Sat.Mar 05, 2022 - Fri.Mar 11, 2022

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Molecular Health and collaborators prove new analytical approach that leverages real-world data to anticipate molecular causation of adverse drug reactions

Drug Discovery Today

Heidelberg, 10 March 2022 Molecular Health and collaborators at the University of Florida College of Pharmacy, Takeda Oncology, and thinkQ² published a triad of articles that describe and prove the concept of a novel systems approach to elucidate molecular mechanisms of drug toxicities using real-world data (RWD).

Pharmacy 100
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The Top 15 U.S. Pharmacies of 2021: Market Shares and Revenues at the Biggest Companies

Drug Channels

Next week, Drug Channels Institute will release our 2022 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers. It’s the 13th edition of our popular and comprehensive examination of the entire drug pricing, reimbursement, and dispensing system. The exhibit below—one of 216 in our new report—provides a first look at the 15 largest organizations, ranked by total U.S. prescription dispensing revenues for calendar year 2021.

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Which pharmaceutical companies have the most cream dosed drugs?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most cream dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most cream dosed drugs…. The post Which pharmaceutical companies have the most cream dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.

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Optimizing Combination Irradiation and Immunotherapy Treatment Strategies

Crown Bioscience

Combination strategies of irradiation and immunotherapy have been shown to harness the immune system to improve responses in difficult-to-treat and/or unresponsive tumors. But, determining the administration sequence of radiotherapy and immunotherapy is not straightforward, so as a result, preclinical studies are being used to pinpoint the precise sequence.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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ChEMBL 30 released

The ChEMBL-og

We are pleased to announce the release of ChEMBL 30. This version of the database, prepared on 22/02/2022 contains: 2,786,911 compound records 2,157,379 compounds (of which 2,136,187 have mol files) 19,286,751 activities 1,458,215 assays 14,855 targets 84,092 documents Data can be downloaded from the ChEMBL FTP site: [link] Please see ChEMBL_30 release notes for full details of all changes in this release: [link] New Deposited Datasets EUbOPEN Chemogenomic Library (src_id = 55, ChEMBL Document I

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Four Things You Need to Know about Hubs in 2022

Drug Channels

Today’s guest post comes from Stacey Little, Senior Vice President of Business Development and Marketing at AssistRx. Stacey analyzes trends in patient support services and reimbursement hubs. Learn more about AssistRx’s specialty therapy initiation and patient support services at Asembia's Specialty Pharmacy Summit on May 2-5, 2022. Click here to schedule your meeting.

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Novartis, Voyager Therapeutics reach license option agreement for next-generation gene therapy vectors for neurological diseases

The Pharma Data

Novartis today announced a license option agreement with Voyager Therapeutics, a gene therapy company focused on next-generation adeno-associated virus (AAV) technologies, for three capsids to use in potential gene therapies for neurological diseases, with options to access capsids for two other targets. A leader in gene therapy with a strong commitment to developing treatments for diseases of the central nervous system, Novartis seeks to apply its expertise and recent learnings to neurological

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Discovery of small-molecule ligands of retinoblastoma-associated protein Rb1 using artificial intelligence

Atomwise Blog

At the American Chemical Society Spring National Meeting & Expo, Atomwise members were selected to present their research and work. Learn what our Atoms have been working on below and visit Atomwise at ACS Spring 2022 National Meeting for other presentation sessions.

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Five secrets to a successful IVD OEM partnership

Tecan

By Nicholas Smith You are considering an Original Equipment Manufacturing (OEM) partner to support you in bringing your idea to market. The planned in vitro diagnostic device may require components, robotics and modules. You may need integration into an existing platform or the development of a completely new customized system. You may need to react quickly to unexpected circumstances requiring rapid changes in the throughput of your instruments.

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Which pharmaceutical drugs have the most drug patents in Norway?

Drug Patent Watch

This chart shows the drugs with the most patents in Norway. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.…. The post Which pharmaceutical drugs have the most drug patents in Norway? appeared first on DrugPatentWatch - Make Better Decisions.

