BioSpace
NOVEMBER 22, 2020
COVID-19 is a cardiac condition as much as it is a pulmonary or respiratory disease. This knowledge is so recent that it often is overlooked by non-cardiologists, according to physicians speaking at Demy-Colton Virtual Salon, “COVID-19: Surprising Cardiac Findings & Concern about the Potential Im.
Scienmag
NOVEMBER 22, 2020
Scientists studying the aerodynamics of infectious disease share steps to curb transmission during indoor activities. Credit: Kelby Kramer and Gerald J. Wang VIRTUAL MEETING (CST), November 22, 2020 — Wear a mask. Stay six feet apart. Avoid large gatherings. As the world awaits a safe and effective vaccine, controlling the COVID-19 pandemic hinges on widespread […].
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BioSpace
NOVEMBER 22, 2020
Maryland-based vaccine company Novavax said its COVID-19 vaccine candidate, NVX?CoV2373, prevented SARS-CoV-2 infection in monkeys, hinting that the product could likewise prove effective in humans.
pharmaphorum
NOVEMBER 22, 2020
Rob Barker has been promoted to chief executive officer of Marlow, UK-based OPEN Health Group after serving as CEO of its Medical Communications practice for the last five years. He takes over as head of the healthcare communications group from co-founder David Rowley, who is stepping down after 10 years as CEO. Barker (pictured above) said: “I am excited to be leading such a talented and expert team who have been instrumental in growing OPEN Health to its current position.
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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
BioSpace
NOVEMBER 22, 2020
Eiger’s Zokinvy is the first-ever approved treatment for children with Huchinson-Gilford Progeria Syndrome and processing-deficient Progeroid Laminopathies.
Scienmag
NOVEMBER 22, 2020
7 grants from California Bureau of Cannabis Control will support research on health, policy and labor Credit: UCLA Health UCLA has received seven grants totaling $6.4 million from the California Bureau of Cannabis Control. The awards will fund studies on topics ranging from the toxicity of inhaled and second-hand cannabis smoke to employment conditions in […].
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NY Times
NOVEMBER 22, 2020
The nonprofit marketing group led a polio vaccine campaign in the 1950s. Now it is working on a $50 million ad blitz to counter concerns about coming treatments.
BioSpace
NOVEMBER 22, 2020
Merck acquired OncoImmune and its COVID-19 therapeutic candidate CD24Fc for $425 million in upfront cash two months after the Phase III asset demonstrated efficacy during an interim analysis.
Scienmag
NOVEMBER 22, 2020
Researchers at Karolinska Institutet in Sweden have studied the incidence and regional distribution of Alzheimer’s disease biomarkers in the brains of people with Down’s syndrome. The results can bring new possibilities for earlier diagnosis and preventive treatment of dementia. The study is published in Molecular Neurodegeneration. While medical advances and improvements of life quality have […].
BioSpace
NOVEMBER 22, 2020
The U.S. Food and Drug Administration (FDA) has a busy end of November planned, with numerous PDUFA dates to address. Here’s a look at the upcoming week.
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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
Scienmag
NOVEMBER 22, 2020
Compared with people who ate meat, vegans with lower calcium and protein intakes on average, had a 43% higher risk of fractures anywhere in the body (total fractures), as well as higher risks of site-specific fractures of the hips, legs and vertebrae, according to a study published in the open access journal BMC Medicine. Vegetarians […].
BioSpace
NOVEMBER 22, 2020
New company looks to revolutionize the biopharmaceutical manufacturing process to make cutting-edge drugs more accessible.
Scienmag
NOVEMBER 22, 2020
Researchers at FAU prove parallel evolution of conodonts Palaeontologists at Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) and the University of Calgary in Canada have provided new proof of parallel evolution: conodonts, early vertebrates from the Permian period, adapted to new habitats in almost identical ways despite living in different geographical regions.
BioSpace
NOVEMBER 22, 2020
Uveal melanoma is a rare and aggressive form of melanoma. It primarily affects the eye. There are no currently accepted optimal management regimens or treatments.
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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.
NY Times
NOVEMBER 22, 2020
The nonprofit marketing group led a polio vaccine campaign in the 1950s. Now it is working on a $50 million ad blitz to counter concerns about coming treatments.
BioSpace
NOVEMBER 22, 2020
Although there was quite a bit of clinical trial news overall, the biggest focus was on COVID-19 vaccines, with the three leaders in the U.S. and Europe all presenting clinical trial news. Here’s a look.
Scienmag
NOVEMBER 22, 2020
A better understanding of iceberg melting and lake ice formation could provide new indicators of climate change. Credit: Chao Sun VIRTUAL MEETING (CST), November 22, 2020 — Eric Hester has spent the last three years chasing icebergs. A mathematics graduate student at the University of Sydney in Australia, Hester and researchers at Woods Hole Oceanographic […].
