Drug Discovery World
DECEMBER 2, 2022
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved a CBD/THC combination treatment under its Named Patient programme and other compassionate areas. Medlab’s NanaBis, to be used under NanaDol, a botanical version of NanaBis, has previously shown encouraging Phase I/II data for the treatment of cancer-induced bone pain and could be a potential alternative to opioids. .
Antidote
NOVEMBER 30, 2022
Antidote’s podcast, Talk of the Towne , focuses on the ultimate sweet spot: that special place where science and patients converge. Our host, Dr. Rich Towne, was trained in pharmacy and currently works in Clinical Informatics at Antidote. In each episode, Rich welcomes a new guest from an Antidote partner organization, and takes an in-depth look at a particular area of interest, zeroing in on the story that Antidote's data is telling about how best to connect patients and research.
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Drug Discovery Today
NOVEMBER 28, 2022
The new facilities will support the increased demand for Optimer technology.
Drug Channels
NOVEMBER 29, 2022
I hope everyone enjoyed the Thanksgiving holiday! Now that you’ve stretched your stomach, stretch your mind with some food for thought. In this issue: Mark Cuban schools Elon Musk on PBMs Market access lessons from Semglee Gen Z rejects the pharmacy career path A potent call for 340B transparency Plus, get ready to love the ‘90s again! P.S. Join my more than 34,000 LinkedIn followers for daily links to neat stuff.
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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.
Drug Discovery World
NOVEMBER 29, 2022
England will become the first country in Europe to roll out darolutamide (Nubeqa) to patients whose prostate cancer has spread to other parts of the body. . The drug works by blocking androgen receptors in cancer cells, which in turn blocks the effect of testosterone that allows the cancer cells to survive and multiply. Studies show the chances of living longer are increased by one third in men who were previously left untreated. .
Antidote
NOVEMBER 28, 2022
Osteoporosis and osteoarthritis (OA) are conditions with different causes and symptoms, but because people are often diagnosed with both, the terms are frequently used interchangeably.
Drug Discovery Digest brings together the best content for drug research and development professionals from the widest variety of industry thought leaders.
Cytel
DECEMBER 2, 2022
For 35 years , Cytel’s scientific rigor and operational excellence have enabled biotech and pharmaceutical companies to navigate uncertainty, prove value, and make evidence-based decisions with confidence. To celebrate this milestone, we invited Cytel’s Co-Founders, Nitin Patel and Cyrus Mehta, and CEO, Joshua Schultz, to offer their reflections on Cytel’s beginnings, its innovations in technology and statistical strategy over nearly four decades, and predictions for the future of the industry.
Drug Discovery World
DECEMBER 2, 2022
The US Food and Drug Administration (FDA) has accepted Sarepta Therapeutics’ Biologics License Application (BLA) seeking accelerated approval of SRP-9001 (delandistrogene moxeparvovec) for the treatment of ambulant individuals with Duchenne muscular dystrophy. . The therapy, which is being developed in partnership with Roche, has been granted Priority Review by the FDA, with a regulatory action date of May 29, 2023. .
Metabolite Tales Blog
DECEMBER 2, 2022
Hypha’s Q4 2022 newsletter – synthesis of deuterated metabolites In our Q4 2022 newsletter we look at how Hypha make deuterated metabolites, illustrated using case studies where biotransformation and late-stage chemical synthesis techniques were employed. Sign up at the bottom of the page in the link here to receive our quarterly newsletter by email Read newsletter Biotransformation of deuterated flurbiprofen to a deuterated form of the main human metabolite using microbes and recomb
Drug Patent Watch
DECEMBER 2, 2022
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 eight…. The post New patent for Pacira Pharms drug EXPAREL appeared first on DrugPatentWatch - Make Better Decisions.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
BMG Labtech
DECEMBER 1, 2022
Proteins are indispensable molecular catalysts of biological reactions and play important structural roles in cells. The way they fold or unfold reveals crucial information about their biological activity.
