pharmaphorum

NOVEMBER 2, 2022

The struggle to manage pain for individuals has been one that goes back a long way in history, with one of the earliest recorded medical prescriptions being for opium. Another key way DTx can improve chronic pain is by helping patients to manage lifestyle factors that have the potential to exacerbate chronic pain diseases.

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Legacy MEDSearch

MARCH 15, 2023

Founded in 2016, LIVMOR developed the Halo+ Atrial Fibrillation (AF) Detection System, the world’s first FDA-cleared prescription wearable for continuous cardiac rhythm monitoring. The acquisition extends HeartBeam’s reach in remote monitoring and detection with full ownership of an existing cutting-edge FDA-cleared product.

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Food and Drug Administration FDA Recruitment Physicians 97

PM360

MAY 25, 2023

The new Food and Drug Administration (FDA)’s Decentralized Clinical Trial Draft Guidance issued May 1 st has started to outline guidelines for increased oversight and planning while simultaneously supporting broader DCT adoption. The guidance document is short at 19 pages, and by design not prescriptive.

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FDA Food and Drug Administration Safety Medicine 104

World of DTC Marketing

APRIL 15, 2021

These groups are also latching onto reports of real deaths following the shot, blaming the vaccine and disregarding medical information that other causes are to blame. While patients have the right to full disclosure, misinformation and scare tactics could lead to more deaths from COVID. A new approach to market was needed.

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Food and Drug Administration Government Safety Manufacturing 203

European Pharmaceutical Review

NOVEMBER 8, 2022

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 5) monitoring access to biosimilars.

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World of DTC Marketing

DECEMBER 13, 2021

OPENING: American cancer patients spent more than $21 billion on their care in 2019. billion and patient time costs of $4.87 Monthly drugs costs may reach $100,000, causing many Americans to struggle with the physical and emotional effects of high out-of-pocket medical costs. billion included out-of-pocket costs of $16.22

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Food and Drug Administration Food Medical Medicine 55

Pharmaceutical Representative Training

DECEMBER 28, 2021

Before 2020, the landscape of drug marketing involved following drug approvals by the Food and Drug Administration ( FDA ), finding which patient population would benefit from therapy, and visiting specialized doctors in-person to advertise its advantages compared to current guidelines.

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Marketing Food and Drug Administration Pharma Doctors 52

Legacy MEDSearch

JULY 6, 2023

MedRhythms announced that MR-001, the company’s evidence-based neurorehabilitation system to improve walking and ambulation in adults with chronic stroke walking deficits, has been listed as a Class II medical device with the U.S. Food and Drug Administration (FDA).

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FDA Food and Drug Administration Recruitment Medical 52

Clarify Health

NOVEMBER 21, 2022

Earlier this year, Clarify Health began offering a new service ( Clarify Trials ) whereby companies could receive a list of the most-ideal sites for studies tied to the characteristics of patients they hope to enroll. It essentially offered an assessment of risk that would initially be available to care-planning clinicians.

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Food and Drug Administration Transportation Food Recruitment 52

Legacy MEDSearch

APRIL 25, 2023

Proprio , a Seattle-based medical technology company, today announced its surgical navigation platform, Paradigm, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). ABOUT PROPRIO Proprio is a leading medical technology company creating the new way of seeing in surgery.

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FDA Food and Drug Administration Recruitment Medical 52

Clarify Health

OCTOBER 26, 2021

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. To advance equity in clinical research, the U.S. However, another study found that 0.1% 2] Figure 1. 2] Figure 1.

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Food and Drug Administration Recruitment Pharmaceutical manufacturing Medical 52

Clarify Health

NOVEMBER 21, 2022

Earlier this year, Clarify Health began offering a new service ( Clarify Trials ) whereby companies could receive a list of the most-ideal sites for studies tied to the characteristics of patients they hope to enroll. It essentially offered an assessment of risk that would initially be available to care-planning clinicians.

Food and Drug Administration 40

Food and Drug Administration Transportation Food Recruitment 40

pharmaphorum

JANUARY 25, 2023

Digital therapeutics company Woebot Health has announced enrolment of the first patient in a pivotal clinical trial to evaluate the safety and efficacy of WB001, an investigational therapeutic for postpartum depression (PPD), granted Breakthrough Device designation by the US Food and Drug Administration (FDA) in 2021.

