Drug Channels

JUNE 14, 2022

Last week, the authors of a new JAMA study claimed that “prices for new drugs are skyrocketing.” Their research, along with a simultaneously released New York Times op-ed, received widespread media coverage. Links below. But as I explain, the study’s headline conclusion is highly misleading. The authors obscure the real story with mathematical sleight-of-hand that misrepresents the underlying data and overlooks the true nature of today’s pharmaceutical innovations.

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The Pharma Data

JUNE 17, 2022

Two broadly neutralizing antibodies show great promise to provide long-acting immunity against COVID-19 in immunocompromised populations according to a paper published June 15 in the Journal of Experimental Medicine (JEM). The antibodies were effective against all SARS-CoV-2 variants of concern tested and could be used alone or in an antibody cocktail to diminish the risk of infection.

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Drug Patent Watch

JUNE 17, 2022

Annual Drug Patent Expirations for EXPAREL Exparel is a drug marketed by Pacira Pharms Inc and is included in one NDA. It is available from one supplier. There are five…. The post New patent for Pacira Pharms drug EXPAREL appeared first on DrugPatentWatch - Make Better Decisions.

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Tecan

JUNE 16, 2022

By Ashesh Saraiya NGS has transformed genomics research and contributed to breakthroughs in many areas of medical science. At the same time, making NGS robust, reliable and cost-effective can be challenging for many labs. In particular, generating libraries for sequencing is a common bottleneck, especially for labs that are processing low sample volumes or not running NGS on a regular basis.

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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

JUNE 17, 2022

Today’s guest post comes from Shawn Seamans, Chief Commercial Officer at CoverMyMeds. Shawn discusses how technology can be combined with human intervention to better help patients access, afford, and adhere to their therapies. He then describes how three patients benefited from support solutions. For more information about how CoverMyMeds’ solutions can support the patient journey for your brand, visit their digital commercialization experience.

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The Pharma Data

JUNE 17, 2022

Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study Adalimumab’s high-concentration 100 mg/mL formulation aims to provide an enhanced yet familiar experience for patients Submission builds on Sandoz’ well established biosimilar immunology portfolio in Europe. Sandoz, a global leader in generic and biosimilar medicines, today announced that the European Medicines Agency (EMA) has accepted the application for high concentration formul

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Advarra

JUNE 16, 2022

Study startup is a complicated, multi-faceted, and time-consuming component of the clinical research lifecycle, one notoriously prone to delays. The key challenge of successful, timely study startup requires careful coordination across multiple constituencies within and external to a research organization. As a result, it is easy to lose track of all the various steps necessary to activate a study efficiently and compliantly. .

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Drug Channels

JUNE 13, 2022

Informa Connect’s IDN & Bio/Pharma Partnering Summit Hybrid Event August 16-17, 2022 | Philadelphia, PA www.informaconnect.com/IDN. Don’t miss the IDN & Bio/Pharma Partnering Summit coming up this summer in Philadelphia, where you'll be part of the important discussions on how to best optimize strategic partnerships to improve patient access and outcomes.

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The Pharma Data

JUNE 17, 2022

In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety profile similar to placebo in young children ages 6 months through 4 years in Phase 2/3 clinical trial Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S. for all individuals 6 months of age and older.

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Drug Patent Watch

JUNE 17, 2022

Annual Drug Patent Expirations for SYMJEPI Symjepi is a drug marketed by Adamis Pharms Corp and is included in one NDA. SYMJEPI drug price trends. The generic ingredient in SYMJEPI…. The post New patent for Adamis Pharms drug SYMJEPI 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

Advarra

JUNE 14, 2022

Pre-screening potential participants for a clinical study is common practice at most research sites. It can save time by quickly identifying those who may qualify for a study prior to having them move on to the informed consent process. Pre-screens can be done in person, over the phone, or in some cases, even online. The role technology can play in this process is important not to overlook.

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Pharma Manufacturing

JUNE 17, 2022

The digitalization journey for pharmaceutical manufacturing can reap many benefits and there are many choices to be made in terms of these technologies and how to deploy them. In this episode, Andrea Corona talks about how digitalization is delivering a competitive advantage and assembly and inspection with Veronica Ghidotti and.

