Drug Discovery World

JANUARY 13, 2023

Cambrian BioPharma has unveiled its latest pipeline company, Isterian Biotech. . The preclinical start-up is working towards the development of first-in-class small molecule inhibitors of transglutaminase 2 (TG2), one of the major crosslinking enzymes in the human body, which becomes more active during ageing, resulting in fibrotic diseases. . With age a chronic increase of crosslinked proteins occurs in the extracellular matrix (ECM).

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Drug Discovery Today

JANUARY 10, 2023

Report highlights personalized medicines ensuring greater efficacy for rare diseases and previously untreatable conditions.

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Drug Channels

JANUARY 13, 2023

Today’s guest post comes from Clay Courville, Chief Product Officer at CoverMyMeds. Clay discusses the ongoing problem of medication errors. He describes CoverMyMeds’ provider alerts solution, which is designed to minimize medication errors. Click here to learn more about CoverMyMeds’ Provider Medication Alerts solution. Read on for Clay’s insights.

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Antidote

JANUARY 12, 2023

Alzheimer’s disease is the most common type of dementia in the United States, impacting around 6.2 million people above the age of 65. Since it was first observed in the early 1900s, a lot of information has been uncovered through medical research.

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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.

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Drug Discovery World

JANUARY 13, 2023

News round-up for 9-13 January by DDW Digital Content Editor Diana Spencer. Once again, research partnerships and licence agreements have dominated the news this week, as drug discovery companies seek new ways to combine their expertise to address unmet medical needs. . The top stories: . Alliance to develop circular RNA-based therapeutics . Esperovax and Ginkgo Bioworks have agreed a partnership to develop circular RNAs (circRNAs) for a variety of therapeutic applications. .

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New Drug Approvals

JANUARY 13, 2023

SC-52458, FORASARTAN Molecular FormulaC 23 H 28 N 8 Average mass416.522 Da PHASE 2, PFIZER, HYPERTENSION 145216-43-9 [RN] 5-[(3,5-Dibutyl-1H-1,2,4-triazol-1-yl)methyl]-2-[2-(1H-tetrazol-5-yl)phenyl]pyridine 5-[(3,5-dibutyl-1H-1,2,4-triazol-1-yl)methyl]-2-[2-(2H-1,2,3,4-tetrazol-5-yl)phenyl]pyridine форасартан [Russian] [INN] , فوراسارتان [Arabic] [INN] , 福拉沙坦 [Chinese] [INN] 065F7WPT0B [DBID] 7415 [DBID] UNII-065F7WPT0B [DBID] SC 52458[DBID] Type-1 angiotensin II receptor Forasartan , otherwise

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Drug Patent Watch

JANUARY 13, 2023

Annual Drug Patent Expirations for WINLEVI Winlevi is a drug marketed by Sun Pharm and is included in one NDA. It is available from one supplier. There are eight patents…. The post New patent for Sun Pharm drug WINLEVI appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Discovery World

JANUARY 12, 2023

Pheno Therapeutics has entered an agreement with UCB for the rights to develop, manufacture and commercialise a preclinical-stage programme of novel small molecules designed to promote remyelination. . “Pheno Therapeutics utilised its proprietary human phenotypic screening platform to discover novel and tractable therapeutic targets to modulate oligodendrocyte biology and promote remyelination.

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Cytel

JANUARY 13, 2023

Bayesian methods, with their ability to facilitate flexibility and learning, are often associated with early-phase clinical trials. Yet there are also many strategic uses of Bayesian methods in late-phase clinical trial design, which can help generate more effective, efficient, and ethical clinical trials.

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Advarra

JANUARY 13, 2023

New privacy regulations seem to form every few months, especially with individual U.S. states adopting their own privacy regulations (e.g., the California Consumer Privacy Act or CCPA ). Endpoint adjudication committees (EACs), also called clinical event committees (CECs), receive potentially identifiable research data from all over the world. Because of this, they need to stay abreast of these rapidly developing requirements and have systems in place to ensure data compliance and protection.

