Sat.Mar 12, 2022 - Fri.Mar 18, 2022

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The 340B Noncompliance Data Gap Leaves Drug Manufacturers in the Dark

Drug Channels

Today’s guest post comes from Ashwin Mundra, Chief Revenue Officer at Kalderos. As Ashwin explains, manufacturers face a gap between visible, non-compliant drug discounts and the actual level of non-compliant discounts. He describe Kalderos’ technology-enabled, machine learning-based methods for identifying drug discount non-compliance. To learn more, register to receive a copy of Kalderos’ annual report, available April 13, 2022: Conquering the “Great Unknown”: Connecting the data gaps that kee

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New patent for Jazz Pharms drug XYREM

Drug Patent Watch

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

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Sanofi moves forward with EUROAPI listing on Euronext Paris

The Pharma Data

Sanofi will give its shareholders the opportunity to be part of EUROAPI’s new chapter of growth through an additional extraordinary dividend in kind EUROAPI listing on Euronext Paris will occur in H1 2022, despite volatile market conditions The French State, through the fund French Tech Souveraineté, intends to acquire 12% of EUROAPI’s capital for up to €150 million from Sanofi to become a long-term reference shareholder of EUROAPI As planned, Sanofi will continue to hold circa 30% of EUROAPI, p

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PharmaIQ Live: SmartLab Digital 2022 - Event Recap

The Strateos Blog: Drug Discovery

Strateos had the pleasure of participating at the PharmaIQ Live: Smartlab Digital 2022 conference held between March 8-9th, which focused on the potential of Lab 4.0 strategies to increase the speed, efficiency and reduce the cost of the drug discovery process. John Harman, Sr. Director of Product Management at Strateos, with over 30 years of small molecule drug discovery experience, gave a talk where he outlined key industry pain points and how cloud labs can provide solutions by increasing con

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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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NOW AVAILABLE: The 2022 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

Drug Channels

I am pleased to announce our new 2022 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers , available for purchase and immediate download. Click here to download a free report overview (including key industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study Examines Consolidation and Vertical Integration of U.S.

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New patent for Lantheus Medcl drug DEFINITY

Drug Patent Watch

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

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Using neopterin as a high inflammation marker indicating infection in blood or urine

Tecan

By Dajana Domik Neopterin is a broad range inflammation marker which can be measured in the blood of patients and indicates a multitude of diseases from acute viral infections to autoimmune conditions. 1 This marker can serve as an essential “catch all” as neopterin levels are elevated due to any viral or bacterial invasion, which indicates an infection within the body without the need of several specific tests to confirm.

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Join me in May at Asembia’s 2022 Specialty Pharmacy Summit

Drug Channels

Asembia’s Specialty Pharmacy Summit 2022. May 2 – 5, 2022 | Las Vegas www.asembiasummit.com. Asembia's Specialty Pharmacy Summit 2022 is back! This is a must-attend event for anyone connected to specialty pharmacy. You'll meet an impressive diversity of people from pharmacies, manufacturers, health plans, wholesalers, hospital systems, pharmacy benefit managers, patient advocacy groups, and more.

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New patent for Lantheus Medcl drug DEFINITY RT

Drug Patent Watch

Annual Drug Patent Expirations for DEFINITY+RT Definity Rt is a drug marketed by Lantheus Medcl and is included in one NDA. It is available from one supplier. There are five…. The post New patent for Lantheus Medcl drug DEFINITY RT appeared first on DrugPatentWatch - Make Better Decisions.

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Adjuvant Therapy in Patients With Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC) Regardless of PD-L1 Expression

The Pharma Data

First Phase 3 Study To Demonstrate Statistically Significant Improvement in DFS in the Adjuvant Setting for Patients With Stage IB-IIIA NSCLC Regardless of PD-L1 Expression. Merck (NYSE: MRK), known as MSD outside the United States and Canada, the European Organisation for Research and Treatment of Cancer (EORTC) and the European Thoracic Oncology Platform (ETOP) today announced results from the pivotal Phase 3 KEYNOTE-091 trial, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS.

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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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The Future of Biotech and Pharma Manufacturing

EG Life Sciences

Many of you reading this blog have asked yourselves, "What does the future in biotech and pharma look like?" When I started thinking about the answer to this question, I remembered the Dick Tracy comic strip in which the hero wore an electronic gadget on his wrist, a 2-way wrist radio. Apple came out with their invention of the Apple Watch as the first smart watch on April 24, 2015, wowing consumers everywhere.

