August, 2021

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ELRIG UK Announces Drug Discovery 2021 Event to Host SLAS’s Innovation AveNEW

Drug Discovery Today

• ELRIG Drug Discovery 2021, ACC Liverpool, UK, 19–20 October• Face-to-face event aims to re-connect, re-invent, and re-imagine drug discovery• SLAS’s Innovation AveNEW promotes start-ups by awarding free-of-charge exhibition space and access to a network of potential business partners

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AdComms – Is FDA Getting Less Advice?

Eye on FDA

As more drugs are being approved, is FDA getting less advice than in the past? FDA maintains a vast network of outside advisors to provide input and counsel to the agency related to decisions on policy as well as product approvals. There are 31 advisory committees on matters ranging from food to medical devices to pediatric care. Within those focused on human drugs , there are 17 committees organized under therapeutic categories (Arthritis, Cardiovascular and Renal, Gastrointestinal, e.g.).

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Upcoming workshop on generic portfolio management

Drug Patent Watch

I’ll be leading a workshop on generic portfolio management, and also giving a talk, at the 14th annual Marcus Evans event on Portfolio Planning and Partnerships for Generics. The event…. The post Upcoming workshop on generic portfolio management appeared first on DrugPatentWatch - Make Better Decisions.

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Why GoodRx—Not Amazon—May Be the True PBM Disrupter

Drug Channels

The generic prescription market is being disrupted—but not by the big, bad spaceman from Seattle. Instead, consider how GoodRx is affecting patients, payers, and PBMs. Below I summarize the latest financial results for GoodRx’s discount card business. We estimate that the company accounted for $4.1 billion in U.S. prescription revenues for 2021. That’s about six times its 2016 figure.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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SK bioscience and GSK start Phase 3 trial of adjuvanted.

The Pharma Data

SK bioscience (SK) and GlaxoSmithKline plc (GSK) today announced the initiation of a Phase 3 clinical study of SK’s COVID-19 vaccine candidate, GBP510, in combination with GSK’s pandemic adjuvant following positive interim Phase 1/2 results. The randomised, active-controlled global trial will enrol around 4,000 participants from a range of countries and will aim to evaluate GBP510’s safety and immunogenicity compared to an active comparator – the AstraZeneca/Oxford Univer

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R Programming Datasets - Are they reliable & efficient for SAS Datasets?

Quanticate

R is the open source software environment and language used for data analysis and statistical computing. A great deal has already been said and written about R’s wide variety of graphical and statistical techniques. Even though R as a programming language is constantly growing in popularity in the pharmaceutical industry, it is still quite unpopular to use R in the preliminary stages of research like importing data from different sources, tidying it, calculating new variables in datasets and mak

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FDA Authorizes Third Dose – Some Implications

Eye on FDA

What does “fully vaccinated” mean today? In the face of the widening spread of the SARS-Cov-2 variant, the rise in breakthrough cases, and data that suggests a slight waning effect over time of vaccines, FDA acted yesterday to protect some of the most vulnerable by amending the Emergency Use Authorization of the mRNA vaccines. People who have had organ transplants and people who are immunocompromised may now get a third dose.

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New patent for Boehringer Ingelheim drug JARDIANCE

Drug Patent Watch

Annual Drug Patent Expirations for JARDIANCE Jardiance is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from four suppliers. There are six patents…. The post New patent for Boehringer Ingelheim drug JARDIANCE appeared first on DrugPatentWatch - Make Better Decisions.

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A Video History of Pharmacies and Prescription Prices: From Soda Fountains to GoodRx

Drug Channels

Charlotte Morabito at CNBC has put together “Why Pharmacies Overcharge,” an entertaining and provocative video on the pharmacy industry and its generic prescription pricing. It’s definitely worth your time. I especially enjoyed the cool visualizations of Drug Channels Institute’s industry data. Links below. The video covers the history of pharmacy, from the “Soda Fountain Era” to “Lick, Stick, and Pour” to the rise of PBMs and GoodRx. .

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Teva and MedinCell Announce FDA Acceptance of New Drug Application.

The Pharma Data

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and MedinCell (Euronext: MEDCL) announced today that the New Drug Application (NDA) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for the treatment of schizophrenia has been accepted by the U.S. Food and Drug Administration (FDA).

