Drug Discovery World

JANUARY 27, 2023

The Winter 2022/2023 issue of Drug Discovery World Magazine is out now. Featuring a Therapeutic Spotlight on Oncology ,  the magazine is available to download free here and read for free on the DDW App. You can also request to receive a copy of the printed magazine here. Key features of the Winter issue include an overview of the drug discovery landscape in 2023, sector successes and challenges in the Scandinavian market, and how a drug sourced from the aerospace industry could offer treatments

Therapies 246

Therapies Laboratories Treatment Disease 246

Drug Patent Watch

JANUARY 25, 2023

Annual Drug Patent Expirations for JANUMET Janumet is a drug marketed by Merck Sharp Dohme and is included in two NDAs. It is available from two suppliers. There are four… The post New patent expiration for Merck Sharp drug JANUMET appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 98

Drugs Marketing 98

Drug Channels

JANUARY 27, 2023

Today’s guest post comes from Saket Patel, Consultant, Advisory Services at MMIT. Saket discusses market access and contracting strategies for medical benefit products when pharmacy benefit biosimilar therapies launch. He then describes how to automate formulary and medical policies to protect manufacturers from overpayment. Click here to learn about MMIT’s Contract Validation solution.

Biosimilars 97

Biosimilars Pharmacy Therapies Production 97

Antidote

JANUARY 26, 2023

Osteoporosis, translated directly to “porous bone,” is a condition that impacts approximately 10 million Americans. The human body is constantly producing bone cells, but they are constantly being lost as well — and when the cells are being dissolved faster than they are being produced, weakness can result. Below, we’ll be taking a closer look at what osteoporosis is, what causes it, and how people can reduce the likelihood of developing the condition in their lifetime.

96

96

Advertisement

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 World

JANUARY 23, 2023

Over the three days of Advanced Therapies Week (ATW) 2023 in Miami, Florida, US, from 18 to 20 January, DDW’s Megan Thomas heard from attendees about what they were most looking forward to learning from the event, as well as why they think the potential of cell and gene therapies outweighs the obstacles that must be overcome to achieve it. Matt Lakelin, co-founder of TrakCel, shared that although ATW took place last year, 2023 sees the first fully subscribed ATW since the coronavirus pandemic.

Therapies 246

Therapies Small Molecule Production Treatment 246

Drug Patent Watch

JANUARY 25, 2023

Annual Drug Patent Expirations for JANUVIA Januvia is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from three suppliers. There are three… The post New patent expiration for Merck Sharp drug JANUVIA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 98

Drugs Marketing 98

Cytel

JANUARY 27, 2023

Should your clinical trial be adaptive? Trials that include a prospectively planned modification based on an interim analysis, otherwise known as adaptive trials , are often associated with greater efficiency and better prospects for patients without compromising statistical rigor. And new holistic approaches to creating these designs are making room for transformative, even revolutionary, changes to strategic drug development.

Clinical Trials 52

Clinical Trials Trials Drug Development Drugs 52

Drug Discovery World

JANUARY 24, 2023

DDW Multimedia Editor Megan Thomas observes the 2023 drug discovery landscape, speaking to industry experts and looking at the foundations of 2022 on which next year will lean. Virtual clinical trials ‘Virtual’ and ‘technology’ are concepts which are readily exchanged in this industry, but these are more than just buzzwords. The overall virtual clinical trials market is currently valued at $7.8 billion, with a projected growth of 14% per annum 1.

Clinical Trials 242

Clinical Trials Trials Drugs Treatment 242

Drug Patent Watch

JANUARY 25, 2023

Annual Drug Patent Expirations for JUVISYNC Juvisync is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are four patents protecting this drug and three… The post New patent expiration for Merck Sharp drug JUVISYNC appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 97

Drugs Marketing 97

Metabolite Tales Blog

JANUARY 26, 2023

Metabolism of 2022 FDA approved small molecule drugs – Part 1 Does CYP3A4 still rule? By Julia Shanu-Wilson It won’t come as much surprise to learn that of the 17 small molecules* approved by the FDA in 2022, CYP3A4 was the major player in drug metabolism. Nonetheless, there are some interesting facets to discover, a selection of which we take a look at in a two-part blog on “Metabolism of 2022 FDA approved small molecule drugs.” Analysis of the 100 most commonly prescribed dr

Small Molecule 52

Small Molecule FDA Approval FDA Drugs 52

Advertisement

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.

