2022

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UK approval for CBD pain treatment

Drug Discovery World

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. .

Treatment 246
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How long do clinical trial phases take?

Antidote

Before a potential new therapy can be administered to patients, it must go through several clinical trial phases designed to test the drug or device for safety and effectiveness. For many new treatments, it will take approximately ten years for the therapy to progress from initial discovery to being approved. Clinical trials alone take six to seven years on average to complete.

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The value of method of use patent claims in protecting your therapeutic assets

Drug Patent Watch

This is a guest post by Ray Miller and Megan E. Bowers, Ph.D. at DLA Piper. Ray may be contacted at raymond.miller@dlapiper.com. When it comes to protecting therapeutic assets, I…. The post The value of method of use patent claims in protecting your therapeutic assets appeared first on DrugPatentWatch - Make Better Decisions.

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What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

FDA Law Blog: Drug Discovery

By Mark A. Tobolowsky & James E. Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Therapies 119
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How Machine Learning Drives Clinical Trial Efficiency

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.

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OPDP Issues First Regulatory Action Letter of 2022

Eye on FDA

FDA’s Office of Prescription Drug Promotion (OPDP) issued the first regulatory action letter for 2022. This one has some notable characteristics. As has been frequently noted, enforcement actions by OPDP have diminished considerably over the years. Another characteristic of recent enforcement actions over the past several years is that smaller, less well-known companies have mostly been the recipients of letters from OPDP.

FDA 108
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USA Clinical Trial Market Size and Opportunities

ProRelix Research

Clinical trials form the crux of all regulatory decisions regarding any new health intervention such as drugs and medical devices and thus require to be performed with the utmost care […]. The post USA Clinical Trial Market Size and Opportunities appeared first on ProRelix Research.

More Trending

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The GoodRx-Kroger Blowup: Spread Pricing, Pharmacy Margins, and the Future of Discount Cards

Drug Channels

A few weeks ago, GoodRx surprised investors with the unpleasant news that a major grocery chain had stopped accepting its discount card for an unspecified number of prescriptions. As I explain below, the unnamed chain appears to be Kroger— the sixth-largest U.S. pharmacy. What’s more, GoodRx disclosed that Kroger accounts for an unexpected one-quarter of its prescription business.

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CBD Research: A Dive into the Regulations of Cannabis Research

Advarra

Cannabis use has become widespread. As such, we are seeing an uptick in research examining the therapeutic effects of cannabis and its constituents. Currently, cannabis use is legal across many states in the U.S., with 37 states approving medicinal use and 18 approving recreationally. However, it’s not legal federally and is considered a Schedule I drug by the U.S.

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A Comprehensive Guide to Atopic Dermatitis

Olympian Clinical Research

Atopic dermatitis is a form of eczema and is the most common chronic inflammatory skin disease. While this condition is often seen in children, around 16.5 million Americans suffer from this itchy skin condition. Although there is no cure for this condition, with the proper knowledge, treatments, and lifestyle changes, those with eczema may manage their symptoms and lead happy, healthy lives.

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Senator Burr: Rip Van Winkle Performance on Drug Importation, Owes Italy an Apology 

Policy Prescription

This past June, during a debate in the Senate Health, Education, Labor and Pensions (HELP) Committee, Senator Richard Burr (R-NC), the committee’s Ranking Member, demonstrated that he does not understand very important developments in our nation’s approach to drug regulation and safety. It was almost as if Sen. Burr had fallen asleep over 20 years ago and woke up believing that nothing had changed in the world of drug regulation.

FDA 89
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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.

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Drug development practices to improve public health policy 

Drug Discovery World

Dr Andrew Garrett, Executive Vice President of Scientific Operations at ICON, explores the benefits of integrating some of the validation and standardisation practices already developed for PIs into the practices around NPIs and public health data; outlines some of the practices that can be implemented in order to do this; and highlights the need for interdisciplinary collaboration between pharmaceutical and non-pharmaceutical researchers and public health centres to consider the overlap between

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Medical terms A to Z: Common and confusing terms used in the doctor’s office

Antidote

Generally, a doctor’s visit is intended to provide clarity and insight into a patient’s concerns — but many people are all too familiar with the feeling of walking out of a clinic more confused than when they arrived. In fact, many Americans find themselves searching for health literacy tips after becoming confused by a doctor’s instructions or the directions on a prescription label.

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DrugPatentWatch Week in Review

Drug Patent Watch

FEATURED ARTICLE Branded Generics Promise Profits for Drugmakers, Peace of Mind for Patients Developing nations offer welcoming and growing markets as Abbott focuses exclusively on reformulating and marketing off-patent medications…. The post DrugPatentWatch Week in Review appeared first on DrugPatentWatch - Make Better Decisions.

