Sat.Jun 12, 2021 - Fri.Jun 18, 2021

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New patent expiration for Merck Sharp drug CLARINEX

Drug Patent Watch

Annual Drug Patent Expirations for CLARINEX Clarinex is a drug marketed by Merck Sharp Dohme and is included in five NDAs. It is available from two suppliers. There are four…. The post New patent expiration for Merck Sharp drug CLARINEX appeared first on DrugPatentWatch - Make Better Decisions.

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What is the additional standard checklist for the FDA 510 k submissions?

Pharmaceutical Development Group

After the FDA 510 k submissions, there is a lengthy review process there that is being performed by the team. Also, getting the certification is not a very easy task. For this reason, a brief checklist is here that are needed to be considered so that the submission and certification procedure will get more hassle-free. 1. Incomplete description When the company is applying for the FDA 510 k submissions , they need to ensure that they have provided a complete description for the product.

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Allergan Aesthetics and BOTOX® Cosmetic (onabotulinumtoxinA) Put Real Stories at the Forefront in New Campaign

The Pharma Data

IRVINE, Calif. , June 8, 2021 /PRNewswire/ — Allergan Aesthetics, an AbbVie company (NYSE: ABBV ), is changing the way BOTOX ® Cosmetic, the #1 selling neurotoxin treatment 1 , is connecting with consumers. Today, the brand is launching ‘ See Yourself’ , a new campaign featuring documentary style shorts that dive deep into the stories of real BOTOX ® Cosmetic patients – people of all shapes, sizes, backgrounds, colors, and origins.

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Exclusive: 340B Continues Its Unbridled Takeover of Pharmacies and PBMs

Drug Channels

Drug Channels Institute’s latest review of contract pharmacies in the 340B Drug Pricing Program reveals that an astonishing 30,000 pharmacy locations—half of the entire U.S. pharmacy industry—now act as contract pharmacies for the hospitals and other healthcare providers that participate in the 340B program. Over the past 12 months, the number of pharmacies in the program has grown by more than 2,000 locations.

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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 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 four patents protecting…. The post New patent for LUPIN drug SOLOSEC appeared first on DrugPatentWatch - Make Better Decisions.

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Antidepressant Shows Potential for Treating COVID-19

PerkinElmer

The speed at which researchers developed effective vaccines to prevent the spread of COVID-19 required unprecedented international cooperation on a scale never seen before. Rollout of approved vaccines is underway in many countries across the globe, giving people hope that the end to the pandemic is finally in sight. Meanwhile, researchers are continuing to investigate possible treatments for patients suffering with the disease.

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EXCLUSIVE: The 340B Program Soared to $38 Billion in 2020—Up 27% vs. 2019

Drug Channels

Despite what you may have heard, the 340B Drug Pricing Program continues to thrive. Discounted purchases under the program reached at least $38 billion in 2020. That figure is an astonishing 27% higher than its 2019 counterpart—and more than quadruple the value of discounted purchases in 2014. Drug Channels has exclusively obtained the 2020 amount from the Health Resources and Services Administration (HRSA).

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New patent for Gilead Sciences drug VEKLURY

Drug Patent Watch

Annual Drug Patent Expirations for VEKLURY Veklury is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are eight…. The post New patent for Gilead Sciences drug VEKLURY 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 nineteen…. The post New patent for Teva Pharm drug ARMONAIR RESPICLICK appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 98
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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 three suppliers. There are twenty-five…. The post New patent for Teva Pharm drug AIRDUO DIGIHALER appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 98
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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 patent for Altathera Pharms drug SOTALOL HYDROCHLORIDE

Drug Patent Watch

Annual Drug Patent Expirations for SOTALOL+HYDROCHLORIDE Sotalol Hydrochloride is a drug marketed by Altathera Pharms Llc, Apotex, Beximco Pharms Usa, Epic Pharma Inc, Impax Pharms, Mylan, Oxford Pharms, Sun Pharm…. The post New patent for Altathera Pharms drug SOTALOL HYDROCHLORIDE appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for Astrazeneca drug DUAKLIR PRESSAIR

