Sat.Nov 13, 2021 - Fri.Nov 19, 2021

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Pathway or Perish: The Two-Pronged Hurdle to Ensuring Access in Oncology

Drug Channels

Today’s guest post comes from Carolyn Zele, Senior Manager of Solution Enablement at MMIT. Carolyn describes how oncology pathways were developed to help standardize treatment and ensure quality care. She argues, however, that these pathways often shut manufacturers out of the market. Click here to learn more about MMIT's Pulse Analytics solution , which provides insight into payer- and pathway-driven barriers to access.

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New patent expiration for Novartis drug AMTURNIDE

Drug Patent Watch

Annual Drug Patent Expirations for AMTURNIDE Amturnide is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug. This drug has one…. The post New patent expiration for Novartis drug AMTURNIDE appeared first on DrugPatentWatch - Make Better Decisions.

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Pfizer to provide U.S. government with 10 million treatment courses of investigational oral antiviral candidate to help combat COVID-19

The Pharma Data

Pfizer moment blazoned an agreement with theU.S. government to supply 10 million treatment courses of its investigational COVID-19 oral antiviral seeker, PAXLOVID ™ (PF-07321332; ritonavir), subject to nonsupervisory authorization from theU.S. Food and Drug Administration (FDA). Still, PAXLOVID, which began in Pfizer’s laboratories, If approved or authorized.

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Covid 19 Booster Dose – Should we consider it?

ProRelix Research

Covid 19 Booster Dose – Should we consider it? The idea of booster doses for Covid-19 vaccinations is gaining traction around the world, but India remains a skeptic. Various countries, […]. The post Covid 19 Booster Dose – Should we consider it? appeared first on ProRelix Research.

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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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CVS, Walgreens, Walmart, and Supermarkets Keep Position in 2022 Part D Preferred Networks—With a Little Help from 340B

Drug Channels

In Consolidation and Preferred Pharmacy Networks in 2022’s Medicare Part D Plans , I highlighted how those networks have hijacked the world of stand-alone Medicare Part D prescription drug plans (PDP) and become a major presence in Medicare Advantage prescription drug (MA-PD) plans. Today, I examine the largest retail chains’ participation in the 21 major 2022 Part D preferred networks that the eight largest plan sponsors will offer.

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New patent for Eirgen drug RAYALDEE

Drug Patent Watch

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

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Early Data Suggest Pfizer Pill May Prevent Severe COVID-19

NIH Director's Blog: Drug Development

Credit: Fizkes/Shutterstock Over the course of this pandemic, significant progress has been made in treating COVID-19 and helping to save lives. That progress includes the development of life-preserving monoclonal antibody infusions and repurposing existing drugs , to which NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV ) public-private partnership has made a major contribution.

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Small Pharmacies Continue to Run Away from Medicare Part D’s Preferred Networks

Drug Channels

In my previous post , I highlighted the largest pharmacy chains that will participate in the 2022 Medicare Part D prescription drug plans (PDP). Today, I examine how smaller pharmacies will participate as preferred cost sharing pharmacies via the pharmacy services administrative organizations (PSAOs) that represent them in negotiations with plans. As you will see here, the largest PSAOs are increasingly rejecting preferred networks.

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New patent for Kadmon Pharms drug REZUROCK

Drug Patent Watch

Annual Drug Patent Expirations for REZUROCK Rezurock is a drug marketed by Kadmon Pharms Llc and is included in one NDA. The generic ingredient in REZUROCK is belumosudil mesylate. Additional…. The post New patent for Kadmon Pharms drug REZUROCK appeared first on DrugPatentWatch - Make Better Decisions.

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Emgality® Versus Nurtec® ODT Head-to-Head Migraine Preventive Treatment Study Now Enrolling Patients

The Pharma Data

– CHALLENGE-MIG is the first and only clinical trial comparing two anti-calcitonin gene-related peptide (CGRP) medicines, Emgality and Nurtec ODT, which work differently – The study’s primary endpoint is the percentage of patients with ?50% reduction from baseline in monthly migraine headache days – The study’s secondary endpoints include quality of life improvements and the percentage of patients with ?

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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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New Antibody Drugs May Release Tumor Blood Vessels to Facilitate the Drug Delivery Process

Creative Biolabs

Vascular dysfunction contributes to the pro-oncogenic tumor microenvironment and impedes the delivery of therapeutic drugs, so normalizing tumor blood vessels may become a potential path. Scientists have developed a new type of therapeutic antibody that may dredge and normalize blood vessels in cancerous tumors, thus providing a more effective drug delivery pathway for targeted cancer treatments, according to a study published on bioRxiv.

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Drug Channels Outlook 2022 (NEW Live Video Webinar)

Drug Channels

Dr. Adam J. Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for a new live video webinar: Drug Channels Outlook 2022. Broadcast live on December 17, 2021. 12:00 p.m. to 1:30 p.m. ET This page describes the event and explains how to purchase a registration. This event is part of The Drug Channels 2021 Quarterly Video Webinar Series.