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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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Accelerating SE(3)-Transformers Training Using an NVIDIA Open-Source Model Implementation

Nvidia Developer: Drug Discovery

SE(3)-Transformers are versatile graph neural networks unveiled at NeurIPS 2020. NVIDIA just released an open-source optimized implementation that uses 43x less. SE(3)-Transformers are versatile graph neural networks unveiled at NeurIPS 2020. NVIDIA just released an open-source optimized implementation that uses 43x less memory and is up to 21x faster than the baseline official implementation.

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High School Grad’s Spacebound Study Began With Astronaut Medical Mystery

Drug Discovery Today

Wallops Flight Facility, VA. August 10, 2021 - An 18-year-old high school graduate has developed an elegant new way to gauge the liver health of astronauts—and it could someday help solve an enduring medical mystery in space.

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IP-NFTs for Researchers: A New Biomedical Funding Paradigm

Molecule Blog

TL;DR: This week, the first university biomedical intellectual property (IP) and research project was funded as an NFT (non-fungible token), enabled by a pioneering innovation at Molecule. The IP-NFT enables new fundraising and collaboration strategies for researchers by combining legal and technical frameworks with NFT technology. Early-stage research can be financed without endless grant applications, creating a startup and raising VC or needing to file a patent.

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New patent for Boehringer Ingelheim drug SYNJARDY

Drug Patent Watch

Annual Drug Patent Expirations for SYNJARDY Synjardy is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from one supplier. There are six patents…. The post New patent for Boehringer Ingelheim drug SYNJARDY appeared first on DrugPatentWatch - Make Better Decisions.

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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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Part B Update: Hospitals Keep Displacing Physicians—And More Practice Acquisitions Loom

Drug Channels

The Medicare Payment Advisory Commission (MedPAC), the independent agency that advises Congress on the Medicare program, recently released its latest Health Care Spending and the Medicare Program databook. This annual report is a treasure trove of useful and fascinating data. The July 2021 edition provides us with the latest pre-pandemic details on the buy-and-bill market in Medicare Part B.

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Lilly to Participate in Citi’s 16th Annual BioPharma Virtual Conference

The Pharma Data

Eli Lilly and Company (NYSE: LLY) will participate in Citi’s 16th Annual BioPharma Virtual Conference on September 8 and 9, 2021. Anat Ashkenazi, senior vice president and chief financial officer, will participate in a virtual fireside chat on Thursday, September 9 at 9:45 a.m., Eastern Time. A live audio webcast will be available on the “Webcasts & Presentations” section of Lilly’s Investor website at [link].

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Next-Generation Sequencing in Cell Line and Biosample Authentication

Crown Bioscience

While the authentication of biosamples (i.e., cell lines, organoids, xenograft and homograft models) has long been recommended, misidentification and contamination remains a problem. In this post, we explore two of the traditional (low throughput) genomic-based assays used for assessing biosample authentication and contamination: short tandem repeat (STR) and single nucleotide polymorphism (SNP) analysis.

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Digital brain biomarker start-up Monument Therapeutics appoints Acacia and Arakis founder Julian Gilbert to Board

Drug Discovery Today

Manchester, UK, August 11, 2021: Monument Therapeutics, a stratified medicine company, today announced Monument Therapeutics the appointment of Dr Julian Gilbert to its Board as a Non-Executive Director. Monument recently raised £2.625 million in seed funding and applies a novel drug development strategy, leveraging digital assessments of cognition to match patients with new pharmaceutical treatments.

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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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‘Synthetic cannabis’: A dangerous misnomer

National Drug & Alcohol Research Centre Blog

Professor Shane Darke The term ‘synthetic cannabis’ (or ‘synthetic marijuana’) has been widely used. The term, however, is wrong. This may sound like a pedantic point, but the misnaming of these drugs has potentially dangerous consequences. In a recent article in the International Journal of Drug Policy we proposed that they be referred to as synthetic cannabinoid receptor agonists (SCRAs), to emphasise that this is a drug class entirely distinct from marijuana.

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New patent for Boehringer Ingelheim drug GLYXAMBI

Drug Patent Watch

Annual Drug Patent Expirations for GLYXAMBI Glyxambi is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are eleven patents…. The post New patent for Boehringer Ingelheim drug GLYXAMBI appeared first on DrugPatentWatch - Make Better Decisions.

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Three Factors to Determine the Best e-Support Services Provider for Your Brand

Drug Channels

Today’s guest post comes from Stacey Little, Senior Vice President of Business Development and Marketing at AssistRx. Stacey discusses how a patient support vendor can help specialty pharmacy patients attain prior authorizations and access critical therapies. She offers three criteria that manufacturers can use to evaluate e-support services providers.

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FDA Approves Updated Indication for Merck’s KEYTRUDA® (pembrolizumab) for Treatment.

