April, 2022

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Thirona’s RetCAD™ and iCare are joining forces in Europe to offer an integral solution for eye screening with artificial intelligence.

Drug Discovery Today

Nijmegen, the Netherlands April 27th, 2022 – Thirona, one of the leading companies specializing in artificial intelligence for medical image analysis, has signed a strategic partnership agreement with iCare, for the implementation of Thirona’s RetCAD™ artificial intelligence software into the iCare solutions for eye disease screening, in Europe. The partnership underpins both companies’ technological leadership in this field.

Disease 157
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The value of method of use patent claims in protecting your therapeutic assets

Drug Patent Watch

This is a guest post by Ray Miller and Megan E. Bowers, Ph.D. at DLA Piper. Ray may be contacted at raymond.miller@dlapiper.com. When it comes to protecting therapeutic assets, I…. The post The value of method of use patent claims in protecting your therapeutic assets appeared first on DrugPatentWatch - Make Better Decisions.

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Five Takeaways from the Big Three PBMs’ 2022 Formulary Exclusions (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: PBM Industry Update: Trends, Controversies, and Outlook. Click here to see the original post and comments from January 2022. For 2022, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)— increased the number of drugs they excluded from their standard formularies.

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“Bayer is on the right track”

The Pharma Data

Operationally and strategically successful in 2021 / Dividend of 2.00 euros per share proposed / Very successful start to 2022. The Bayer Group was operationally and strategically successful in 2021. “ We achieved a lot, and there’s a lot of good news to report as regards our functional performance, invention power and sustainability. Bayer is on the right track,” said Werner Baumann, Chairman of the Board of Management, at the company’s virtual Annual Stockholders’Meeting in Leverkusen on

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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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Why clinical trial site support matters: A Q&A with Lauren Schill

Antidote

Antidote and other digital vendors work closely with clinical trial sites to ensure patient enrollment runs smoothly. Among the recruitment solutions we offer to sponsors is site follow-up services. We sat down with Lauren Schill, Senior Manager, Clinical Site Operations, to get her take on why site follow-up is a key component of clinical trial recruitment.

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Natural Antibodies Detected in Tumors—Expected to Improve Cancer Immunotherapy

Creative Biolabs

Even through relying on the immune system of patients, cancer immunotherapy is still far from fully utilizing the entire body’s natural defense system. In fact, most of these treatments only utilize the ability of T cells to fight tumors. In a new study, researchers paved the way for the development of immunotherapy using a different, novel, and naturally occurring antibody.

More Trending

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New patent for Janssen Pharms drug INVEGA TRINZA

Drug Patent Watch

Annual Drug Patent Expirations for INVEGA+TRINZA Invega Trinza is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. There is one…. The post New patent for Janssen Pharms drug INVEGA TRINZA appeared first on DrugPatentWatch - Make Better Decisions.

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Who Will Pay for Prescription Drugs in 2030? (Hint: It’s Us)

Drug Channels

The econowonks at the Centers for Medicare & Medicaid Services (CMS) recently released the latest projections for U.S. spending on healthcare. (See links below.) These data provide our first official look at post-pandemic U.S. healthcare spending. As you will see below, outpatient prescription drugs dispensed by retail and mail pharmacies are projected to remain a small share (8.4%) of total U.S. healthcare spending.

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FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID- 19 Vaccines

The Pharma Data

Today, the U.S. Food and Drug Administration is announcing its plans to hold virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in anticipation of complete submissions of emergency use authorization (EUA) requests in the coming months that have been publicly announced by COVID-19 vaccine manufacturers. It is important to note that the dates below are tentative as none of the submissions are complete.

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Antidote’s ESG initiative: Building a culture of environmental sustainability

Antidote

ESG, short for “Environmental, Social, and Governance,” is a set of standards for a company’s operations that socially conscious investors use to screen potential investments. This year, Antidote is tackling the environmental piece of ESG head-on.

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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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Combating Cancer Drug Resistance with In Vivo Models

Crown Bioscience

Drug resistance to cancer therapy is a significant problem facing patients. It has been identified as the major factor limiting greater treatment success.