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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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Efanesoctocog alfa met primary and key secondary endpoints in pivotal study in hemophilia A, demonstrating superiority to prior factor prophylaxis treatment

The Pharma Data

Once-weekly efanesoctocog alfa met primary endpoint in phase 3 study, resulting in a clinically meaningful prevention of bleeding episodes (bleed protection) In the key secondary endpoint, efanesoctocog alfa demonstrated superiority in prevention of bleeding episodes, showing a statistically significant and clinically meaningful reduction in annualized bleeding rate compared to prior factor VIII prophylaxis therapy Efanesoctocog alfa is a novel and investigational factor VIII therapy designed to

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Adolescent psychosocial alcohol-related harms increase risk of later alcohol use disorder

National Drug & Alcohol Research Centre Blog

Wing See Yuen Alcohol-related harms are a broad range of negative consequences that can result from drinking alcohol. These can range from things that only affect your body, such as feeling sick or having a hangover, to things that affect you psychologically and socially, such as having problems with friends or getting into fights. Our study examined whether adolescents experienced different patterns of alcohol-related harm as they age, whether there are any factors in early adolescence that can

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Manitoba Judge’s Opinion Reveals Different Side of the CanadaDrugs Case

Policy Prescription

A recent opinion from an appeals court in Manitoba, Canada sheds new and more favorable light about the CanadaDrugs-related wholesale drug importation case that was first covered a decade ago in the Wall Street Journal. The case pertained to an indictment of CanadaDrugs, Ltd. for sales of mostly misbranded (but not counterfeit drugs) and two batches of counterfeit drugs.

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Free Online Course on Drug Patents, Generic and Branded Drugs

Drug Patent Watch

DrugPatentWatch developed this course to help users better understand the complexities and common strategies around brand erosion and generic entry. The positive responses received made it apparent that the course…. The post Free Online Course on Drug Patents, Generic and Branded Drugs 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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Pfizer Initiates Phase 2/3 Study of Novel COVID-19 Oral Treatment in Pediatric Participants

The Pharma Data

PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) is the first oral therapy specifically designed to combat COVID-19 to be evaluated in a pediatric clinical study PAXLOVID is currently authorized under U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) in both high-risk adult and high-risk pediatric patients 12 years of age and older weighing at least 40 kg Clinical data from the EPIC-HR study showed PAXLOVID reduced risk of hospitalization or death from

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FDCA Expressly Preempts State-Law Claim Challenging Labeling Statement Authorized By FDA Regulations

Drug & Device Law

A few weeks ago, we reported on Chong v. Kind LLC , 2022 WL 464149 (N.D. Cal. 2022), a decision holding that 21 U.S.C. § 337(a) as construed in Buckman v. Plaintiffs’ Legal Committee , 531 U.S. 341 (2001), impliedly preempts claims based on California’s Sherman Act, which adopts the FDCA as state law. As we noted at the time, although the case arose in the food context, its analysis is directly applicable to drug and device cases.

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New patent for Abbvie Inc drug MAVYRET

Drug Patent Watch

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

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New patent for Ironshore Pharms drug JORNAY PM

Drug Patent Watch

Annual Drug Patent Expirations for JORNAY+PM Jornay Pm is a drug marketed by Ironshore Pharms and is included in one NDA. There are thirteen patents protecting this drug. JORNAY PM…. The post New patent for Ironshore Pharms drug JORNAY PM appeared first on DrugPatentWatch - Make Better Decisions.

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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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New patent for Boehringer Ingelheim drug GILOTRIF

Drug Patent Watch

Annual Drug Patent Expirations for GILOTRIF Gilotrif is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are five patents…. The post New patent for Boehringer Ingelheim drug GILOTRIF appeared first on DrugPatentWatch - Make Better Decisions.

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Scientists identify possible new treatment for COVID-19

The Pharma Data

Investigators at Cedars-Sinai have identified a potential new therapy for COVID-19: a biologic substance created by reengineered human skin cells. Scientists found the substance stopped SARS-CoV-2, the virus that causes COVID-19, from reproducing itself and also protected infected cells when tested in human lung cells. Although still in the early stages, the findings open the possibility of having a new therapy for COVID-19 patients.

