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.

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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.

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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.

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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.

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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

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.

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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.

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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

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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

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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.

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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.

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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

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.

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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.

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Drug Patent Watch

JANUARY 21, 2023

This chart shows the companies which have received the most New Patient Population exclusivities in the past five years. New Patient Populations are one of the categories for which the… The post Pharmaceutical companies with the most ‘New Patient Population’ drugs appeared first on DrugPatentWatch - Make Better Decisions.

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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.

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Clinical Trials

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.

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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

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Drug Patent Watch

JANUARY 27, 2023

This chart shows the drugs with the most supplementary protection certificates (SPCs). SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating for the long… The post Which drugs have the most supplementary protection certificates? appeared first on DrugPatentWatch - Make Better Decisions.

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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.

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Clinical Trials

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.

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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.

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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.

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Elrig

JANUARY 26, 2023

CRISPR in Drug Discovery 2023: Bringing together the genome engineering community Now in its fifth year, ELRIG’s CRISPR in Drug Discovery: From Targets to Therapeutics event has become an annual highlight of the genome engineering community. With a comprehensive programme, the meeting will explore: The use of genome engineering in the identification of novel drug targets through large-scale CRISPR-based functional genomics studies.

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Molecular Design

JANUARY 24, 2023

> I had originally intended to look at permeability in this post but I do need to respond to Dan Erlanson’s post at Practical Fragments. I see Dan’s position ( “everything is an artifact until proven otherwise” ) as actually very similar to my position ( “chemical probes will have to satisfy the same set of acceptability criteria whether or not they trigger structural alerts” ) and we’re both saying that you need to perform the necessary measurements if you’re going to claim that a compound i

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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.

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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.

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Precision for Medicine

JANUARY 23, 2023

QuartzBio’s suite of end-to-end SaaS solutions provides pharmaceutical and biotech clients with a fully connected data ecosystem linking sample, biomarker, and clinical data to improve collaboration, planning and R&D productivity. [Frederick, MD – January 24, 2023] Precision for Medicine, the first global, precision medicine clinical research services organization, today announced the strategic acquisition of SolveBio by QuartzBio.

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FDA Law Blog: Drug Discovery

JANUARY 23, 2023

By Faraz Siddiqui & Deborah L. Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA). This requirement, enacted under section 3601 of Food and Drug Omnibus Reform Act (FDORA), will apply to clinical trials that commence enrollment 180 days after FDA finalizes guidance on the topic

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Advarra

JANUARY 26, 2023

Medicare coverage analysis (MCA) is a systemic process of developing a billing plan for a clinical research study. Also known as coverage analysis, MCA provides an in-depth analysis of how all the items and services listed in the clinical research protocol are billed per guidelines provided by the federal agencies. The Centers for Medicare and Medicaid Services (CMS) provides information and guidelines to determine whether billable items and services to be billed to the third party (insurance/pa

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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.

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Drug & Device Law

JANUARY 24, 2023

Almost a year ago we wrote a post called Learned Intermediary – Not Just for Failure to Warn about a California putative economic loss class action that was dismissed for failing to plead any allegations about whether the drug manufacturer had adequately warned plaintiff’s prescribing physician. Fast forward about 9 months and we posted about the California Amiodarone decision that rejected plaintiffs’ argument that the learned intermediary doctrine was an affirmative defense and could not be t

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Drug Patent Watch

JANUARY 25, 2023

This chart shows the pharmaceutical companies with the most patents in Australia. 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 Australia? appeared first on DrugPatentWatch - Make Better Decisions.

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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.

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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.

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