Drug Channels

MAY 20, 2022

Today’s guest post comes from Jane Barlow, Chief Clinical Officer, and Susan Raiola, President of Real Endpoints. Jane and Susan discuss the mechanism and benefits of warranties in the realm of value-based contracts. To learn more about payer-pharma warranty contracts and whether these agreements can solve issues that limit the utility of more traditional value-based contracts, sign up for Real Endpoints’ free June 9 webinar: Putting Innovative Contracts Under Warranty.

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Drug Patent Watch

MAY 18, 2022

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

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The Pharma Data

MAY 16, 2022

Today, the U.S. Food and Drug Administration is announcing a guidance that outlines increased flexibilities regarding importation of certain infant formula products to further increase the availability of infant formula across the country while protecting the health of infants. The agency is encouraging infant formula manufacturers worldwide to take advantage of these flexibilities.

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Crown Bioscience

MAY 16, 2022

In this blog we explore how drug efficacy studies can incorporate highly comprehensive morphology readouts that extend beyond cell viability assessments by leveraging high content screening (HCS), high content imaging (HCI), and high content analysis (HCA).

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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 Channels

MAY 17, 2022

Two weeks ago, Paula and I had the pleasure of attending Asembia’s 2022 Specialty Pharmacy Summit at the wonderful Wynn Las Vegas. Below, I violate Vegas code and tell you what happened there. I offer reflections on my keynote session with Scott Gottlieb, share my experiences during the featured session, and highlight three crucial specialty industry trends.

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Drug Patent Watch

MAY 16, 2022

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

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Antidote

MAY 20, 2022

Happy Clinical Trials Day! Here at Antidote, today is an opportunity to talk about why medical research matters – and to celebrate the volunteers who make it possible.

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Pharma Manufacturing

MAY 18, 2022

Modern manufacturing solutions can spare pharma the worst of ongoing labor shortages

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Drug Patent Watch

MAY 17, 2022

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

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The Pharma Data

MAY 16, 2022

The profound health and economic impact of the Pfizer-BioNTech vaccine during its first year of rollout in the US is described in detail in a new study in the peer-reviewed Journal of Medical Economics. It is estimated that in 2021 the vaccine, the most widely used against COVID-19 in the US, prevented 8.7 million symptomatic cases of the virus, as well as 690,000 hospitalizations and more than 110,000 deaths.

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Clinical Trials

Drug & Device Law

MAY 17, 2022

We’re not the font of all legal knowledge; we don’t claim to be. Every now and then we come across material published by our colleagues at other firms defending prescription medical product liability litigation that we think would be valuable to our readers, so we ask if we can republish. That’s how our 50-state survey on state tolling statutes came about.

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Pharma Manufacturing

MAY 20, 2022

Supply chain challenges and industry trends are spurring new business strategies

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Drug Patent Watch

MAY 20, 2022

Annual Drug Patent Expirations for NATROBA Natroba is a drug marketed by Parapro Llc and is included in one NDA. It is available from two suppliers. There is one patent…. The post New patent for Parapro Llc drug NATROBA appeared first on DrugPatentWatch - Make Better Decisions.

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The Pharma Data

MAY 16, 2022

A total of 27 abstracts reinforce AbbVie leadership in advancing research and the standards of care across multiple gastroenterological conditions, including inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS) Presentations include further analyses of Phase 3 clinical study programs for RINVOQ ® (upadacitinib) in moderately to severely active ulcerative colitis and investigational use of risankizumab in moderately to severely active Crohn’s disease.

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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

MAY 18, 2022

Famous (and infamous) American trial lawyer Clarence Darrow once said that he never wished a man dead, but had occasionally read some obituaries with great satisfaction. (That same quote is sometimes incorrectly attributed to Mark Twain.) . We’re no Darrow. We’ve never saved a client from capital punishment, or discredited a former presidential candidate in a courtroom, or made any sort of mark in the culture wars, or bribed a juror.

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Pharma Manufacturing

MAY 18, 2022

The state of the antibiotics market should alarm the world

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Drug Patent Watch

MAY 20, 2022

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

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The Pharma Data

MAY 16, 2022

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) has lifted the clinical hold placed on the company’s Investigational New Drug Application (IND) to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis (PrEP). As previously announced , the FDA had placed a clinical hold on the use of injectable lenacapavir in borosilicate vials due to a vial compatibility issue.

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Drug & Device Law

MAY 19, 2022

This is a follow-up post on the case of Knapp v. Zoetis, Inc. – an animal drug case. While not our typically fare, it is still a prescription drug case involving adverse event reporting to the FDA and the learned intermediary doctrine. So, while this patient had four legs instead of two, the legal framework is primarily the same. . A year ago we reported on the court’s decision to drastically cut down the case by tossing out the class allegations and dismissing without prejudice plaintiff’s ne

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Drug Patent Watch

MAY 20, 2022

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

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Drug Patent Watch

MAY 20, 2022

Annual Drug Patent Expirations for SYMBICORT Symbicort is a drug marketed by Astrazeneca and is included in one NDA. It is available from three suppliers. There are ten patents protecting…. The post New patent for Astrazeneca drug SYMBICORT appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

MAY 19, 2022

Annual Drug Patent Expirations for ZERBAXA Zerbaxa is a drug marketed by Cubist Pharms Llc and is included in one NDA. It is available from one supplier. There are thirteen…. The post New patent for Cubist Pharms drug ZERBAXA appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

MAY 19, 2022

Annual Drug Patent Expirations for ADASUVE Adasuve is a drug marketed by Alexza Pharms and is included in one NDA. There are seven patents protecting this drug. Drug patent litigation…. The post New patent expiration for Alexza Pharms drug ADASUVE appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

MAY 19, 2022

Annual Drug Patent Expirations for CAPLYTA Caplyta is a drug marketed by Intra-cellular and is included in one NDA. There are thirteen patents protecting this drug. CAPLYTA drug price trends.…. The post New patent for Intra-cellular drug CAPLYTA appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

MAY 19, 2022

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

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Drug Patent Watch

MAY 19, 2022

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

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Drug Patent Watch

MAY 18, 2022

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

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Drug Patent Watch

MAY 18, 2022

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

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Drug Patent Watch

MAY 18, 2022

Annual Drug Patent Expirations for VIEKIRA+PAK+%28COPACKAGED%29 Viekira Pak (copackaged) is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There are…. The post New patent for Abbvie Inc drug VIEKIRA PAK (COPACKAGED) appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

MAY 18, 2022

Annual Drug Patent Expirations for ORKAMBI Orkambi is a drug marketed by Vertex Pharms Inc and is included in two NDAs. It is available from one supplier. There are twenty…. The post New patent for Vertex Pharms drug ORKAMBI appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

MAY 18, 2022

Annual Drug Patent Expirations for TRULANCE Trulance is a drug marketed by Salix and is included in one NDA. It is available from two suppliers. There are nine patents protecting…. The post New patent for SALIX drug TRULANCE appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

MAY 18, 2022

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

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Drug Patent Watch

MAY 18, 2022

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

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Drug Patent Watch

MAY 17, 2022

Annual Drug Patent Expirations for FLEQSUVY Fleqsuvy is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. The generic ingredient in FLEQSUVY…. The post New patent for Azurity drug FLEQSUVY appeared first on DrugPatentWatch - Make Better Decisions.

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