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Drug Patent Watch

JANUARY 13, 2023

Annual Drug Patent Expirations for SAVELLA Savella is a drug marketed by Allergan and is included in one NDA. It is available from two suppliers. There are two patents protecting…. The post New patent expiration for Allergan drug SAVELLA appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Discovery World

JANUARY 12, 2023

Airsupra (albuterol/budesonide) has been approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. . Airsupra is a pressurised metered-dose inhaler (pMDI), fixed-dose combination of albuterol, a short-acting beta2-agonist (SABA), and budesonide, an anti-inflammatory inhaled corticosteroid (ICS).

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Cytel

JANUARY 12, 2023

Statistical methods have long been fundamental to drug development, and advancements in the last few decades in computing power have opened the door to more widespread use of Bayesian methods in clinical trials. Interest in Bayesian methods is growing – in particular due to what these approaches enable. So why aren’t more clinicians using Bayesian methods?

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ProRelix Research

JANUARY 12, 2023

In India, the Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services, Government of India is the National Regulatory Authority (NRA) responsible for the approval of […]. The post Clinical Trial Application and Import Requirement in India with respect to SUGAM portal appeared first on ProRelix Research.

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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

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Drug Patent Watch

JANUARY 12, 2023

Annual Drug Patent Expirations for PLENVU Plenvu is a drug marketed by Salix and is included in one NDA. It is available from one supplier. There are nine patents protecting…. The post New patent for SALIX drug PLENVU appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Discovery World

JANUARY 12, 2023

X-Chem and Sironax have agreed a research partnership, in which X-Chem will use its DEL platform to support Sironax’s drug discovery pipeline. . Through the collaboration, X-Chem will screen its DNA-encoded libraries (DEL) against difficult-to-drug targets implicated in neurodegenerative disease to discover hits. In turn, Sironax will prosecute these hits into transformational medicines for degenerative disease. .

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Crown Bioscience

JANUARY 11, 2023

It is well-known that drug attrition rates for anticancer agents are very high. In fact, only about 5% of compounds in preclinical development eventually becoming approved for clinical use. The need for more clinically relevant preclinical models has been identified as one of the areas that can reduce this attrition rate by enabling better decisions when selecting agents to advance to the clinic.

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Advarra

JANUARY 10, 2023

As the clinical research industry becomes more centered on technology, perhaps one of its most underused solutions is the electronic consent (eConsent) platform. A valuable tool for both sites and participants, there are many benefits to adopting eConsent. This blog outlines why adopting an eConsent platform is a beneficial and strategic step sites can take right now. eConsent Gives Sites Flexibility.

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Drug Patent Watch

JANUARY 12, 2023

Annual Drug Patent Expirations for EPINEPHRINE Epinephrine is a drug marketed by Armstrong Pharms, Am Regent, Bpi Labs, Intl Medication Sys, Hospira, and Teva Pharms Usa and, and is included…. The post New patent for Bpi Labs drug EPINEPHRINE appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Discovery World

JANUARY 11, 2023

AbbVie and Immunome have agreed a worldwide collaboration with the aim of discovering up to 10 novel antibody-target pairs arising from three specified tumour types using Immunome’s Discovery Engine. . Steve Davidsen, Vice President, Oncology Discovery Research, AbbVie. “Immunome’s approach has the potential to unlock novel cancer biology and yield multiple therapeutic candidates.

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Molecule Blog

JANUARY 9, 2023

The future of research is collaborative, digital, and highly autonomous. Patents today are not. We are building the intellectual property system that will help usher in this new era. IP-NFTs and Decentralized, Autonomous Science Today, most science is conducted at centralized institutions with a high barrier to entry and a reliance on imprecise human labor.

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DS in Pharmatics

JANUARY 7, 2023

Cell and gene therapies for treating multiple myeloma, such as CAR-T, have resulted in breakthrough health outcomes for patients. In the last decade, approval of cell and gene therapy (CGT) products has increased significantly.

