therapeutics has announced the status has been granted to BNT200, a device to treat anxiety and depression in acute myeloid leukemia patients.

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Enhanced statistical models will aid conservation of killer whales and other species

Scienmag

Ecologists need to understand wild animal behaviours in order to conserve species, but following animals around can be expensive, dangerous, or sometimes impossible in the case of animals that move underwater or into areas we can’t reach easily. Credit: Evan Sidrow Ecologists need to understand wild animal behaviours in order to conserve species, but following […].

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Poolbeg Pharma dives into nasally administered antivirals

Pharma Times

If we have learnt anything from the last two years, it’s that virus protection is not to be sniffed at

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Shifting ocean closures best way to protect animals from accidental catch

Scienmag

FROM: Michelle Ma Credit: Ed Melvin/Washington Sea Grant FROM: Michelle Ma University of Washington mcma@uw.edu (NOTE: Researcher contact information at end) Embargoed by Proceedings of the National Academy of Sciences For public release at noon Pacific Time / 3 p.m. Eastern Time on Monday, Jan. 17, 2022 Shifting ocean closures best way to […].

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The New Age of Decentralized Clinical Trials

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.

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CDI prevention reaches date with destiny

Pharma Times

Clinical stage outfit, Destiny Pharma, provides a positive summary of the year ahead

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The circadian clock in heart failure

Scienmag

Disrupting circadian rhythms, which change naturally on a 24-hour cycle, has been implicated in heart disease, but it is unclear how it leads to the condition. A research team at Baylor College of Medicine and collaborating institutions investigated the function of the protein Rev-erb?/?, a key component of the circadian clock, on heart disease development […].

Protein 77
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Electronic Decision Support for Deprescribing in Hospitalized Older Adults

JAMA Internal Medicine

This randomized clinical trial examines the impact of electronic decision support on postdischarge adverse drug events and deprescribing among hospitalized patients 65 years or older at 11 hospitals in Canada.

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Newly discovered carbon may yield clues to ancient Mars

Scienmag

NASA’s Curiosity rover landed on Mars on Aug. 6, 2012, and since then has roamed Gale Crater taking samples and sending the results back home for researchers to interpret. Analysis of carbon isotopes in sediment samples taken from half a dozen exposed locations, including an exposed cliff, leave researchers with three plausible explanations for the […].

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Accelerating Clinical Supply Through Integrated Drug Development

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.

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Association of CT Screening Promotion With Lung Cancer Overdiagnosis Among Asian Women

JAMA Internal Medicine

This cohort study investigates whether opportunistic screening for lung cancer among Taiwanese women who rarely smoke is associated with overdiagnosis of lung cancer.

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Bone growth inspired “microrobots” that can create their own bone

Scienmag

Inspired by the growth of bones in the skeleton, researchers at the universities of Linköping in Sweden and Okayama in Japan have developed a combination of materials that can morph into various shapes before hardening. The material is initially soft, but later hardens through a bone development process that uses the same materials found in […].

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Association of Telomere Length With Risk of Disease and Mortality

JAMA Internal Medicine

This cohort study examines the association between leukocyte telomere length and overall as well as disease-specific mortality and morbidity.

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Nanotherapy offers new hope for the treatment of Type 1 diabetes

Scienmag

Individuals living with Type 1 diabetes must carefully follow prescribed insulin regimens every day, receiving injections of the hormone via syringe, insulin pump or some other device. And without viable long-term treatments, this course of treatment is a lifelong sentence. Pancreatic islets control insulin production when blood sugar levels change, and in Type 1 diabetes, […].

Insulin 59
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How Machine Learning Drives Clinical Trial Efficiency

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.

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New patent expiration for Allergan drug ALPHAGAN P

Drug Patent Watch

Annual Drug Patent Expirations for ALPHAGAN+P Alphagan P is a drug marketed by Allergan and is included in two NDAs. It is available from one supplier. There are eight patents…. The post New patent expiration for Allergan drug ALPHAGAN P appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Support for populist politics ‘collapsed’ during the pandemic – global report

Scienmag

Support for populist parties and politicians, and agreement with populist sentiment, has diminished during the pandemic, according to a “mega-dataset” taking in attitudes of over half a million people across 109 countries since 2020. A University of Cambridge team say there are clear signs of a turning tide for the “populist wave”, as the mishandling […].

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Parallel Trade 2022

pharmaphorum

SMi presents its 16th annual Parallel Trade conference on the 21st and the 22nd March 2022. As the only parallel trade conference in Europe, this event provides the perfect platform for industry experts from both sides of the coin to come together and share perspectives on the practice of parallel trade. The 2022 event will be more significant than ever before due to the transition period after Brexit coming to an end.

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ACP releases two new clinical guidelines on the diagnosis and management of diverticulitis

Scienmag

ACP releases two new clinical guidelines on the diagnosis and management of diverticulitis Guidelines highlight opportunity to manage most patients with uncomplicated disease in outpatient settings and to initially manage select patients without antibiotics; Patients with complicated disease should be referred for colonoscopy after initial episode if they have not had a recent colonoscopy Full […].

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.