Wed.Mar 16, 2022

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FDA sets out advice to developers of gene editing medicines

Bio Pharma Dive

Draft recommendations from the agency were generally straightforward, analysts said, although the document emphasized the potential safety risks of gene editing.

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Does anyone really believe pharma cares what people think?

World of DTC Marketing

The pharma industry’s reputation continues to slip from a pandemic halo-high of 62% in February 2021 to now when fewer than half, just 47%, of people have a favorable view of the industry, according to the Harris Poll’s latest survey. (Source: Endpoints News ) Does anyone believe that pharma cares? Like it or not, the media has had pharma in their crosshair for a long time.

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With trial success in kidney disease, Lilly, Boehringer make case for broader use of diabetes drug

Bio Pharma Dive

The positive results are the latest evidence supporting a broader role for so-called SGLT2 inhibitors, which started out as diabetes medicines but have since shown promise in a range of metabolic diseases.

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Novel theory of entropy may solve materials design issues

Scienmag

A challenge in materials design is that in both natural and manmade materials, volume sometimes decreases, or increases, with increasing temperature. While there are mechanical explanations for this phenomenon for some specific materials, a general understanding of why this sometimes happens remains lacking. Credit: Elizabeth Flores-Gomez Murray/Jennifer M.

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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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New patent for Jazz Pharms drug XYREM

Drug Patent Watch

Annual Drug Patent Expirations for XYREM Xyrem is a drug marketed by Jazz Pharms and is included in one NDA. It is available from one supplier. There are seven patents…. The post New patent for Jazz Pharms drug XYREM appeared first on DrugPatentWatch - Make Better Decisions.

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Exact Sciences and Katie Couric Partner for Colon Cancer Awareness Month with Cologuard TV Ad

XTalks

Exact Sciences and long-time colon cancer screening advocate and award-winning journalist Katie Couric have teamed up for Colon Cancer Awareness Month this March in a TV ad for the company’s at-home screening test Cologuard. The ad is part of Exact Sciences’ “Mission to Screen” campaign that was launched this week. The branded campaign includes a TV commercial (linked in the image above) that features Couric cooking dinner with her 30-year-old daughter Ellie as well as snippets of her conversati

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Severe COVID-19 linked to risk of mental health effects

Pharma Times

Patients who were bedridden for seven days or longer were at increased risk of depression and anxiety over the study period

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Newswire hacker case reveals how traders with private information make choices

Scienmag

Newswire hacker case reveals how traders with private information make choices Credit: Rotman School of Management Newswire hacker case reveals how traders with private information make choices Illegal traders looked for similar hard and soft signals, shows new study Toronto – A group of Russian and Ukrainian cyber-hackers were clearly risk-takers. But their actions after […].

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The right tech can fill gap between lab scientist and data: ACD/Labs

Outsourcing Pharma

An expert from the R&D tech provider discusses how automation, integration, and other tools can help with effective access and analysis of lab information.

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Light elements make a difference in noble metal catalysis

Scienmag

Noble metals have been widely used as heterogeneous catalysts because they easily stand out with high activity and selectivity for many reactions of both scientific and industrial interest. At least a century ago, some light alloying elements with small atomic radii are known to easily permeate into the interstitial location of metal lattice. The catalytic […].

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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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Oracle: How can clinical trials better fill the patient inclusivity gap?

Outsourcing Pharma

While strides have been made recruiting more representative patient populations, more can and should be done, according to an Oracle Health Sciences leader.

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Tiny battery-free devices float in the wind like dandelion seeds

Scienmag

Wireless sensors can monitor how temperature, humidity or other environmental conditions vary across large swaths of land, such as farms or forests. Credit: Mark Stone/University of Washington Wireless sensors can monitor how temperature, humidity or other environmental conditions vary across large swaths of land, such as farms or forests. These tools could provide unique insights […].

