August, 2022

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A More Connected Future for Pharma

Drug Discovery Today

In the lead up to the inaugural launch of Connect In Pharma, co-founder Wilfried Phipps provides insight into what visitors can expect at this new annual event designed to help shape the future of pharmaceutical packaging and manufacturing projects

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3 reasons why patients want to participate in a clinical trial

Antidote

In the world of medical research, experts are constantly looking for new drugs, treatments, and therapies for a variety of conditions — but the process of getting these treatments approved is only possible if they are tested through clinical trials.

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Your Brand Just Got Added to a Must-Have Formulary: Now What?

Drug Channels

Today’s guest post comes from Chris Dowd, Senior Vice President of Market Development at ConnectiveRx. Chris discusses the benefits of using in-electronic health record (EHR) messaging to communicate formulary information to both healthcare providers and patients during the patient encounter. Click here to learn more about ConnectiveRx’s in-EHR messaging.

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Senator Burr: Rip Van Winkle Performance on Drug Importation, Owes Italy an Apology 

Policy Prescription

This past June, during a debate in the Senate Health, Education, Labor and Pensions (HELP) Committee, Senator Richard Burr (R-NC), the committee’s Ranking Member, demonstrated that he does not understand very important developments in our nation’s approach to drug regulation and safety. It was almost as if Sen. Burr had fallen asleep over 20 years ago and woke up believing that nothing had changed in the world of drug regulation.

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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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New patent for Alkermes Inc drug ARISTADA

Drug Patent Watch

Annual Drug Patent Expirations for ARISTADA Aristada is a drug marketed by Alkermes Inc and is included in two NDAs. It is available from one supplier. There are sixteen patents…. The post New patent for Alkermes Inc drug ARISTADA appeared first on DrugPatentWatch - Make Better Decisions.

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What They Said – Looking Back the First 6-Months of FDA Communications

Eye on FDA

Periodically I write a posting to look back at what FDA is talking about to get some perspective. Each individual press release tells us something, but looking back at the aggregate can also provide insights. Not long ago, a retrospective look that compared the ratio and trend of COVID versus non-COVID related news out of FDA suggested that not only was COVID becoming less of a topic for the agency, but also presented the possibility that there was increasing room for other topics.

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More Trending

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How to find research studies near you and frequently asked questions about participating in a clinical trial

Antidote

Clinical research studies around the United States are in need of participants to learn more about various conditions. For those interested in learning how to take part in research, finding clinical trials that might be a fit can be simple — by answering a few questions about your location and medical history, you can see all the active trials you may be eligible for.

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The 340B Program Climbed to $44 Billion in 2021—With Hospitals Grabbing Most of the Money

Drug Channels

Here’s a summer surprise for fans of the 340B Drug Pricing Program: Drug Channels has just obtained the 2021 figures from the Health Resources and Services Administration (HRSA)! Even better, my Freedom of Information Act (FOIA) request was able to pry out detailed purchases by covered entity type. The data tell a familiar story. For 2021, discounted purchases under the 340B program reached a record $43.9 billion —an astonishing $5.9 billion (+15.6%) higher than its 2020 counterpart.

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Regulatory, Clinical, and Quality Considerations for Device Research

Advarra

In response to a growing demand for faster, approved, and cost-effective medical devices for chronic diseases, medical device manufacturers and emerging biotech companies are facing increasingly complex pathways to successfully bring their innovative ideas to the market. If a new medical device, software as a medical device (SaMD), or in vitro diagnostic (IVD) is poised to successfully make it through the development process to commercialization, sponsors must consider a trifecta of interconnect

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New patent for Pharmacyclics Inc drug IMBRUVICA

Drug Patent Watch

Annual Drug Patent Expirations for IMBRUVICA Imbruvica is a drug marketed by Pharmacyclics Inc and is included in two NDAs. It is available from one supplier. There are forty patents…. The post New patent for Pharmacyclics Inc drug IMBRUVICA 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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Using PDX Models to Tackle Acquired Drug Resistance to Targeted Cancer Therapies

Crown Bioscience

Targeted therapies have altered the landscape of cancer treatment across an increasing number of cancer types. While these drugs have significantly benefited many cancer patients, a major ongoing challenge associated with targeted therapies is acquired drug resistance, which is believed to be a key factor in cancer-related deaths. In this post we explore how acquired drug resistance to targeted therapies can be tackled by using in vivo patient-derived xenograft (PDX) models, which are effective

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NIHR and Sanofi announce first patient enrolled in large European clinical study to investigate protection against RSV, the leading cause of infant hospitalisation worldwide

Drug Discovery Today

Reading, 12 August 2022. Sanofi (EURONEXT: SAN and NASDAQ: SNY) and the National Institute for Health and Care Research (NIHR) have today announced that the first patient has been enrolled in the Hospitalised RSV Monoclonal Antibody Prevention (HARMONIE) study. The large European interventional clinical study is investigating protection against Respiratory syncytial virus (RSV) in infants.

