Bio Pharma Dive
JULY 2, 2021
The agency is under pressure to grant full approvals to two coronavirus vaccines and faces important questions on how to handle the next Alzheimer's drugs after Aduhelm. A safety review of several arthritis medicines, meanwhile, is ongoing.
World of DTC Marketing
JULY 2, 2021
SUMMARY: Leadership is the ability to influence or guide others. Too many pharma CEOs are bad leaders because they fear failure, losing power, and focus too much on metrics not important to the rank and file. Six out of 10 employees said they feel demotivated by their CEOs; 70% say CEO pay was too high in general. The median CEO of the drug companies outpaced the more modest pay gains of their employees.
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Bio Pharma Dive
JULY 2, 2021
The pharmaceutical giant best known for its work in cancer, HIV and respiratory illnesses is now paying at least $700 million to get its hands on two experimental drugs from Alector.
XTalks
JULY 2, 2021
There have been growing reports of women experiencing changes in their menstrual cycle after receiving a shot of a COVID-19 vaccine. Some women have said they got their periods early following vaccination, or that their periods were unusually heavy and/or painful. There have also been reports of post-menopausal women and trans men experiencing bleeding or spotting after getting the shot.
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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
pharmaphorum
JULY 2, 2021
AstraZeneca has reported the first phase 2 results with a drug for heart failure with preserved ejection fraction (HFpEF), showing it worked as expected but wasn’t able to provide any clinical benefit to patients. . Daily doses of AZD4831 were able to reduce the activity of myeloperoxidase (MPO), an enzyme linked to tissue and blood vessel damage due to inflammation and scar tissues formation (fibrosis) in models of cardiovascular disease, by 69% after 30 days in the phase 2a SATELLITE stu
Scienmag
JULY 2, 2021
New experimental data pinpoints a molecular component responsible for modulating the damage the flu can wreck on the lungs Credit: Joana Carvalho, IGC 2021 The seasonal flu kills up to 600 000 people a year worldwide and has a century-long history of pandemics. Examples include the Spanish flu in the late 1910’s or the H1N1 […].
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Scienmag
JULY 2, 2021
Optimized sputtering technique helps minimize stress in tungsten thin films Credit: Tokyo Metropolitan University Tokyo, Japan – Researchers from Tokyo Metropolitan University have used high power impulse magnetron scattering (HiPIMS) to create thin films of tungsten with unprecedentedly low levels of film stress. By optimizing the timing of a “substrate bias pulse” with microsecond precision, […].
Pharma Times
JULY 2, 2021
Rylaze has been specifically developed for patients who have developed hypersensitivity to E.
Scienmag
JULY 2, 2021
Credit: Jorge Paul Orduño García. Guadalupe fur seals (Arctocephalus townsendi) have established a large resting colony in the Gulf of California–bringing the total number of sites where this endangered species now occurs to just four. This new haul-out was discovered on El Farallón de San Ignacio Island, along the mainland coast of Mexico, according to […].
pharmaphorum
JULY 2, 2021
Zydus Cadila has filed for emergency use approval (EUA) in India of its plasmid DNA-based vaccine for COVID-19, which if given a green light could become the first shot of its type to be cleared for widespread use in humans. . Leaving aside the possible technological milestone, the ZyCOV-D vaccine has a few characteristics that could stand in the way of its rollout, including a need for three doses, whereas all India’s current vaccines only need two.
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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
JULY 2, 2021
Studies using human cell lines and tumors grown in mice provide early evidence that inhibiting RNA-binding proteins, a previously overlooked family of molecules, might provide a new approach for treating some cancers Credit: UC San Diego Health Sciences In cancer research, it’s a common goal to find something about cancer cells — some sort of […].
Drug Patent Watch
JULY 2, 2021
Annual Drug Patent Expirations for NOXAFIL Noxafil is a drug marketed by Merck Sharp Dohme and Schering and is included in three NDAs. It is available from three suppliers. There…. The post New patent for Merck Sharp drug NOXAFIL appeared first on DrugPatentWatch - Make Better Decisions.
Pharma Times
JULY 2, 2021
AZD4831 is being investigated in patients with heart failure with preserved ejection fraction (HFpEF)
pharmaphorum
JULY 2, 2021
Swiss food giant Nestle has firmed up its five-year-old alliance with US microbiome specialist Seres, paying $175 million upfront for North American co-marketing rights to its lead drug for Clostridium difficile infections. Under the terms of the new deal, Nestle’s Health Sciences unit will pay Seres another $125 million if the FDA approves the drug – called SER-109 – and is also line for up to $225 million in commercial milestones tied to sales targets.
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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.
Scienmag
JULY 2, 2021
LOS ANGELES – Dr. Elizabeta Nemeth, professor of medicine and director of the Center for Iron Disorders at the David Geffen School of Medicine at UCLA, has been awarded the 2021 William Dameshek Prize by the American Society of Hematology (ASH) for her contributions to the field of hematology. The award recognizes Nemeth for her […].