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Food and Drug Administration Prescription Media FDA 91

PM360

AUGUST 9, 2022

Addressing the issue of medication adherence begins before a patient even fills their first prescription. According to a recent IQVIA analysis, only one in four patients who were new to a brand in 2021 successfully initiated therapy. “To

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Food and Drug Administration Prescription Patients Medical 105

Clarivate

MARCH 17, 2022

Drug developers often face a Catch-22 regarding clinical trials and pregnancy. How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? We look at the outcome of a recent Food and Drug Administration meeting and their draft guidance for more information.

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Food and Drug Administration Safety FDA Ethics 10

MedCity News

JUNE 12, 2023

One of the fastest-growing frontiers of healthcare is Digital Therapeutics (DTx), which utilizes clinically tested software to prevent, treat, and manage a growing range of medical conditions. The goal was simple: provide access and focused support to patients remotely while simultaneously relieving overtaxed healthcare facilities.

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Food and Drug Administration Prescription Government FDA 85

Pharmaceutical Technology

MAY 24, 2023

The US Food and Drug Administration (FDA) has approved Braeburn’s Brixadi (buprenorphine) – a subcutaneous extended-release injection available in weekly or monthly treatments. Weekly doses of Brixadi will range from 8 mg to 32 mg and monthly doses will be 64 mg, 96 mg, and 128 mg.

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FDA Food and Drug Administration Prescription Medical 59

Pharmaceutical Technology

AUGUST 8, 2022

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug. Proteus’s profile grew considerably; it was soon valued at $1.5

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Food and Drug Administration FDA Medicine Patients 122

World of DTC Marketing

JULY 12, 2022

Imbruvica, a cancer medication, carries a wholesale price of about $16,000 a month. Patients on Medicare who don’t qualify for low-income subsidies could see out-of-pocket costs for the drug of over $12,000. Isn’t it time for Congress to finally pass legislation that helps patients? Administration on Aging.

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Healthcare Healthcare Food and Drug Administration Government 227

Cadensee

JULY 20, 2021

He is one of the first advocates for patient centric health care more than a decade ago when patient opinions and requests were not part of the equation in the system. Uri founded and continues to contribute insights through his digital magazine, e-Pochonder and is one of the first advocates for patient centric health care.

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Pharmaceutical Technology

MAY 31, 2023

The US Food and Drug Administration (FDA) has proposed a new model for prescription medication guides for brand name and generic drugs, to increase accessibility and reduce medication nonadherence.

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Prescription FDA Food and Drug Administration Medical 52

Pharmaceutical Technology

APRIL 26, 2023

Packaging plays a critical part in the pharmaceuticals and medical devices industries and is developed with its own set of security standards for the safety of consumers. The document contains detailed information on the providers and their product offerings, alongside contact details to aid your purchasing or hiring decision.

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Pharmaceutical Technology

MAY 26, 2023

The FDA has flagged this issue as pharmacies selling prescription drugs illegally have proliferated over the years. The FDA has flagged this issue as pharmacies selling prescription drugs illegally have proliferated over the years.

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Food and Drug Administration Prescription FDA Medical 52

Pharmaceutical Technology

MAY 11, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of giving HRA Pharma’s Opill (norgestrel) over-the-counter (OTC) availability. The FDA approved Opill for prescription use in 1973. The therapy only contains the hormone progestin and is taken once daily.

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FDA Food and Drug Administration Prescription Pharma 52

World of DTC Marketing

APRIL 7, 2022

Obesity costs our health care system $147 billion per year, yet there is a movement underway to tell HCPs not to weigh patients during routine visits. The seventh leading cause of death in the United States, diabetes costs $327 billion in medical costs and lost work and wages. Launch prices of new cancer drugs in the U.S.

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Healthcare Healthcare Food and Drug Administration Government 215

World of DTC Marketing

SEPTEMBER 22, 2020

Under no circumstances can ANY pharma company allow this administration to fastback a COVID vaccine for political purposes. To do so would derail our drug safety and lead to patients and HCP’s to question all prescription drug data. Pharma has to fight with everything in their arsenal.

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World of DTC Marketing

AUGUST 25, 2020

That should tell you all you need to know about how bad things are with the FDA and trust in drug approvals. I spent a lot of time in my career working with and talking to clinical scientists about the “drug approval process” The more questions I asked the more I learned. Dr. Stephen Hahn, the F.D.A.’s

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Food and Drug Administration FDA Ethics Prescription 188

World of DTC Marketing

MAY 6, 2021

Some say pharma should be allowed to make as much as they want because we live in a capitalist society but JAMA recently found out that price increases in branded drugs means that people will often go without their medications. But what about the costs to develop new drugs and the failure rates?

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