Drug Discovery World
DECEMBER 2, 2022
Neuroscientists have identified and developed a new drug candidate that has the potential to effectively treat temporal lobe epilepsy (TLE) by suppressing neuroinflammation. . Although symptomatic medications are available, one-third of TLE patients remain unresponsive to current treatment, so new drug targets are critically needed. Most of these drugs target neurons and synapses in the brain, but overlook neuroinflammation. .
The Open Targets Blog
DECEMBER 2, 2022
Artificial Intelligence and Machine Learning (AI/ML) have applications across all areas of drug discovery and development. At Open Targets, our main focus is target identification and prioritisation, and a 2017 analysis by Enrico Ferrero shows that the data linking genes and diseases in the Open Targets Platform is already sufficient to effectively predict novel targets for which therapies are actively being pursued or are already on the market.
Drug Patent Watch
DECEMBER 2, 2022
Annual Drug Patent Expirations for FOTIVDA Fotivda is a drug marketed by Aveo Pharms and is included in one NDA. It is available from one supplier. There are two patents…. The post New patent for Aveo Pharms drug FOTIVDA appeared first on DrugPatentWatch - Make Better Decisions.
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
Drug Channels
DECEMBER 1, 2022
Today’s guest post comes from Deepak Thomas, Founder and CEO of PHIL Inc. Deepak explains how a manufacturer’s net revenues are affected when that manufacturer helps patients access, afford, and adhere to medication therapy. He provides three suggestions for building a channel strategy to optimize gross-to-net while also improving clinical, financial, and operational outcomes.
Drug Discovery World
DECEMBER 2, 2022
News round-up for 28 November – 2 December by DDW Digital Content Editor Diana Spencer . The last seven days have seen breakthroughs announced in malaria treatment, epilepsy and major depressive disorders. The NHS in England has fast tracked another cancer drug, and, in Covid-19 news, researchers have emphatically proven that prednisolone should not be prescribed for olfactory disorders. .
The Premier Consulting Blog
NOVEMBER 30, 2022
Computer modeling and simulation of humans, both healthy and with diseases, is a powerful tool. It can augment preclinical and clinical research through mechanistic and predictive investigations that would otherwise be impossible. In recent years, regulatory agencies have begun to accept evidence obtained through modeling and simulation, and in silico clinical trials have emerged as an important approach for virtual testing of pharmacological therapies and medical devices.
Drug Patent Watch
DECEMBER 2, 2022
Annual Drug Patent Expirations for ASPRUZYO+SPRINKLE Aspruzyo Sprinkle is a drug marketed by Spil and is included in one NDA. It is available from one supplier. There is one patent…. The post New patent for SPIL drug ASPRUZYO SPRINKLE appeared first on DrugPatentWatch - Make Better Decisions.
Olympian Clinical Research
DECEMBER 1, 2022
Psoriasis is a chronic, autoimmune skin condition. By speeding up the growth cycle of skin cells, psoriasis creates thick, red patches on the skin that are frequently covered in white scale-like tissue. Various types of psoriasis affect nearly 7.5 million US adults. . The type of psoriasis you experience can influence the symptoms and complications associated with your condition as well as the treatment plan that is right for you.
Drug Discovery World
DECEMBER 1, 2022
Extensive manipulation, mechanical force and labelling methods used to enrich cells activate transcriptional programs that mask molecular profiles truly significant to any underlying disease. The consequence is the identification of drug targets that are not relevant to the biological process under study. . Camila Egidio. Based on Nakhoda and Olszanski, 2022 (Addressing Recent Failures in Immuno-Oncology Trials to Guide Novel Immunotherapeutic Treatment Strategies), lack of an optimal biomarker
Crown Bioscience
NOVEMBER 30, 2022
This post explores applications of genetically engineered organoids and cell lines to expand and accelerate anti-cancer drug discovery and development. We first provide a brief overview of two major methods that are used to develop engineered organoids/cell lines (i.e., lentiviral transduction and PiggyBac), followed by typical workflows for generating these models.
Drug Patent Watch
DECEMBER 1, 2022
Annual Drug Patent Expirations for LIVMARLI Livmarli is a drug marketed by Mirum and is included in one NDA. There are three patents protecting this drug. This drug has one…. The post New patent for MIRUM drug LIVMARLI appeared first on DrugPatentWatch - Make Better Decisions.