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NICE to improve diagnosis for foetal alcohol spectrum disorder

Pharma Times

Better treatment for conditions experienced by individuals who were exposed to alcohol before birth

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Trial testing cocoa flavanol supplement shows promise for reducing cardiovascular risk

Scienmag

The first large-scale trial to test the long-term effects of a cocoa flavanol supplement to prevent cardiovascular disease offers promising signals that cocoa flavanols could have protective cardiovascular effects. In papers published in The American Journal of Clinical Nutrition, a team led by Howard Sesso, ScD, MPH, and JoAnn Manson, MD, DrPH, both of the […].

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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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Praxis: ‘No quick fix’ for increasing clinical trial inclusivity

Outsourcing Pharma

A leader from the patient recruitment specialist discusses the industryâs ongoing challenges with patient population diversity, and potential solutions.

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Burst of rapid cell motion in 3D tumour model

Scienmag

Biological processes such as wound healing and cancer cell invasion rely on the collective and coordinated motion of living cells. A little understood aspect that influences these processes is the pressure differences within and between different parts of the body. Researchers from Göttingen University and Münster University designed model tumour systems using cervical cancer cells […].

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ARTICLE ON FUTURISTIC APPROACH FOR MEDICAL DIAGNOSTICS ; BIOCHIP

Pharma Tutor

ARTICLE ON FUTURISTIC APPROACH FOR MEDICAL DIAGNOSTICS ; BIOCHIP. About Author. Meenu Maurya. Email : meenudinesh15@gmail.com. admin. Wed, 03/16/2022 - 15:06. Tags. Articles.

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Multi-omics modeling in a twin cohort to predict blood pressure values

Scienmag

New Rochelle, NY, March 16, 2022—Based on data from more than 400 twins, researchers used multi-omics data integration to develop a model for predicting blood pressure values. Their research is described in the peer-reviewed OMICS: A Journal of Integrative Biology. Click here to read the article now. Credit: Mary Ann Liebert, Inc., publishers New Rochelle, NY, March […].

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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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Exosomes: A Deeper Look into Service Providers Market

Roots Analysis

Over the years, applications of exosomes in therapeutics have undergone an evolutionary change, in terms of cost of research, technology used, and duration of the study. Moreover, various startups and small firms have entered into collaborations in order to advance their innovations and offer specialized research expertise, services and technologies.

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Engineers at Woods Hole Oceanographic Institution invent adjustable, compact marine winch, offering flexibility and improved vessel operations

Scienmag

Woods Hole, MA (March 16, 2022) – Most research operations and missions require winches for hauling and retrieving equipment over the side of ships. A winch is used to hoist items to and from the deck such as nets, vehicles and other scientific equipment. Typically, marine winches in use today have large on-deck footprints, can […].

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Update: FDA clears first generic of AZ’s blockbuster Symbicort

pharmaphorum

Viatris (formerly Mylan) has become the first drugmaker to win full FDA approval for a generic version of AstraZeneca’s top-selling respiratory drug Symbicort, although launch plans remain uncertain for now. Viatris’ generic of Symbicort (budesonide and formoterol fumarate dihydrate) – developed by Viatris in collaboration with 3M spin-off company Kindeva Drug Delivery and called Breyna – has been cleared for the same indications as the brand, namely maintenance treatment for asthma

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Molecular imaging uncovers effects of COVID-19 on the brain

Scienmag

Reston, VA—A significant number of COVID-19 neurological complications— such as fatigue, headache, and cognitive impairment—are ultimately reversible, according to new research summarized by The Journal of Nuclear Medicine. The comprehensive literature review of molecular imaging findings sheds light on how COVID-19 affects the brain and identifies important implications for other neurological conditions, like Parkinson’s disease or […].

