Bio Pharma Dive

JANUARY 14, 2021

A new commissioner, high-stakes coronavirus vaccine reviews and a rising gene therapy workload will test the agency this year.

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World of DTC Marketing

JANUARY 14, 2021

SUMMARY : Digital marketing is not a tactic. It’s a mindset. With the changes to healthcare on the horizon, the time has come to start building digital capabilities in all areas of company functions. Global digital advertising growth is expected to accelerate to about 18% year-over-year during 2021, up from about 10% growth in 2020 — and continue to show annual growth in the low double digits over the next five years, according to Cowen’s 9 th Annual Ad Outlook report.

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BioSpace

JANUARY 14, 2021

Like many biopharma companies, the global COVID-19 pandemic has caused delays while also offering opportunities for NeuroRx.

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XTalks

JANUARY 14, 2021

Mealworms, the larval form of the mealworm beetle, have become the first insect in Europe deemed safe for human consumption. After receiving an application from Micronsutris , a French insect farmer, the European Food Safety Authority (EFSA) found no safety concerns for dried yellow mealworms. The EFSA’s decision is the first step in heralding in EU-wide approval of snacks and other foods containing the insect as an ingredient.

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Allergies Protein Containment Sales 97

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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

Clinical Research

BioPharma Reporter

JANUARY 14, 2021

Samsung Biologics is aiming to become âa full-service biopharmaceutical companyâ: creating a greater global footprint for its CDMO business, continuing to advance its biosimilars business, and laying the groundwork for novel drug development.

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BioSpace

JANUARY 14, 2021

The filing to the U.S. District Court District of New Jersey, dated December 31st, 2020, states that the materials include compound data, strategic plans related to translational and biomarker data, therapeutic program reviews, abstract publications, plans for Congressional presentations, drug mo.

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BioSpace

JANUARY 14, 2021

Many buyers are becoming increasingly interested in buying these promising companies before they go public, as this often makes the purchase more economically feasible.

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Scienmag

JANUARY 14, 2021

Credit: Noce, S., Caporaso, L. & Santini, M. A new global dataset of bioclimatic indicators. Sci Data 7, 398 (2020). [link] Creative Commons License: CC BY… Climate change impacts, affecting primarily ecosystems’ functions and consequently human sectors, have become a crucial topic. Observed and expected variations in climate conditions can in fact undermine the ecosystems’ […].

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Licensing Licensing 75

BioSpace

JANUARY 14, 2021

Billionaire entrepreneur Mark Cuban, best known as the owner of the Dallas Mavericks and an investor on the ABC business reality series “Shark Tank,” is diving into generic drugs with a new startup, dubbed Mark Cuban Cost Plus Drug Company.

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Generic Drugs Drugs Marketing 96

BioPharma Reporter

JANUARY 14, 2021

Pfizer is investing US$25m in a US developer of live biotherapeutics, Vedanta Biosciences; that project is one of four investments, totaling US$120m, made by Pfizer in the second half of 2020 under its breakthrough growth program focused on clinical stage biotech companies of potential future strategic interest to the pharma giant.

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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

BioSpace

JANUARY 14, 2021

Janet Woodcock, the longtime director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration is set to take over the top spot of the regulatory agency on an interim basis following the presidential inauguration of Joe Biden.

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Scienmag

JANUARY 14, 2021

Credit: Space Telescope Science Institute The sun is the only star in our system. But many of the points of light in our night sky are not as lonely. By some estimates, more than three-quarters of all stars exist as binaries — with one companion — or in even more complex relationships. Stars in close […].

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Engineer 71

BioSpace

JANUARY 14, 2021

A total of 50 countries have reported cases of B117, the more transmissible variant of COVID-19 which was first reported in the U.K. The number of countries reporting this emerging strain is up 40 from last week.

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pharmaphorum

JANUARY 14, 2021

When Eli Lilly reported results for donanemab in Alzheimer’s disease earlier this week it was hailed as a rare win for the amyloid hypothesis, although there’s no shortage of candidates that have failed despite positive mid-stage trial results. Some analysts have intimated that given the small size of the study at just over 270 patients, rival amyloid drug developers Biogen and Eisai could claim the biggest benefit from the data in positive sentiment ahead of an FDA decision later this year.

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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.

Clinical Supply

BioSpace

JANUARY 14, 2021

A drop-off in virulence is possible for the SARS-CoV-2 virus -- once enough of the global population has been vaccinated or exposed to it, according to a new study from scientists at Emory University and The Pennsylvania State University.

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Pharma Times

JANUARY 14, 2021

Qualified pharmacists will administer the Pfizer/BioNTech vaccine at an in-store pharmacy

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Vaccination Vaccine Pharmacy 94

BioSpace

JANUARY 14, 2021

With meth related deaths on the rise and no FDA-approved treatments, researchers are finding repurposed drugs that may help addicts stay clean.