Drugs 52
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VectorBuilder to expand with $500 million ‘Gene Delivery Research and Manufacturing Campus’

Drug Discovery Today

April 7, 2022, VectorBuilder Inc. – a global leader in gene delivery solutions – has announced the construction of a new R&D and manufacturing center in Guangzhou, China. The ‘Gene Delivery Research and Manufacturing Campus’ will significantly expand VectorBuilder’s R&D capabilities and its production capacity for both research-use and cGMP-grade gene delivery vectors, allowing the company to continue supporting groundbreaking research worldwide.

Research 113
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New patent for Melinta drug BAXDELA

Drug Patent Watch

Annual Drug Patent Expirations for BAXDELA Baxdela is a drug marketed by Melinta and is included in two NDAs. It is available from one supplier. There are thirteen patents protecting…. The post New patent for Melinta drug BAXDELA appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Channels News Roundup, April 2022: 340Boom, 340B Profits for Pharmacies & PBMs, Fixing Insulin, Walgreens’ Robots, and Doctors’ Day

Drug Channels

Baseball season is in full swing! Oil up your glove, lace up your cleats, and let's run the bases around this month's news stories. Remember: Sometimes you win, sometimes you lose, and sometimes it rains. In this issue: Green Monster : The 340B market hits new highs in 2021 Not-Free Agents : Big 340B profits for CVS, Walgreens, Express Scripts, et al Batter Up : Fixing the insulin market Pinch Hitters : Walgreens bets on robots Plus, Dr.

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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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Pfizer Shares Top-Line Results from Phase 2/3 EPIC-PEP Study of PAXLOVID™ for Post-Exposure Prophylactic Use

The Pharma Data

Pfizer Inc. (NYSE: PFE) today shared top-line results from the Phase 2/3 EPIC-PEP ( E valuation of P rotease I nhibition for C OVID-19 in P ost- E xposure P rophylaxis) study evaluating PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for post-exposure prophylactic use. In this trial, compared to placebo, Pfizer observed risk reductions of 32% and 37% in adults who received PAXLOVID for five and ten days, respectively, to prevent infection.

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7 clinical trial advertising do's and don'ts

Antidote

Is it possible to be creative in clinical trial advertising while following FDA guidelines , social media ad rules, and additional IRB constraints? You can create compelling ads without breaking the rules if you take the time to strategize.

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Sygnature Discovery acquires Peak Proteins

Sygnature Discovery

Sygnature have acquired Peak Proteins Ltd. Following an extensive partnership between the two companies, this deal will enable seamless integration of protein production and related structure determination projects within Sygnature. Peak Proteins was set up in 2014 by scientists previously from AstraZeneca’s protein biochemistry and structural biology groups.

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B or not to B: Insights in the regulation of anti-viral immunity

Drug Discovery Today

Researchers delve into the inner workings of the antibody immune response, finding key differences in the metabolism of two closely related immune cell subsets.

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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 fifteen patents…. The post New patent for Alkermes Inc drug ARISTADA appeared first on DrugPatentWatch - Make Better Decisions.

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The Top Pharmacy Benefit Managers of 2021: The Big Get Even Bigger

Drug Channels

The highly-consolidated PBM market notched another year of increased concentration. Consider Drug Channels Institute's latest estimates of pharmacy benefit manager (PBM) market share, shown in the chart below. For 2021, we estimate that the three biggest PBMs accounted for 80% of total equivalent prescription claims. Significant business relationships among the largest companies continue to shift market share.

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The Pharma Data - Untitled Article

The Pharma Data

SK bioscience and GSK announced submission of a biologics license application for SKYCovione™ a recombinant protein-based COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant, to the Korean Ministry of Food and Drug Safety (KMFDS) following positive Phase III clinical data. SK bioscience conducted a Phase III clinical trial in 4,037 adults over 18-year-old across 6 countries (Thailand, Vietnam, New Zealand, Ukraine, the Philippines and South Korea).

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A conversation with BrightFocus Foundation about their new live-streaming talk show

Antidote

We’re excited to share new ways that partners in our network are moving the research and advocacy fronts forward. BrightFocus Foundation funds exceptional scientific research worldwide to defeat Alzheimer’s disease, macular degeneration, and glaucoma. They recently started a live-streaming talk show, Brain Info Live , as part of their mission to provide expert information on Alzheimer’s disease and related dementias and overall brain health.

