Drug Discovery World

JULY 8, 2022

A Covid-19 lawsuit, a heart attack treatment developed using spider venom and a collaboration to fight antimicrobial resistance (AMR) are some of the theme’s of this week’s news round-up. . News round-up by DDW’s Reece Armstrong for 4 – 8 July. CureVac lawsuit against BioNTech over Covid-19 vaccine technology. Biopharmaceutical company CureVac has filed a lawsuit against BioNTech SE and two of its subsidiaries in relation to an alleged infringement of the company’s portfolio used in

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Drug Discovery Today

JULY 7, 2022

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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Antidote

JULY 8, 2022

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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Drug Channels

JULY 6, 2022

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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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.

Clinical Trials

Drug Discovery World

JULY 8, 2022

GSK’s annual Palio meeting is taking place with a focus on how preventative approaches to disease can help mitigate climate change. . GSK’s ‘Vaccines for a sustainable planet’ meeting is gathering 65 experts across immunology, vaccinology, epidemiology, and policy throughout 7-8 July. . The meeting will include a range of plenary sessions and working group discussions that cover topics on how vaccines can mitigate the effects of environmental change; vaccine development to prevent human-animal

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Advarra

JULY 5, 2022

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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Drug Channels

JULY 7, 2022

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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Drug Discovery World

JULY 8, 2022

Biotechnology company Immutep has been a granted a patent for its immunosuppressive antibody by the Japanese Patent Office. . Immutep’s IMP761 is an immunosuppressive agonist antibody to LAG-3 – a cell surface molecule which plays a role in regulating T cell function, and which has been identified as a new immune-checkpoint. . Immutep is looking to use IMP761 to address the root cause of autoimmune disease through its function to silence autoimmune memory T cells that accumulate at the diseas

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Eye on FDA

JULY 5, 2022

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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Drug Patent Watch

JULY 5, 2022

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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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.

Clinical Trials

Drug Channels

JULY 5, 2022

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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Drug Discovery World

JULY 8, 2022

? Work has started on the first wholly speculative development of new multi-let laboratory and office space at Cambridge Biomedical Campus in the UK, which is specifically targeting a range of growing biotech and life science businesses. . The new building will form part of the campus’ growing ecosystem of clinical, academic, and commercial excellence and will provide a range of laboratory and office space. .

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Antidote

JULY 5, 2022

When performing medical research, clinical trial patient recruitment is frequently cited as the biggest obstacle to getting studies underway. In fact, 80% of studies fail to meet their patient recruitment goals within their targeted timeframe. Implementing the right clinical trial recruitment strategies is a must for advancing the field of medical research, but how can the sponsors of clinical trials proactively identify and overcome the issues that often arise?

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Drug Patent Watch

JULY 8, 2022

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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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

Clinical Trials

Drug & Device Law

JULY 5, 2022

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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Drug Discovery World

JULY 8, 2022

Pharmaceutical company Novavax is attempting to expand the use of its Covid-19 vaccine Nuvaxovid into adolescents aged 12-17 year and as a booster dose for adults. . The company has submitted a request to Swissmedic to expand the conditional marketing authorisation (CMA) of Nuvaxovid. The request is based on data from the company’s ongoing PREVENT-19 Phase III clinical trial, which is assessing the vaccine in 2,247 adolescents aged 12 through 17 years across 73 sites in the US 1. .

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Drug Patent Watch

JULY 8, 2022

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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Drug Patent Watch

JULY 8, 2022

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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Drug Patent Watch

JULY 8, 2022

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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Drug Patent Watch

JULY 8, 2022

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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Drug Patent Watch

JULY 4, 2022

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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Drug Patent Watch

JULY 7, 2022

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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Drug Patent Watch

JULY 2, 2022

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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Drug Patent Watch

JULY 5, 2022

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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Drug Patent Watch

JULY 6, 2022

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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Drug Patent Watch

JULY 8, 2022

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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Drug Patent Watch

JULY 3, 2022

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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Drug Discovery World

JULY 8, 2022

Join 10x Genomics for this free webinar to learn more about resolving complex biology with single cell and spatial multiomics. The event is hosted by DDW and supported by 10x Genomics. The event will take place on 20 July 15:00 BST and will explain how single cell and spatial tools from 10x Genomics are designed to deliver powerful, multiomic insights from complex disease samples that enable you to confidently fuel your target identification pipeline with the most promising candidates.

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Drug & Device Law

JULY 8, 2022

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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Drug & Device Law

JULY 7, 2022

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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Drug & Device Law

JULY 6, 2022

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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