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A monoclonal antibody: a promising treatment for human multiple myeloma

Creative Biolabs

Multiple myeloma is a largely incurable cancer of plasma cells with an extremely poor prognosis. However, in a recent study published in Science Translational Medicine entitled “Selective targeting of multiple myeloma cells with a monoclonal antibody recognizing the ubiquitous protein CD98 heavy chain”, scientists have discovered the CD98 heavy chain, a common component of amino acid transporters, may represent a promising monoclonal antibody for the treatment of multiple myeloma.

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New patent for Alnylam Pharms drug OXLUMO

Drug Patent Watch

Annual Drug Patent Expirations for OXLUMO Oxlumo is a drug marketed by Alnylam Pharms Inc and is included in one NDA. There are eleven patents protecting this drug. This drug…. The post New patent for Alnylam Pharms drug OXLUMO appeared first on DrugPatentWatch - Make Better Decisions.

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The Better Life Farming Alliance launches in Latin America

The Pharma Data

The Better Life Farming Alliance (BLF) supports smallholder farmers to improve their livelihoods / Bayer is a part of the BLF global alliance along with the International Finance Corporation (IFC) – a member of the World Bank Group –, Netafim – a global irrigation specialist, and more than 30 local partners / Opening of first BLF Center in Mexico. The Better Life Farming (BLF) Alliance has been launched in Latin America starting with the opening of the first BLF Center in Córdoba, Mexico in Febr

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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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Advantages of Conducting Clinical Trials in Australia

ProRelix Research

Clinical trials are research studies in which participants volunteer to test new treatments, therapies, or tests in the hopes of preventing, detecting, treating, or managing a wide range of diseases […]. The post Advantages of Conducting Clinical Trials in Australia appeared first on ProRelix Research.

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Another Reason MDL Defendants Should Not Waive Their Lexecon Rights

Drug & Device Law

This post is from the non-Dechert side of the blog. From the first time that we discussed Lexecon, Inc. v. Milberg Weiss Bershad Hynes & Lerach , 523 U.S. 26 (1998), and the related MDL concept of Lexecon waivers, we’ve been plenty leery of defendants in cases transferred into multidistrict litigation waiving their retransfer rights under Lexecon and exposing their cases to the “MDL treatment” in bellwether trials.

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New patent expiration for Ucb Inc drug VIMPAT

Drug Patent Watch

Annual Drug Patent Expirations for VIMPAT Vimpat is a drug marketed by Ucb Inc and is included in three NDAs. It is available from three suppliers. There is one patent…. The post New patent expiration for Ucb Inc drug VIMPAT appeared first on DrugPatentWatch - Make Better Decisions.

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ADUHELM® Continues to Reduce Underlying Pathologies of Alzheimer’s Disease in Patients Treated for More Than Two Years

The Pharma Data

ADUHELM continued to reduce two key Alzheimer’s disease pathologies, amyloid beta plaques and p-tau181, in patients treated for up to two and a half years Data from both Phase 3 studies also show that clinical decline was reduced in participants who had plasma p-tau181 reduction at 78 weeks These data further inform the scientific evidence for amyloid as a surrogate biomarker and the importance of continuation of treatment.

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ADUHELM® Phase 3 EMERGE and ENGAGE Data in The Journal of Prevention of Alzheimer’s Disease

The Pharma Data

Biogen Inc. (Nasdaq: BIIB) announced that The Journal of Prevention of Alzheimer’s Disease (JPAD) today published a peer-reviewed manuscript detailing data from the pivotal Phase 3 EMERGE and ENGAGE trials for ADUHELM ® (aducanumab-avwa) 100 mg/mL injection for intravenous use in early Alzheimer’s disease. The publication includes results from the primary, secondary and tertiary endpoints in the trials, as well as safety data and biomarker sub-studies.

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Roche provides molecular testing solutions to identify and differentiate SARS-CoV-2 Omicron variants of concern

The Pharma Data

Roche and its subsidiary, Tib Molbiol, confirm that it has tests for research use that identify the SARS-CoV-2 subvariants of concern, Omicron: BA.1, BA.1.1, BA.2, BA.2.2, BA.3 and Delta The World Health Organization (WHO) has recently reported that the BA.2 subvariant is steadily increasing in prevalence, specifically in Denmark Use of these tests assess the spread of circulating variants and can help monitor the potential impact of therapeutics, vaccines and public health interventions All R

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Jardiance® phase III EMPA-KIDNEY trial will stop early due to clear positive efficacy in people with chronic kidney disease

The Pharma Data

The Independent Data Monitoring Committee recommended that the EMPA-KIDNEY trial be stopped early, following a formal interim assessment EMPA-KIDNEY is the largest and broadest dedicated SGLT2 inhibitor trial in chronic kidney disease to date Detailed results are expected to be presented later this year. The EMPA-KIDNEY trial, evaluating the effect of Jardiance® (empagliflozin) in adults with chronic kidney disease (CKD), will stop early based on a recommendation from the trial’s Independe

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2021 Hansen Family Award goes to Professor Kai Johnsson

The Pharma Data

The Director of the Chemical Biology Department at the Max Planck Institute for Medical Research in Heidelberg receives the award in recognition of his ground-breaking work / Four young scientists are presented with the Early Excellence in Science Award / Werner Baumann: “Breakthrough innovation at the intersection of biology, chemistry and artificial intelligence”.

