Fri.Jan 22, 2021

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Long-acting HIV drug secures FDA approval, giving GSK a competitive boost

Bio Pharma Dive

Rather than a once-a-day pill, Cabenuva comes as a once-a-month injection. That convenience could become a valuable tool for GSK as it tries to broaden adoption of two-drug treatments.

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Pfizer Will Ship Fewer Covid-19 Vaccine Vials to Account for ‘Extra’ Doses

NY Times

After the surprise discovery of an extra dose in every vial, Pfizer executives successfully lobbied the F.D.A. to change the vaccine’s formal authorization language. The company charges by the dose.

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Pricing challenge looms for Novartis as cholesterol drug's US fate remains unclear

Bio Pharma Dive

Pricing inclisiran roughly on par with injectable medicines Repatha and Praluent would be cost-effective, an ICER analysis found. But the FDA recently delayed a decision on the Novartis therapy, leaving it in regulatory limbo.

Medicine 156
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Gilead says Veklury should work against COVID-19 variants

pharmaphorum

Gilead Sciences says its antiviral Veklury should be effective against the new, more contagious COVID-19 variants discovered in the UK and South Africa. According to the US biopharma company, genetic analyses of publicly available sequences for the new variants of SARS-CoV-2 suggest the mutations in the viral spike protein that have made them more transmissible shouldn’t affect the way Veklury (remdesivir) works.

In-Vitro 141
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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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Pfizer/BioNTech COVID-19 vaccine is safe for elderly people, says WHO

BioPharma Reporter

The World Health Organizationâs Global Advisory Committee on Vaccine Safety says it has not seen any unexpected or untoward increase in fatalities in frail and elderly individuals who have received the Pfizer/BioNTech vaccine.

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Assessing physician practices and expectations in the post-COVID era

pharmaphorum

The ongoing COVID-19 pandemic has affected the routines of many practicing physicians, including an impact on their prescribing decisions. New research from CRA shows that for many physician practices, prescribing has shifted based on route of administration. These changes, initially presumed to be temporary, may continue beyond the pandemic. As several COVID-19 vaccine candidates progress to patients and with more than 150 other vaccines in clinical development, global communities look forward

Pharmacy 105

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NICE rejects BMS’ Zeposia MS pill in provisional guidance

pharmaphorum

NICE has said that the NHS should not fund Bristol-Myers Squibb’s multiple sclerosis pill Zeposia (ozanimod) for relapsing multiple sclerosis in first draft guidance. The cost-effectiveness body said that trial evidence showed Zeposia cuts the number of relapses and brain lesions compared with Biogen’s Avonex (interferon beta-1a). But in its first draft guidance NICE said that Zeposia’s effect on progression of disability is unclear.

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Tiny particles that seed clouds can form from trace gases over open sea

Scienmag

Understanding previously undocumented source of new particle formation will improve models of aerosols, clouds, and their impact on Earth’s climate Credit: Image courtesy of the U.S. Department of Energy Atmospheric Radiation Measurement (ARM) user facility. UPTON, NY – New results from an atmospheric study over the Eastern North Atlantic reveal that tiny aerosol particles that […].

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Gilead's Veklury should be effective against COVID-19 variants

Pharma Times

Company has completed genetic analysis for UK and South African variants

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Crystal structures in super slow motion

Scienmag

Physicists from Göttingen first to succeed in filming a phase transition with extremely high spatial and temporal resolution Credit: Dr Murat Sivis Laser beams can be used to change the properties of materials in an extremely precise way. This principle is already widely used in technologies such as rewritable DVDs. However, the underlying processes generally […].

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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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NICE no for BMS’ multiple sclerosis drug Zeposia

Pharma Times

Cost-effectiveness estimates 'uncertain', according to NICE

Drugs 123
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A professor from RUDN University developed new liquid crystals

Scienmag

Credit: RUDN University A professor from RUDN University together with his Indian colleagues synthesized and studied new dibenzophenazine-based liquid crystals that could potentially be used in optoelectronics and solar panels. The results of the study were published in the Journal of Molecular Liquids. Liquid crystals are an intermediate phase between a liquid and a solid […].

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3 practical steps for improving patient support

pharmaphorum

Research Partnership’s Emilie Braund and Harrison Gaiger dig down into the top insights pharma companies can harness to make their patient support programmes as powerful as possible. The pandemic has undoubtedly disrupted the healthcare landscape and amplified the complex factors that influence and shape patient journeys. Findings from our recently published whitepaper ‘Free thinking: The impact of COVID-19 on chronic disease management and the implications for pharma marketing’ revealed that, i

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Regulating the ribosomal RNA production line

Scienmag

Cryo-electron microscopy study allows researchers to visualize structural changes in an E. coli enzyme synthesizing ribosomal RNA that shift it between turbo- and slow-modes depending on the bacteria’s growth rate Credit: Murakami Laboratory, Penn State The enzyme that makes RNA from a DNA template is altered to slow the production of ribosomal RNA (rRNA), the […].

RNA 85
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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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Servier and MiNA Therapeutics ink neurology pact

Pharma Times

Companies will develop saRNA therapies to treat neurological diseases

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A method for calculating optimal parameters of liquid chrystal displays developed at RUDN University

Scienmag

Credit: RUDN University A professor from RUDN University together with his colleagues from Saratov Chernyshevsky State University and D. Mendeleev University of Chemical Technology of Russia developed a method for calculating the parameters of diffraction optical elements used in LCDs. In particular, the new technology can be used to expand the angle of view while […].