Clinical Trials

New Drug Approvals

JANUARY 25, 2023

Amcenestrant (SAR 439859) アムセネストラント Molecular Weight 554.48 Formula C 31 H 30 Cl 2 FNO 3 CAS No. 2114339-57-8 6-(2,4-dichlorophenyl)-5-[4-[(3 S )-1-(3-fluoropropyl)pyrrolidin-3-yl]oxyphenyl]-8,9-dihydro-7 H -benzo[7]annulene-2-carboxylic acid Amcenestrant 8-(2,4-dichlorophenyl)-9-(4-{[(3 S )-1-(3-fluoropropyl)pyrrolidin-3-yl]oxy}phenyl)-6,7-dihydro – 5H- Benzo[7]annulene-3-carboxylic acid 8-(2,4-Dichlorophenyl)-9-(4-{[(3 S )-1-(3-fluoropropyl)pyrrolidin-3-yl]oxy}phenyl)-6,7-dihydro-5 H -be

International 52

International Treatment Production 52

Drug Discovery World

JANUARY 27, 2023

Myosana Therapeutics has completed a seed funding round totalling over $5 million led by investor John Ballantyne. The capital will go towards developing Myosana’s gene therapy platform for neuromuscular and cardiac disease, with the goal of identifying the first development candidate for Duchenne muscular dystrophy by 2025. “Built on decades of expertise in neuromuscular diseases, Myosana’s muscle-specific non-viral gene therapy platform is poised to change the way patients are treated for

Therapies 130

Therapies Disease Drug Development Drugs 130

Drug Patent Watch

JANUARY 27, 2023

Annual Drug Patent Expirations for NOURIANZ Nourianz is a drug marketed by Kyowa Kirin and is included in one NDA. It is available from one supplier. There are four patents… The post New patent expiration for Kyowa Kirin drug NOURIANZ appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52

Drugs Marketing 52

Cytel

JANUARY 25, 2023

People think in Bayesian terms all the time: we use prior information and the evidence at hand to make decisions in our day-to-day lives. And it is this adaptive thinking that can be so useful in clinical trials, for example, in oncology trials where the standard of care might evolve during the course of the trial. In his recent webinar, “Novel Methods of Trial Design,” Prof.

Trials 52

Trials Clinical Trials Clinical Development 52

Advertisement

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

Clinical Trials

DrugBank

JANUARY 25, 2023

The world of artificial intelligence (AI) is rapidly changing, and one of the shifts we’re most excited about is a refocusing on data. As a bit of background, AI is made up of two major components, the model and the data. The models are essentially the tools or algorithms that enable computers to analyze data. The data is what the models are using to make decisions from.

Engineering 52

Engineering Research Treatment Science 52

Drug Discovery World

JANUARY 27, 2023

News round-up for 23-27 January by DDW Digital Content Editor Diana Spencer. Cell and gene therapies have been making the news this week, as we launch our very own guide to global innovation in CGT with the Winter issue of DDW, as well as an exciting new virtual event on the same topic. The top stories: Gene therapy for cystic fibrosis receives EC orphan drug designation The European Commission has granted orphan designation for Krystal Biotech’s KB407 for the treatment of cystic fibrosis

RNA 130

RNA Therapies Drugs Virus 130

Drug Patent Watch

JANUARY 26, 2023

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

Drugs 52

Drugs Marketing 52

keypoint

JANUARY 23, 2023

On March 24, 2023, Keystone Symposia will hosted a live ePanel event featuring the recipients of the Michelson Prizes: Next Generation Grants , an international prize that supports early-career researchers who are applying disruptive concepts and inventive processes to advance human immunology, vaccine discovery, and immunotherapy research. The prize is a collaboration between the Michelson Medical Research Foundation and the Human Immunome Project.

Vaccine 52

Vaccine International Research 52

Drug Channels

JANUARY 24, 2023

Now that 2023 is underway, let’s review employer-sponsored coverage for prescription drugs and speculate on what’s ahead. Below I examine the latest data on pharmacy benefits: cost sharing tier structures, copayment vs. coinsurance, and out-of-pocket obligations. As you will see, pharmacy benefit designs again increased the use of coinsurance for specialty and fourth-tier drugs.

Pharmacy 52

Pharmacy Drugs 52

Drug Discovery World

JANUARY 27, 2023

Enhertu has been approved in the EU as the first HER2 directed therapy for patients with HER2 low metastatic breast cancer. The drug is approved as monotherapy for adult patients who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. Enhertu is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca

Drugs 130

Drugs Engineering Therapies International 130

Drug Patent Watch

JANUARY 26, 2023

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

Drugs 52

Drugs Marketing 52

Cytel

JANUARY 23, 2023

Ever since the first immune checkpoint inhibitor was approved for market nearly twelve years ago, the industry has witnessed a steady rise in the search for new immunotherapies. This has aligned with the broader curation of a number of new dose-escalation and efficacy designs for clinical development in oncology. Hastening the search for novel treatment options therefore benefits from exploration of how these complex early and late-phase designs interact with each other, and what special design

Clinical Development 52

Clinical Development Trials Clinical Research Treatment 52

Antidote

JANUARY 23, 2023

Increasing diversity, equity, and inclusion (DEI) in clinical trials is a topic that has received a lot of attention in recent years, especially on the heels of the most recent guidance from the Food and Drug Administration — but it is still an area ripe for improvement.