Cytel
NOVEMBER 29, 2022
Bayesian methods have continuously played a key role in transforming clinical research in therapeutic areas such as oncology and rare diseases, and in addressing clinical development challenges for COVID-19 drugs, devices, and biologics. From early-phase trials to late-phase development, utilizing Bayesian tools can expedite and/or de-risk trials, even when used to augment a Frequentist framework.
Drug Discovery World
DECEMBER 1, 2022
PerkinElmer has launched ready-to-use adeno-associated virus vectors ( AAV ) detection kits to support researchers working on gene therapies for a variety of serious diseases. . The validated and fully automatable assays are built on PerkinElmer’s AlphaLISA technology which requires no separation and are optimised, no-wash AAV detection assays.
BMG Labtech
NOVEMBER 29, 2022
What are proteins? Next to carbohydrates, lipids and nucleic acids, proteins are one of the main macromolecule building blocks of life. On a molecular basis, they can be described as complex polymers of amino acids, connected via a peptide bond backbone (fig.1). There are 20 different types of amino acids available as possible residues of individual subunits of a protein.
Drug Patent Watch
DECEMBER 1, 2022
Annual Drug Patent Expirations for MAVYRET Mavyret is a drug marketed by Abbvie Inc and is included in two NDAs. It is available from one supplier. There are nine patents…. The post New patent for Abbvie Inc drug MAVYRET appeared first on DrugPatentWatch - Make Better Decisions.
Advarra
NOVEMBER 29, 2022
The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines. There have been recent signals indicating the Food and Drug Administration (FDA) plans to provide greater support for CGT, addressing key issues continuing to impede their development.
Drug Discovery World
NOVEMBER 30, 2022
The UK government has promised that patients will benefit from cutting-edge new treatments with the introduction of a Vaccine Taskforce style approach to tackling health challenges. . The government has committed over £113 ($135) million to fund research into four healthcare missions – cancer, obesity, mental health and addiction. Building on the Vaccine Taskforce model, the government says it will “harness world-leading research expertise, remove unnecessary bureaucracy, strengthen partnership
Zobio
NOVEMBER 28, 2022
In person On 8th December 2022, the Society for Medicines Research and the Biological and Medicinal Chemistry Sector of the Royal Society of Chemistry were jointly hosting a 1-day meeting in London on Recent Trends in Medicinal Chemistry and Enabling Technologies. The meeting was a combination of medicinal chemistry, chemistry-based drug discovery enabling technologies and.
Drug Patent Watch
DECEMBER 1, 2022
Annual Drug Patent Expirations for BLUDIGO Bludigo is a drug marketed by Provepharm Sas and is included in one NDA. There is one patent protecting this drug. This drug has…. The post New patent for Provepharm Sas drug BLUDIGO appeared first on DrugPatentWatch - Make Better Decisions.
Advarra
DECEMBER 1, 2022
The research informed consent form (ICF) is designed to provide prospective participants with the necessary information to make an informed decision about whether to participate in a clinical trial. Frequently included in the informed consent is an institution’s Health Insurance Portability and Accountability Act (HIPAA) statement, which informs participants of how their protected health information (PHI) may be used or disclosed by covered entities for research purposes.
Drug Discovery World
NOVEMBER 30, 2022
The University of Queensland is set to take a second-generation molecular clamp vaccine to a proof-of-concept human trial. . The Coalition for Epidemic Preparedness Innovation (CEPI) has committed up to AU$8.5 ($5.7) million to support further development of the re-engineered technology for use in the global response to future disease outbreaks. .
sptlabtech
DECEMBER 2, 2022
We sat down with Paul Lomax, Head of Genomics at SPT Labtech, to find out how exciting new technological developments have opened up opportunities for widespread innovation. In this interview, Paul touches on the history and current state of play of automation technologies for genomics before giving us a glimpse into what we can look forward to in the near future.
Drug Patent Watch
NOVEMBER 30, 2022
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