Sun.Nov 15, 2020

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Mouse Seeking Elephant: Innovators Address Unmet Needs in Biotech and Analytics

BioSpace

The 2020 Virtual Texas Life Science Forum, sponsored by BioHouston November 10-12, showcased dozens of innovative, early stage companies seeking partners to reach the next level.

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Former piece of Pacific Ocean floor imaged deep beneath China

Scienmag

Study offers clues about the fate of tectonic plates that sink deep in Earth’s mantle Credit: Courtesy of Rice University HOUSTON – (Nov. 16, 2020) – In a study that gives new meaning to the term “rock bottom,” seismic researchers have discovered the underside of a rocky slab of Earth’s surface layer, or lithosphere, that […].

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New patent for Astrazeneca Ab drug BYDUREON

Drug Patent Watch

Annual Drug Patent Expirations for BYDUREON Bydureon is a drug marketed by Astrazeneca Ab and is included in two NDAs. It is available from one supplier. There are thirty patents…. The post New patent for Astrazeneca Ab drug BYDUREON appeared first on DrugPatentWatch - Make Better Decisions.

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J&J Secures Additional $1 Billion in Funding for COVID-19 Vaccine

BioSpace

Johnson & Johnson secured more than $1 billion in additional funding for its COVID-19 vaccine research through an expansion of its partnership with the Biomedical Advanced Research and Development Authority.

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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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Omega-3 fatty acids vs corn oil, major adverse cardiovascular events in patients at high risk

Scienmag

What The Study Did: This randomized trial examines the effects on cardiovascular outcomes of a carboxylic acid formulation of EPA and DHA (omega-3 CA) with documented favorable effects on lipid and inflammatory markers in patients with atherogenic dyslipidemia and high cardiovascular risk. Authors: Steven E. Nissen, M.D.,of the Cleveland Clinic Heart and Vascular Institute in Cleveland, […].

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Retrophin Switches Name to Travere Therapeutics in Reflection of Evolving Pipeline

BioSpace

Travere Therapeutics will also begin trading under the new ticker symbol, “TVTX” on the Nasdaq Global Select Market beginning on Nov. 19.

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On the Heels of $46.7 Million Financing, Glympse Bio Announces Positive Data for NASH Sensors

BioSpace

Glympse Bio’s novel injectable mixture of synthetic sensors, which quantify protease activity and predict treatment response in non-alcoholic steatohepatitis (NASH), was demonstrated as safe and well-tolerated in healthy volunteers in a gene expression study of advanced fibrosis.

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Trends in Outpatient Care Delivery and Telemedicine During the COVID-19 Pandemic in the US

JAMA Internal Medicine

This cohort study examines trends in the use of telemedicine and in-person outpatient visits in 2020 among a national sample of 16.7 million individuals with commercial or Medicare Advantage insurance.

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FDA CRL Delays Sanofi’s Hopes of Approval for First CAD Treatment

BioSpace

Late Friday, the regulatory agency rejected the medication due to deficiencies from a pre-license inspection of a third-party manufacturing facility.

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Patients taking statins experience similar side effects from dummy pills

Scienmag

People taking dummy pills and statins experienced similar side effects in a new study. In a clinical trial of 60 patients, led by researchers at Imperial College London and clinicians at Imperial College Healthcare NHS Trust, 90 per cent of symptoms experienced by patients whilst taking statins were all present when they took placebo pills. […].

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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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Clinical Catch-Up: November 9-13

BioSpace

It was a particularly busy week for clinical trial updates, mostly because of several virtual conferences, including the virtual American Heart Association Scientific Sessions 2020 and The Society for Immunotherapy of Cancer’s Annual Meetings. Here's a look.

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New method brings physics to deep learning to better simulate turbulence

Scienmag

Credit: Jonathan Freund, The Grainger College of Engineering Deep learning, also called machine learning, reproduces data to model problem scenarios and offer solutions. However, some problems in physics are unknown or cannot be represented in detail mathematically on a computer. Researchers at the University of Illinois Urbana-Champaign developed a new method that brings physics into […].

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Moderna's COVID-19 Vaccine Interim Readout Suggests 94.5% Efficacy

BioSpace

Only a week after Pfizer and BioNTech’s preliminary data readout of its COVID-19 vaccine suggested a 90% efficacy rate, Moderna reported interim efficacy data for its vaccine of 94.5%.

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Suffering in silence: two-thirds of older adults say they won’t treat their depression

Scienmag

New nationwide poll shows 1 in 3 respondents age 65+ think they can just “snap out of it” Credit: Myriad Neuroscience, makers of the GeneSight test SALT LAKE CITY, November 16, 2020 – A new nationwide poll, the GeneSight Mental Health Monitor, shows that nearly two-thirds (61%) of Americans age 65 or older who have […].

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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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Sumitovant to Snap Up Development Partner Urovant Sciences

BioSpace

In a deal set to be finalized early in 2021, Urovant Sciences has agreed to be fully acquired by largest investor and close partner, Sumitovant Biopharma.

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Diaphragm Pathology in Critically Ill Patients With COVID-19 and Postmortem Findings From 3 Medical Centers

JAMA Internal Medicine

This case-control study examines the association of COVID-19 with the respiratory muscles in Dutch critically ill patients.

