2019

Drug Development for an Aging Population

Camargo

Fueled by unprecedented medical, technological and social advancements of the past century, it should be. The post Drug Development for an Aging Population appeared first on Camargo. Blog Combination Products

Perioperative Management of Patients With Atrial Fibrillation Receiving a Direct Oral Anticoagulant

JAMA Internal Medicine

This cohort study examines the risk of bleeding and stroke associated with surgical procedures and the value of perioperative management among patients with atrial fibrillation who use anticoagulants

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Decentralized Clinical Trials Enable Participation for Immobile Patients

VirTrial

Clinical trials require a significant commitment from patients, particularly in regard to travel time to research sites for regular visits.

Investing In The U.S. Health System By Lowering Drug Prices, Reducing, Out-of-Pocket Costs and Improving the Medicare Benefit

Pharmacy Checkers

The following statement , recently published in the Congressional Record , was submitted by Gabriel Levitt on October 30, 2019, on behalf of PharmacyChecker and Prescription Justice, to the Committee on Ways and Means of the U.S.

Customer Success: Will a generic version of a drug launch? And when?

Drug Patent Watch

DrugPatentWatch serves companies across the drug development-delivery sector. A common request among drug manufacturers, payers, and suppliers alike is anticipation of which branded drugs will face generic competition, and when…. The post Customer Success: Will a generic version of a drug launch?

Bill Jenkins and the legacy of the Tuskegee Syphilis Study

Research Ethics Blog

It’s been a while – a LONG while – but here goes a renewed effort to try to keep people engaged in all things research ethics. It’s a busy time of life for us, with a ton of demands, but I’m feeling a strong pull towards trying to rekindle the Research Ethics Blog. Let’s start with a post about something with which most of you will be familiar. Bill Jenkins died recently. Many of you will not know his name – I also admit I didn’t, until now.

Siteless Clinical Trials Are Changing the Game for Patients

Science 37

Siteless Clinical Trials: Thinking Outside the Box by Putting Clinical Research in a Box. Clinical research is a long process that involves a series of studies that gives Food and Drug Administration (FDA) regulators the information needed to determine whether the drug is safe and effective — and ultimately whether it should be approved for use.

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Migraine Clinical Trials at Riverside Clinical Research

Riverside Clinical Research

Migraines are recurring, pulsing headaches and are often accompanied by nausea and sensitivity to light and sound. Although they most typically affect one side of the head, migraines can produce steady, painful throbs on the sides and front of the head and even around the eyes.

Novartis confirms $9.7bn takeover of The Medicines Company

Una Com Pharma

MedCo is a company that has produced an inhibitor that lowers cholesterol by blocking the synthesis of PCSK9 in the liver rather than targeting the protein itself.

Why designing a modern study protocol can save your clinical trial

Clairnes

The post Why designing a modern study protocol can save your clinical trial appeared first on Clinical Trial Recruitment & Management Services. Blog Clariness

The Opportunity for Generics Companies and Value Added Medicines in the US and Europe

Camargo

To succeed in today’s highly competitive pharmaceutical landscape, differentiation is key. In recent years, many. The post The Opportunity for Generics Companies and Value Added Medicines in the US and Europe appeared first on Camargo. 505(b)(2) Development Blog Regulatory Strategy & Submissions

Anticholinergic Drug Exposure and the Risk of Dementia

JAMA Internal Medicine

This nested case-control study including 58?769 769 patients diagnosed with dementia and 225?574 574 matched controls 55 years or older evaluates whether, and to what extent, anticholinergic drug exposure was associated with dementia risk

Drugs 63

Standardizing Terminology is a Step Toward Advancing the Clinical Research Industry

VirTrial

Clinical research is a critical component in determining the safety and effectiveness of medications, devices, and treatment regimens. Whether used for prevention, treatment, diagnosis or simply symptom relief, the pharmaceutical industry relies on clinical researchers to test and validate potential new remedies. Without the valuable work of professional clinicians, the industry would stall.

Through the Looking Glass: Is FDA really the “Gold Standard” in Drug Safety?

Pharmacy Checkers

Canada believes it is too small to facilitate U.S. wholesale importation of lower-cost drugs. This post will explore a much greater potential for importation from the European Union. Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e.

