Bio Pharma Dive
APRIL 14, 2021
Advisers to the agency agreed to wait for more data before recommending new guidance, but aim to reconvene quickly to decide on whether vaccinations with J&J's should be resumed, and for whom.
Camargo
APRIL 14, 2021
In 2020, CDER approved 68 NDAs that used the 505(b)(2) pathway, representing important advances in patient care across a wide range of therapeutic areas. 505(b)(2) Drug Improvement Approvals by Year. In spite of an unusual year due to the COVID-19 pandemic, NDA approvals via the 505(b)(2) pathway increased 6% from 64 in 2019 to 68* in 2020 (Figure 1).
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Bio Pharma Dive
APRIL 14, 2021
Updated study results show Moderna's coronavirus vaccine was strongly protective against COVID-19 through six months. But executives outlined contingency plans in case those effects fade.
World of DTC Marketing
APRIL 14, 2021
QUICK READ: Pfizer has already announced a price increase to the EU for their Covid Vaccine. With a CEO who earns more than $20 million annually and the potential for billions in profit Pfizer is reminding us that Wall Street is once again their primary customer. Bulgarian Prime Minister Bokyo Borissov this morning said the US pharmaceutical giant has increased the cost of future orders sold to the EU from €12 per dose to €19.50.
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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
Bio Pharma Dive
APRIL 14, 2021
The ALS Association demanded the FDA "move with the urgency" other agencies have in reviewing a drug from Amylyx Pharmaceuticals.
Pharma Mirror
APRIL 14, 2021
The pharmaceuticals industry is responsible for the research, development, production and of medications and generates over 1.25 trillion in revenue globally. While experiencing significant growth over the last two decades, the industry has become even more significant over the past year. The role of pharma sales reps is an incredibly important part of this lifecycle from initial research to point of sale and distribution, with reps connecting the groundbreaking research and technology of pharma
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Mirror
APRIL 14, 2021
ATMPS Ltd, a leader in blockchain-based “vein to vein” cell orchestration platforms for advanced therapies, and Ori Biotech, an innovator in cell and gene therapy (CGT) manufacturing platforms, today announce a global collaboration to create seamless integration between their respective data platforms to support the development of Advanced Therapies.
pharmaphorum
APRIL 14, 2021
More than 5,000 collaborative studies were thwarted by GDPR rules in 2019 – but is there a way to protect sensitive data while still allowing international health research to thrive? . A coalition of European academy networks has called upon European Union (EU) leaders to rethink how General Data Protection Regulation (GDPR) rules are applied to health data.
BioSpace
APRIL 14, 2021
Shares of Inovio are climbing in early trading this morning after the company announced its DNA vaccine candidate for COVID-19 induced a robust T-cell response against multiple variants of the SARS-CoV-2 virus.
pharmaphorum
APRIL 14, 2021
A phase 3 trial of Romark’s antiviral drug NT-300 has missed the main objective in a phase 3 trial in mild to moderate COVID-19 patients, but could still have a shot at emergency use authorisation (EUA), according to the US company. . The Florida-based firm has just released top-line results from the 1,092-patient study , showing that patients treated NT-300 – an orally-active, long-acting formulation of the established drug nitazoxanide – didn’t differ significantly from a placebo group i
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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
BioSpace
APRIL 14, 2021
The U.S. CDC said up to 5,800 people who have been fully vaccinated against coronavirus disease 2019 (COVID-19) have been infected by the novel coronavirus following vaccination.
Scienmag
APRIL 14, 2021
Korea Institute of Materials Science/Samsung Medical Center, Rapid and sensitive multiplex molecular diagnosis of respiratory pathogens using plasmonic isothermal RPA array chip Credit: Korea Institute of Materials Science (KIMS) Researchers in South Korea developed a plasmonic isothermal recombinase polymerase amplification (RPA) array chip, the world’s first plasmoinc isothermal PCR technology which can detect 8 types […].
Pharma Times
APRIL 14, 2021
Dosing has begun in a Phase III study evaluating the contraceptive efficacy of relugolix combination tablet
Scienmag
APRIL 14, 2021
Credit: S. Yoshi Maezumi If you were to visit the Great Basin and Colorado Plateau a thousand years ago, you’d find conditions remarkably familiar to the present. The climate was warm, but drier than today. There were large populations of Indigenous people known as the Fremont, a who hunted and grew crops in the area. […].