Drug Patent Watch

Annual Drug Patent Expirations for DUAKLIR+PRESSAIR Duaklir Pressair is a drug marketed by Astrazeneca and is included in one NDA. There are four patents protecting this drug. This drug has…. The post New patent for Astrazeneca drug DUAKLIR PRESSAIR appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for Amarin Pharms drug VASCEPA

Drug Patent Watch

Annual Drug Patent Expirations for VASCEPA Vascepa is a drug marketed by Amarin Pharms and is included in one NDA. It is available from two suppliers. There are sixty-two patents…. The post New patent for Amarin Pharms drug VASCEPA appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for Eyepoint Pharms drug DEXYCU KIT

Drug Patent Watch

Annual Drug Patent Expirations for DEXYCU+KIT Dexycu Kit is a drug marketed by Eyepoint Pharms and is included in one NDA. There are five patents protecting this drug. This drug…. The post New patent for Eyepoint Pharms drug DEXYCU KIT 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 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 three suppliers. There are twenty-one…. The post New patent for Teva Pharm drug AIRDUO RESPICLICK appeared first on DrugPatentWatch - Make Better Decisions.

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New patent expiration 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 three patents…. The post New patent expiration for Xspire Pharma drug ZONTIVITY appeared first on DrugPatentWatch - Make Better Decisions.

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New patent expiration for Janssen R drug INTELENCE

Drug Patent Watch

Annual Drug Patent Expirations for INTELENCE Intelence is a drug marketed by Janssen R And D and is included in one NDA. It is available from one supplier. There is…. The post New patent expiration for Janssen R drug INTELENCE appeared first on DrugPatentWatch - Make Better Decisions.

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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-one…. 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 Branded drug PROAIR DIGIHALER

Drug Patent Watch

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

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New patent for Teva Branded drug PROAIR RESPICLICK

Drug Patent Watch

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

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New patent for Rempex drug VABOMERE

Drug Patent Watch

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

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New patent for Acrotech drug EVOMELA

Drug Patent Watch

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

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New patent expiration for Novartis drug TRILEPTAL

Drug Patent Watch

Annual Drug Patent Expirations for TRILEPTAL Trileptal is a drug marketed by Novartis and is included in two NDAs. It is available from three suppliers. There is one patent protecting…. The post New patent expiration for Novartis drug TRILEPTAL appeared first on DrugPatentWatch - Make Better Decisions.

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New patent expiration for Takeda Pharms drug OSENI

Drug Patent Watch

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

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New patent expiration for Merck Sharp drug CLARINEX D 24 HOUR

Drug Patent Watch

Annual Drug Patent Expirations for CLARINEX+D+24+HOUR Clarinex D 24 Hour is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are three patents protecting this…. The post New patent expiration for Merck Sharp drug CLARINEX D 24 HOUR appeared first on DrugPatentWatch - Make Better Decisions.

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New patent expiration for Merck Sharp drug CLARINEX-D 12 HOUR

Drug Patent Watch

Annual Drug Patent Expirations for CLARINEX-D+12+HOUR Clarinex-d 12 Hour is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from one supplier. There…. The post New patent expiration for Merck Sharp drug CLARINEX-D 12 HOUR appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Expirations for the Week of June 13, 2021

Drug Patent Watch

OSENI (alogliptin benzoate; pioglitazone hydrochloride) Takeda pharms usa Patent: 6,329,404 Expiration: Jun 19, 2021 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence…. The post Drug Patent Expirations for the Week of June 13, 2021 appeared first on DrugPatentWatch - Make Better Decisions.

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The Lancet Publishes Results from Pivotal Global Phase 3 Program Evaluating RINVOQ® (upadacitinib) in Atopic Dermatitis

The Pharma Data

NORTH CHICAGO, Ill. , May 24, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced The Lancet published primary analysis results from the pivotal global Phase 3 clinical trials – Measure Up 1, Measure Up 2 and AD Up – evaluating RINVOQ ® (upadacitinib) in adults and adolescents with moderate to severe atopic dermatitis who were candidates for systemic treatment.