Pharma Times
JULY 2, 2021
Congenital adrenal hyperplasia (CAH) is a rare condition caused by deficiency of adrenal enzymes
Scienmag
JULY 2, 2021
A newly developed CRISPR-Cas9-based tool carries out efficient and long-term gene silencing by epigenetic editing Credit: BioDesign Research Originally discovered as a bacterial mode of defense against invading viruses, the remarkable ability of CRISPR-Cas9 to modify specific locations of DNA has made it a researcher favorite among gene editing tools.
ECRG Media's Clinical Research Podcast
JULY 2, 2021
More Research Spending Means More Opportunity Don't forget to Subscribe for new content! Subscribe: [link] Email: eliteclinicalgroup@gmail.com Podcast: [link] Steemit: [link] Advertise: eliteclinicalgroup@gmail.com Watch: » Industry News: [link] » All Videos: [link] » Interview Recaps: [link] » Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education Elite Clinical Research Group or
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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
JULY 2, 2021
It is the membrane of cancer cells that is at the focus of the new research now showing a completely new way in which cancer cells can repair the damage that can otherwise kill them. In both normal cells and cancer cells, the cell membrane acts as the skin of the cells. And damage to […].
ECRG Media's Clinical Research Podcast
JULY 2, 2021
More Research Spending Means More Opportunity. Don't forget to Subscribe for new content! Subscribe: [link] Email: eliteclinicalgroup@gmail.com Podcast: [link] Steemit: [link] Advertise: eliteclinicalgroup@gmail.com Watch: » Industry News: [link] » All Videos: [link] » Interview Recaps: [link] » Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education.
Scienmag
JULY 2, 2021
Credit: Kansas State University MANHATTAN, KANSAS — A recent study by Kansas State University virologists demonstrates successful postinfection treatment for SARS-CoV-2, the virus that causes COVID-19. College of Veterinary Medicine researchers Yunjeong Kim and Kyeong-Ok “KC” Chang published the study in the prestigious journal Proceedings of the National Academy of Sciences of the United States […].
Pharma Business Blog
JULY 2, 2021
Dear pharma members. Germany has recently published a court decision with major impact on the pharma supply chain (commercial and clinical) in the EU Member States: The court decision in a nutshell. • German pharmaceutical wholesalers are only allowed to purchase drugs from companies holding an appropriate authorization granted in one of the EU Member States. • An equivalent authorization (e.g. a wholesale distribution license “WDA”) from a third party country like e.g.
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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.
Scienmag
JULY 2, 2021
What The Study Did: Researchers estimated the frequency and magnitude of surprise bills for deliveries and newborn hospitalizations, which are the leading reasons for hospitalization in the United States, to illustrate the potential benefits of federal legislation that will protect families from most surprise bills. Potential surprise bills were defined as claims from out-of-network clinicians […].
Drug Patent Watch
JULY 2, 2021
Annual Drug Patent Expirations for INGREZZA Ingrezza is a drug marketed by Neurocrine and is included in one NDA. It is available from one supplier. There are fifteen patents protecting…. The post New patent for Neurocrine drug INGREZZA appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
JULY 2, 2021
The Arizona Center for Rural Health’s mission to improve the health and wellness of Arizona’s rural and vulnerable populations through its state and federally designated and funded State Office of Rural Health program will continue thanks to a $4.4 million grant from the U.S. Health Resources and Services Administration (HRSA). “We are very honored and […].
Drug Patent Watch
JULY 2, 2021
Annual Drug Patent Expirations for PERSERIS+KIT Perseris Kit is a drug marketed by Indivior Inc and is included in one NDA. It is available from one supplier. There are seven…. The post New patent for Indivior Inc drug PERSERIS KIT appeared first on DrugPatentWatch - Make Better Decisions.
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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.
Scienmag
JULY 2, 2021
What The Study Did: Researchers in this study aimed to determine how each state and the District of Columbia planned to ensure equitable COVID-19 vaccine distribution. Authors: Juan C. Rojas, M.D., of the University of Chicago, is the corresponding author. To access the embargoed study: Visit our For The Media website at this link [link] (doi:10.1001/jamanetworkopen.2021.15653) […].
pharmaphorum
JULY 2, 2021
The Association of the British Pharmaceutical Industry (ABPI) has launched its 2021 Code of Practice to help companies operate to high ethical standards. . The ABPI Code of Practice is the industry’s commitment to operate in a professional, ethical, and transparent manner, for the benefit of patients and the public. It is independently administered by the Prescription Medicines Code of Practice Authority (PMCPA).
Scienmag
JULY 2, 2021
Vulnerable populations are most likely to experience negative consequences of wheelchair breakdown, such as missing work or school or being stranded outside the home Credit: Kessler Foundation East Hanover, NJ. July 2, 2021. Among wheelchair users with spinal cord injury 42 percent reported adverse consequences related to needing wheelchair repair, according to a team of […].
pharmaphorum
JULY 2, 2021
GlaxoSmithKline’s board had responded to the broadside attack delivered by activist investor Elliott Management yesterday, saying it stands firmly behind the leadership of chief executive Emma Walmsley. The drugmaker rejected calls by Elliott to change its board and accelerate the complete divestment of its consumer health unit which is due to be split from the ‘new GSK’ pharma business next year, and said it had “widespread and strong support” among shareholders fo
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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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