The Pharma Data
NOVEMBER 22, 2020
Nov. 23, 2020 13:30 UTC. SAN DIEGO–( BUSINESS WIRE )– Vividion Therapeutics , a biotechnology company discovering and developing selective small molecule medicines that drug traditionally inaccessible targets, today announced that Jeffrey Hatfield has been appointed as the company’s chief executive officer. Mr. Hatfield brings more than 35 years of successful industry leadership to Vividion, having held multiple senior executive, CEO and board director roles during his career at both
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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.
Scienmag
NOVEMBER 22, 2020
Social needs–such as food and economic insecurity, poor housing and neighborhood conditions, and lack of access to transportation–were common in a group of African American cancer survivors in Detroit, and they were associated with lower health-related quality of life (HRQOL). The findings are published early online in CANCER, a peer-reviewed journal of the American Cancer […].
The Pharma Data
NOVEMBER 22, 2020
The U.S. Food and Drug Administration (FDA) has a busy end of November planned, with numerous PDUFA dates to address. Here’s a look at the upcoming week. Blueprint Medicines’ Pralsetinib for Non-Small Cell Lung Cancer. Blueprint Medicines had a target action date of November 23, 2020 for pralsetinib for locally advanced or metastatic RET fusion-positive non-small cell lung cancer (NSCLC).
Scienmag
NOVEMBER 22, 2020
An England-wide study led by Queen Mary University of London has shown that, despite major improvements in diagnostic techniques and treatments, mammography screening continues to play an important role in lowering the risk of dying from breast cancer An England-wide case-control study led by Queen Mary University of London has shown that, despite major improvements […].
The Pharma Data
NOVEMBER 22, 2020
Pascal Soriot, CEO of AstraZeneca, pictured above. Photo courtesy of AstraZeneca. . As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. The analysis was from the trials in the UK and Brazil and demonstrated efficacy of up to 90%.
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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.
BioTech 365
NOVEMBER 22, 2020
IGC Reports Financial Results for September 30, 2020 Quarter and Start of Phase 1 Cannabinoid Clinical Trial for Alzheimer’s Patients IGC Reports Financial Results for September 30, 2020 Quarter and Start of Phase 1 Cannabinoid Clinical Trial for Alzheimer’s Patients … Continue reading →
The Pharma Data
NOVEMBER 22, 2020
SOUTH SAN FRANCISCO, Calif., Nov. 23, 2020 (GLOBE NEWSWIRE) — Cytokinetics, Inc. (Nasdaq: CYTK) today announced that Amgen has elected to terminate the Collaboration and Option Agreement, dated December 20, 2006 between the companies (the “Agreement”) and thereby end its collaboration with Cytokinetics, effective May 20, 2021, and intends to transition development and commercialization rights for omecamtiv mecarbil and AMG 594 to Cytokinetics.
BioTech 365
NOVEMBER 22, 2020
BioShin enrolls first patient into an Asia-Pacific regional multi-center phase III clinical trial of rimegepant (BHV-3000) for the acute treatment of migraine.
The Pharma Data
NOVEMBER 22, 2020
Nov. 23, 2020 10:10 UTC. PORTO, Portugal & CAMBRIDGE, England & LONDON–( BUSINESS WIRE )– FairJourney Biologics S.A (FJB) and IONTAS Limited (IONTAS), leaders in the discovery and optimization of VHH and fully human antibodies, today announced they have signed an agreement to discover antibodies with Pandion Therapeutics (Pandion).
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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.
BioTech 365
NOVEMBER 22, 2020
Shareholder structure of Pixium Vision following the capital increase with pre-emptive subscription rights of €7.
The Pharma Data
NOVEMBER 22, 2020
As the countdown begins toward an eagerly anticipated FDA authorization for Pfizer’s COVID-19 vaccine candidate, an advisory committee of the Centers for Disease Control and Prevention (CDC) is meeting today to discuss the phased distribution of coronavirus vaccines. Source link.
BioTech 365
NOVEMBER 22, 2020
Notification of Managers’ transactions Notification of Managers’ transactions Company announcement no.
The Pharma Data
NOVEMBER 22, 2020
SUNDAY, Nov. 22, 2020 — Pandemic lockdowns will increase Americans’ risk of loneliness and depression this holiday season, an expert warns. “People are grieving for similar reasons: loss of family members, jobs, relationships, friendships and physical touch. Everyone is suffering,” said Dr. Asim Shah. He’s professor and executive vice chair of psychiatry and behavioral sciences at Baylor College of Medicine in Houston. “Holiday blues will affect a lot of peopl
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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.
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