Customer Success: How do we identify generic entrants before they get FDA approval?

Drug Patent Watch

DrugPatentWatch can help identify generic entrants at the earliest stages Many clients come to DrugPatentWatch seeking to identify generic entrants well before they launch. CDMOs, equipment manufacturers, regulatory consultants, and…. The post Customer Success: How do we identify generic entrants before they get FDA approval? appeared first on DrugPatentWatch - Make Better Decisions. Customer Success Stories Insights Tips, Tricks, and Case Studies

What Are The Reasons Of Popularization And Future Aspects Of Pharma Franchise Business?

Fossil Remedies

POPULARIZATION AND FUTURE ASPECTS OF PHARMA FRANCHISE BUSINESS. Are you planning to launch a pharma franchise business? If yes, then it is essential to know everything about its prospects and reasons for its popularity. What are the primary reasons that affect it? Experts say that pharma franchise business is different, and hence, it is all the more important to understand it in detail. What is pharma franchise business? Pharma franchise is an agreement between the franchiser and franchisee.

We’re Making History Here!

Olympian Clinical Research

The FDA has voted to approve SPRAVATO TM (esketamine)! SPRAVATO TM is a nasal spray for adults with treatment-resistant depression. I know what you’re probably thinking…nasal spray?? That’s right! SPRAVATO will offer the first new mechanism of action in 30 years to treat this debilitating disease, continuing Janssen’s 60-plus-year history and commitment to research that make a difference for people living with mental illnesses, including severe mood disorders.” [1].

Writing for Clinical Trials

Imperical Blog

We’ve just released our latest ebook. It is called 6 Essentials When Writing Content for Clinical Trials; Engage Patients, Sites, and Providers. Here at Imperial, we generate millions of words for the clinical trial industry every year. Millions? Something like that, anyway. We specialize in writing recruitment, retention, and professional materials for clinical studies.

Happy Show Season – Hope To See You On The Fall Trail!

Pharma Packaging Solutions

We’re back on the trail of fall shows where we hope we will run into you. If you will be at Pack Expo Las Vegas, Contract Pharma or CPhI Worldwide, will you let us know? We have plenty of new things to talk about including sustainable packaging – this seems to be a hot topic and we are your sustainability packaging partner. Of course, if you need blister packaging or bottling or vial labeling, we can discuss that too.

Novartis unveils its long-term strategy highlighting 25 potential blockbusters

Una Com Pharma

At a R&D event in London, Novartis unveiled their long-term growth strategy, highlighting 25 or more potential blockbusters. Among these products are a group that are set to enter into pivotal trials in the coming year.

4 Best Practices in TrialKit for Greater Patient Engagement

Crucial Data Soutions

Patient engagement is a multifaceted term that has no standard definition. As an industry, we’ve agreed on its importance, yet still have difficulties settling on how to define it. Instead, experts have suggested four key factors in patient engagement : willingness to be involved, willingness to take a proactive approach, technology adaptability, and availability of psychosocial support.

What Do Patients Want from a Clinical Trial?

Clairnes

The post What Do Patients Want from a Clinical Trial? appeared first on Clinical Trial Recruitment & Management Services. Blog Clariness Patient Recruitment

Association of Step Volume and Intensity With All-Cause Mortality in Older Women

JAMA Internal Medicine

This cohort study of 16?741 741 older women from the Women’s Health Study examines associations of number of steps per day and stepping intensity with all-cause mortality

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VirTrial Acquires SnapMD and Bolsters Virtual Care Management Platform

VirTrial

Scottsdale, AZ (December 12, 2019) – VirTrial , a portfolio company of Kinderhook Industries, LLC , announced today the acquisition of SnapMD , an industry-leading provider of telemedicine tools and services that improve patient engagement. The acquisition bolsters VirTrial’s capabilities with access to SnapMD’s telemedicine platform and technical expertise.

Hitting Pause on Criticism of the FDA, Just for Today

Pharmacy Checkers

The Food and Drug Administration (FDA) is just one agency out of the many that make up the United States Department of Health and Human Services and, from PharmacyChecker’s relatively small (non-regulatory) role of helping verify online pharmacies to protect public health, I’ve learned just how insanely massive its mandate is.