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3 digital spaces for patients to find community and support

Antidote

Online communities have long provided people with the opportunity to connect with others across the globe, and as the internet has become more ubiquitous in our day-to-day lives, their popularity has only increased. Online groups often pop up surrounding a variety of focuses, from gardening to antiquing to listening to a particular podcast — but they have also become an important way for patients to connect with one another.

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Texas Shows Us Where PBMs’ Rebates Go

Drug Channels

Over the weekend, the U.S. Senate passed a massive overhaul of the Medicare Part D program. If passed into law, these changes will have many unintended consequences , but will not address the warped incentives baked into our current rebate system. This makes it a good time to review the murky, little-seen economics of how commercial plan sponsors and payers access the billions of dollars in manufacturer rebates and fee that are negotiated by their pharmacy benefit managers (PBMs).

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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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Safe Sharps Handling When Dispensing Investigational Products

Advarra

Institutional biosafety committees (IBCs) frequently receive questions about the proper methodology for preparing a syringe for transport from a drug room or pharmacy to the clinic where the injection will be administered. This article explores tools and techniques to safely mitigate occupational exposure risks when preparing a syringe for transport to the clinic.

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New patent for Otsuka Pharm drug ABILIFY MAINTENA KIT

Drug Patent Watch

Annual Drug Patent Expirations for ABILIFY+MAINTENA+KIT Abilify Maintena Kit is a drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. It is available from one supplier.…. The post New patent for Otsuka Pharm drug ABILIFY MAINTENA KIT appeared first on DrugPatentWatch - Make Better Decisions.

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Proteogenomics reveals markers of chemotherapy resistance and outcome in triple negative breast cancer

Broad Institute

Proteogenomics reveals markers of chemotherapy resistance and outcome in triple negative breast cancer By Tom Ulrich August 24, 2022 Breadcrumb Home News Proteogenomics reveals markers of chemotherapy resistance and outcome in triple negative breast cancer Integrated approach highlights potential therapeutic opportunities for a challenging tumor type By Molly Chiu, Baylor College of Medicine August 24, 2022 NCI )" title="Triple-negative breast cancer cells (blue).

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European pharma needs to keep manufacturing on the continent and become more digitised to stay competitive, say speakers at new event

Drug Discovery Today

The newly announced agenda for Connect in Pharma focuses on innovation as the foundation of a strong pharmaceutical industry in Europe

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5 things you may not know about celiac disease

Antidote

Celiac disease, an autoimmune disorder that causes a reaction to gluten, is a condition that impacts about 1 in 141 people in the United States. For those with celiac disease, ingesting gluten creates toxins that destroy the villi of the small intestine, which makes it difficult for the body to absorb nutrients from food.

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The Next Great Healthcare Surge: A ‘Diagnosis Explosion’

Drug Channels

Today’s guest post comes from H. John Beardsley, Senior Vice President of Corporate Strategy at CoverMyMeds. John discusses how a patient-centric technology solution can increase access and affordability for patients. He goes on to describe how human contact and support helps patients understand their disease and their treatment plan, thus increasing adherence.

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Real-World Evidence Studies: Introduction, Purpose, and Data Collection Strategy

ProRelix Research

Real-World Evidence Studies: Introduction, Purpose, and Data Collection Strategy The first image that comes to mind when one thinks of where safety and efficacy data for a new treatment is […]. The post Real-World Evidence Studies: Introduction, Purpose, and Data Collection Strategy appeared first on ProRelix Research.

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New patent expiration for Sucampo Pharma drug AMITIZA

Drug Patent Watch

Annual Drug Patent Expirations for AMITIZA Amitiza is a drug marketed by Sucampo Pharma Llc and is included in one NDA. It is available from three suppliers. There are nine…. The post New patent expiration for Sucampo Pharma drug AMITIZA appeared first on DrugPatentWatch - Make Better Decisions.