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Drug Patent Watch

JANUARY 11, 2023

Annual Drug Patent Expirations for WINLEVI Winlevi is a drug marketed by Sun Pharm and is included in one NDA. It is available from one supplier. There are eight patents…. The post New patent expiration for Sun Pharm drug WINLEVI appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Discovery World

JANUARY 11, 2023

AstraZeneca has entered into an agreement to acquire CinCor Pharma, a clinical-stage biopharmaceutical company, focused on developing treatments for resistant and uncontrolled hypertension as well as chronic kidney disease. . As part of the deal, the company will acquire CinCor’s candidate drug, baxdrostat (CIN-107), an aldosterone synthase inhibitor (ASI) for blood pressure lowering in treatment-resistant hypertension. .

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Antidote

JANUARY 9, 2023

As a digital company, Antidote does not produce goods or services that have a major environmental impact — however, we understand that small changes still have a big impact.

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Precision for Medicine

JANUARY 10, 2023

Precision for Medicine will be exhibiting at OCT Southeast in Raleigh NC. Contact us here to schedule a meeting or stop by out booth to meet the team! At OCT Southeast pharmaceutical, biotechnology, and medical device communities come together and discuss strategies for operational success in clinical trials The post OCT Southeast (March 28-29) appeared first on Precision For Medicine.

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Drug Patent Watch

JANUARY 11, 2023

Annual Drug Patent Expirations for IBRANCE Ibrance is a drug marketed by Pfizer and is included in two NDAs. It is available from two suppliers. There are six patents protecting…. The post New patent for Pfizer drug IBRANCE appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Discovery World

JANUARY 10, 2023

For over 50 years, Bethyl Laboratories (now a Fortis Life Sciences brand) has been dedicated to improving lives by supporting scientific discovery through qualified antibody products and custom services. We are vertically-integrated from immunisation through manufacturing and validation. All of our antibodies are highly validated using six pillars of validation, meaning that our antibodies do what we say they’ll do.

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Drug & Device Law

JANUARY 9, 2023

The flimsy decision in In re Acetaminophen − ASH-ADHD Products Liability Litigation , 2022 WL 17348351 (S.D.N.Y. Nov. 14, 2022), leaves us scratching our heads. First, it claims to find “helpful guidance,” id. at *7, in Wyeth v. Levine , 555 U.S. 555 (2009), a prescription drug preemption case, despite the relevant drug(s) being over-the-counter (“OTC”), and thus approved under an entirely different FDA regulatory process.

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Precision for Medicine

JANUARY 9, 2023

Precision for Medicine will be exhibiting and speaking at Biomarkers UK in Manchester. Schedule a meeting here or stop by our booth! Biomarkers UK is Europe’s flagship event for Biomarker research and provides a forum to engage with the latest trends transforming biomarker and translational research. The post Biomarkers UK (February 27-28) appeared first on Precision For Medicine.

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Drug Patent Watch

JANUARY 11, 2023

Annual Drug Patent Expirations for TAGRISSO Tagrisso is a drug marketed by Astrazeneca and is included in one NDA. It is available from one supplier. There are three patents protecting…. The post New patent for Astrazeneca drug TAGRISSO appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Discovery World

JANUARY 10, 2023

The American Association for Cancer Research (AACR) Annual Meeting 2023 will be held April 14-19 at the Orange County Convention Center in Orlando, Florida. The meeting is the focal point of the American cancer research community, where scientists, clinicians, health care professionals, survivors, patients, and advocates share the latest advances in cancer science and medicine. .

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Drug & Device Law

JANUARY 7, 2023

As 2022 has come to an end, our loyal readers have joined us in reviewing our worst decisions of the past year and our best decisions of the past year. As we do each year, we’re pleased to announce that three of your bloggers – Bexis, Steven Boranian, and Rachel Weil – will be presenting a free 90-minute CLE webinar on “The good, the bad and the ugly: The best and worst drug/medical device decisions of 2022” on Thursday, January 19 th at 1 p.m.

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Drug Discovery World

JANUARY 10, 2023

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for VAX-24, Vaxcyte’s 24-valent pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease. . The decision was based on positive topline results from a Phase I/II proof-of-concept study, which evaluated the safety, tolerability and immunogenicity of VAX-24 in adults 18-64 years of age. .

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