Sat.Jul 02, 2022 - Fri.Jul 08, 2022

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Touchlight signs patent license agreement with Pfizer for the use of dbDNA for the manufacture of mRNA-based vaccines, therapeutics and gene therapies

Drug Discovery Today

Pfizer and Touchlight agree to patent license for Pfizer to utilise rapid, scalable, enzymatic doggybone DNA (dbDNA) in Pfizer’s clinical and commercial manufacture of its mRNA vaccines, therapeutics, and gene therapiesAgreement includes upfront payment, potential development and commercial milestone payments, and royalties upon commercializationAccess to dbDNA patent rights enables Pfizer’s rapid production of DNA template as starting materials for mRNA-based vaccines and other therapeutics

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From Research Studies to Your Pharmacy Shelves: The Drug Development Process

Antidote

When you head to the pharmacy to pick up medicine, you likely aren’t thinking about all the steps it had to take to get into your hands — but did you know that on average, it takes about ten years for a new medication to make it to market ? This includes the six to seven years that the medicine will go through clinical trial phases, plus a few others that we’ll discuss below.

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Return of Research Results to Study Participants

Advarra

Individuals invest a great deal to participate in clinical research, undertaking risks and burdens, while giving of their time and energies to advance scientific knowledge and the public good. Empirical research into participant views and experiences has consistently shown participants desire to learn the results of research to which they’ve contributed.

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How Copay Accumulators and Maximizers Have Changed Payers’ View of Copay Support

Drug Channels

The boom in copay accumulators and maximizers has radically shifted payers’ views on manufacturers’ copay support programs for specialty drugs. Below, I review a new survey of commercial plan sponsors and contrast the findings to a comparable survey from 2018. As you will see, plan sponsors now perceive manufacturers’ patient assistance programs primarily as a source of funding for their own plans.

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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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Which pharmaceutical drugs have the most drug patents in Philippines?

Drug Patent Watch

This chart shows the drugs with the most patents in Philippines. 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 Philippines? appeared first on DrugPatentWatch - Make Better Decisions.

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New Approvals in 2022

Eye on FDA

We are at mid-year, a good time to check in and see how we are doing on a number of fronts – including where we are with new drug approvals. Over the years, Congress has acted to enhance the ability to bring more new treatments from test tube to medicine chest more quickly. Most notably in 2012 the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law, bring to bear among other things, breakthrough therapy designation.

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Specialty Drugs Update: Trends, Controversies, and Outlook (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 video webinar: Specialty Drugs Update: Trends, Controversies, and Outlook. This event will be broadcast live on July 29, 2022 , from 12:00 p.m. to 1:30 p.m. ET This article describes the event and explains how to purchase a registration to participate in the event.

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Which pharmaceutical companies have the most insert dosed drugs?

Drug Patent Watch

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

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Georgia Dismisses Supplement Case on Primary Jurisdiction Grounds

Drug & Device Law

Today’s case – Smith v. Hi-Tech Pharmaceuticals, Inc. , — S.E.2d –, 2022 WL 2285920 (Ga. Ct. App. Jun. 24, 2022 — does not break new ground. But it is a published decision by a state appellate court and for that reason, it deserves some attention. Plaintiff, a resident of Washington, DC, brought a single claim under the District of Columbia Consumer Procedures and Protection Act (“DC CPPA”) alleging that defendant manufactured dietary supplements containing methylsynephrine which plaintiff cla

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GoodRx Pharma Manufacturer Solutions: Partnering for Patient Access and Affordability

Drug Channels

Today’s guest post comes from Akeel Williams, VP of Strategy and Operations, Pharma Manufacturer Solutions at GoodRx. Akeel provides an overview of GoodRx’s Pharma Manufacturer Solutions business. He describes how GoodRx leverages its consumer reach to help biopharma companies boost awareness and utilization of manufacturers’ copay assistance programs.

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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 AMRYT drug MYCAPSSA

Drug Patent Watch

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

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New patent for Hope Pharms drug SODIUM NITRITE

Drug Patent Watch

Annual Drug Patent Expirations for SODIUM+NITRITE Sodium Nitrite is a drug marketed by Hope Pharms and is included in one NDA. It is available from one supplier. There is one…. The post New patent for Hope Pharms drug SODIUM NITRITE appeared first on DrugPatentWatch - Make Better Decisions.

