Mon.Dec 28, 2020

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The immediate future of DTC

World of DTC Marketing

As we look forward to 2021 DTC marketers should be noting the changes in consumer attitudes and the way they request new treatments. Much has changed but a lot is also the same. Business magazines are writing about the “digital future” of healthcare but are consumers ready? Some are, but most aren’t. First, let’s dispel a recent topic: telehealth.

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New Life Sciences Campus Planned for California’s Bay Area

BioSpace

Presidio Bay Ventures partnered with Kinship Capital to acquire a piece of property in the Northern California city to redevelop into a space for the life sciences industry.

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NEW FEXOFENADINE over the counter – Allevia tablets

Druggist

Fexofenadine recently received a green light and soon will be available over the counter without a prescription. Until now, fexofenadine was a prescription-only medication. The Government recently announced the reclassification of fexofenadine 120mg, which will be available as General sale Medication (GSL), sold as branded products – Allevia 120mg tablets.

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rBIO Launches with Technology to Hyper-Produce Insulin Cost-Effectively, at Scale

BioSpace

rBIO launched last week with technology that can reduce the cost of insulin by 30 percent, making U.S. manufacturing cost-effective for insulin and several other drugs.

Insulin 101
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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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For Covid-19 Vaccines, Some Are Too Rich — and Too Poor

NY Times

Global inequality is shaping which countries get vaccines first. In South Africa, people’s best chance for vaccines anytime soon is to join an experimental trial.

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U.S. Department of Defense Awards Moderna $1.97 Billion COVID-19 Vaccine Contract

BioSpace

The U.S. Department of Defense awarded Moderna a contract worth $1,966,598,000 for an additional 100 million doses of its COVID-19 vaccine.

More Trending

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Biopharma Update on the Novel Coronavirus: December 29

BioSpace

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 29, 2020.

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These Famous Foods Were Invented For (and By) the US Military

XTalks

In today’s modern world, a plethora of new technologies have been instrumental in creating new foods, especially plant-based foods. But even with today’s available food tech, some of America’s most popular foods were born out of necessity for, and by, the US military — the necessity being to develop compact and nutritional ways to feed soldiers. The food processing techniques pioneered by the military didn’t just stay within the military.

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Common brain malformation traced to its genetic roots

Scienmag

Discovery could aid early screening, shed light on how Chiari malformation arises Credit: David Limbrick About one in 100 children has a common brain disorder called Chiari 1 malformation, but most of the time such children grow up normally and no one suspects a problem. But in about one in 10 of those children, the […].

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Biopharma Update on the Novel Coronavirus: December 29

The Pharma Data

News information is not all-inclusive and updates are published once a week on Tuesdays. . Testing Therapies, Antivirals and Vaccines. The Nanovaccine Institute at Iowa State University (ISU) is using nanotechnology to develop a vaccine will be able to be administered without needles and in one dose. It also won’t require refrigeration. Eurofins Genomics launched an optimized next-generation sequencing service providing full-length viral genome sequences for COVID-19.

Genome 52
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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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Large transporter protein linked to schizophrenia

Scienmag

Investigations of a cellular protein have uncovered a possible link with schizophrenia Credit: Mindy Takamiya/Kyoto University iCeMS Scientists have suspected mutations in a cellular cholesterol transport protein are associated with psychiatric disorders, but have found it difficult to prove this and to pinpoint how it happens. Now, Kazumitsu Ueda of Kyoto University’s Institute for Integrated […].

Protein 52
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Fulgent Genetics Extends Partnership with New York City Test and Trace for COVID-19 Testing, Awarded Contract for 2021 School Year

The Pharma Data

TEMPLE CITY, Calif., Dec. 29, 2020 (GLOBE NEWSWIRE) — Fulgent Genetics, Inc (Nasdaq: FLGT), a technology company providing comprehensive testing solutions through its scalable technology platform, today announced that the Company has extended its partnership with the New York City Department of Education (or “NYC DOE”) and NYC Health + Hospitals for COVID-19 testing through the remainder of the 2021 school year.