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Pediatric Psoriasis vs. Eczema

Olympian Clinical Research

Psoriasis and eczema are both chronic conditions that can affect children and adults alike. While these conditions may be similar, there are some distinguishing characteristics. Knowing the difference between pediatric psoriasis and eczema may help you get the correct diagnosis for your child and help them find relief. While these conditions cannot be cured, there are treatments available that may lessen the symptoms.

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The Current issue of “The view from here” is concerned with Medicinal Chemistry

Drug Discovery Today

The topic of this month’s newsletter from Drug Discovery Today is “Medicinal Chemistry”.

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Idiopathic pulmonary fibrosis research round-up

Antidote

Though idiopathic pulmonary fibrosis (IPF) is the most common type of pulmonary fibrosis , it still has no known cause and no known cure. Because it causes scarring of the lungs, IPF can make it difficult to breathe and gets worse over time — meaning researchers are continually searching for breakthroughs that allow for a better understanding of the condition and how best to treat it.

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Three Technology Tactics for Overcoming Prior Authorization Hurdles

Drug Channels

Today’s guest post comes from Karina Castagna, SVP of Access and Adherence at OptimizeRx. Karina discusses the challenges health care providers and patients face in their quest to secure prior authorizations from payers. She argues that manufacturers adopt an electronic health record-based solution to facilitate access to therapies, from the point of prescription through the point of dispensing at the pharmacy.

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Authenticating Your Cell Lines – Why, When and How!

Crown Bioscience

Are you confident that your cell lines and biological models are really what you think they are? Do you know that common PCR-based cell line authentication services may not be able to detect contamination of up to 20% of your cell line?

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New patent for Azurity drug NYMALIZE

Drug Patent Watch

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 five patents protecting…. The post New patent for Azurity drug NYMALIZE appeared first on DrugPatentWatch - Make Better Decisions.

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Regulatory and Ethical Considerations for eConsent in Research

Advarra

In the last few years, the clinical research industry has seen a bigger push for electronic informed consent (eConsent) than ever before. Although it’s becoming more widespread, there are currently no definitions for eConsent in the Human Subjects Protection– it’s a concept only described in guidance. eConsent typically refers to the use of electronic systems and processes to: Convey information related to the study, and/or.

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ChEMBL 31 is out!

The ChEMBL-og

We are pleased to announce the release of ChEMBL 31! This version of the database, prepared on 12/07/2022 contains: 2,967,627 compound records 2,331,700 compounds (of which 2,304,875 have mol files) 19,780,369 activities 1,498,681 assays 15,072 targets 85,431 documents New Data Sources MMV Malaria HGL Fraunhofer HDAC6 Updated Data Sources Scientific Literature Patent Bioactivity Data Donated Chemical Probes - SGC Frankfurt EUbOpen Chemogenomic Library Newly Deposited Datasets CHEMBL4888484 - Rep

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Creating communities around medical research: Q&A with Heart Valve Voice

Antidote

Medical research is how new treatments and therapies move forward, but challenges surrounding patient recruitment can often lead to delays. Patients often have misconceptions about participating in a clinical trial — and if they are interested, they often aren’t sure where to begin.

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Improving Out-of-Pocket Cost Transparency For Physicians

Drug Channels

Today’s guest post comes from Divya Iyer, VP, Strategy and Business Development, Pharma Manufacturer Solutions at GoodRx. Divya highlights new GoodRx research on the out-of-pocket cost gap between brand-name and generic prescriptions. She discusses the challenges that providers face when having real-time discussions with patients about out-of-pocket costs.

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Mouse Models of Inflammatory Bowel Disease

Crown Bioscience

In this post, we explore the wide variety of inflammatory bowel disease (IBD) mouse models available to researchers, including their unique characteristics. Understanding important differences between these models is key to selecting the optimal one for your specific research questions.

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New patent for Glenmark Specialty drug RYALTRIS

Drug Patent Watch

Annual Drug Patent Expirations for RYALTRIS Ryaltris is a drug marketed by Glenmark Specialty and is included in one NDA. It is available from one supplier. There are twelve patents…. The post New patent for Glenmark Specialty drug RYALTRIS appeared first on DrugPatentWatch - Make Better Decisions.

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