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WHO announces Film Festival shortlist and jury, including Sharon Stone, Emilia Clarke, Mia Maestro, Anita Abada, Eddie Ndopu and Dr Eckart von Hirschhausen

The Pharma Data

Entries for 3rd edition in 2022 takes total of short films received to nearly 3500 since the initiative launched in 2020. More than 1000 film makers from over 110 countries have submitted short films for the 3rd edition of the WHO Health for All Film Festival (HAFF), on themes ranging from the trauma of war to living with COVID-19. Some 70 films have been chosen for the shortlist, which will be reviewed by international actors and development leaders, before the announcement of the winners in mi

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New patent for Takeda Pharms drug ICLUSIG

Drug Patent Watch

Annual Drug Patent Expirations for ICLUSIG Iclusig is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. There are five…. The post New patent for Takeda Pharms drug ICLUSIG appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for JAZZ drug XYWAV

Drug Patent Watch

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

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Teva Announces Donations of Essential Medicines in Support of Ukrainian Refugees

The Pharma Data

Teva is donating medicines valued at over $11M, for acute therapies in support of Ukrainian refugees The donations include over 1 million packages of antibiotics and other essential medicines as well as hygienic products for Ukrainian infants and children. Teva Pharmaceutical Industries Ltd. today announced a donation of essential medical products valued at over $11M, for acute therapies in humanitarian support of Ukrainian refugees.

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GSK announces appointments to Designate Haleon Board

The Pharma Data

Demerger and listing of Haleon expected in July 2022. GlaxoSmithKline plc (GSK) (LSE/NYSE: GSK) today announced the appointment of six directors to the designate Board of Haleon, the new independent company to be formed following the demerger of the GSK Consumer Healthcare business, expected in July 2022. Haleon will be a new global-leading company in Consumer Health, and is strongly positioned to deliver better everyday health, sustainable above-market growth and attractive returns to sharehold

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Update on US regulatory review of Fasenra in chronic rhinosinusitis with nasal polyps

The Pharma Data

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for Fasenra (benralizumab) for patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). The sBLA submitted to the FDA by AstraZeneca included data from the OSTRO Phase III trial, which met both co-primary endpoints with a safety profile consistent with the known profile of the medicine. 1 The CRL requested additional

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LASTACAFT® Provides Eye Allergy Itch Relief in Minutes that Lasts Through 16 Hours

The Pharma Data

Itchy allergy eyes affect an estimated 40% of Americans 1. – LASTACAFT is a once-daily eye drop that works within minutes against seasonal and year-round allergens to relieve itchy eyes. – Previously available only by prescription, LASTACAFT is now available over the counter nationwide. Allergan, an AbbVie (NYSE: ABBV) company, today announced that LASTACAFT ® (alcaftadine ophthalmic solution 0.25%) is now available without a prescription for the estimated 40% of Americans

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FDA Approves First Generic of Symbicort to Treat Asthma and COPD

The Pharma Data

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. Today, the U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health conditions: asthma in patients six years of age and older; and the maintenance treatment of airflow obstruction and reducing exacerbations for patients with

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Sanofi announces €300 million collaboration with Blackstone Life Sciences to advance an innovative treatment for multiple myeloma

The Pharma Data

Investment will accelerate the overall Sarclisa ® development program Sanofi will continue to fully manage the clinical program and retain full rights and control of Sarclisa ® (isatuximab). Sanofi and Blackstone (NYSE: BX) today announced a strategic, risk-sharing collaboration under which funds managed by Blackstone Life Sciences (BXLS) will contribute up to €300 million to accelerate the global pivotal studies and the clinical development program for the subcutaneous formulation and deliver

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Spider silk can stabilize cancer-suppressing protein

The Pharma Data

The p53 protein protects our cells from cancer and is an interesting target for cancer treatments. The problem is, however, that it breaks down rapidly in the cell. Researchers at Karolinska Institutet in Sweden have now found an unusual way of stabilising the protein and making it more potent. By adding a spider silk protein to p53, they show that it is possible to create a protein that is more stable and capable of killing cancer cells.

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New patent for Biogen Inc drug TECFIDERA

Drug Patent Watch

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

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New patent for Therapeuticsmd Inc drug IMVEXXY

Drug Patent Watch

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

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