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New patent expiration for Novartis drug TYKERB

Drug Patent Watch

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

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Gilead Exercises Options to Three Arcus Biosciences Clinical-Stage Programs and Adds Research Collaboration

The Pharma Data

— Gilead Exercises Options to Arcus’s Anti-TIGIT Program (Domvanalimab and AB308), Etrumadenant (A2a/A2b Adenosine Receptor Antagonist) and Quemliclustat (Small Molecule CD73 Inhibitor) — — Arcus to Receive Option Payments Totaling $725 million — Gilead Lores,Inc. (Nasdaq GILD) and Arcus Biosciences,Inc. (NYSE RCUS) moment blazoned that Gilead has exercised its options to three programs in Arcus’s clinical- stage portfolio, including bothanti-TIGIT motes, domvanalimab and

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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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Is drug R&D more like poker or chess?

Plenge Gen

[Disclaimers: I am an employee of Bristol Myers Squibb. The views expressed here are my own. Also, I am not a particularly good poker or chess player. It is one reason I am a popular invited guest to poker nights with friends.] I posted on poll on Twitter to ask the question is drug discovery more like poker or chess. There were over 300 responses, with the results split nearly equally (54% poker, 46% chess).

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The Once and Future FDA Commissioner

Eye on FDA

In what has been a glacially paced nomination process, the Biden Administration announced on November 12 that it would, in fact, be nominating Dr. Robert Califf to return to his role as FDA Commissioner. Acting Comissioner Janet Woodcock indicated in a tweet that she would be remaining in the role of Acting Commissioner during the confirmation process.

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New patent for Beigene drug BRUKINSA

Drug Patent Watch

Annual Drug Patent Expirations for BRUKINSA Brukinsa is a drug marketed by Beigene and is included in one NDA. There are three patents protecting this drug. This drug has thirty-six…. The post New patent for Beigene drug BRUKINSA appeared first on DrugPatentWatch - Make Better Decisions.

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Sanofi invests $180 million equity in Owkin’s artificial intelligence and federated learning to advance oncology pipeline

The Pharma Data

Combined efforts will work to build robust disease models while preserving privacy of large data sets from various research institutions and hospitals Collaboration to focus on four types of cancer. Sanofi blazoned moment an equity investment of$ 180 million and a new strategic collaboration with Owkin comprised of discovery and development programmes in four exclusive types of cancer, with a total payment of$ 90 million for three times plus fresh exploration corner- grounded payments.

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FDA Approves Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery

The Pharma Data

KEYTRUDA Is Now Approved for the Adjuvant Treatment of Patients With RCC at Intermediate-High or High Risk of Recurrence Following Nephrectomy, or Following Nephrectomy and Resection of Metastatic Lesions. KEYTRUDA Is the First Immunotherapy Approved for the Adjuvant Treatment of These Patients With RCC. Merck known as MSD outside the United States and Canada, moment blazoned that theU.S.

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European Commission approves Nucala (mepolizumab) in three additional eosinophil-driven diseases

The Pharma Data

Approval for the first targeted treatment for eosinophilic granulomatosis with polyangiitis and the first anti-IL-5 biologic treatment for patients with hypereosinophilic syndrome or chronic rhinosinusitis with nasal polyps in Europe Mepolizumab is now the only treatment approved in Europe for use in four eosinophil-driven diseases. GlaxoSmithKline (GSK) plc moment blazoned that the European Commission has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), fo

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PFIZER AND THE MEDICINES PATENT POOL (MPP) SIGN LICENSING AGREEMENT FOR COVID-19 ORAL ANTIVIRAL TREATMENT CANDIDATE TO EXPAND ACCESS IN LOW- AND MIDDLE-INCOME COUNTRIES

The Pharma Data

Agreement builds on Pfizer’s comprehensive strategy to work toward equitable access to COVID-19 vaccines and treatments for all people, particularly those living in the poorest parts of the world Agreement will enable qualified sub-licensees to supply countries comprising approximately 53% of the world’s population Interim data from the Phase 2/3 EPIC-HR study demonstrated an 89% reduction in risk of COVID-19-related hospitalization or death compared to placebo in non-hospitalized high-risk adul

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PFIZER SEEKS EMERGENCY USE AUTHORIZATION FOR NOVEL COVID-19 ORAL ANTIVIRAL CANDIDATE

The Pharma Data

If approved or authorized, PAXLOVID™ (PF-07321332; ritonavir) would be the first oral antiviral of its kind, a 3CL protease inhibitor specifically designed to combat SARS-CoV-2 EUA submission includes clinical data from an interim analysis of the Phase 2/3 EPIC-HR study, which demonstrated an 89% reduction in risk of COVID-19-related hospitalization or death compared to placebo in non-hospitalized high-risk adults with COVID-19 Rolling submissions have commenced in several countries including in

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PFIZER ANNOUNCES RETIREMENT OF CHIEF FINANCIAL OFFICER FRANK D’AMELIO

The Pharma Data

Pfizer moment blazoned that Frank D’Amelio will retire from his position as Chief Financial Officer and Executive Vice President of Global Supply at Pfizer after a nearly 15 time distinguished career with the Company. Pfizer has initiated an external hunt for a new Chief Financial Officer and D’Amelio has agreed to stay on board through this process and serve in a consulting part through the transition.

