European Pharmaceutical Review

JULY 27, 2023

Pharmacological therapies mainly address symptoms and unfortunately a significant number of patients do not respond adequately, progressing to congestive heart failure and eventually needing a heart transplant. Despite these trials varying in design, they confirmed the feasibility and safety of the procedure.

Pharmacology 92

Pharmacology Manufacturing Leads Patients 92

European Pharmaceutical Review

SEPTEMBER 22, 2023

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline. Treatment with the mAbs delayed cognitive decline by 2.6 months for lecanemab and 5.5

Food and Drug Administration 78

Food and Drug Administration Safety Patients Leads 78

Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

FDA 105

FDA Pharmacology Patients Pharmaceutical 105

Pharmaceutical Technology

AUGUST 8, 2022

Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug. You don’t want to use this to stigmatize patients or to ‘catch them lying.’ A patient probably does not know what they’re signing, but still do it in order to access whatever treatment they need, she adds.

Food and Drug Administration 122

Food and Drug Administration FDA Medicine Patients 122

Pharmaceutical Technology

FEBRUARY 13, 2023

As well as presenting an acceptable PK profile and demonstrating in-vivo efficacy, it becomes important to show that the candidate drug has a good safety pharmacology margin with an acceptable drug-drug interaction (DDI) profile.

Food and Drug Administration 52

Food and Drug Administration Leads Pharmaceutical Pharmaceutical research 52

Quantified

JUNE 28, 2022

On the one hand, patient need for access and business need to restore and accelerate sales and prescription momentum have never been more critical. Having a flawless technical grasp of the medicine is no longer sufficient. On the other hand, HCP access for the field force has never been more challenging.

Sales 52

Sales Pharma Training Management 52

Pharmaceutical Technology

OCTOBER 10, 2022

The company is aiming to enrol the first patient in the ALETTA Phase III trial in Q1 or Q2 of 2023, says Dr. Jan van der Mooren, Freya’s chief medical officer (CMO). Despite the recognized need and demand for options to treat female sexual dysfunction, several safety and access issues associated with the use of available options.

Pharmacology 59

Pharmacology Side effects FDA Safety 59

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. For this approach, a “3+3” model is used where a study enrolls three patients into a given dose cohort.

FDA 115

FDA Side effects Pharmacology Patients 115