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The Pharma Data

JUNE 12, 2022

Investigational phase 3 data for Sogroya ® ( somapacitan ) injection in children with growth hormone deficiency presented today at the ENDO 2022 Congress 1. Today, Novo Nordisk announced results of once-weekly Sogroya ® (somapacitan) injection in helping children achieve growth targets of annualised height velocity (AHV). 1 These phase 3 results from the REAL 4 study, in prepubertal children with growth hormone deficiency (GHD), were presented today at the Endocrine Society’s Annual Me

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Drug Patent Watch

JUNE 16, 2022

Annual Drug Patent Expirations for CRESTOR Crestor is a drug marketed by IPR and is included in one NDA. It is available from four suppliers. There is one patent protecting…. The post New patent expiration for IPR drug CRESTOR 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

Advarra

JUNE 14, 2022

Like every institutional review board (IRB) – commercial or local – Advarra is subject to inspections from time to time. The Food and Drug Administration (FDA) inspects IRBs to ensure human participants’ rights and welfare are properly protected. The Association for the Accreditation of Human Research Protection Programs (AAHRPP) regularly examines us as part of our accreditation maintenance.

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Pharma Manufacturing

JUNE 13, 2022

Lacking an established workforce, the nascent cell and gene therapy industry must grow its own talent

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The Pharma Data

JUNE 17, 2022

Third approved indication for SKYRIZI (risankizumab-rzaa) is supported by safety and efficacy data from two induction and one maintenance clinical trials evaluating SKYRIZI in moderately to severely active Crohn’s disease, ADVANCE, MOTIVATE and FORTIFY 1-4. – As early as week 4 in the induction studies, clinical response and clinical remission were achieved by significantly more subjects treated with SKYRIZI versus placebo, as were co-primary endpoints of endoscopic response and clin

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Drug Patent Watch

JUNE 15, 2022

Annual Drug Patent Expirations for HETLIOZ+LQ Hetlioz Lq is a drug marketed by Vanda Pharms Inc and is included in one NDA. It is available from one supplier. There are…. The post New patent for Vanda Pharms drug HETLIOZ LQ appeared first on DrugPatentWatch - Make Better Decisions.

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Drug & Device Law

JUNE 15, 2022

An amendment to the FDCA, called the “Verifying Accurate Leading-edge IVCT Development Act” – or VALID Act (cute) for short – has been wending its way through Congress. It appears intended to codify FDA regulatory authority over in vitro chemical tests, and is not the kind of thing we would ordinarily concern ourselves with on this Blog. It’s not like such tests have been a product liability hotbed.

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Pharma Manufacturing

JUNE 14, 2022

Comprehensive strategies to save time and reduce cost in end-to-end clinical development

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Drug Patent Watch

JUNE 15, 2022

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

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Drug Patent Watch

JUNE 13, 2022

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

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Drug Patent Watch

JUNE 12, 2022

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

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Drug Patent Watch

JUNE 15, 2022

CRESTOR (rosuvastatin calcium) Ipr Patent: 6,858,618 Expiration: Jun 17, 2022 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or…. The post Drug Patent Expirations for the Week of June 12, 2022 appeared first on DrugPatentWatch - Make Better Decisions.

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Pharma Manufacturing

JUNE 17, 2022

Continuous manufacturing may finally come into its own, according to an industry panel

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Pharma Manufacturing

JUNE 15, 2022

Three priorities for re-strategizing digital transformation post-COVID

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Drug Patent Watch

JUNE 17, 2022

This chart shows the patent expirations for tablet dosed drugs over the next decade. The term of drug patents varies. The basic term for a patent is 20 years from…. The post Tablet dosed drug patent expirations by year appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JUNE 16, 2022

This chart shows the pharmaceutical companies with the most patents in Peru. 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 Peru? appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JUNE 15, 2022

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

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Drug Patent Watch

JUNE 14, 2022

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

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Drug Patent Watch

JUNE 13, 2022

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

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Drug Patent Watch

JUNE 12, 2022

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

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Drug & Device Law

JUNE 13, 2022

We’ve seen a couple of decisions recently in which defendants raised the “commonly known” hazards exception for medical device labeling, so we thought we’d give it a look. The FDA’s regulations for medical device labeling generally require that such labeling include “any relevant hazards, contraindications, side effects, and precautions.” 21 C.F.R. §801.109(c).

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Drug & Device Law

JUNE 14, 2022

Today’s case is Glover v. Bausch & Lomb, Inc. , — A.3d –, 2022 WL 2035805 (Ct. S. Ct. Jun. 7, 2022). And all we can say is Boo! Not a Halloween, Casper-type Boo! But a real Queen of Putrescence-type Boo ! Because unfortunately, the Connecticut Supreme Court, responding to a certified question from the Second Circuit, found that Connecticut law allows a common-law claim for liability for failure to report adverse events to the FDA.

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