The Pharma Data

today announced a label update for KEYTRUDA, Merck’s anti-PD-1 therapy, for its indication in first-line advanced urothelial carcinoma (bladder cancer) in the U.S. The U.S. Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval. In addition, as part of the label update, this indication has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-

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Announcing the first biopharma IPNFT Transaction

Molecule Blog

Announcing the first biopharma IP-NFT Transaction Funding the first longevity research project by utilizing intellectual property NFTs in the pharmaceutical space Summary The vote has passed, the decision is made: The Scheibye-Knudsen Lab will be the first research organisation to fund their longevity research via an IPNFT. This historic moment needs to be celebrated properly!

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Genetic Analysis co-develops HumGut – the world’s first complete database of reference genomes from the human gut microbiome

Drug Discovery Today

(Oslo, August 5, 2021) Molecular diagnostics specialist, Genetic Analysis AS (GA) today announced the first publication from the comprehensive HumGut microbiome database has appeared in the leading scientific journal Microbiome. HumGut comprises a collection of about 30,000 genomes, covering the broad diversity of bacterial genomes found in the human gut.

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Acceptance of foreign clinical trials data by US FDA

ProRelix Research

Acceptance of foreign clinical trials data by US FDA Foreign Clinical Trials (FCTs) Prior to the 1962 Kefauver-Harrison Amendments, it was uncommon for a Sponsor to submit FCTs data. In […]. The post Acceptance of foreign clinical trials data by US FDA appeared first on ProRelix Research.

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Which pharmaceutical companies have the most drug patents in Bulgaria?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Bulgaria. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is…. The post Which pharmaceutical companies have the most drug patents in Bulgaria? appeared first on DrugPatentWatch - Make Better Decisions.

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Leveraging Mobile Patient Support to Boost Adherence

Drug Channels

Today’s guest post comes from Ian Ocilka, Senior Vice President of Client Solutions at ConnectiveRx. . Ian discusses how mobile platforms like mobileCare Manager can boost patient adherence to specialty therapies. To learn more, register for ConnectiveRx's free panel discussion on September 15, 2021, at 1:00 p.m. ET. Email inquiries@ConnectiveRx.com with any questions.

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Striving to Deliver Better Outcomes: Janssen to Showcase Commitment to.

The Pharma Data

Compelled to advance innovation for patients and the urology community, oral presentations highlight real-world effectiveness of and patient adherence to ERLEADA ® (apalutamide), plus PSA response from Phase 3 TITAN and SPARTAN studies in patients with advanced prostate cancer. The Janssen Pharmaceutical Companies of Johnson & Johnson announced today multiple company-sponsored presentations in prostate and bladder cancers will be highlighted at the virtual 2021 American Urological Associati

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Optimization of Pharmaceutical Dosage/ Formulation Chemistry

Pharmaceutical Development Group

Formulation chemistry is the systematic and step-by-step approach to pharmaceutical development. Nowadays, as the usage of medicines is increasing, pharmaceutical companies are more eager to bring manufacturing a new look in quality and performance. It involves designing, analyzing, and controlling manufacturing by taking timely measurements to ensure final product quality, efficacy, and safety.

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Bruntwood SciTech creates new director of life sciences role

Drug Discovery Today

New role for Dr Kath Mackay reflects ambitions of Bruntwood SciTech and growth of the UK’s life sciences sector

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Molecule’s Biopharma IPNFTs?—?A Technical Description

Molecule Blog

Molecule’s Biopharma IP-NFTs — A Technical Description Summary Creating legal agreements between two parties for (pre-patent) biopharma assets is complicated, in-transparent and lengthy. Molecule is proposing a new kind of marketplace for early-stage biopharma IP through which stated IP can easily be bought, funded and collaborated on. This marketplace needs to enable transparent IP rights and legal agreement construction, meanwhile accounting for the sensitivity of early-stage IP.

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Which pharmaceutical companies have the most spray dosed drugs?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most spray dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most spray dosed drugs…. The post Which pharmaceutical companies have the most spray dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.

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In vivo preclinical models for immune-mediated inflammatory disease drug development

Crown Bioscience

In this blog we will explore immune-mediated inflammatory diseases (IMIDs) —which represent a diverse group of conditions characterized by an excessive and/or inappropriate immune response. Interest in IMIDs has grown rapidly in recent years, largely fueled by the view that IMIDs share common inflammatory pathways, and therefore, there is the possibility that novel therapies that work in one IMID may work in other IMIDs.

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