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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.
BioSpace
APRIL 14, 2021
This marks another setback for Merck in the battle against COVID-19 after it shuttered its pandemic vaccine program in January following poor responses in Phase I studies.
Scienmag
APRIL 14, 2021
Credit: University of Texas at Dallas New research by University of Texas at Dallas scientists could help solve a major challenge in the deployment of certain COVID-19 vaccines worldwide — the need for the vaccines to be kept at below-freezing temperatures during transport and storage. In a study published online April 13 in Nature Communications, […].
BioSpace
APRIL 14, 2021
BGE-105 (formerly AMG 986) mimics the production of apelin, a peptide that has been found in animal studies to improve muscle regeneration and decrease mouse frailty.
Scienmag
APRIL 14, 2021
Researchers from Penn State led two international collaborations to prototype a wireless, wearable transmitter while also improving the transmitter design process Credit: Huanyu Cheng, Penn State Current research on flexible electronics is paving the way for wireless sensors that can be worn on the body and collect a variety of medical data. But where do […].
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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.
XTalks
APRIL 14, 2021
New research published in Science Advances has suggested that a natural cyan blue extracted from red cabbage could replace synthetic blue dyes in food. Food coloring is an essential part of the food and beverage industry; however, some research suggests that using synthetic dyes is not healthy for the consumer. The color cyan blue is not easy to find in nature, making this discovery significant for the industry’s innovation and developments.
Scienmag
APRIL 14, 2021
TTUHSC researcher analyzes factors driving the increase in age at natural menopause Credit: TTUHSC As females age, their bodies typically undergo two significant changes that generally occur during adolescence and middle age. The first, known as menarche, is the time during puberty when a girl begins having monthly menstruation cycles, which often tends to range […].
BioSpace
APRIL 14, 2021
GlaxoSmithKline halted two mid-stage studies assessing feladilimab combined with Merck’s Keytruda as a potential treatment in different oncology settings.
Scienmag
APRIL 14, 2021
Credit: UNIST A recent study has unveiled the reason behind the exceptional catalytic performance of non-noble metal-base mixed catalysts. This is thanks to a new synthetic strategy for the production of cube-shaped catalysts that could further simplify the structure of complex catalysts. This breakthrough has been led by Professor Kwangjin An and his research team […].
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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.
BioSpace
APRIL 14, 2021
The medical device maker has been dropping money like rain this spring, spending close to $19 billion in acquisitions over the past four months.
Scienmag
APRIL 14, 2021
Credit: David Rojas/Colorado State University Most people by now have memorized the public health guidelines meant to help minimize transmission of COVID-19: wash your hands, wear a mask, keep six feet apart from others. That part is easy. What some may not realize is that upholding these guidelines in certain urban areas can present new […].
Pharma Times
APRIL 14, 2021
US Food and Drug Administration approved antibody drug conjugate based on Phase II trial results
Scienmag
APRIL 14, 2021
Credit: by Ying Jiang, Shula Chen, Weihao Zheng, Biyuan Zheng and Anlian Pan TMDs vdW heterostructures generally possess a type-II band alignment which facilitates the formation of interlayer excitons between the constituent monolayers. Manipulation of the interlayer excitons in TMDs vdW heterostructures hold great promise for developing excitonic integrated circuits that serve as the counterpart […].
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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.
Outsourcing Pharma
APRIL 14, 2021
The drug-discovery firm has partnered with several academic institutions to explore a Novartis lung-cancer treatmentâs potential in treating COVID-19.
Scienmag
APRIL 14, 2021
Credit: UCI School of Medicine Irvine, CA – April 14, 2021 – A new study, led by the University of California, Irvine (UCI), reveals how chronic inflammation promotes muscle fibrosis, which could inform the development of new therapies for patients suffering from Duchenne muscular dystrophy (DMD), a fatal muscle disease. Titled, “A Stromal Progenitor and […].
BioSpace
APRIL 14, 2021
As the world adapts to a new normal, here are a few new concepts that will be a part of work-from-home workplaces in the future.
Scienmag
APRIL 14, 2021
Credit: NIAID WHAT: The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has established a network of research sites to study the natural history, transmission and pathogenesis of influenza and provide an international research infrastructure to address influenza outbreaks. The program, called the Centers of Excellence for Influenza […].
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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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