Food and Drug Administration, Leads, Physicians and Safety

Parkinson’s infusion treatment demonstrates advantage over oral delivery

European Pharmaceutical Review

MARCH 18, 2024

A Phase III trial has shown that compared oral drug delivery, administering levodopa through an infusion pump led to nearly two hours of day (1.72) of additional time in which the medicine reduced symptoms in Parkinson’s patients. The research paper comparing the two drug delivery methods was published in The Lancet Neurology.

Food and Drug Administration

Food and Drug Administration Medicine Physicians Food

FDA accepts resubmission of Ardelyx’s NDA for XPHOZAH

Pharmaceutical Technology

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmission of a new drug application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adults with chronic kidney disease on dialysis who have had insufficient response or intolerance to a phosphate binder treatment.

Food and Drug Administration

Food and Drug Administration FDA Physicians Food

Delivery systems for biologics

European Pharmaceutical Review

MARCH 4, 2024

1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5

Food and Drug Administration

Food and Drug Administration Transportation FDA Medical

Why Is FDA Issuing Fewer Marketing Violation Letters?

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

Marketing

Marketing FDA Food and Drug Administration Pharmaceutical

FDA accepts Ardelyx’s NDA resubmission for XPHOZAH

Pharma Leaders

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.

Food and Drug Administration

Food and Drug Administration FDA Side effects Prospecting

The future of medical cannabis development in Europe

European Pharmaceutical Review

JULY 13, 2023

In many European countries physicians can now prescribe medical cannabis for an array of chronic health conditions, including chronic pain, mental health disorders and neurological conditions. 3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside.

Medical

Medical Food and Drug Administration Pharmacology Medicine

UroMems Announces First-Ever Smart Artificial Urinary Sphincter Implant in a Female Patient

Legacy MEDSearch

JULY 21, 2023

“We are addressing the observations by so many physicians that there is a vast unmet need for a better way to definitively treat this female population.” This first-in-female procedure was approved by the National Agency for the Safety of Medicines and Health Products (or ANSM, the French equivalent to the U.S.

Food and Drug Administration

Food and Drug Administration Patients Safety Recruitment

Techsomed Announces FDA Clearance for Ablation Treatment Planning and Confirmation Software

Legacy MEDSearch

SEPTEMBER 5, 2023

a medical software innovator dedicated to enhancing clinical impact in ablation therapy, announced today that it has received 510(k) clearance from the USA Food and Drug Administration (FDA) for its VisAble.IO Techsomed Ltd., VisAble.IO “We are excited to receive 510(k) clearance for our VisAble.IO

FDA

FDA Food and Drug Administration Physicians Recruitment

Recor Medical and Otsuka Medical Devices Announce Positive Vote from the FDA Advisory Committee Meeting on the Paradise™ Ultrasound Renal Denervation System

Legacy MEDSearch

AUGUST 23, 2023

Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise Ultrasound Renal Denervation (RDN) system, indicated to reduce blood pressure in patients with hypertension.

Medical

Medical Food and Drug Administration FDA Recruitment

Vertex and CRISPR Therapeutics submit BLAs to FDA for exa-cel

Pharmaceutical Technology

APRIL 4, 2023

Vertex Pharmaceuticals and CRISPR Therapeutics have completed the rolling submission of biologics licence applications (BLAs) to the US Food and Drug Administration (FDA) for exagamglogene autotemcel (exa-cel) to treat sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).

Food and Drug Administration

Food and Drug Administration FDA Medicine Physicians

Private Patient Advocacy: The Medical Sales Rep’s Role In The Nursing World With Antra Boyd And Karen DiMarco, Part 2

Evolve Your Success

MAY 17, 2022

You know when they are trying to push a drug and white-knuckling it. When a physician decides to use a robotic machine, that is not part of my decision-making process and the OR manager. You ask the hospital administrators to figure out the financial aspects of that side of it. What drugs are we using? Sales can be pushy.

Medical sales

Medical sales Medical Sales Patients

Why aren’t digital pills taking off?

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

Food and Drug Administration

Food and Drug Administration FDA Medicine Patients

The FDA now recommends that clinical trial sponsors submit a Race and Ethnicity Diversity Plan

Clarify Health

MAY 27, 2022

The US Food and Drug Administration (FDA) recently announced new draft guidance for life science companies on increasing diversity and inclusion in clinical trials to improve enrollments of underrepresented racial and ethnic populations.

FDA

FDA Food and Drug Administration Recruitment Transportation

The FDA now recommends that clinical trial sponsors submit a Race and Ethnicity Diversity Plan

Clarify Health

MAY 27, 2022

The US Food and Drug Administration (FDA) recently announced new draft guidance for life science companies on increasing diversity and inclusion in clinical trials to improve enrollments of underrepresented racial and ethnic populations.

FDA

FDA Food and Drug Administration Recruitment Transportation

Developing point-of-care CAR T manufacturing

European Pharmaceutical Review

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. Being a cellular therapy that involves cell manipulation and molecular transfection – and above all, being a living drug – makes CAR T-cell therapy a somewhat challenging immunotherapy to manufacture in‑house.

Manufacturing

Manufacturing Food and Drug Administration Patients Pharma

Pharma Rep Focus

Parkinson’s infusion treatment demonstrates advantage over oral delivery

FDA accepts resubmission of Ardelyx’s NDA for XPHOZAH

Trending Sources

Delivery systems for biologics

Why Is FDA Issuing Fewer Marketing Violation Letters?

FDA accepts Ardelyx’s NDA resubmission for XPHOZAH

The future of medical cannabis development in Europe

UroMems Announces First-Ever Smart Artificial Urinary Sphincter Implant in a Female Patient

Techsomed Announces FDA Clearance for Ablation Treatment Planning and Confirmation Software

Recor Medical and Otsuka Medical Devices Announce Positive Vote from the FDA Advisory Committee Meeting on the Paradise™ Ultrasound Renal Denervation System

Vertex and CRISPR Therapeutics submit BLAs to FDA for exa-cel

Private Patient Advocacy: The Medical Sales Rep’s Role In The Nursing World With Antra Boyd And Karen DiMarco, Part 2

Why aren’t digital pills taking off?

The FDA now recommends that clinical trial sponsors submit a Race and Ethnicity Diversity Plan

The FDA now recommends that clinical trial sponsors submit a Race and Ethnicity Diversity Plan

Developing point-of-care CAR T manufacturing

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