Mon.Jan 25, 2021

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Merck stops coronavirus vaccine development in surprise setback

Bio Pharma Dive

The drugmaker, one of the largest vaccine developers globally, won't move forward with either of two candidates it's been testing after disappointing data in early trials.

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The complicated ROI measurement for pharma

World of DTC Marketing

SUMMARY: The LinkedIn team had a unique take on measuring ROI. “77% of marketers measure ROI within the first month of their campaign, knowingly trying to “prove ROI in a shorter amount of time than their typical sales cycle., while only 4% of marketers even measure ROI over a six-month period or longer.” So how should DTC marketers really measure ROI?

Marketing 187
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FDA approves first-of-its-kind lupus drug

Bio Pharma Dive

Lupkynis, the first oral drug approved for lupus nephritis, comes with a high list price. Its developer, Aurinia Pharmaceuticals, expects average net revenue of roughly $65,000 per patient per year.

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Over-the-Counter Nasal Spray Could Be Effective Against COVID-19

BioSpace

An in vitro study conducted by scientists from Northwestern University and Utah State University concluded that components found within the Xlear nasal spray, particularly grapefruit seed extract and xylitol, were successful in statistically reducing the amount of SARS-CoV-2 in a patient.

In-Vitro 145
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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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Moderna to study vaccine booster aimed at coronavirus variant

Bio Pharma Dive

Laboratory tests indicated the biotech's shot would still protect against virus variants detected in the U.K. and South Africa, although the latter appeared to result in a weaker immune response.

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Clinical research in 2021: A new era of collaboration and innovation

pharmaphorum

The clinical research community has been disrupted in a number of ways due to COVID-19 and sparked a spirit of collaboration and innovation. Worldwide Clinical Trial’s Aman Khera gives five predictions of how clinical research could change in 2021. The pandemic has propelled the life science industry toward higher expectations for faster, more responsive and more inclusive drug development.

More Trending

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Spotlight on EU executive’s handling of vaccine supply contracts

BioPharma Reporter

The European Ombudsman is investigating the secrecy with which the EU executive is handling COVID-19 vaccine supply contracts.

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COVID-19 study builds at pandemic speed

Bio Pharma Dive

How to accelerate time-to-market, gain greater control of study data and execution, and optimize the entire trial lifecycle.

Trials 162
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UK doctors ask for ‘urgent review’ of COVID-19 vaccine second dose delay

BioPharma Reporter

The British Medical Association (BMA), the trade union and professional body for doctors in the UK, is calling for the delay between Pfizer/BioNTech COVID-19 vaccine doses to be reduced from 12 weeks to six weeks.

Doctors 111
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PharmaTimes confirms INTCR 2021 virtual finals days

Pharma Times

The 2021 International Clinical Researcher of the Year competition will continue the successes of last year and be conducted virtually.

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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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Are Gene Therapies the Medicine of the Future?

BioSpace

Gene therapies offer great reward in the form of treating various devastating diseases, but there are also significant risks.

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eCOA tech helps trials tackle COVID-19 obstacles: IQVIA

Outsourcing Pharma

Two leaders from the clinical technology solutions company discuss how digital tools like eCOAs have been invaluable in facing pandemic-related challenges.

Trials 117
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Moderna developing COVID-19 vaccine booster shot against South Africa variant

BioPharma Reporter

An in vitro study shows Moderna's existing mRNA COVID-19 vaccine provides protection against strains that have emerged from South Africa and the UK. But it does suggest reduced protection against the South Africa strain, and so the company is also developing a new booster designed for maximum efficacy against this variant.

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COVID-19 Variants: More Infectious, More Lethal, but Vaccines Could Still Be Effective

BioSpace

British scientists suggested last week that the U.K. variant may be approximately 30% more lethal than the most common strain that came out of China. But they’re not completely sure of this yet.

Scientist 101
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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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Inequality in medieval Cambridge was ‘recorded on the bones’ of its residents

Scienmag

Credit: Nick Saffell Social inequality was “recorded on the bones” of Cambridge’s medieval residents, according to a new study of hundreds of human remains excavated from three very different burial sites within the historic city centre. University of Cambridge researchers examined the remains of 314 individuals dating from the 10th to the 14th century and […].

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Wugen Ramps Up Off-the-Shelf Gene Therapies to Fight Cancer

BioSpace

The “Woogies” at Wugen have been busy these past three years. BioSpace sat down with CEO John McKearn, Ph.D. to find up what his company has been up to.

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Merck exits COVID-19 vaccine development, cites disappointing data

BioPharma Reporter

Merck is shutting down the programs linked to its two COVID-19 vaccine candidates following early trial data indicating that they failed to generate immune responses comparable to a natural infection or existing vaccines.