Marketing 120
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Vaccination – No Religious Exemption Required

Drug & Device Law

As we mentioned in last year’s comprehensive “ Survival of the Vaxxest ” blogpost on the constitutionality (for over a century) of governmental vaccine mandates, there is no appellate precedent requiring any sort of religious exemption to such mandates. Freedom of religion does not mean freedom to infect everyone else. While some jurisdictions allow exceptions to mandatory vaccination for “religious” reasons, that’s a matter of grace, not any sort of constitutional requirement.

Vaccine 105
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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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

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Tick Tock re Tik Tok and FDA’s OPDP

Eye on FDA

Tik Tok was first released in 2016. While slow out of the starting gate with emergent media opportunities, in 2022, pharma is embracing the platform in both unbranded and branded efforts. While historically, a lot of Tik Tok use has been comprised of individuals releasing videos of them showing off dance moves and physique, the time for embracing the platform by institutional users appears has arrived.

FDA 89
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Clinical Trial Outsourcing and Management in USA

ProRelix Research

A lot has changed over the past few decades in the way clinical trials are conducted. Advances in data management systems, risk-based monitoring, pharmacovigilance, electronic databases, and application of complex […]. The post Clinical Trial Outsourcing and Management in USA appeared first on ProRelix Research.

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6 Operational Considerations You Need To Know for Psychedelic Trials

Conversations in Drug Development Trends

Bringing a psychedelic into a clinical trial setting is complex and requires a thorough operational approach to ensure the study’s success. Having worked in psychedelic research since the advent of industry-sponsored trials, Worldwide Clinical Trials has amassed the expertise needed to execute these studies successfully, recently sharing insights in a webinar titled “ Demystifying Complex Operations in Psychedelic Research ,” available on-demand now.

Trials 97
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The Inflation Reduction Act: Three Unintended Consequences for Biosimilars, Health Plans, Providers, and Pharmacies (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Drug Channels Outlook 2023. Click here to see the original post and comments from September 2022. During Friday’s webinar, I’ll be sharing my updated thoughts about the IRA’s impact on manufacturers, Part D plans, and patient behavior. By now, you have already read innumerable articles explaining what’s in the new Inflation Reduction Act of 2022 (IRA; P.L. 117-169).

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Return of Research Results to Study Participants

Advarra

Individuals invest a great deal to participate in clinical research, undertaking risks and burdens, while giving of their time and energies to advance scientific knowledge and the public good. Empirical research into participant views and experiences has consistently shown participants desire to learn the results of research to which they’ve contributed.

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7 Most Common Types of Depression

Olympian Clinical Research

Depression is an illness that affects nearly 280 million people worldwide. There are several types of depression, each with its own set of symptoms and recommended treatment methods. Therefore, overcoming depression requires understanding the type of depression you may be facing and getting the proper help. 1. Major Depressive Disorder. Major depressive disorder ( MDD ), also known as clinical depression, is characterized by a persistent feeling of sadness or emptiness lasting for at least two w

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UK fast tracks approval for life-extending prostate cancer drug

Drug Discovery World

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. .

Drugs 246
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How antibiotic resistant gut bacteria cause lung infections

Drug Discovery World

An Oxford University study has provided the first evidence that antibiotic resistant bacteria can travel from the gut to the lung, increasing the risk of deadly infections. . The findings coincide with World Antimicrobial Awareness Week and shed light on how antimicrobial resistance (AMR) arises and persists. . The study, which has been published in Nature Communications highlights the importance of preventing pathogenic bacteria from translocating from the gut to other organs where they can

Hospitals 246
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Novel peptide targets early molecular trigger of Alzheimer’s

Drug Discovery World

A new study has demonstrated the ability of a novel peptide to selectively detect and neutralise an early molecular trigger of Alzheimer’s and other neurodegenerative diseases. . The Proceedings of the National Academy of Sciences (PNAS) will publish results of the groundbreaking study demonstrating a customised, synthetic peptide’s ability to selectively detect Alzheimer’s disease. .

Disease 245
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Stem cell rejuvenation startup secures investment 

Drug Discovery World

Biotech company Mogling Bio has successfully has completed its first seed investment round with a sole investor, Kizoo Technology Capital. Mogling Bio is developing new pharmacological approaches to rejuvenate old stem cells of the hematopoietic (blood cell formation) system. Ageing causes stem cells to lose their normal structure by increased activity of the protein CDC42. [.].