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Thrombocytopenia Drugs Market: What Newer Agents Are Expected To Enter The Market?

Delveinsight

The launch of a novel drug in the market is not less than a celebration in the pharmaceutical and healthcare market; however, it also brings the real challenge of sustenance in the market. Similar is the picture of the Thrombocytopenia Drugs Market. Thrombocytopenia pipeline possesses potential drugs in mid-stage developments to be approved shortly.

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OHIO’s Jason Trembly awarded $1 million in grants for Sustainable Construction Materials

Scienmag

The U.S. Department of Energy recently announced $8.7 million in awards to “Develop Emerging Carbon-Based Building and Construction Materials,” with OHIO’s Jason Trembly receiving two $500,000 grants for two separate projects focused on addressing climate change and sustainability issues surrounding construction and infrastructure.

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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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US green light for long-acting HIV regimen Cabenuva

Pharma Times

Cabenuva consists of ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine

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Massey researchers review geographic factors that affect HPV vaccination rates

Scienmag

Human papillomavirus (HPV) is the most common sexually transmitted infection, with an estimated 79 million Americans currently infected with the virus, according to the Centers for Disease Control and Prevention. If a high-risk HPV infection does not go away, it can lead to the development of a variety of cancers, including 91% of all cervical […].

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Modern Meat Expands Plant-Based Portfolio Through Acquisition of Kitskitchen Soups

XTalks

Vancouver, Canada-based Modern Meat announced the planned acquisition of plant-based soup company Kitskicthen Health Foods , further expanding its plant-based portfolio. Kitskitchen will join Modern Meat’s line of 100 percent vegan, GMO-free meat alternatives and its newest line of dairy alternative milk , featuring Oat M*lk, Almond M*lk and Barista Edition Alternative M*lk.

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University of Cincinnati research unveils possible new combo therapy for head and neck cancer

Scienmag

Study found an approved drug could make radiation therapy more effective Credit: Colleen Kelley/University of Cincinnati Head and neck cancer is the sixth most common cancer worldwide, and while effective treatments exist, sadly, the cancer often returns. Researchers at the University of Cincinnati have tested a new combination therapy in animal models to see if […].

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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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Nearly half of UK young people buy meds after consulting “Dr Google”

pharmaphorum

It’s evident that relying on Google for a health diagnosis isn’t a good idea, but it seems a majority of UK people still do – and even buy medicines based on what they find. A new UK survey finds that overall 59% of 1,000 respondents Google their health symptom before consulting a doctor, with 16% reporting that as a consequence a condition has gone undiagnosed by a doctor for some time.

Doctors 59
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No more needles for diagnostic tests?

Scienmag

Nearly pain-free microneedle patch can test for antibodies and more in the fluid between cells Credit: Image: Sisi Cao Blood draws are no fun. They hurt. Veins can burst, or even roll — like they’re trying to avoid the needle, too. Oftentimes, doctors use blood samples to check for biomarkers of disease: antibodies that signal […].

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Ukraine Ended Secret Government Spending. Vaccine Makers Now Demand It.

NY Times

Seeking to secure vital supplies, the authorities in the country maneuvered around anticorruption rules that require public disclosure of contracts.

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Climate and carbon cycle trends of the past 50 million years reconciled

Scienmag

Credit: NASA image courtesy Jeff Williams Predictions of future climate change require a clear and nuanced understanding of Earth’s past climate. In a study published today in Science Advances, University of Hawai’i (UH) at M?noa oceanographers fully reconciled climate and carbon cycle trends of the past 50 million years–solving a controversy debated in the scientific […].

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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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Lupus Research Alliance Hails Approval of Aurinia’s Lupkynis(TM) (voclosporin)

The Pharma Data

NEW YORK , Jan. 22, 2021 /PRNewswire/ — The Lupus Research Alliance (LRA) is excited to share that the U.S. Food and Drug Administration (FDA) approved the use of Aurinia Pharmaceuticals’ Lupkynis TM (voclosporin) as the first oral treatment developed specifically for adults with active lupus nephritis (LN) in combination with standard of care.

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Join best-selling author James Nestor on ‘breath’ and sinus health

Scienmag

James Nestor joins American Rhinologic Society to launch sinushealth.com, first-ever patient-focused online resource dedicated to nasal and sinus conditions and treatments powered by experts from the American Rhinologic Society WHAT: Chronic sinusitis is a major health problem, impacting 30 million Americans. For more than 65 years, the American Rhinologic Society (ARS) has promoted excellence in […].

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New patent for Pf Prism drug INLYTA

Drug Patent Watch

Annual Drug Patent Expirations for INLYTA Inlyta is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from two suppliers. There are four…. The post New patent for Pf Prism drug INLYTA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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New technique builds super-hard metals from nanoparticles

Scienmag

Credit: Chen Lab / Brown University PROVIDENCE, R.I. [Brown University] — Metallurgists have all kinds of ways to make a chunk of metal harder. They can bend it, twist it, run it between two rollers or pound it with a hammer. These methods work by breaking up the metal’s grain structure — the microscopic crystalline […].

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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.