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Which pharmaceutical companies have the most film dosed drugs?

Drug Patent Watch

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

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Which pharmaceutical companies have the most gas dosed drugs?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most gas dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most gas dosed drugs…. The post Which pharmaceutical companies have the most gas dosed 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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Which pharmaceutical drugs have the most drug patents in Eurasian Patent Organization?

Drug Patent Watch

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

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New patent for Gilead Sciences drug DESCOVY

Drug Patent Watch

Annual Drug Patent Expirations for DESCOVY Descovy is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from two suppliers. There are seven…. The post New patent for Gilead Sciences drug DESCOVY appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for Teva Pharm drug AIRDUO DIGIHALER

Drug Patent Watch

Annual Drug Patent Expirations for AIRDUO+DIGIHALER Airduo Digihaler is a drug marketed by Teva Pharm and is included in one NDA. It is available from four suppliers. There are twenty-three…. The post New patent for Teva Pharm drug AIRDUO DIGIHALER appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for Teva Pharm drug ARMONAIR RESPICLICK

Drug Patent Watch

Annual Drug Patent Expirations for ARMONAIR+RESPICLICK Armonair Respiclick is a drug marketed by Teva Pharm and is included in one NDA. It is available from one supplier. There are thirteen…. The post New patent for Teva Pharm drug ARMONAIR RESPICLICK 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 Teva Pharm drug ARMONAIR DIGIHALER

Drug Patent Watch

Annual Drug Patent Expirations for ARMONAIR+DIGIHALER Armonair Digihaler is a drug marketed by Teva Pharm and is included in one NDA. It is available from one supplier. There are twenty…. The post New patent for Teva Pharm drug ARMONAIR DIGIHALER appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for Teva Pharm drug AIRDUO RESPICLICK

Drug Patent Watch

Annual Drug Patent Expirations for AIRDUO+RESPICLICK Airduo Respiclick is a drug marketed by Teva Pharm and is included in one NDA. It is available from four suppliers. There are sixteen…. The post New patent for Teva Pharm drug AIRDUO RESPICLICK appeared first on DrugPatentWatch - Make Better Decisions.

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Which pharmaceutical drugs have the most drug patents in Greece?

Drug Patent Watch

This chart shows the drugs with the most patents in Greece. 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 Greece? appeared first on DrugPatentWatch - Make Better Decisions.

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Which pharmaceutical drugs have the most drug patents in South Africa?

Drug Patent Watch

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

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Washington Court of Appeals: Registering to Do Business Does Not Constitute Consent to Personal Jurisdiction

Drug & Device Law

As we have previously observed , limits on personal jurisdiction matter because the outcome of litigation is heavily influenced by where a case is filed. Since the Supreme Court confirmed the narrow confines of general jurisdiction in Goodyear Dunlop Tires Operations, S.A. v. Brown , 564 U.S. 915 (2011), and Daimler AG v. Bauman , 571 U.S. 117 (2014), plaintiffs, always eager to engage in litigation tourism, have doggedly tried to expand the bounds of specific jurisdiction, as we reported here ,

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New Jersey Federal Court Applies North Carolina Law to Cut Back Pelvic Mesh Case

Drug & Device Law

It is beach weather, but which beach? The Jersey shore is close, has fun boardwalks and rides, and offers the comfort of the familiar. Then again, you must pay to get on sand covered with New Yorkers. The Outer Banks are lovely, with dunes, wild horses along the surf, splendid lighthouses, and the spot where the Wright Brothers flew into the modern age.

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“Information and Belief” Do Not a Fact Make, Says the Southern District of New York

Drug & Device Law

We just bought tickets for ourselves and a dear visiting colleague to see Barry Manilow in concert next month. We love everything about Barry – his songwriting (we orchestrated many a youthful breakup with “Even Now” played over and over again), his chutzpah (just shy of his 79 th birthday, he premiered a new musical, to raves , at the National Yiddish Theatre Folkbiene) and his unabashed and unapologetic joie de vivre and showmanship.

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