Sat.May 14, 2022 - Fri.May 20, 2022

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It’s Time to Put Innovative Contracts Under Warranty

Drug Channels

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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New patent for Ironwood Pharms drug DUZALLO

Drug Patent Watch

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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FDA Encourages Importation of Safe Infant Formula and Other Flexibilities to Further Increase Availability

The Pharma Data

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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Using High Content Screening to Move Beyond Cell Viability Assessments for Quantifying Drug Efficacy

Crown Bioscience

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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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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The State of Specialty Pharmacy 2022: Reflections, Trends, and Photos from #Asembia22

Drug Channels

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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Which pharmaceutical drugs have the most drug patents in Ireland?

Drug Patent Watch

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

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This Clinical Trials Day, Share Why You Support Medical Research

Antidote

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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Digitize to curb staffing challenges

Pharma Manufacturing

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

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New patent for Genentech Inc drug ESBRIET

Drug Patent Watch

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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FDA Lifts Clinical Hold on Investigational Lenacapavir for the Treatment and Prevention of HIV

The Pharma Data

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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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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Ninth Circuit – First Amendment Prevails Over Prop 65

Drug & Device Law

California’s Proposition 65, which has spawned litigation over scientifically questionable “known to the state [of California] to cause cancer” warnings on such everyday products as cola drinks, coffee, beer, and soy sauce, see Riva v. Pepsico, Inc. , 82 F. Supp.3d 1045, 1062 (N.D. Cal. 2015), took one on the chin recently in the Ninth Circuit at the hands of free speech under the First Amendment.

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Reevaluating pharma packaging priorities

Pharma Manufacturing

Supply chain challenges and industry trends are spurring new business strategies

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Which pharmaceutical companies have the most suppository dosed drugs?

Drug Patent Watch

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

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Nearly 700,000 US hospitalizations and 110,000 deaths prevented from the Pfizer-BioNTech COVID-19 vaccine

The Pharma Data

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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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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Valuable Piece on Class Action Fairness Act (“CAFA”) Advanced Removal Strategies – Distributed with Permission

Drug & Device Law

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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Fearing the burn: A critical market is on fire

Pharma Manufacturing

The state of the antibiotics market should alarm the world

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New patent for Ironwood Pharms drug ZURAMPIC

Drug Patent Watch

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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AbbVie to Showcase Depth of Gastroenterology Portfolio and Pipeline at Digestive Disease Week

The Pharma Data

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 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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Illinois Court Imposes Sanctions for Invalid Precomplaint Discovery

Drug & Device Law

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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Which pharmaceutical companies have the most drug patents in Malaysia?

Drug Patent Watch

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

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New patent for Parapro Llc drug NATROBA

Drug Patent Watch

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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New patent for Genentech Inc drug XOFLUZA

Drug Patent Watch

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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New patent for Janssen Pharms drug SPRAVATO

Drug Patent Watch

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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New patent for Astrazeneca drug SYMBICORT

Drug Patent Watch

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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New patent for Cubist Pharms drug ZERBAXA

Drug Patent Watch

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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New patent expiration for Alexza Pharms drug ADASUVE

Drug Patent Watch

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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New patent for Intra-cellular drug CAPLYTA

Drug Patent Watch

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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New patent for LUPIN drug SOLOSEC

Drug Patent Watch

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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New patent for Takeda Pharms drug ALUNBRIG

Drug Patent Watch

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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Which pharmaceutical drugs have the most drug patents in Portugal?

Drug Patent Watch

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

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New patent for Sun Pharm drug ODOMZO

Drug Patent Watch

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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New patent for Xspire Pharma drug ZONTIVITY

Drug Patent Watch

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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New patent for Abbvie Inc drug VIEKIRA PAK (COPACKAGED)

Drug Patent Watch

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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