Tue.Dec 29, 2020

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Vulnerable should all get COVID-19 shot before summer, says NHS chief

pharmaphorum

NHS England’s chief executive Sir Simon Stevens has said that all vulnerable people over the age of 50 will be offered a COVID-19 vaccine by “late spring” in a message to healthcare workers. The prediction comes after the NHS announced on Christmas Eve that more than half a million people had received the Pfizer/BioNTech shot approved in early December, but will depend on additional vaccine supplies coming “on stream”, according to Stevens.

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Operation Warp Speed Slow to Ramp Up COVID-19 Vaccine Distribution

BioSpace

Operation Warp Speed succeeded on the development component, but is failing in the early stages of distribution.

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

Pharma Marketing Network

2020 was a year defined by unexpected challenges – and related opportunity – for pharmaceutical marketers. The COVID-19 pandemic pushed the industry to experiment with new media, emerging technologies and innovative platforms to keep physicians, providers and patients informed, engaged and empowered. As telehealth appointments replaced office visits, webinars replaced in-person conferences and digital communication replaced reps in the field, what have we learned about how to create connec

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Sustained cellular immune dysregulation in individuals recovering from COVID-19

Scienmag

Observational clinical research of COVID-19 patients can help clinicians better understand how the previously unknown SARS-CoV-2 virus acts, and findings from this research can better inform treatment and vaccine design. Credit: UAB BIRMINGHAM, Ala. – COVID-19, which has killed 1.7 million people worldwide, does not follow a uniform path. Many infected patients remain asymptomatic or […].

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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COVID-19 Vaccines Are Safer Than COVID, Despite Adverse Events

BioSpace

A great deal remains unknown about the SARS-CoV-2 virus, its mutations, transmissibility and long-term effects. Here’s what we do know.

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An explanation for the lack of blood oxygenation detected in many COVID-19 patients

Scienmag

One of the physiopathological characteristics of COVID-19 that has most baffled the scientific and medical community is what is known as “silent hypoxemia” or “happy hypoxia” Patients suffering this phenomenon, the causes of which are still unknown, have severe pneumonia with markedly decreased arterial blood oxygen levels (known as hypoxemia).

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Soliton Appoints Sean J. Shapiro as Vice President of Sales

The Pharma Data

. HOUSTON , Dec. 30, 2020 /PRNewswire/ — Soliton, Inc., (Nasdaq: SOLY) (“Soliton” or the “Company”), a medical device company with a novel and proprietary platform technology, today announced the appointment of Sean J. Shapiro as Vice President of Sales, effective January 1, 2021. Brad Hauser , Soliton’s President and CEO, commented, “We are very excited to have Sean join our team during this pivotal time for th

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UK Government Authorizes AstraZeneca’s COVID-19 Vaccine for Emergency Use

BioSpace

Overnight, U.K. health authorities authorized the COVID-19 vaccine developed by AstraZeneca and Oxford University for emergency use.

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Tetra Bio-Pharma Files New Drug Submission for REDUVO(TM) in Canada

The Pharma Data

The addressable market is estimated to be $80M CDN by 2022. Tetra meets another key milestone before the end of the year. OTTAWA, ON / ACCESSWIRE / December 30, 2020 / Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) ( TSX:TBP )( OTCQB:TBPMF ), a leader in cannabinoid-derived drug discovery and development announced today that the New Drug Submission (NDS) for the Dronabinol Soft Gel capsules, has been filed with Health Canada.

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Protalix's Fabry Disease Treatment Hits the Mark in Phase III Switch-Over Study

BioSpace

Fabry disease is a rare, X-linked inherited disease that results from abnormal deposits of a fatty substance in blood vessels.

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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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Optimity 2020 COVID-19 Vaccine Survey Finds That 59% of Canadians are Concerned About Side Effects from the Vaccine

The Pharma Data

Dec. 30, 2020 11:00 UTC. Insights from Optimity app user survey finds that 43% believe the COVID-19 vaccine should be mandatory, while 53% believe that Canadians should have a choice of which vaccine to receive. TORONTO–( BUSINESS WIRE )– Optimity Inc. , a mission-driven technology company focused on improving population health, today unveiled results from the 2020 COVID-19 Vaccine Survey of Optimity app users.