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Which pharmaceutical companies have the most solution dosed drugs?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most solution dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most solution dosed drugs…. The post Which pharmaceutical companies have the most solution dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for Benuvia drug SYNDROS

Drug Patent Watch

Annual Drug Patent Expirations for SYNDROS Syndros is a drug marketed by Benuvia and is included in one NDA. There are three patents protecting this drug and two Paragraph IV…. The post New patent for Benuvia drug SYNDROS appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for Abbvie Inc drug MAVYRET

Drug Patent Watch

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

Drugs 52
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Janssen Seeks Approval of a New Indication for IMBRUVICA® (ibrutinib) for Use in Patients with Untreated Mantle Cell Lymphoma

The Pharma Data

Application based on Phase 3 SHINE study results, which investigated the safety and efficacy of all-oral ibrutinib in combination with bendamustine and rituximab in adult patients with previously untreated mantle cell lymphoma [1]. The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new indication for IMBRUVICA ® (ibrutinib) in combination with bendamustine and

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Omicron SARS-CoV-2 Variant from the WHO Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC)

The Pharma Data

The Label-CO-VAC is reviewing available data to optimize vaccine intermediated protection against current circulating variants. The Label-CO-VAC explosively supports critical and broad access to current COVID-19 vaccines for primary series and supporter boluses, particularly for groups at threat of developing severe complaint, given that current COVID-19 vaccines continue to give high situations of protection against severe complaint and death, indeed in the environment of the rotation of Omicro

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New strategy for COVID-19 prophylaxis?

The Pharma Data

SARS-CoV-2 viruses can hide from recognition by the immune system. However, the antiviral immune receptor RIG-I can be stimulated, which improves protection against lethal SARS-CoV-2 infections. Researchers led by Prof. Dr. Gunther Hartmann from the Institute of Clinical Chemistry and Clinical Pharmacology at the University Hospital Bonn, in cooperation with other members of the cluster of excellence ImmunoSensation2 at the University of Bonn, have shown this in mice.

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New patent expiration for Novartis drug LEQVIO

Drug Patent Watch

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

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Which pharmaceutical companies have the most SPCs in Luxembourg?

Drug Patent Watch

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

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New patent for Alkermes Inc drug LYBALVI

Drug Patent Watch

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

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New patent for Baudax drug ANJESO

Drug Patent Watch

Annual Drug Patent Expirations for ANJESO Anjeso is a drug marketed by Baudax and is included in one NDA. There are six patents protecting this drug. Drug patent litigation for…. The post New patent for Baudax drug ANJESO appeared first on DrugPatentWatch - Make Better Decisions.

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Jardiance® (empagliflozin) becomes the first and only approved treatment in Europe for adults with symptomatic chronic heart failure regardless of ejection fraction

The Pharma Data

The breakthrough approval expands the existing indication of Jardiance® to include adults with heart failure with preserved ejection fraction (HFpEF), an underserved patient population that previously had no approved therapies in Europe European marketing authorization follows the U.S. Food and Drug Administration (FDA)’s approval received on 24 February 2022.

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Teva Announces Launch of a First Generic Version of Revlimid® (lenalidomide capsules), in the U.S.

The Pharma Data

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the launch of a first generic version of Revlimid® 1 (lenalidomide capsules), in 5mg, 10mg, 15mg, and 25mg strengths, in the United States. Teva’s Lenalidomide capsules are a prescription medicine used in adults for the treatment of (1) multiple myeloma in combination with the medicine dexamethasone, (2) certain myelodysplastic syndromes, and (3) mantle cell lymphoma following spe

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GLOBAL BIOTECHNOLOGY LEADER AMGEN BREAKS GROUND ON NEW MANUFACTURING FACILITY IN NORTH CAROLINA

The Pharma Data

Amgen (NASDAQ:AMGN) today announced the groundbreaking of its newest biomanufacturing facility, located in Holly Springs, North Carolina. The facility, expected to be operational by 2025, will support the growing demand for Amgen’s medicines that treat serious illnesses such as cancer and heart disease. “Amgen is adding to North Carolina’s strong economic growth with the addition of its newest manufacturing plant to our already robust biomanufacturing ecosystem,” said Roy

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