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New patent for Nevakar drug EPHEDRINE SULFATE

Drug Patent Watch

Annual Drug Patent Expirations for EPHEDRINE+SULFATE Ephedrine Sulfate is a drug marketed by Akorn, Amneal, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Nevakar, and Sandoz Inc and, and is included…. The post New patent for Nevakar drug EPHEDRINE SULFATE appeared first on DrugPatentWatch - Make Better Decisions.

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Moleculin Announces Annamycin Receives FDA Orphan Drug Designation for Soft Tissue Sarcomas

The Pharma Data

. HOUSTON , Dec. 29, 2020 /PRNewswire/ — Moleculin Biotech , Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Annamycin for treatment of soft tissue sarcomas. . Moleculin recently announced that the FDA had allowed

Drugs 52
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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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Surveys identify relationship between waves, coastal cliff erosion

Scienmag

Study shows waves, rainfall important parts of erosion process, providing new opportunity to improve forecasts Credit: Erik Jepsen/UC San Diego Scripps Institution of Oceanography at UC San Diego researchers have uncovered how rain and waves act on different parts of coastal cliffs. Following three years of cliff surveys in and near the coastal city of […].

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Eyenovia Submits New Drug Application to FDA for Pharmacologic Mydriasis with MydCombi Targeting 80 Million Patient Encounters in the U.S. Annually

The Pharma Data

Dec. 29, 2020 12:00 UTC. NEW YORK–( BUSINESS WIRE )– Eyenovia , Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company with Phase 3 programs in presbyopia, myopia and mydriasis, today announced that it has submitted a New Drug Application (NDA) to the U. S. Food and Drug Administration (FDA) for MydCombi , a unique fixed combination mydriatic (pupil dilation) agent.

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The brain network driving changes in consciousness

Scienmag

Activity of brain network linked to changes in connectedness for both sleep and anesthesia Credit: Scheinin et al., JNeurosci 2020 The loss and return of consciousness is linked to the same network of brain regions for both sleep and anesthesia, according to new research published in JNeurosci. The biological basis of consciousness has confounded scientists […].

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Scopus BioPharma Announces Appointment of Additional Directors

The Pharma Data

NEW YORK , Dec. 29, 2020 /PRNewswire/ — Scopus BioPharma Inc. (Nasdaq: SCPS) today announced the appointment of additional members to its Board of Directors. Scopus is a biopharmaceutical company whose lead drug candidate is a novel, targeted immuno-oncology gene therapy for the treatment of multiple cancers. Joshua R. Lamstein , Chairman of Scopus BioPharma, stated, “We are delighted to be in a position to attract prominent industry leaders to our Board.

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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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Do toddlers learning to spoon-feed seek different information from caregivers’ hands & faces?

Scienmag

Credit: (Illustrations by MATSUMURA Minami) When toddlers begin to use a spoon to eat by themselves, what kind of interactions occur between them and their caregiver to facilitate this behavior? An international research collaboration led by Kobe University’s Professor NONAKA Tetsushi (Graduate School of Human Development and Environment) and the University of Minnesota’s Professor Thomas […].

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Amphastar Announces Approval for Glucagon for Injection Kit, 1mg

The Pharma Data

RANCHO CUCAMONGA, Calif., Dec. 29, 2020 (GLOBE NEWSWIRE) — Amphastar Pharmaceuticals, Inc. , (NASDAQ: AMPH) announced that the U.S. Food and Drug Administration (“FDA”) has approved its Abbreviated New Drug Application (“ANDA”) for Glucagon for Injection Emergency Kit, 1 mg. Glucagon is indicated for the treatment of severe hypoglycemia and is also used as a diagnostic aid.

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Groups of bacteria can work together to better protect crops and improve their growth

Scienmag

Credit: Noam Eckshtain-Levi, Susanna Leigh Harris, Reizo Quilat Roscios, and Elizabeth Anne Shank Certain bacteria, known as plant-growth-promoting bacteria (PGPB), can improve plant health or protect them from pathogens and are used commercially to help crops. To further improve agricultural yields, it is helpful to identify factors that can improve PGPB behavior.