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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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Merck trial of Keytruda, Lynparza combo in prostate cancer fails

pharmaphorum

Merck & Co’s two powerhouse oncology drugs – Keytruda and Lynparza – have failed to show efficacy when used in combination for patients with previously treated metastatic castration-resistant prostate cancer (mCRPC). The disappointing result comes from the KEYLYNK-010 trial, which looked at the combination of PD-1 inhibitor Keytruda (pembrolizumab) with AstraZeneca-partnered PARP inhibitor Lynparza (olaparib) in men whose cancer had progressed after chemotherapy and anti-androgen thera

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45th Annual UNC Lineberger Scientific Symposium: The biology of aggressive cancers and tumor-stroma interactions

Scienmag

The University of North Carolina Lineberger Comprehensive Cancer Center’s 45th annual scientific symposium on April 18-19, 2022, will feature 14 talks addressing the central theme: The biology of aggressive cancers and tumor-stroma interactions.” The scientific meeting is free and it will take place in Chapel Hill, NC. It also will be streamed online for those […].

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ADUHELM® Continues to Reduce Underlying Pathologies of Alzheimer’s Disease in Patients Treated for More Than Two Years

The Pharma Data

ADUHELM continued to reduce two key Alzheimer’s disease pathologies, amyloid beta plaques and p-tau181, in patients treated for up to two and a half years Data from both Phase 3 studies also show that clinical decline was reduced in participants who had plasma p-tau181 reduction at 78 weeks These data further inform the scientific evidence for amyloid as a surrogate biomarker and the importance of continuation of treatment.

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NIH-funded research to investigate lower jaw development

Scienmag

How the lower jaw — mandible — develops and consequently how and why some developmental birth defects occur is the focus of a five-year, $2.8 million grant to Joan Richtsmeier, distinguished professor of anthropology, Penn State, from the National Institutes of Health’s National Institute of Dental & Craniofacial Research. Credit: Joan T. Richtsmeier, Penn State […].

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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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ADUHELM® Phase 3 EMERGE and ENGAGE Data in The Journal of Prevention of Alzheimer’s Disease

The Pharma Data

Biogen Inc. (Nasdaq: BIIB) announced that The Journal of Prevention of Alzheimer’s Disease (JPAD) today published a peer-reviewed manuscript detailing data from the pivotal Phase 3 EMERGE and ENGAGE trials for ADUHELM ® (aducanumab-avwa) 100 mg/mL injection for intravenous use in early Alzheimer’s disease. The publication includes results from the primary, secondary and tertiary endpoints in the trials, as well as safety data and biomarker sub-studies.

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UTEP physics professor receives prestigious Cottrell Scholar Award

Scienmag

EL PASO, Texas (March 16, 2022) — Jorge Muñoz, Ph.D., assistant professor of physics at The University of Texas at El Paso, has been named a 2022 Cottrell Scholar by the Research Corporation for Science Advancement. Credit: UTEP Marketing and Communications. EL PASO, Texas (March 16, 2022) — Jorge Muñoz, Ph.D., assistant professor of physics […].

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Roche provides molecular testing solutions to identify and differentiate SARS-CoV-2 Omicron variants of concern

The Pharma Data

Roche and its subsidiary, Tib Molbiol, confirm that it has tests for research use that identify the SARS-CoV-2 subvariants of concern, Omicron: BA.1, BA.1.1, BA.2, BA.2.2, BA.3 and Delta The World Health Organization (WHO) has recently reported that the BA.2 subvariant is steadily increasing in prevalence, specifically in Denmark Use of these tests assess the spread of circulating variants and can help monitor the potential impact of therapeutics, vaccines and public health interventions All R

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Scientists from NTU Singapore and Korea’s KIMM devise new technique to increase chip yield from semiconductor wafer

Scienmag

Scientists from the Nanyang Technological University, Singapore (NTU Singapore) and the Korea Institute of Machinery & Materials (KIMM) have developed a technique to create a highly uniform and scalable semiconductor wafer, paving the way to higher chip yield and more cost-efficient semiconductors. Credit: NTU Singapore Scientists from the Nanyang Technological University, Singapore (NTU Singapore) and […].

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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.