Fri.Feb 05, 2021

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Bristol Myers finally wins FDA approval for cancer cell therapy

Bio Pharma Dive

Delays tied to factory inspections had pushed an FDA decision on Breyanzi past a key deadline, allowing Bristol Myers to avoid paying billions of dollars in payouts to investors.

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Pharma’s horrible website metrics

World of DTC Marketing

SUMMARY: The number of visitors to your website doesn’t mean anything if you have high bounce rates and low page views/time on site. More than half of mobile users leave a website that takes more than three seconds to load, yet too many pharma sites are not optimized for mobile. Houston, we have a problem. Attention spans online are declining rapidly.

Branding 187
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Gilead sales propped up by COVID-19 drug Veklury

Bio Pharma Dive

Sales of the antiviral drug accounted for a quarter of the biotech's product revenue in the fourth quarter, disguising hits to its business elsewhere.

Sales 294
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Why we need the human element of remote clinical trials

pharmaphorum

Over the last year, we’ve noticed that “connectivity” doesn’t always equate to “connected” – and that’s just as true in the realm of clinical trials as it is in our personal lives. Amanda Barrell reports from a panel at the Patients as Partners Europe conference on remote clinical trials. Decentralised trials have been growing in popularity in recent years, and the COVID-19 pandemic has served to accelerate that progress.

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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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PTC aims again for FDA review of Duchenne drug despite latest miss

Bio Pharma Dive

The FDA has rejected PTC's treatment three times, but the biotech's CEO hopes the "totality" of the results it's now accrued will finally lead to a different outcome.

Drugs 269
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Pharma Rivals Step Up to Assist with COVID-19 Vaccine Production

XTalks

As COVID-19 vaccines continue to be in short supply around the world, pharma giants such as Bayer (Nasdaq: BAYRY ) are stepping up to help fulfill the need. Bayer has agreed to assist in the manufacturing of an mRNA-based coronavirus vaccine, CVnCOV, developed by fellow German biopharma company CureVac (Nasdaq: CVAC ). In early January, Bayer also struck an agreement with the company to support the further development, supply and key territory operations of CureVac’s COVID-19 vaccine candidate.

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Top 60 U.S. Brand Name Drug Prices are 75% Lower Internationally, According to Rand Corporation Study

Pharmacy Checkers

Original post found on PharmacyChecker.com. The Rand Corporation has released an impressive study showing that brand name drugs cost far more in the United States than in other countries – on average 344% more. For those of you looking for a methodologically strong analysis of international drug prices and a history of related studies, this is the report for you.

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Scientists extract pigments from algae for food supplements

Scienmag

Researchers obtained microalgae biomass with a high content of carotenoid pigments, which is suitable for the food industry through targeted cultivation Credit: Peter the Great St.Petersburg Polytechnic University In the framework of the Chlorella microalgae cultivation process, the researchers from Peter the Great St.Petersburg Polytechnic University (SPbPU) obtained microalgae biomass with a high content of […].

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How Scientists Shot Down Cancer’s ‘Death Star’

NY Times

No drug could touch a quivering protein implicated in a variety of tumors. Then one chemist saw an opening.

Scientist 104
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nTIDE January 2021 jobs report: Recovery stalls for people with disabilities

Scienmag

National Trends in Disability Employment (nTIDE) – issued semi-monthly by Kessler Foundation and the University of New Hampshire Credit: Kessler Foundation East Hanover, NJ – February 5, 2021 – As COVID-19 outbreaks continue to affect national and local economies, the job market struggled to maintain momentum, according to today’s National Trends in Disability Employment – […].

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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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Keytruda recommended for routine NHS use in lung cancer

Pharma Times

Immunotherapy recommended for patients with or without PD-L1 tumour expression

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Tiny sensor technique reveals cellular forces involved in tissue generation

Scienmag

Credit: Darling Lab / Brown University PROVIDENCE, R.I. [Brown University] — A new technique developed by Brown University researchers reveals the forces involved at the cellular level during biological tissue formation and growth processes. The technique could be useful in better understanding how these processes work, and in studying how they may respond to environmental […].

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VPAS: Achievements so far on affordability

pharmaphorum

In the second part of this series taking stock of t he 2019 Voluntary Scheme for Branded Medicines Pricing and Access objectives, Leela Barham looks at the second VPAS objective that relates to affordability (spoiler alert: government gets millions in payments). The affordability objective is broken down further to: ensure that the Voluntary Scheme contributes to maintaining affordability of overall UK Branded Health Service Medicines’ spend and to provide predictability for all Parties. to enab

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New study shows pandemic’s toll on jobs, businesses, and food security in poorer countries

Scienmag

A new study by an international team of economists published Feb.5 in Science Advances finds COVID-19 and its economic shock present a stark threat to residents of low- and middle-income countries — where most of the world’s population resides. Credit: Innovations for Poverty Action Washington, D.C. — The onset of the COVID-19 pandemic caused a […].

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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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Multiple rolling reviews kick-off for Novavax’s COVID-19 vaccine

Pharma Times

Jab recently demonstrated 89.

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Climate change may have driven the emergence of SARS-CoV-2

Scienmag

Credit: Dr Robert Beyer Global greenhouse gas emissions over the last century have made southern China a hotspot for bat-borne coronaviruses, by driving growth of forest habitat favoured by bats. A new study published today in the journal Science of the Total Environment provides the first evidence of a mechanism by which climate change could […].