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Top 10 Stories from 2020: COVID, COVID and More COVID

BioSpace

Keeping in mind that COVID-19 has dominated the news cycle, here are the top 10 stories of 2020 in no particular order.

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Ascentage Pharma Officially Included in Shenzhen-Hong Kong Stock Connect Program

The Pharma Data

SUZHOU, China and ROCKVILLE, Md., Dec. 30, 2020 /PRNewswire/ — Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the company was officially included into the Shenzhen-Hong Kong Stock Connect program (the “Hong Kong Stock Connect”).

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Insilico partners with APRINOIA on AI-powered neurodegenerative drug discovery

Scienmag

Insilico enters into a collaboration with APRINOIA to apply novel generative AI-powered system to discover novel compounds for neurodegenerative diseases Credit: Insilico Wednesday, 30th of December, 2020 (9:00AM, Taipei) – Insilico Medicine is pleased to announce that it has entered into a research collaboration with APRINOIA Therapeutics to utilize Insilico’s novel generative artificial intelligence (AI) […].

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA Authorizes Marketing of EndoRotor System

The Pharma Data

News. Professional. FDA Authorizes Marketing of EndoRotor System. TUESDAY, Dec. 29, 2020 — The U.S. Food and Drug Administration granted marketing authorization to the EndoRotor System, which provides a minimally invasive way to resect and remove necrotic tissue for patients with walled-off pancreatic necrosis (WOPN), the agency announced last week.

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Oragenics Announces Closing of $6.5 Million Registered Direct Offering

BioTech 365

Oragenics Announces Closing of $6.5 Million Registered Direct Offering Oragenics Announces Closing of $6.5 Million Registered Direct Offering TAMPA, Fla.–(BUSINESS WIRE)–Oragenics, Inc.

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Cybin Announces First Quarter Financial Results of Clarmin Explorations Inc.

The Pharma Data

Dec. 30, 2020 01:00 UTC. TORONTO–( BUSINESS WIRE )– Cybin Inc. ( NEO:CYBN ) (“ Cybin ”), a life sciences company focused on psychedelic pharmaceutical therapies, announces the unaudited financial results of Clarmin Explorations Inc. (now Cybin Inc.) for the three month period ended October 31, 2020. A copy of the unaudited consolidated financial statements prepared in accordance with International Financial Reporting Standards and the corresponding management’s discussion and analysi

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Polysaccharides from red algae affect mice immune systems, say FEFU scientists

Scienmag

Credit: FEFU press office Carrageenans, biologically active polysaccharides isolated from red algae and widely used in the food industry as stabilizers, thickeners, or jelly agents have an express effect on the immune systems of mice, a study reports. The research was carried out by scientists from the School of Biomedicine of Far Eastern Federal University […].

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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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One in Four Older Adults Have Used Emergency Dept in Past Few Years

The Pharma Data

News. Professional. One in Four Older Adults Have Used Emergency Dept in Past Few Years. TUESDAY, Dec. 29, 2020 — Older adults often use the emergency department when they cannot get timely outpatient appointments, according to a report published online Dec. 15 based on the results of the University of Michigan National Poll on Healthy Aging. Preeti Malani, M.D., from the University of Michigan Institute for Healthcare Policy and Innovation in Ann Arbor, and colleagues surveyed a national

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Study examines the most effective COVID-19 control policies

Scienmag

Credit: Rotman School of Management Toronto – With the arrival of effective vaccines for the COVID-19 virus, the end of the pandemic is on the horizon but in the short term the virus continues to spread. A timely new study published today by PLOS ONE examines the effectiveness of COVID-19 control policies in 40 jurisdictions […].

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Seizure Frequency Not Up in Pregnancy for Women With Epilepsy

The Pharma Data

News. Professional. Seizure Frequency Not Up in Pregnancy for Women With Epilepsy. TUESDAY, Dec. 29, 2020 — Among women with epilepsy, the percentage who have a higher incidence of seizures during pregnancy than in the postpartum period is similar to that seen during corresponding epochs in women who are not pregnant, according to a study published in the Dec. 24 issue of the New England Journal of Medicine.