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Combination Regimen Reduces Pain for Women with Endometriosis

BioSpace

Findings from a Phase III long-term extension study show a once-daily therapy consisting of relugolix with estradiol and norethindrone acetate leads to clinically meaningful reductions in menstrual pain and non-menstrual pelvic pain over one year in women with endometriosis.

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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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Domino effects and synchrony in seizure initiation

Scienmag

Credit: Figure courtesy of Jennifer Creaser and Sprice Machines. Epilepsy, a neurological disease that causes recurring seizures with a wide array of effects, impacts approximately 50 million people across the world. This condition has been recognized for a long time — written records of epileptic symptoms date all the way back to 4000 B.C.E. But […].

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PMN WEBINAR: Video, Voice, and Virtual: Applying New Digital Technology to Enhance Customer Experience

Pharma Marketing Network

Pharma-Marketing is owned and operated by eHealthcare Solutions. The post PMN WEBINAR: Video, Voice, and Virtual: Applying New Digital Technology to Enhance Customer Experience appeared first on Pharma Marketing Network.

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Mitochondria-Targeted Drug Development Digital Summit

pharmaphorum

The Mitochondria-Targeted Drug Development Digital Summit (April 27-29) is the only industry-led meeting focused on end-to-end mitochondria-targeting. Explore success stories from leading experts overcoming common challenges whilst exploring what’s next to help you accelerate your pipeline into the clinic. With 20+ hours of content, 2 interactive workshops and over 5 hours of networking with 80+ key industry leaders from Stealth BioTherapeutics , Cohbar , GenSight Biologics , Minovia Therape

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Experts call for more pragmatic approach to higher education teaching

Scienmag

Millions of students around the world could benefit if their educators adopted a more flexible and practical approach, say Swansea University experts Credit: Swansea University Millions of students around the world could benefit if their educators adopted a more flexible and practical approach, say Swansea University experts. After analysing the techniques current being used in […].

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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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CSL: Driven by Its Promise to Deliver for COVID-19 Patients

BioSpace

Industry-leading biotech CSL is leveraging its integrated global portfolio to bring urgently needed therapeutic COVID-19 treatments to patients around the world.

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Aging-US: Nicotinamide mononucleotide in degenerative model of retinal detachment

Scienmag

‘This Aging-US article concludes that NMN administration exerts neuroprotective effects on photoreceptors’ Credit: Correspondence to: Demetrios G. Vavvas email: demetrios_vavvas@meei.harvard.edu Aging-US published “Neuroprotective effects and mechanisms of action of nicotinamide mononucleotide (NMN) in a photoreceptor degenerative model of retinal detachment” which reported that here, the authors investigated nicotinamide mononucleotide, a precursor of nicotinamide adenin

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Regeneron’s COVID-19 Antibody Cocktail Works as 'Passive Vaccine'

BioSpace

Regeneron announced positive initial data from its ongoing Phase III trial of its antibody cocktail, REGEN-COV, as a passive vaccine to prevent COVID-19 in people at high risk of infection from household exposure.

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Governments need to set clear rules for vaccinating health care workers against COVID-19

Scienmag

CMAJ analysis by members of uOttawa’s Faculty of Law and Faculty of Medicine find legal justification for mandating vaccinating health care workers against SARS-CoV-2 Credit: University of Ottawa An analysis undertaken by Faculty of Law professors and a physician-researcher from the Faculty of Medicine at the University of Ottawa feels provincial and territorial governments should […].

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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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Roche targets wet AMD with faricimab and its 16-week regimen

pharmaphorum

Twin late-stage trials of Roche’s ophthalmology drug faricimab have hit the mark in “wet” age-related macular degeneration trial, as the company’s challenge to rivals from Novartis and Bayer strengthens. With faricimab Roche is aiming to outperform rivals in a highly competitive market by doubling the time taken between doses compared with standard care to 16 weeks.

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Aging-US: Growth factor beta type 1 and hypoxia-inducible factor 1 transcription complex

Scienmag

‘The Aging-US authors report for the first time that in human breast cancer, AML and embryonic cells, HIF-1 and AP-1 upregulate the expression of TGF-?’ Credit: Correspondence to: Vadim V. Sumbayev email: V.Sumbayev@kent.ac.uk and Elizaveta Fasler-Kan email: elizaveta.fasler@insel.ch Aging-US recently published “Transforming growth factor beta type 1 (TGF-?

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2021 Biopharma Update on the Novel Coronavirus: January 26

BioSpace

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for January 26, 2021.

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Global ice loss increases at record rate

Scienmag

Credit: Ian Joughin The rate at which ice is disappearing across the planet is speeding up, according to new research. And the findings also reveal that the Earth lost 28 trillion tonnes of ice between 1994 and 2017 – equivalent to a sheet of ice 100 metres thick covering the whole of the UK. 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.