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Northwestern Medicine Opens Comprehensive Program for Vulvar and Vaginal Health

The Pharma Data

Part of Center for Sexual Medicine and Menopause offering women one-stop shop for unique health care needs. CHICAGO , Dec. 29, 2020 /PRNewswire/ — Northwestern Medicine is now offering a specialized clinic for women with complex vulvar and vaginal conditions. Led by Rajal Patel , MD , the Comprehensive Program for Vulvar and Vaginal Health is the latest clinic integrated into the Northwestern Medicine Center for Sexual Health and Menopause. “No woman should suffer these in silence be

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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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Industry collaboration leads to important milestone in the creation of a quantum computer

Scienmag

Credit: Fabio Ansaloni Quantum computer: One of the obstacles for progress in the quest for a working quantum computer has been that the working devices that go into a quantum computer and perform the actual calculations, the qubits, have hitherto been made by universities and in small numbers. But in recent years, a pan-European collaboration, […].

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BetterLife Pharma Strengthens Board of Directors

The Pharma Data

VANCOUVER, Dec. 28, 2020 (GLOBE NEWSWIRE) — BetterLife Pharma Inc. (“ BetterLife ” or the “ Company ”) CSE: BETR / OTCQB: BETRF / FRA: NPAU) an emerging biotech company, is pleased to announce that it has added Mr. Sergei Stetsenko to its Board of Directors to prepare for its growth phase in psychedelic medicines. Mr. Stetsenko is a financier and venture capitalist who is acting Chief Executive Officer of CRG Finance AG (“CRG Finance”), a private venture capital firm in Zurich, Switzerland

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Quick look under the skin

Scienmag

Self-learning algorithms analyze medical imaging data Credit: Astrid Eckert / TUM Imaging techniques enable a detailed look inside an organism. But interpreting the data is time-consuming and requires a great deal of experience. Artificial neural networks open up new possibilities: They require just seconds to interpret whole-body scans of mice and to segment and depict […].

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CDC: Travelers From the U.K. Must Have Negative COVID-19 Test

The Pharma Data

News. Professional. CDC: Travelers From the U.K. Must Have Negative COVID-19 Test. MONDAY, Dec. 28, 2020 — Travelers flying to the United States from the United Kingdom will now need a negative COVID-19 test no more than 72 hours before leaving Britain, the U.S. Centers for Disease Control and Prevention said Thursday. The test is needed to guard against the spread of a new form of the virus found in the United Kingdom that may be 70 percent more contagious than other forms of COVID-19.

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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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Extremely energy efficient microprocessor developed using superconductors

Scienmag

Credit: Yokohama National University Researchers from Yokohama National University in Japan have developed a prototype microprocessor using superconductor devices that are about 80 times more energy efficient than the state-of-the-art semiconductor devices found in the microprocessors of today’s high-performance computing systems. As today’s technologies become more and more integrated in our daily lives, the need […].

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Privileged White U.S. Citizens Have Better Health Outcomes

The Pharma Data

MONDAY, Dec. 28, 2020 — Privileged White U.S. citizens have better health outcomes than average U.S. citizens for several health outcomes, but health outcomes are not always better than those in other developed countries, according to a study published online Dec. 28 in JAMA Internal Medicine. Ezekiel J. Emanuel, M.D., Ph.D., from the University of Pennsylvania in Philadelphia, and colleagues compared health outcomes of White U.S. citizens living in the 1 and 5 percent highest-income count

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Process Of Consent In Clinical Research That CRCs and CRAs Need To Know

Clinical Trial Gurus

There are different examples of how a consent SOP should look like but most follow a similar format. Sites will typically give patients an ample amount of time to review the consent and ask questions. It is very important for the patients to demonstrate that they understand the study prior to enrolling.

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WHO Calls for New Measures to Identify COVID-19 Variants

The Pharma Data

News. Professional. WHO Calls for New Measures to Identify COVID-19 Variants. MONDAY, Dec. 28, 2020 — The World Health Organization says steps to expand genome sequencing of new variants of the coronavirus are needed as the pandemic enters its second year, the Associated Press reported. New variants found in Britain and South Africa appear to be more contagious and have triggered new travel restrictions.

Genome 52
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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.