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‘The global built environment sector must think in new, radical ways, and act quickly’

Scienmag

The construction sector, the real estate industry and city planners must give high priority to the same goal – to drastically reduce their climate impacts Credit: Per Pixel Petersson The construction sector, the real estate industry and city planners must give high priority to the same goal – to drastically reduce their climate impacts. Powerful, […].

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Albireo Pharma Eyes Potential Approval for First PFIC Treatment

BioSpace

On Friday, the Boston-based company presented positive Phase III data in progressive familial intrahepatic cholestasis (PFIC) at the American Association for the Study of Liver Diseases’ annual meeting.

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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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Pharmacy dropboxes can help improve proper drug disposal, PSU study finds

Scienmag

Proper disposal of leftover medications can prevent overdoses and protect waterways from becoming polluted by pharmaceuticals. Drug take-back boxes are a safe and secure way to dispose of unwanted medications, but a new Portland State University study shows awareness of these dropboxes as well as knowledge about risks of improper disposal remain low.

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Sumitovant to Snap Up Development Partner Urovant Sciences

The Pharma Data

In a deal set to be finalized early in 2021, Urovant Sciences has agreed to be fully acquired by largest investor and close partner, Sumitovant Biopharma. As its name aptly suggests, Urovant is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions such as overactive bladder (OAB) and maladies involving adjacent areas of the human anatomy. .

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Study finds antibiotics before age 2 associated with childhood health issues

Scienmag

ROCHESTER, Minn. — In a retrospective case study, Mayo Clinic researchers have found that antibiotics administered to children younger than 2 are associated with several ongoing illnesses or conditions, ranging from allergies to obesity. The findings appear in Mayo Clinic Proceedings. Using health record data from the Rochester Epidemiology Project, a population-based research collaboration in […].

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iSTAR Medical’s glaucoma device MINIject shows positive one-year results in European trial

The Pharma Data

Growing body of evidence confirms MINIject is safe and effective with results sustained over time. WAVRE, Belgium , Nov. 16, 2020 /PRNewswire/ –: iSTAR Medical , a medtech company developing minimally invasive ophthalmic implants for treatment of patients with glaucoma, today announced positive one-year results from the European STAR-II clinical trial of its micro-invasive glaucoma surgery (MIGS) device, MINIject TM.

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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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UTIA’s Lori Duncan named Trusted Adviser of the Year

Scienmag

Row Crop Sustainability Specialist Honored by Field to Market Alliance Credit: Photo by T. Salvador, courtesy UTIA. KNOXVILLE, Tenn. – A University of Tennessee Extension specialist has been recognized for outstanding leadership and impactful work in sustainability efforts across Tennessee. Lori Duncan, row crop sustainability specialist at UTIA, has been named Field to Market’s 2020 […].

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Moderna Says Interim Analysis Will Assess Higher Number of Cases than Anticipated

The Pharma Data

Moderna announced last week that it has seen an increased rate of COVID-19 cases across sites in its late-stage vaccine trial and, as a result, its first interim analysis will include significantly more coronavirus cases than anticipated. Source link.

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New patent for Catalyst Pharms drug FIRDAPSE

Drug Patent Watch

Annual Drug Patent Expirations for FIRDAPSE Firdapse is a drug marketed by Catalyst Pharms and is included in one NDA. It is available from one supplier. There is one patent…. The post New patent for Catalyst Pharms drug FIRDAPSE appeared first on DrugPatentWatch - Make Better Decisions.

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European Commission Approves Anti-Epileptic Fycompa as Adjunct for Children | 2020-11-16

The Pharma Data

Eisai’s Fycompa (perampanel) has received approval from the European Commission as an adjunct treatment for partial-onset seizures in children 4 years and older, and for seizures in children 7 years and older with generalized epilepsy. The approval was supported by positive results from two late-stage global trials that assessed patients for up to 41 weeks following treatment.

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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.

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New patent for Astrazeneca Ab drug BYDUREON BCISE

Drug Patent Watch

Annual Drug Patent Expirations for BYDUREON+BCISE Bydureon Bcise is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There are twenty-one…. The post New patent for Astrazeneca Ab drug BYDUREON BCISE appeared first on DrugPatentWatch - Make Better Decisions.

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Towards Cervical Cancer elimination in the Americas

The Pharma Data

On the occasion of the launch of the Global Strategy for the Elimination of Cervical Cancer, adopted by the World Health Assembly in November 2020, PAHO/WHO is organizing a regional event to present this global strategy, and review progress with the Regional Action Plan on the Prevention and Control of Cervical Cancer. This event will also be an opportunity to exchange information on progress and strengthen commitments to implement activities in the Region to reach the global goals of: 90

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New patent for Glaxosmithkline drug TRELEGY ELLIPTA

Drug Patent Watch

Annual Drug Patent Expirations for TRELEGY+ELLIPTA Trelegy Ellipta is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. There are nineteen patents…. The post New patent for Glaxosmithkline drug TRELEGY ELLIPTA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Too Many Kids Still Get Antipsychotics They Don’t Need

The Pharma Data

SUNDAY, Nov. 15, 2020 — Prescriptions of antipsychotic medications for young children are declining, a new study finds. However, doctors are continuing to prescribe the drugs “off-label” for kids with conditions like attention deficit hyperactivity disorder (ADHD), anxiety, depression and conduct disorders, the research found. The medications don’t have the safety and effectiveness data needed, nor do they have U.S.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.