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FDA Approval Drugs Research 77

Scienmag

JANUARY 14, 2021

Credit: Drawing by Tom Bjorklund Roughly 8,200 years ago, the island of Yuzhniy Oleniy Ostrov in Lake Onega in the Republic of Karelia, Russia, housed a large burial ground where men, women and children of varying ages were buried. Many of the graves contain an abundance of objects and red ochre, signifying the wish to […].

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Containment 68

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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.

Clinical Trials

pharmaphorum

JANUARY 14, 2021

Previous COVID-19 infection provides some immunity for at least five months, but people may still carry and transmit the virus, according to a study by Public Health England. A first report from PHE’s SIREN study found antibodies from previous COVID-19 infection provide 83% protection against reinfection for at least five months. It found that reinfections in people with antibodies were rare, with only 44 potential reinfections among 6,614 participants who showed evidence of previous infection.

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Scienmag

JANUARY 14, 2021

Engineers invent device that requires no electricity or moving parts, lets users collect water as they usually do Credit: Amy Pickering MEDFORD/SOMERVILLE (January 14, 2021) – A team of researchers led by engineers at Tufts University’s School of Engineering and Stanford University’s Program on Water, Health and Development have developed a novel and inexpensive chlorine […].

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JAMA Internal Medicine

JANUARY 14, 2021

This systematic review and meta-analysis assess the diagnostic accuracy of saliva nucleic acid amplification tests for diagnosis of coronavirus disease 2019.

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Scienmag

JANUARY 14, 2021

Credit: Tuomas Kankaanpaa Climate and changes in it have direct impacts on species of plant and animals – but climate may also shape more complex biological systems like food webs. Now a research group from the University of Helsinki has investigated how micro-climate shapes each level of the ecosystem, from species’ abundances in predator communities […].

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Research 66

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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.

Clinical Supply

JAMA Internal Medicine

JANUARY 14, 2021

This cohort study compares the clinical characteristics and outcomes of hospitalized women who gave birth with and without coronavirus disease 2019.

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Scienmag

JANUARY 14, 2021

Credit: University of Exeter Just like humans trying to stick to New Year’s resolutions, guppies have varying levels of self-control, a new study shows. Researchers from the University of Exeter and Ghent University studying the behaviours of Trinidadian guppies tested “inhibitory control” (suppressing unhelpful impulses or urges).

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pharmaphorum

JANUARY 14, 2021

US cost effectiveness watchdog ICER found 10 examples of substantial price rises for top-selling medicines in 2019, and concluded that seven of those were not backed by any clinical evidence. The cost to the American taxpayer from those increases? Around $1.2 billion for the seven drugs alone, says the organisation, which also found that for all but one the list price increase was at least double the US rate of inflation in that year.

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Scienmag

JANUARY 14, 2021

Rising temperatures contribute to child malnutrition and reduced diet quality Credit: C. Shubert (CCAFS) A first-of-its-kind, international study of 107,000 children finds that higher temperatures are an equal or even greater contributor to child malnutrition and low quality diets than the traditional culprits of poverty, inadequate sanitation, and poor education.

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Production Development Medicine 59

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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.

Clinical Trials

BioSpace

JANUARY 14, 2021

Although there are now two authorized vaccines against COVID-19 available in the United States and a third likely on the way with Johnson & Johnson’s candidate, the nation and world are nowhere near being done with the novel coronavirus, especially with new, more contagious variants now circulating.

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Vaccination Vaccine 57

Scienmag

JANUARY 14, 2021

Researchers reports a new strategy for the microbial production of multiple short-chain primary amines via retrobiosynthesis Credit: KAIST KAIST metabolic engineers presented the bio-based production of multiple short-chain primary amines that have a wide range of applications in chemical industries for the first time. The research team led by Distinguished Professor Sang Yup Lee from […].

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Engineer Production Research 58

The Pharma Data

JANUARY 14, 2021

Jan. 15, 2021 11:55 UTC. SOUTH SAN FRANCISCO, Calif.–( BUSINESS WIRE )– Five Prime Therapeutics, Inc. (NASDAQ: FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer.

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Scienmag

JANUARY 14, 2021

Newly identified pathway explains why antihistamine drugs often don’t work to control severe itch Credit: Illustration by Madison Mack In addition to a skin rash, many eczema sufferers also experience chronic itching, but sometimes that itching can become torturous. Worse, antihistamines — the standard treatment for itching and allergy — often don’t help.

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Allergies Drugs Research Dermatology 57

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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.

Clinical Trials