Disease 52
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Latest news on drug repurposing in oncology #15

The Anticancer Fund

1 April 2022 Language EN Drug repurposing is a strategy for identifying new uses for approved drugs, outside the scope of the original indication. It is one of the focus areas of the Anticancer Fund. Below, we have listed recent findings about the repurposing of generic drugs in oncology. Our intention is to help bring these findings to the attention of the broader cancer research community.

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Proofig launches first commercial automated image duplication and manipulation detection software for scientific publications

Drug Discovery Today

To provide publishers, universities and scientific researchers with a tool to check image integrity before submission, Dr. Dror Kolodkin-Gal, founder of Proofig, have launched an automated image integrity detection software. This automated artificial intelligence (AI) tool detects the majority of forms of image duplication and some of the manipulation.

Research 100
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New patent for Janssen Prods drug EDURANT

Drug Patent Watch

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

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Four Reasons Why PBMs Gain As Maximizers Overtake Copay Accumulators (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for today’s live video webinar: PBM Industry Update: Trends, Controversies, and Outlook. Click here to see the original post and comments from February 2022. More than four years ago, I warned about the emerging trend of copay accumulators and outlined the costly consequences for patients. The latest data reveal that copay accumulator adjustment programs are now in the word list for a growing share of pharmacy benefit designs.

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WHO reveals shocking extent of exploitative formula milk marketing

The Pharma Data

The second report in a series detailing exploitative marketing practices employed by $55 billion baby formula industry, shows parents, particularly mothers, are being insidiously and persistently targeted online. Formula milk companies are paying social media platforms and influencers to gain direct access to pregnant women and mothers at some of the most vulnerable moments in their lives.

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How Antidote’s Contact Center gets to the heart of patient-centricity: A Q&A with Andy Schulz

Antidote

Two of the most critical components of any clinical trial recruitment campaign are patient-centricity and trust. Antidote has a robust Contact Center with personable and knowledgeable agents that walk patients through the prescreening process and answer any questions along the way. We spoke with our Contact Center Operations Manager, Andy Schulz, about why he joined the team, what his team’s day-to-day looks like, why it is so important to provide patients with a positive experience during their

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How we overhauled our literature processing pipeline using Named Entity Recognition

The Open Targets Blog

The Open Targets Platform integrates data from several sources, making connections between targets and diseases or phenotypes and providing context for these associations. In particular, bibliography is a unique source of information to identify and prioritise targets since the whole corpus of literature represents the accumulated knowledge driving therapeutic discoveries.

Disease 52
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Novel Drug from Neuro-Bio Effective in a Mouse Model of Alzheimer’s Disease Nbp14 Targets Possible Primary Driver of Neurodegeneration

Drug Discovery Today

Neuro-Bio Ltd, finds its new drug candidate effectively treats neurodegeneration in a mouse model of Alzheimer’s disease.

Disease 100
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New patent for Apellis Pharms drug EMPAVELI

Drug Patent Watch

Annual Drug Patent Expirations for EMPAVELI Empaveli is a drug marketed by Apellis Pharms and is included in one NDA. There are seven patents protecting this drug. This drug has…. The post New patent for Apellis Pharms drug EMPAVELI appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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How the Medicaid Copay Accumulator Rule Will Hurt Prescription Affordability

Drug Channels

Today’s guest post comes from Fauzea Hussain, Vice President of Public Policy at McKesson. Fauzea succinctly describes the complicated and contradictory aspects of the Centers for Medicare & Medicaid Services' Final Rule on Best Price, a.k.a. the Medicaid copay accumulator rule. She then outlines how the rule, if implemented, is likely to hurt patients.

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Biogen To Offer Continuity of Care Plan for U.S. Patients Currently Treated with ADUHELM® (aducanumab-avwa)

The Pharma Data

Biogen is announcing plans to help patients in the U.S. currently on ADUHELM avoid any treatment interruptions following the final national coverage determination by Centers for Medicare & Medicaid Services (CMS) that could result in a loss of coverage for Medicare beneficiaries. All U.S. patients who began treatment on or before April 7, 2022 are now eligible to receive ADUHELM at no cost for the duration of their treatment or for the duration of the program.

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Enforcement Update: OPDP Issues Untitled Letter

Eye on FDA

We are four months into the year, and this week OPDP has issued its fourth regulatory action letter of 2022. Two of the previous were Warning Letters, considered the more serious of the two categories, and two, including the latest, were Untitled Letters. As noted in past updates, FDA’s OPDP enforcement letters have dropped off considerably over the years.

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