Clinical Trials 52

Clinical Trials Trials Drugs 52

Drug Discovery World

JANUARY 27, 2023

DDW Editor Reece Armstrong looks into recent research which may explain why cancers can become more aggressive. Researchers in London and Milan may have discovered why cancers can become more aggressive without relying only on DNA mutations. A lot of research to do with cancer has focused on the way cancers can occur and evolve [.] To read this content in full, you need to login.

DNA 130

DNA Research Drugs 130

Drug Patent Watch

JANUARY 25, 2023

Annual Drug Patent Expirations for JANUMET+XR Janumet Xr is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from one supplier. There are… The post New patent expiration for Merck Sharp drug JANUMET XR appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52

Drugs Marketing 52

New Drug Approvals

JANUARY 22, 2023

Admin note for myself. I am up for Grabs I myself Dr Anthony Melvin Crasto Looking for a post retirement assignment as Advisor API & INT, Chem. With 36 yrs rich experience, about dozen patents, 10000plus steps covered, 200 API targets, 30 plus products commercialization in plant in full career. Hands on knowledge of Synthesis, Process, scaleup, cost reduction, DOE , softwares etc Kindly contact me Dr Anthony Melvin Crasto +919321316780 amcrasto@gmail.

International 52

International Production Organic Chemistry Drugs 52

Zobio

JANUARY 25, 2023

In person ZoBio was attending 16th Winter Conference on Medicinal & Bioorganic Chemistry held in the beautiful Steamboat Springs Resort, Colorado. The conference exposed attending scientists to cutting edge synthetic and medicinal chemistry as well as latest developments in technologies that foster innovation in drug discovery.In addition to the scientific presentations, this meeting provided a.

Drugs 40

Drugs 40

Drug Discovery World

JANUARY 26, 2023

DDW Editor Reece Armstrong explores recent research looking into why cancer cells are so effective at avoiding the body’s immune system. Scientists may have discovered clues to why cancer cells can avoid the body’s immune system in a study conducted by researchers at Harvard Medical School. For years now, scientists have been trying to understand why emerging tumour cells are able to dodge the body’s immune system, even though it’s designed to identify and defend against attacks from defective c

Medical Schools 130

Medical Schools Cell Biology Research Therapies 130

Drug Patent Watch

JANUARY 25, 2023

Annual Drug Patent Expirations for STEGLUJAN Steglujan is a drug marketed by Msd Sub Merck and is included in one NDA. It is available from one supplier. There are five… The post New patent expiration for Msd Sub drug STEGLUJAN appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52

Drugs Marketing 52

PerkinElmer

JANUARY 25, 2023

Laboratory professionals in all areas of science have experienced significant changes in recent years, and 2022 was no exception. As steady progress continues in returning to normalcy as we’ve learned how to manage COVID-19, the emergence of mpox last year brought a new set of challenges for healthcare professionals, laboratories and diagnostics developers to navigate.

Science 52

Science Laboratories Immune Response Disease 52

Zobio

JANUARY 25, 2023

In person ZoBio was attending 16th Winter Conference on Medicinal & Bioorganic Chemistry held in the beautiful Steamboat Springs Resort, Colorado. The conference exposed attending scientists to cutting edge synthetic and medicinal chemistry as well as latest developments in technologies that foster innovation in drug discovery.In addition to the scientific presentations, this meeting provided a.

Drugs 40

Drugs 40

Drug Discovery World

JANUARY 26, 2023

Organic chemists at t he University of California, Los Angeles (UCLA) have created the first synthetic version of a molecule recently discovered in a sea sponge that may have therapeutic benefits for Parkinson’s disease and similar disorders. The molecule, known as lissodendoric acid A, appears to counteract other molecules that can damage DNA, RNA and proteins and even destroy whole cells.

Organic Chemistry 130

Organic Chemistry Laboratories RNA DNA 130

Drug Patent Watch

JANUARY 25, 2023

Annual Drug Patent Expirations for BRAFTOVI Braftovi is a drug marketed by Array Biopharma Inc and is included in one NDA. It is available from one supplier. There are thirteen… The post New patent for Array Biopharma drug BRAFTOVI appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52

Drugs Marketing 52

Eye on FDA

JANUARY 26, 2023

Each year Eye on FDA provides a look-back to see what the agency was talking about and what has changed over time. This year is a telling one and FDA may be changing the nature of the way they are communicating with the public. Moreover, this year is marked by the fact that the agency appeared to have less to say than in most recent years – perhaps taking a breather after the frenzy of the COVID-19 pandemic years.

FDA 60

FDA Vaccine Treatment Drugs 60