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Imaging of ballistic wounds, bullet composition and implications for MRI safety

Scienmag

Since patients with ballistic embedded fragments are frequently denied MRI, due to indeterminate bullet composition sans shell casings, radiography and CT can be used to identify nonferromagnetic projectiles that are safe for MRI Credit: American Roentgen Ray Society (ARRS), American Journal of Roentgenology (AJR) Leesburg, VA, December 29, 2020–According to an article in ARRS’ American […].

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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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Knee Osteoarthritis Symptoms Improved With Stepped Care

The Pharma Data

News. Professional. Knee Osteoarthritis Symptoms Improved With Stepped Care. TUESDAY, Dec. 29, 2020 — A stepped exercise program results in modest improvements for symptoms of knee osteoarthritis, according to a study published online Dec. 29 in the Annals of Internal Medicine. Kelli D. Allen, Ph.D., from the Durham VA Health Care System in North Carolina, and colleagues conducted a randomized controlled trial at two U.S.

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Sugars influence cell-to-surface adhesion

Scienmag

Biotechnologists measure the forces with which algae cells adhere to surfaces and move on them Credit: Lara Hoepfner How can cells adhere to surfaces and move on them? This is a question which was investigated by an international team of researchers headed by Prof. Michael Hippler from the University of Münster and Prof. Kaiyao Huang […].

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Anticoagulants Not Tied to Higher Risk for GI Bleed in COVID-19

The Pharma Data

News. Professional. Anticoagulants Not Tied to Higher Risk for GI Bleed in COVID-19. TUESDAY, Dec. 29, 2020 — Use of anticoagulation or antiplatelet agents is not a risk factor for gastrointestinal (GI) bleeding among hospitalized COVID-19 patients, according to a study published online Dec. 20 in the Journal of Internal Medicine. Arvind J. Trindade, M.D., from the Feinstein Institutes for Medical Research at Northwell Health in Manhasset, New York, and colleagues examined risk factors ass

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Army research leads to more effective training model for robots

Scienmag

Credit: (Photo illustration / U.S. Army) ADELPHI, Md. — Multi-domain operations, the Army’s future operating concept, requires autonomous agents with learning components to operate alongside the warfighter. New Army research reduces the unpredictability of current training reinforcement learning policies so that they are more practically applicable to physical systems, especially ground robots.

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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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SARS-CoV-2 Reinfection Risk Drops With Presence of Antibodies

The Pharma Data

News. Professional. SARS-CoV-2 Reinfection Risk Drops With Presence of Antibodies. TUESDAY, Dec. 29, 2020 — Health care workers with anti-spike or anti-nucleocapsid immunoglobulin G (IgG) antibodies have a reduced risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reinfection in the following six months, according to a study published online Dec. 23 in the New England Journal of Medicine.

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The puzzle of nonhost resistance: why do pathogens harm some plants but not others?

Scienmag

Credit: Ralph Panstruga & Matthew Moscou People have puzzled for years why pathogen Phytophthora infestens causes the devastating late blight disease, source of the Irish Potato famine, on potatoes, but has no effect at all on plants like apple or cucumber. How are apple trees and cucumber plants able to completely shake off this devastating […].

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ADHD Raises Adult Suicide Risk, Especially for Women

The Pharma Data

TUESDAY, Dec. 29, 2020 — Adults with attention-deficit/hyperactivity disorder (ADHD) have a strikingly high prevalence of attempted suicide, with women being at particular risk, researchers say. The study of nearly 22,000 Canadian adults found that 14% of those with ADHD had attempted suicide. That was roughly five times the rate of adults without ADHD, at 2.7%.

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2020-2025 Dietary Guidelines for Americans recommend grains at all life stages

Scienmag

Guidelines maintain existing serving size for whole and enriched grains Credit: The Grain Chain The Grain Chain, a farm to fork coalition of stakeholders in the grain industry sector and chaired by the American Bakers Association (ABA), celebrates the recommendation published today in the 2020-2025 Dietary Guidelines for Americans (DGAs) to “consume half of your […].

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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.