Bio Pharma Dive
DECEMBER 23, 2021
The decision follows worrisome results in lab studies that indicated omicron can evade both drugs and leaves the U.S. with fewer treatments to respond to the variant's spread.
pharmaphorum
DECEMBER 23, 2021
The FDA has published draft guidance on how digital health technologies (DHTs) like smart and wearable devices can be used to capture data remotely from patients in clinical trials – an approach that has come to the fore since the start of the pandemic. The new guidance sets out the regulator’s current thinking on how trial sponsors to incorporate DHTs in the design of studies of drugs or medical devices.
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Scienmag
DECEMBER 23, 2021
Credit: Julianna Han, Ward Lab at Scripps Research LA JOLLA, CA—Scientists at Scripps Research, University of Chicago and Icahn School of Medicine at Mount Sinai have identified a new Achilles’ heel of influenza virus, making progress in the quest for a universal flu vaccine. Antibodies against a long-ignored section of the virus, which the team […].
pharmaphorum
DECEMBER 23, 2021
At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. The FDA has approved the drug under the Leqvio trade name as an adjunct to maximum-dose statin drugs for people who need further LDL-cholesterol reduction to reach targets, a year after it was given a green light in Europe.
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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
Pharma Times
DECEMBER 23, 2021
Government vaccine advisers have said vulnerable primary school children should be offered a low-dose of a COVID-19 vaccine.
pharmaphorum
DECEMBER 23, 2021
COVID-19 has changed everything – at least that’s David Hunt’s plan for pharmaceutical marketing. The former CEO of Havas Lynx recently launched a new agency in the US called The Considered, with the intent to break the traditional pharma marketing rules and shake up the industry. “There is some brilliant work that takes place by some incredibly intelligent agencies and individuals, but I know how formulaic we’ve become as an industry where next year’s tactics are probably very similar to this y
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Scienmag
DECEMBER 23, 2021
Avoid or compete, eat or be eaten, exploit or cooperate – biotic communities are shaped by species interactions in many different ways. Urban environments represent a special case as human presence and influence may have fundamentally changed the rules of the game. Around 150 wildlife cameras installed by Berlin citizen scientists in their gardens in […].
Pharma Times
DECEMBER 23, 2021
WHO officials remain cautious about claiming Omicron as a milder variant of the COVID-19 virus.
Scienmag
DECEMBER 23, 2021
A “game changing” new telescope will be blasted into space tonight to embark on a lonely 1.5-million-kilometre orbit around the Sun to provide a clearer view of the ever-expanding universe. The James Webb Space Telescope (JWST) is the largest telescope ever to be launched into space and will be used by University of Queensland researchers […].
Fossil Remedies
DECEMBER 23, 2021
When you run a PCD Pharma Company , your prime objective is to earn profit. For that,it is essential to generate a greater number of queries. When you do it, the business performs well. When it performs well, you enhance your market position. Bigger sales mean your company is viewed as a successful company. What are the different ways of generating enquiries?
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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
DECEMBER 23, 2021
Blocking function of a blood-clotting protein prevented bone loss from periodontal (gum) disease in mice, according to research led by scientists at the National Institute of Dental and Craniofacial Research (NIDCR), part of the National Institutes of Health. Drawing on animal and human data, the researchers found that buildup of the protein, called fibrin, triggers […].
NY Times
DECEMBER 23, 2021
The F.D.A. said the drug should be prescribed mainly when other treatments were “not accessible or clinically appropriate.”.
Scienmag
DECEMBER 23, 2021
CORVALLIS, Ore. – Melanoma patients receiving therapy that makes it easier for their immune system to kill cancer cells respond to treatment better when their diet is rich in fiber, according to a large, international research collaboration that includes the Oregon State University College of Pharmacy. Published today in Science, the study led by the […].
Pharma in Brief
DECEMBER 23, 2021
Changes to the Patented Medicine Prices Review Board ( PMPRB ) regime, contained in pending amendments to the Patented Medicines Regulations , have been delayed until July 1, 2022. These amendments form the basis for new PMPRB Guidelines. The PMPRB has updated its website to indicate that the new Guidelines will be in place as of the coming-into-force of the amendments.
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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
DECEMBER 23, 2021
HSE academics joined researchers from the Turner Scientific Research Institute for Children’s Orthopaedics to study how the brains of children with arthrogryposis control elbow flexion after muscle transplantation. They found that in such patients, more motor neuron activity occurs, which means that the start of a new movement requires more effort from the brain.
pharmaphorum
DECEMBER 23, 2021
Daiichi Sankyo has been granted breakthrough status by the FDA for patritumab deruxtecan, a HER3-targeted antibody-drug conjugate (ADC) in clinical trials for lung cancer. The designation – which is awarded to therapies that could represent a significant improvement over standard of care in either efficacy, safety, or both – has been awarded on the strength of phase 1 results in patients with metastatic or locally advanced EGFR-mutated non-small cell lung cancer (NSCLC).