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AbbVie Presents New Late-Breaking Data Analyses Showing Risankizumab (SKYRIZI®) Achieves Clinical Remission and Endoscopic Response at Week 12 in Patients with Moderate to Severe Crohn’s Disease

The Pharma Data

NORTH CHICAGO, Ill. , May 24, 2021 /PRNewswire/ — Late-breaking data analyses presented by AbbVie (NYSE: ABBV) at Digestive Disease Week ® (DDW) Virtual Conference 2021 showed significantly greater proportions of patients with moderately to severely active Crohn’s disease treated with both doses of investigational risankizumab (600 mg or 1200 mg) met the co-primary endpoints of clinical remission and endoscopic response at week 12 compared to placebo (p<0.001 for each) in two Pha

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New Long-Term Efficacy and Safety Analyses Evaluating RINVOQ® (upadacitinib) in Patients with Rheumatoid Arthritis to be Presented at EULAR 2021 Virtual Congress

The Pharma Data

NORTH CHICAGO, Ill. , June 2, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced new analyses to be presented at the EULAR 2021 Virtual Congress showing patients with moderate to severe rheumatoid arthritis on background methotrexate (MTX) treated with RINVOQ ® (upadacitinib, 15 mg, once daily) maintained higher rates of clinical remission and low disease activity through three years compared to those patients treated with HUMIRA ® (adalimumab). 1 Additionally, a separate integrated s

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AbbVie to Present Analysis Evaluating Continuous RINVOQ® (upadacitinib) Treatment in Psoriatic Arthritis for More Than One Year at EULAR 2021 Virtual Congress

The Pharma Data

NORTH CHICAGO, Ill. , June 2, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced results of an analysis from the Phase 3 SELECT-PsA 2 clinical trial, showing that continuous treatment with RINVOQ ® (upadacitinib, 15 mg, once daily) resulted in sustained improvements in disease activity for more than one year (56 weeks) among patients with active psoriatic arthritis who have responded inadequately to one or more biologic disease modifying anti-rheumatic drugs (bDMARDs). 1 At week 56,

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Phase 3 Maintenance Results Show Patients with Crohn’s Disease Receiving Risankizumab (SKYRIZI®) Achieved Endoscopic Response and Clinical Remission at One Year

The Pharma Data

NORTH CHICAGO, Ill. , June 2, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced positive top-line results from the Phase 3 maintenance study, FORTIFY, showing risankizumab 360 mg (subcutaneous [SC]; administered every eight weeks) achieved the co-primary endpoints of endoscopic response and clinical remission at one year in adult patients with moderate to severe Crohn’s disease. 1.

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Human infection with avian influenza A (H5N8) – the Russian Federation

The Pharma Data

On 18 February 2021, the National IHR Focal Point for the Russian Federation notified WHO of detection of avian influenza A(H5N8) in seven human clinical specimens. These are the first reported detection of avian influenza A(H5N8) in humans. Positive clinical specimens were collected from poultry farm workers who participated in a response operation to contain an avian influenza A(H5N8) outbreak detected in a poultry farm in Astrakhan Oblast in the Russian Federation.

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New Data Shows AbbVie’s VENCLYXTO®/VENCLEXTA® Fixed Duration Combination Demonstrates Sustained Progression-Free Survival in Chronic Lymphocytic Leukemia Patients after Three Years off Treatment

The Pharma Data

NORTH CHICAGO, Ill. , June 11, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced results from a four-year follow-up analysis of the Phase 3 CLL14 trial, which showed that previously untreated patients with chronic lymphocytic leukemia (CLL) with coexisting conditions who were treated with VENCLYXTO ® /VENCLEXTA ® (venetoclax) plus obinutuzumab continued to show longer progression-free survival (PFS) and higher rates of undetectable minimal residual disease (MRD) compared to patients