Bio Pharma Dive
MARCH 7, 2022
The gene therapy developer's top financial executive, Gina Consylman, is stepping down amid concerns the company needs to raise additional cash to survive for more than a year.
World of DTC Marketing
MARCH 7, 2022
Biotech start-ups face challenges in raising money and cutting through the “noise” of other prominent pharma marketers, but their website can provide a wealth of insights into what visitors want to know. One of our most frequent requests is to analyze small biotech websites. Some are in the start-up mode and don’t have the money to hire full-time digital marketers; others may have just received limited approval of one of their drugs and are still in clinical trials.
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Bio Pharma Dive
MARCH 7, 2022
The study is an important test of whether the drug, called Trodelvy, can live up to expectations set by Gilead's $21 billion deal to acquire it.
Pharma Mirror
MARCH 7, 2022
With the recent pandemic lingering on, and the new devastating news of a potential global war, prioritizing your overall health and well-being has never been more critical. While the covid19 pandemic showed us just how important physical health and a robust immune system are, the news of the war is quickly showing us the importance of mental well-being.
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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
MARCH 7, 2022
Roche and J&J, which both run medical device businesses alongside their drug units, said they're working to ensure supplies of their products can flow to Ukraine and Russia.
pharmaphorum
MARCH 7, 2022
A new company set up to use machine learning to find new anti-infective drugs – ArrePath – has launched onto the scene with $20 million in seed financing from a group of investors including the Boehringer Ingelheim Venture Fund. The Princeton, New Jersey-based startup will use the funding to develop its artificial intelligence and imaging based drug discovery platform, used to identify compounds with new and under-exploited mechanisms of action.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
MARCH 7, 2022
The World Health Organization (WHO) announced the opening of a global biomanufacturing hub located in South Korea to provide training to low- and middle-income countries seeking to produce vaccines and other biologics, such as insulin and monoclonal antibodies. . Vaccines are a powerful tool and crucial part of fighting diseases, such as tetanus, measles, meningitis, and, recently, COVID-19.
Bio Pharma Dive
MARCH 7, 2022
Opdivo is now the first immunotherapy approved to treat lung cancer before surgery, a milestone in drugmaker efforts to establish the medicines earlier in the course of patients' disease.
pharmaphorum
MARCH 7, 2022
Young entrepreneurs launch healthcare communications company Collected Group to tackle unmet needs in healthcare professional engagement. Collected Group will offer scientific and strategic services focused on an innovative approach called omniverse communication to drive improvement in people health. London, 7 th March, 2022 – Healthcare communication entrepreneurs, Emily Harrison, and Mohammed Saleh Bham have launched Collected Group, a healthcare communication company aimed at helping b
BioPharma Reporter
MARCH 7, 2022
Clinical Research Organization Veristat has acquired SLF (Solutions for Life Sciences): adding capabilities to support biotech, pharmaceutical and medtech companies.
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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
Pharma Times
MARCH 7, 2022
Fully-automated molecular system with small footprint provides greater flexibility for laboratories without much space
Scienmag
MARCH 7, 2022
Carbohydrate chains play physiologically relevant roles. For instance, many biologically important proteins and lipids inside our body have carbohydrate chains attached to them. These “sugar” chains, in fact, even play key roles in altering the functions of organic molecules like aromatic compounds to which they are commonly attached. It is a known fact that these […].
Pharma Times
MARCH 7, 2022
Largest unmet need in cardiovascular medicine finally receives approved therapy
Scienmag
MARCH 7, 2022
(BOSTON) — Today, the Wyss Institute for Biologically Inspired Engineering at Harvard University and Australian biotech company The iQ Group Global Ltd. announced that the Institute’s electrochemical eRapid technology has been licensed to Antisoma Therapeutics Pty. Ltd., a subsidiary of The iQ Group Global. The licensing agreement was coordinated by Harvard University’s Office of Technology Development and grants the company exclusive, worldwide access to the Wyss Institute’s […].
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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.
pharmaphorum
MARCH 7, 2022
Astellas looks to be in pole position to bring a new non-hormonal therapy for symptoms of menopause to market, after its candidate fezolinetant cleared a phase 3 safety study. The SKYLIGHT 4 was investigating the safety and tolerability of fezolinetant – an orally-active neurokinin-3 (NK3) receptor antagonist – over 52 weeks in women with vasomotor symptoms (VMS) like hot flushes and night sweats associated with menopause.
Scienmag
MARCH 7, 2022
New York, NY—March 7, 2022—Researchers from Columbia Engineering, Fiocruz’s Center for Technological Development in Health and the Oswaldo Cruz Institute in Brazil, Memorial Sloan Kettering Cancer Center, and Rockefeller University recently reported that, by combining inhibitors of polymerases and exonucleases–enzymes that allow SARS-CoV-2 to reproduce–they were able to reduce SARS-CoV-2 replication 10 times more than […].
The Pharma Data
MARCH 7, 2022
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced topline results from the Phase 3 SKYLIGHT 4™ clinical trial investigating the long-term safety of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms associated with menopause (VMS) which will support future regulatory filing submissions.
