Drug Discovery Today

OCTOBER 27, 2022

On October 26?27, Vilnius will host the EFIB’2022 event which will bring the European life science sector together. In the field of life sciences, Lithuania is best known for the discovery of gene scissors by Prof. Virginijus Šikšnys. The country now hosts the EMBL Partnership Institute for Genome Editing Technologies at the Vilnius University Life Sciences Center aiming to advance gene editing technologies.

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Antidote

JULY 13, 2022

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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Drug Patent Watch

APRIL 5, 2022

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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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

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.

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Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Treatment

Eye on FDA

JANUARY 26, 2022

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.

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Chemical Biology and Drug Design

DECEMBER 15, 2022

The microtubule targeting agents plinabulin, docetaxel, and vinblastine interrupt MT polymerization by altering both MT conformation and binding free energy of the neighboring tubulin subunits. Abstract The natural products plinabulin, docetaxel, and vinblastine are microtubule targeting agents (MTAs). They have been used alone or in combination in cancer treatment.

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ProRelix Research

DECEMBER 27, 2022

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.

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Drug Channels

MAY 24, 2022

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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Conversations in Drug Development Trends

NOVEMBER 8, 2022

At Worldwide, we are committed to a cause that extends beyond ourselves. Our mission is to work with passion and purpose every day to improve lives. Our study teams are committed to working collaboratively with our sponsors, united in purpose. Worldwide aims to become an employer of choice?for veterans, military members, and?their families, by creating an?

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Olympian Clinical Research

JUNE 10, 2022

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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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.

Clinical Trials

Drug Discovery Today

APRIL 29, 2022

Nijmegen, the Netherlands April 27th, 2022 – Thirona, one of the leading companies specializing in artificial intelligence for medical image analysis, has signed a strategic partnership agreement with iCare, for the implementation of Thirona’s RetCAD™ artificial intelligence software into the iCare solutions for eye disease screening, in Europe. The partnership underpins both companies’ technological leadership in this field.

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Disease 157

Antidote

DECEMBER 29, 2022

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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Drug Patent Watch

JUNE 7, 2022

This article was originally published by Guy Shtar, Louise Azulay, Omer Nizri, Lior Rokach & Bracha Shapira in Scientific Data volume 9, Article number: 263 under a Creative Commons Attribution…. The post CDCDB: A large and continuously updated drug combination database appeared first on DrugPatentWatch - Make Better Decisions.

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Advarra

JULY 26, 2022

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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Clinical Trials

Eye on FDA

OCTOBER 19, 2022

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.

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Chemical Biology and Drug Design

NOVEMBER 22, 2022

Scomberomorus niphonius is the fish eaten worldwide. In this study, we extracted phospholipids from these fish bones using an advanced supercritical CO 2 extraction technique and tested them against neuroblastoma and normal (HUVEC) cells. The molecular findings indicate phospholipids have an apoptotic activity in neuroblastoma. Abstract Among various types children's health challenges, neuroblastoma is the most serious solid neoplasm forming outside the cranium.

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DrugBaron

OCTOBER 17, 2022

Asset-centric is a term coined by Medicxi founding partner Francesco De Rubertis to describe an investment strategy he pioneered, together with Kevin Johnson and Michele Ollier, in the early years of the 21 st Century. The key was focusing investment on a single asset to avoid the problem with pipelines in early-stage biotech companies. While it seemed superficially attractive to hedge against failure of the lead asset by having a second or a third program in the wings, the reality usually turne

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ProRelix Research

FEBRUARY 8, 2022

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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Clinical Trials

Drug Channels

DECEMBER 12, 2022

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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Conversations in Drug Development Trends

OCTOBER 26, 2022

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.

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Olympian Clinical Research

JULY 12, 2022

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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Drug Discovery Today

NOVEMBER 24, 2022

Over the last decade, co-crystallization has become an attractive alternative to improve the physiochemical properties of drugs without affecting their pharmacology. As a result of the pharmaceutical benefits co-crystals exhibit, industrial interest is on the rise. Here Dr. Thomas Kendall, application specialist at crystallization and solid-state specialist Technobis Crystallization Systems, gives a perspective on the benefits of co-crystals and explains how they can be screened.

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Antidote

DECEMBER 20, 2022

At Antidote, we consider the patient voice in how we think about the entire clinical trial process. From recruitment to randomization, the patient journey is a driving force in all that we do — and we think this strategy is helpful for clinical trial sponsors, as well. Designing treatments, clinical trials, and health solutions around patients practicing patient centricity, and it can have key benefits for everyone involved.

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Drug Patent Watch

MARCH 22, 2022

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.

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Advarra

JULY 5, 2022

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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Eye on FDA

AUGUST 2, 2022

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years. In 1998, there were 156 letters issued in a single year.

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Chemical Biology and Drug Design

NOVEMBER 15, 2022

Sinomenine protected WI-38 cells against lipopolysaccharide-caused viability reduction, inflammation and apoptosis via downregulating glutathione S-transferase M1 expression. Abstract Pediatric pneumonia is an infectious lung disease with high morbidity and mortality. Sinomenine, an alkaloid extracted from Caulis Sinomenii , exerts anti-inflammatory and anti-apoptotic activities.

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DrugBaron

JULY 19, 2022

Despite the current hype around so called “advanced therapies”, which range from gene editing to cell therapies, and the inexorable advance of biologic therapeutics such as monoclonal antibodies, even in 2022 the majority of drugs in development and reaching patients are still small organic molecules. From enzyme inhibitors to receptor antagonists, allosteric modulators to suicide substrates, small molecules can modulate protein function in uniquely diverse ways.

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Drug Discovery Today

NOVEMBER 10, 2022

Joint publication in Nature Chemistry between OMass Therapeutics’ scientists and co-founder Professor Dame Carol Robinson’s team at Oxford University. Data demonstrates the ability of native mass spectrometry (MS) to interrogate the pharmacology of the beta-1 adrenergic receptor (ß1AR), a G protein-coupled receptor (GPCR).

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Drug Patent Watch

MARCH 22, 2022

Drugs contain ingredients with therapeutic activity, so-called “active ingredients” as well as inactive ingredients. These inactive ingredients, called excipients, are included in oral products for various reasons, such as to…. The post 2 Strategies to Grow Your Excipient Business by Tracking Drug Patents appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Discovery Today

NOVEMBER 28, 2022

The new facilities will support the increased demand for Optimer technology.

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Drug Discovery Today

NOVEMBER 17, 2022

98 per cent of exhibitors sign up for Lab Innovations 2023 after a record breaking event this year

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Drug Discovery Today

NOVEMBER 16, 2022

Collaboration with innovative Finnish software company to explore how to reduce the time and cost of drug discovery and development using quantum computers

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