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FDA holds back from action over Xeljanz safety study

pharmaphorum

The FDA has said it will wait for additional results from last week’s trial showing an increased risk of cardiac side effects with Pfizer’s arthritis blockbuster Xeljanz before deciding on further action. The post-marketing ORAL Surveillance safety study showed that JAK inhibitor Xeljanz (tofacitinib) was associated with a higher rate of heart attacks and cancer than a TNF inhibitor in patients aged over 50 with underlying cardiovascular risk factors.

Sales 62
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Silicon anode structure generates new potential for lithium-ion batteries

Scienmag

Scientists reveal a new nanostructure that could revolutionize technology in batteries and beyond. Credit: Schematic created by Pavel Puchenkov, OIST Scientific Computing & Data Analysis Section. New research has identified a nanostructure that improves the anode in lithium-ion batteries Instead of using graphite for the anode, the researchers turned to silicon: a material that stores […].

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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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La búsqueda de tratamientos contra la COVID-19 quedó rezagada

NY Times

El desarrollo de las vacunas superó las expectativas de todos. Pero durante los próximos meses muchas personas enfermarán y, lamentablemente, los médicos tienen pocos fármacos para tratarlas.

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Researchers find peptide that treats, prevents killer citrus disease

Scienmag

Treatment causes deadly bacterium to leak and die Credit: Hailing Jin/UCR New research affirms a unique peptide found in an Australian plant can destroy the No. 1 killer of citrus trees worldwide and help prevent infection. Huanglongbing, HLB, or citrus greening has multiple names, but one ultimate result: bitter and worthless citrus fruits. It has […].

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The Mesh of the Generics and the Potential of Emerging Therapies in the Smoking Cessation Market

Delveinsight

Smoking is the leading preventable cause of death in the world. However, prior to 1900, tobacco smoking was an uncommon sight. It was not until the 20th century that smoking cigarettes became a routine or more precisely a popular trend among youths and adults. What helped in booming its adoption were effective advertising campaigns, standard cigarettes-making machines that would yield perfectly rolled cigarettes, and introduction of safety matches that contributed to the magnificent success of t

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Drug ‘breakthrough’ gives longest-ever survival in nonresectable liver cancer patients

Scienmag

The IMbrave150 trial found median overall survival was 19.2 months in patients treated with atezo+bev vs 13.4 months for those treated with sorafenib alone, the current standard treatment Credit: EASL 6 February: The IMbrave150 trial found median overall survival was 19.2 months in patients treated with atezo+bev vs 13.4 months for those treated with sorafenib […].

Trials 86
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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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Key attributes to look for when picking your CTMS vendor 

Cloudbyz

Investing in a CTMS is a big decision as it is the first step towards scaling up your operations. Whether you’re kicking off your first trial or just migrating from excel to a more sophisticated system, you need to spend some time researching to find that ideal CTMS vendor for your business. But how do you determine which is the right CTMS vendor for your business?

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Severely frail individuals with COVID-19 are three times more likely to die, study finds

Scienmag

Credit: University of Birmingham New research led by the University of Birmingham has revealed for the first time the extent to which frailty increases the risk of mortality in COVID-19 patients. The clinical observational study, involving 5,711 patients with COVID-19 at 55 hospitals across 12 countries, found that very severely frail individuals with COVID-19 are […].

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New patent for Amarin Pharms drug VASCEPA

Drug Patent Watch

Annual Drug Patent Expirations for VASCEPA Vascepa is a drug marketed by Amarin Pharms and is included in one NDA. It is available from two suppliers. There are fifty-nine patents…. The post New patent for Amarin Pharms drug VASCEPA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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People infected with COVID-19 have a higher risk of dying after a cardiac arrest

Scienmag

Women are nine times more likely to die Credit: European Heart Journal COVID-19 patients who suffer a cardiac arrest either in or out of hospital are far more likely to die than patients who are not infected with the coronavirus. In particular, women have the highest risk of dying: they are nine times more likely […].

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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 for Antares Pharma drug XYOSTED (AUTOINJECTOR)

Drug Patent Watch

Annual Drug Patent Expirations for XYOSTED+%28AUTOINJECTOR%29 Xyosted (autoinjector) is a drug marketed by Antares Pharma Inc and is included in one NDA. It is available from one supplier. There are…. The post New patent for Antares Pharma drug XYOSTED (AUTOINJECTOR) appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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UTIA researchers work to improve eastern grasslands

Scienmag

NIFA grant should improve productivity, sustainability and resiliency of grassland agroecosystems Credit: Photo by Rebekah Norman, UT Extension agent and county director, Montgomery County, Tennessee. KNOXVILLE, Tenn. — Researchers at the University of Tennessee Institute of Agriculture have been awarded nearly $500,000 from the USDA National Institute of Food and Agriculture to improve productivity, resiliency […].

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Intouch Sponsors HBA Conference on Critical Healthcare Issues

Intouch Solutions

What happened at this year's uber-exclusive J.P. Morgan Health Care conference? If your invite got 'lost in the mail', register for this conference, sponsored by Intouch Group, where you'll hear key takeaways from the J.P. Morgan event. The post Intouch Sponsors HBA Conference on Critical Healthcare Issues appeared first on Intouch Solutions.

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Shuffling bubbles reveal how liquid foams evolve

Scienmag

Distinct ‘relaxation’ identified in foams Credit: Tokyo Metropolitan University Tokyo, Japan – Researchers from Tokyo Metropolitan University studied the dynamics of foams. When a drop of water was added to a foam raft, the bubbles rearranged themselves to reach a new stable state. The team found that bubble movement was qualitatively different depending on the […].

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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.