Scienmag
MARCH 7, 2022
Within the 50,000 known species of spiders about 20 have developed a permanent social life characterised by a remarkable cooperation1. Among these, one or two species hunt “in packs”, such as the Anelosimus eximius spiders of French Guyana, whose colonies can house several thousand individuals of all ages, coexisting peacefully in gigantic webs that often […].
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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.
The Pharma Data
MARCH 7, 2022
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the launch of a first generic version of Revlimid® 1 (lenalidomide capsules), in 5mg, 10mg, 15mg, and 25mg strengths, in the United States. Teva’s Lenalidomide capsules are a prescription medicine used in adults for the treatment of (1) multiple myeloma in combination with the medicine dexamethasone, (2) certain myelodysplastic syndromes, and (3) mantle cell lymphoma following spe
Scienmag
MARCH 7, 2022
Ever since pushing a large landlord in Cincinnati to correct toxic housing conditions in 2009, clinicians at Cincinnati Children’s have had powerful anecdotal evidence that a long-running partnership with the Legal Aid Society of Greater Cincinnati was making real improvement in child health outcomes. Credit: Cincinnati Children’s Ever since pushing a large landlord in Cincinnati […].
The Pharma Data
MARCH 7, 2022
Amgen (NASDAQ:AMGN) today announced the groundbreaking of its newest biomanufacturing facility, located in Holly Springs, North Carolina. The facility, expected to be operational by 2025, will support the growing demand for Amgen’s medicines that treat serious illnesses such as cancer and heart disease. “Amgen is adding to North Carolina’s strong economic growth with the addition of its newest manufacturing plant to our already robust biomanufacturing ecosystem,” said Roy
Scienmag
MARCH 7, 2022
In order to better treat patients diagnosed with acute myeloid leukaemia (AML), researchers need to understand the pathological processes and distinguish between different subgroups of the disease. With the help of proteome and genetic analysis, researchers at the Max Planck Institute of Biochemistry in Martinsried, together with cooperation partners from the Frankfurt University Hospital, German […].
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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.
The Pharma Data
MARCH 7, 2022
Thousands of migrants go missing or die each year along migration routes. In 2018, United Nations Member States committed to “save lives and establish coordinated international efforts on missing migrants” by adopting the Global Compact for Safe, Orderly and Regular Migration (GCM). Four years and more than 15,000 documented deaths later, efforts to provide a meaningful response to this ongoing human tragedy cannot be put off any further.
Scienmag
MARCH 7, 2022
Location, location, location—it’s the first rule of real estate. For a long time, it’s been widely assumed that being close to resources drives settlement patterns, with cities generally founded near water and fertile land for growing crops. But a new paper by a husband-and-wife archaeological team questions that idea, using the example of an ancient […].
The Pharma Data
MARCH 7, 2022
Decision Regarding Slick-Haired Cattle is Agency’s First Enforcement Discretion Decision for an Intentional Genomic Alteration in an Animal for Food Use. Today, the U.S. Food and Drug Administration announced it has made a low-risk determination for the marketing of products, including food, from two genome-edited beef cattle and their offspring after determining that the intentional genomic alteration (IGA) does not raise any safety concerns (low-risk determination).
Scienmag
MARCH 7, 2022
March 7, 2022 — White potatoes — especially French fries — are often described in nutrition research literature and dietary guidance statements as having associations with obesogenic diets and as increasing chronic disease risk based on observational research findings. However, there is limited evidence from randomized controlled trials (RCTs) testing cause-and-effect relationships.
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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.
The Pharma Data
MARCH 7, 2022
By combining CRISPR technology with a protein designed with artificial intelligence (AI), it is possible to awaken individual dormant genes by disabling the chemical “off switches” that silence them. Researchers from the University of Washington School of Medicine in Seattle describe this finding in the journal Cell Reports. The approach will allow researchers to understand the role individual genes play in normal cell growth and development, in aging, and in such diseases as cancer, said Shiri
Scienmag
MARCH 7, 2022
Credit: Tel Aviv University The researchers: “Based on our findings we argue that prehistoric humans’ practice of recycling old stone tools stemmed from the significance attributed by humans to artifacts produced by their predecessors.” In the prehistoric world, much like today, these artifacts carried emotional significance – the memory of ancestors who had produced […].
Drug Patent Watch
MARCH 7, 2022
Annual Drug Patent Expirations for RAYALDEE Rayaldee is a drug marketed by Eirgen and is included in one NDA. It is available from one supplier. There are fourteen patents protecting…. The post New patent for Eirgen drug RAYALDEE appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
MARCH 7, 2022
(Boston)— Internationally-renowned researchers from Boston University (BU) and the University of California, San Francisco (UCSF) are launching a new study, called the Head Impact & Trauma Surveillance Study (HITSS). HITSS will examine the risks for developing dementia, cognitive decline, and changes in behavior and mood later in life from repetitive head impacts (RHI) in soccer […].
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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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