Scienmag
DECEMBER 23, 2021
Ishikawa, Japan – The ability to sense the magnitude and polarity of the electric field is of great scientific interest. It has various real-life applications, such as early prediction of lightning and detection of supersonic aircraft. Presently, field mills are the widely used electric field sensors. While they can detect electric fields of either polarity […].
BioTech 365
DECEMBER 23, 2021
Smile Makeovers Barton Creek TX Update – Cosmetic Dentistry Metal-Free Crowns Smile Makeovers Barton Creek TX Update – Cosmetic Dentistry Metal-Free Crowns West Lake Hills Dental Arts (+1-512-328-0155) a dental care center specializing in cosmetic dentistry has launched its smile … Continue reading →
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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
DECEMBER 23, 2021
HOUSTON ? Patients with melanoma who reported eating more fiber-rich foods when they began immunotherapy treatment survived longer without cancer growth than patients with insufficient dietary fiber intake, according to new research from The University of Texas MD Anderson Cancer Center published today in Science. The benefit was most noticeable in patients who did not take […].
Drug Patent Watch
DECEMBER 23, 2021
Annual Drug Patent Expirations for EXPAREL Exparel is a drug marketed by Pacira Pharms Inc and is included in one NDA. It is available from one supplier. There are two…. The post New patent expiration for Pacira Pharms drug EXPAREL appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
DECEMBER 23, 2021
An international team of researchers have used a unique tool inserted into an electron microscope to create a transistor that’s 25,000 times smaller than the width of a human hair. Credit: QUT An international team of researchers have used a unique tool inserted into an electron microscope to create a transistor that’s 25,000 times smaller […].
Drug Patent Watch
DECEMBER 23, 2021
Annual Drug Patent Expirations for CLENPIQ Clenpiq is a drug marketed by Ferring Pharms Inc and is included in one NDA. It is available from one supplier. There are two…. The post New patent for Ferring Pharms drug CLENPIQ appeared first on DrugPatentWatch - Make Better Decisions.
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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
DECEMBER 23, 2021
In collaboration with an international team of researchers, Michigan State University has helped create the world’s lightest version, or isotope, of magnesium to date. Credit: Image credit: S. M. Wang/Fudan University and Facility for Rare Isotope Beams In collaboration with an international team of researchers, Michigan State University has helped create the world’s lightest version, […].
Drug Patent Watch
DECEMBER 23, 2021
Annual Drug Patent Expirations for CAPLYTA Caplyta is a drug marketed by Intra-cellular and is included in one NDA. There are nine patents protecting this drug. CAPLYTA drug price trends.…. The post New patent for Intra-cellular drug CAPLYTA appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
DECEMBER 23, 2021
Tsukuba, Japan – Technologists envisage an electronically interconnected future that will depend on cheap, lightweight, flexible devices. Efforts to optimize the semiconductor materials needed for these electronic devices are therefore necessary. Researchers from the University of Tsukuba have reported a record-breaking germanium (Ge) thin film on a plastic substrate that offers flexibility without compromising performance. […].
Drug Patent Watch
DECEMBER 23, 2021
Annual Drug Patent Expirations for LYBALVI Lybalvi is a drug marketed by Alkermes Inc and is included in one NDA. It is available from one supplier. There are nine patents…. The post New patent for Alkermes Inc drug LYBALVI 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
DECEMBER 23, 2021
East Hanover, NJ. December 22, 2021. Unemployment moved downward for people with disabilities after stalling in October, according to today’s National Trends in Disability Employment (nTIDE) COVID Update. For the first time, their unemployment levels dipped below pre-pandemic lows, in contrast with their peers without disabilities. Credit: Kessler Foundation East Hanover, NJ.
Drug Patent Watch
DECEMBER 23, 2021
Annual Drug Patent Expirations for JATENZO Jatenzo is a drug marketed by Clarus and is included in one NDA. It is available from one supplier. There are five patents protecting…. The post New patent for Clarus drug JATENZO appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
DECEMBER 23, 2021
The two-meter skull of a newly discovered species of giant ichthyosaur, the earliest known, is shedding new light on the marine reptiles’ rapid growth into behemoths of the Dinosaurian oceans, and helping us better understand the journey of modern cetaceans (whales and dolphins) to becoming the largest animals to ever inhabit the Earth. Credit: Photo […].
Drug Patent Watch
DECEMBER 23, 2021
Annual Drug Patent Expirations for HETLIOZ+LQ Hetlioz Lq is a drug marketed by Vanda Pharms Inc and is included in one NDA. It is available from one supplier. There are…. The post New patent for Vanda Pharms drug HETLIOZ LQ appeared first on DrugPatentWatch - Make Better Decisions.
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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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