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PFIZER COMPLETES ACQUISITION OF TRILLIUM THERAPEUTICS

The Pharma Data

Acquisition enhances Pfizer’s Oncology portfolio with addition of coming- generation, investigational immuno- rectifiers for hematological malice. Pfizer moment blazoned the successful completion of its accession of Trillium Rectifiers, a clinical stage immuno-oncology company developing innovative curatives for the treatment of cancer. As Trillium becomes part of Pfizer, it brings an emotional portfolio that includes biologics that are designed to enhance the capability of cases’ ingrain vulner

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Repurposing a familiar drug for COVID-19

The Pharma Data

For the past year and a half, the COVID-19 pandemic has continued to engulf the globe, fueled in part by novel variants and the uneven distribution of vaccines. Every day, hundreds of thousands of new COVID-19 cases and thousands of new deaths are still being reported worldwide, creating a need for drugs that can combat the disease caused by SARS-CoV-2.

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The European Commission Grants Marketing Authorization for VUMERITY® (diroximel fumarate) as Oral Treatment for Relapsing-Remitting Multiple Sclerosis

The Pharma Data

VUMERITY is a next-generation oral fumarate treatment for people with relapsing-remitting MS with established efficacy and well-characterized safety, building on Biogen’s leadership in MS oral therapies Phase 3 data have demonstrated that treatment with VUMERITY results in low discontinuation rates due to its gastrointestinal (GI) tolerability profile European Union authorization follows approvals in United States, Great Britain and Switzerland, providing patients another important option as the

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Update on Regulatory Review of Aducanumab in the European Union

The Pharma Data

BiogenInc. and EisaiCo.,Ltd. (Tokyo, Japan) blazoned moment an update on the ongoing review of the Marketing Authorization Operation for aducanumab 100 mg/ mL concentrate result for infusion for the treatment of Alzheimer’s complaint by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Following an oral explanation held at the November meeting of the CHMP, Biogen entered a negative trend vote on the aducanumab Marketing Authorization Operation.

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Amgen Awards The Bath Institute of Rheumatic Diseases $25,000 Through UPLIFT Innovation Challenge

The Pharma Data

Grant to Support New Digital Programs to Reconnect Psoriatic Arthritis Patients with Healthcare Providers. Amgen (NASDAQAMGN) moment blazoned the awarding of a one- time$ entitlement to the Bath Institute of Rheumatic Conditions ( Raspberry) as part of the Understanding Psoriatic Disease Using Perceptivity for Treatment (UPLIFT) Innovation Challenge.

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Two billion doses of AstraZeneca’s COVID-19 vaccine supplied to countries across the world

The Pharma Data

AstraZeneca and its partners have released for supply two billion doses of their COVID-19 vaccine to more than 170 countries across every continent on the planet in the last 11 months. Approximately two-thirds of these have gone to low- and lower-middle-income countries, including more than 175 million doses delivered to 130 countries through the COVAX Facility.

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Bayer, Microsoft Enter into Strategic Partnership to Optimize and Advance Digital Capabilities for Food, Feed, Fuel, Fiber Value Chain

The Pharma Data

Bayer agronomic moxie and leading digital husbandry platform, combined with Microsoft Azure, form the foundation for new digital results to advance husbandry and conterminous diligence. Moment, Bayer blazoned a strategic cooperation with Microsoft to make a new pall- grounded set of digital tools and data wisdom results for use in husbandry and conterminous diligence, bringing new structure and foundational capabilities to accelerate invention, boost effectiveness and support sustainability acro

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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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New patent expiration for Takeda Pharms drug ROZEREM

Drug Patent Watch

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

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New patent for Kai Pharms drug PARSABIV

Drug Patent Watch

Annual Drug Patent Expirations for PARSABIV Parsabiv is a drug marketed by Kai Pharms Inc and is included in one NDA. It is available from one supplier. There are six…. The post New patent for Kai Pharms drug PARSABIV appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for Beigene drug BRUKINSA

Drug Patent Watch

Annual Drug Patent Expirations for BRUKINSA Brukinsa is a drug marketed by Beigene and is included in one NDA. There are three patents protecting this drug. This drug has thirty-six…. The post New patent for Beigene drug BRUKINSA appeared first on DrugPatentWatch - Make Better Decisions.

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