Drugs 246
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Webinar: How to uncover the best drug targets

Drug Discovery World

Kevin Holden. CRISPR-based knockouts are the gold-standard genetic perturbation method in target identification and validation. However, efficient CRISPR knockout editing and transfection for arrayed screening require specialised skills and infrastructure that your organisation may not have. What if you could receive ready-to-use CRISPR-edited cells without needing to handle, optimise, and transfect your CRISPR library?

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Why genomic healthcare data matters in the development of new therapies 

Drug Discovery World

Genomic healthcare data is critical to identify disease risk, ancestry, traits and response to medicines and aids in the development of new targeted therapies – precision medicines. DDW’s Megan Thomas observes developments of accessibility in this sector and the potential impact. . The origins . One might argue that this all started getting exciting with the launch of the Human Genome Project, which the National Human Genome Research Institute consider to be one of the greatest scientifi

Therapies 246
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Can Europe become a major player in cell and gene therapy?

Drug Discovery World

With European life sciences R&D investment at a 20-year low, biopharmaceutical associations and MEPs are calling on the EU to modernise its policies. DDW’s Diana Spencer asks what will be needed for Europe to compete in the growing global market for advanced therapies. . A new report by Charles River Associates for the European Federation of Pharmaceutical Industries and Associations (EFPIA has revealed that Europe is falling behind the US and Asia in its pharmaceutical R&D investment,

Therapies 245
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Is single-cell gene expression the next trend in next generation sequencing? 

Drug Discovery World

By Dr Dina Finan, PhD, Product Manager at 10x Genomics and Dr Nick Downey, PhD, NGS Collaborations Lead at Integrated DNA Technologies. RNA sequencing has become a widely used tool that can explore the transcriptome in a seemingly endless number of applications. While bulk sequencing—or sequencing the transcriptome of an entire sample at once—has contributed to many [.].

RNA 246
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New platform could streamline cell manufacturing

Drug Discovery World

A new bioreactor platform that aims to support the cell and gene therapy (CGT) sector from process development to commercial manufacturing has been launched. The Quantum Flex Cell Expansion System has been created by medical technology company Terumo Blood and Cell Technologies (Terumo BCT). Using the system, developers can complete early process development on the same platform as manufacturing.

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Polymer-based drug delivery system for mRNA wins Excellence Award

Drug Discovery World

A new polymer-based drug delivery system for mRNA and other nucleic acids has won the CPHI Excellence in Pharma Award in the category “Packaging and Drug Delivery”. . The system was developed by Evonik Health Care together with researchers at Stanford University. . Developed together with Professors Robert Waymouth, Paul Wender and Ronald Levy from the University of Stanford in the US, the prize-winning polymer-based platform complements Evonik’s existing portfolio of lipid-based drug de

Packaging 245
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Lab of the future uncovered at Tech Theatre, ELRIG Drug Discovery 2022

Drug Discovery World

Nicola Richmond, VP of AI, BenevolentAI, will be speaking at the Tech Theatre, ELRIG Drug Discovery 2022, sponsored by DDW. Nicola Richmond is a mathematician with over 20 years’ experience of developing digital solutions to problems in drug discovery and development. She will be presenting a talk on ‘The lab of the future is now: Using AI or automation for the drug discovery process’ The Tech Theatre will feature a series of seminars focused on automation and technology for dr

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What to expect from Advanced Therapies Europe 2022

Drug Discovery World

The Phacilitate Advanced Therapies Europe 2022 conference will take place from 30 August to 1 September at the Royal Lancaster in London, UK. The conference is the European twin to Phacilitate Advanced Therapies Week, an event held in January in Florida, US. The event is tailored to a European audience looking to commercialise ATMPs globally, as well as a global audience looking to understand and expand into the European market.

Therapies 246
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Bayer gets go-ahead for Huntington’s Disease gene therapy trial  

Drug Discovery World

A Phase I/II clinical trial targeting a treatment for Huntington’s Disease (HD) using a gene therapy has been given the clearance to go ahead in France. . The National Agency for Safety of Medicines and Health Products (ANSM) gave the go-ahead to Bayer AG to conduct the clinical trial through its subsidiary BrainVectis to investigate its gene therapy, BV-101 in the treatment for Huntington’s Disease (HD). .

Therapies 246
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Covid researchers launch Monkeypox study  

Drug Discovery World

A new study investigating a potential treatment for people who have been diagnosed with monkeypox has been launched by the same team who helped develop Covid-19 treatments. . Led by the University of Oxford, the PLATINUM study will investigate the use of Tecovirimat to see if it can help speed up the recovery of Monkeypox patients. . The trial will see participants receive either a 14-day course of 600 mg tecovirimat twice daily or a matched placebo treatment.

Research 246