European Pharmaceutical Review

JULY 19, 2023

The data “are compelling, particularly the significant improvements observed in both depressive and anhedonic symptoms,” stated Dr Roger S McIntyre, FRCPC, Professor of psychiatry and pharmacology, University of Toronto and Executive Director of the Brain and Cognition Discovery Foundation in Toronto, Canada.

Pharmacology 95

Pharmacology Patients Safety Medicine 95

Contrarian Sales Techniques

FEBRUARY 25, 2023

During my pharmacology class, I learned that there are no safe drugs, only safe patients. This highlights the importance of taking an individualized approach to medicine and considering a patient's unique medical history, current health status, and other relevant factors when prescribing medication.

Side effects 52

Side effects Medical sales reps Insurance Pharmacology 52

PM360

NOVEMBER 29, 2022

Drug labels hold value for life sciences companies because they are rich, extensive documents that can be used across labeling, regulatory, safety, and medical affairs. Understanding patient sub-group exceptions for competitive or for label development purposes. Food and Drug Administration (FDA) or European Medicines Agency (EMA).

Food and Drug Administration 98

Food and Drug Administration Competition Safety Pharmacology 98

Pharmaceutical Technology

AUGUST 16, 2022

Recently, Q32 concluded a Phase I clinical trial to evaluate the pharmacokinetics, pharmacodynamics and safety of ADX-914, which showed a pharmacological effect on T cells in healthy subjects. antibody, ADX-914 re-regulates adaptive immune function by hindering IL-7 and TSLP-facilitated signalling.

Food and Drug Administration 52

Food and Drug Administration Pharmacology Food Safety 52

pharmaphorum

DECEMBER 22, 2022

Meanwhile, in the longer-term ELEVATE UC 52 study, clinical remission was seen in 27% of etrasimod patients and 7% of the placebo group at the 12-week timepoint, and came in at 32% and 7% respectively after a year. In ELEVATE UC 12, etrasimod achieved a 25% clinical remission rate after 12 weeks, compared to 15% for a matched placebo group.

Pharmacology 52

Pharmacology Safety Patients Marketing 52

pharmaphorum

JANUARY 17, 2023

Angion chalked up a series of trial failures for its hepatocyte growth factor (HGF) mimetic ANG-3777 over the last couple of years, and turned its attention to tyrosine kinase receptor inhibitor ANG-3070 in kidney diseases and fibrotic disorders, before abandoning the drug due to safety concerns in the middle of 2022.

Pharmacology 74

Pharmacology Engineering Consulting Leads 74

Legacy MEDSearch

DECEMBER 12, 2022

“Nerivio is an excellent treatment option for our patients with migraine, especially those who do not respond to medications, or cannot tolerate their side effects. ” Clinical studies have shown Nerivio to be as effective as standard of care pharmacological options for acute migraine treatment.

Side effects 98

Side effects Insurance FDA Pharmacology 98

Legacy MEDSearch

AUGUST 25, 2022

The PiCSO-AMI-II multicenter, randomized trial will enroll 300 patients with anterior ST-segment Elevation Myocardial Infarction (STEMI) presenting with TIMI flow 0, 1, and 2 within 12 hours of symptom onset. The primary safety endpoint is a performance goal for device and procedure related adverse events at 30 days.

Medical 52

Medical FDA Recruitment Pharmacology 52

pharmaphorum

DECEMBER 20, 2022

Earlier this year, Madrigal reported positive results in another phase 3 trial of resmetirom called MAESTRO-NAFLD-1, including some patients with NASH, and said a filing in the lead indication of non-cirrhotic NASH with liver fibrosis hinged on a positive readout in MAESTRO-NASH.

Pharmacology 52

Pharmacology Pharma Marketing Biopharma 52

European Pharmaceutical Review

MARCH 11, 2024

3 While gone are the days when an HIV diagnosis necessitated taking so many pills that patients had to set multiple alarm clocks, self-stigma and concerns of external stigma still exist. With therapeutic expertise in HIV, hepatology and rare diseases, Sherene has additional expertise in clinical pharmacology and drug safety.

Medicine 93

Medicine Pharmacology Healthcare Healthcare 93

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 94

Pharmacology Manufacturing Leads Medicine 94

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 81

Food and Drug Administration Safety Patients Leads 81

European Pharmaceutical Review

DECEMBER 11, 2023

The first approved ASO was designed for injection directly into the eye for the local treatment of cytomegalovirus (CMV) retinitis in immunocompromised AIDS patients. mAbs have well-established safety profiles, high specificity and affinity and long half-lives – they have been used in drug development for more than 30 years.

Pharmacology 87

Pharmacology Safety Engineering Medical 87

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

Medgadget

MAY 2, 2023

The system uses the patient’s EEG data to calculate a value for the amygdala-derived-EFP biomarker, and meanwhile the patient tries various mental strategies that may help to reduce the value. These treatments at times come with a long list of side effects, leaving many patients in search of an effective long-term solution.

Side effects 87

Side effects Prescription Healthcare Healthcare 87

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. Equally, certification can support compliance, fair balance and consistent inclusion of important safety information. Step 4: Commit to Regular Sales Training & Certification.

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

Pharmaceutical Technology

MARCH 16, 2023

However, health specialists refute most safety concerns for the use of drug classes as part of gender affirming care, citing years of research and care. Dr. Barry DeCoster, PhD, an associate professor of bioethics at the University of Michigan, describes gender affirming care as “safe and effective” for most patients.

Ethics 144

Ethics Prescription Safety Healthcare 144