The effect of patent expiration on sales of branded competitor drugs in a therapeutic class

Drug Patent Watch

DrugPatentWatch was used in a recent research study on branded drug sales following generic entry. In this paper, authors Jeffrey Fujimoto, Daniel M Tien, Sophie Snyder, Jeppe A Hertz, and….

How to Start a Pharmaceutical Distribution Company?

Fossil Remedies

STEPS TO START A PHARMACEUTICAL DISTRIBUTION COMPANY. When the pharma secto r is touching new heights year after year, it is a great idea to take the business benefits from it. Due to technological and scientific advances, pharmaceutical innovations are happening every second day. It means the opportunities are more than ever, especially if you are an enthusiastic entrepreneur. Start your pharmaceutical distribution company today. What does a pharma distribution company do?

Adult ADHD – Signs and Symptoms

Olympian Clinical Research

We often hear, or even know of children with Attention Deficit Hyperactivity Disorder (ADHD) , but it is much less common to hear of adults with ADHD. The reality is, however, that about 50% of children that are diagnosed with ADHD have continued challenges into adulthood. One of the main reasons we don’t think of adults having ADHD is that they are often better at hiding or masking their symptoms. But the reality is, it’s still a big struggle for many to cope with.

Introducing Clinical Study Finder

Patient Wise

PatientWise is excited to introduce you to Clinical Study Finder (CSF), a website powered by us and created with the sole purpose of connecting clinical research sites to the right patients. We understand that your clinical trials are nothing without volunteers. That’s why PatientWise envisioned a tool to bring patients and researchers together to drive the advancement of medicine.

Pharma Packaging Solutions Expanding Capacity and Services

Pharma Packaging Solutions

With two busy 2019 quarters booked, Pharma Packaging Solutions knew it needed to expand capacity quickly. Investments totaling over $2,7 million were made in several areas. One major investment included additional portable serialization and aggregation equipment to improve efficiency on primary and secondary lines. Additional labeling equipment was ordered and installed along with a leading-edge environmental control system.

Amgen raises its 2019 forceasts after successfully completing $13.4bn purchase of Otezla

Una Com Pharma

The $13.4bn deal was in response to competition authorities imposing a key requirement onto the proposed BMS/Celgene acquisition to divest Celgene’s blockbuster Otezla.

eClinical Provider, Crucial Data Solutions, Names Jeff Rogers as President

Crucial Data Soutions

As it experiences significant growth in the eClinical market, Crucial Data Solutions selects its new President. Reno, NV, August 6, 2019 —Crucial Data Solutions, a provider of innovative technologies to advance clinical research, announced today that industry veteran Jeff Rogers has joined the company as President.

What Patient Recruitment Support Do Leaders Want and Need?

Clairnes

The post What Patient Recruitment Support Do Leaders Want and Need? appeared first on Clinical Trial Recruitment & Management Services. Blog Clariness Patient Recruitment

Association Between Soft Drink Consumption and Mortality in Europe

JAMA Internal Medicine

This cohort study examines whether soft drink consumption is associated with all-cause and cause-specific mortality in a large cohort of European adults

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EIT Health launches 2020 Wild Card with €4 million investment for innovations addressing Women’s Health and Digital Therapeutics.

Drug Discovery Today

EIT Health will invest up to €2 million in two start-ups that offer the most effective and disruptive solutions to address either Women’s Health or Digital Therapeutics.Applications for the Wild Card programme are open until 9th February 2020

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China Opens the Door to Personal Medicine Imports and Third-Party Online Platform Sales

Pharmacy Checkers

A new Chinese law (in effect as of December 1, 2019) makes third-party online platform medicine sales legal, appropriately ends a draconian definition of counterfeit drugs, and effectively decriminalizes personal drug importation, but with a lot of gray!

Mistakes to Be Avoided When Preparing a Drug Launch

Drug Patent Watch

The launch of a new product can be a daunting task. The main reason this happens is that no matter how many times your company has managed to enter new…. The post Mistakes to Be Avoided When Preparing a Drug Launch appeared first on DrugPatentWatch - Make Better Decisions. Insights