pharmaphorum

OCTOBER 26, 2022

Psoriasis is a tricky disease to manage, as drawbacks and side effects loom with each and every type of treatment. Patients afflicted with psoriasis have a malfunctioning immune system that mistakenly attacks the body by overproducing skin cells, which leads to a build-up of scaly plaques. Side effects, front and centre.

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Side effects Food and Drug Administration Patients Management 97

European Pharmaceutical Review

NOVEMBER 9, 2023

Positively, Brager shared that in clinical trials , the company’s lead clinical candidate has demonstrated ability to cross the blood-brain barrier and to “not cause serious side effects common with traditional immunosuppressive therapies that treat inflammation.”

Food and Drug Administration 102

Food and Drug Administration Side effects Pharmaceutical Leads 102

European Pharmaceutical Review

OCTOBER 21, 2022

The most common side effects related to vaccination were injection site pain, malaise, fatigue, muscle aches and headaches. The international study will continue to examine the effects of two-dose HEPLISAV-B. A two-dose version of the vaccine was approved by the US Food and Drug Administration (FDA) in 2017.

Patients 71

Patients Food and Drug Administration Side effects Food 71

Pharmaceutical Technology

JUNE 16, 2023

Belgium-headquartered ANeuroTech is participating in a Series B round, which will raise up to $150m to power the pivotal programme of its lead candidate ANT01 for use as an adjunctive treatment for major depressive disorder (MDD).

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Food and Drug Administration Side effects Safety Recruitment 52

pharmaphorum

AUGUST 11, 2022

Identifying those variations helps to target medication changes that can be safer and more effective. Some people are hyper-metabolisers, meaning a drug may move too fast through their system and not deliver the intended therapeutic effect; while others may metabolise a drug too slowly, triggering an adverse side effect or overdose.

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Side effects Medical Prescription Patients 91

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).

Food and Drug Administration 91

Food and Drug Administration Side effects Leads Patients 91

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).

Food and Drug Administration 91

Food and Drug Administration Side effects Leads Patients 91

European Pharmaceutical Review

AUGUST 3, 2023

The US Food and Drug Administration (FDA) recently converted the accelerated approval of the drug, granted in January 2023 , to a full authorisation on the back of data from pivotal clinical studies conducted by the marketing authorisation holder, Eisai 1. This conclusion was based on the same data submitted to the FDA.

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Food and Drug Administration Medicine FDA Marketing 52

European Pharmaceutical Review

NOVEMBER 4, 2022

based treatment concomitant with reductions in traditionally unavoidable and problematic side effects. Type A Meeting Between FDA and Athenex Discusses Oral Paclitaxel Plus Encequidar for Metastatic Breast Cancer [Internet]. FDA Feedback Leads to Discontinuation of Tesetaxel Development in Solid Tumors [Internet].

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Food and Drug Administration FDA Pharmaceutical Patients 79

PM360

AUGUST 9, 2022

The industry has been limited in its ability to implement creative solutions to engage and motivate patients because the FDA has strict guidelines for what pharma companies can communicate with patients. How can data itself play a larger role in addressing adherence? Jason Burum.

Medical 105

Medical Electronics Patients Healthcare 105

World of DTC Marketing

SEPTEMBER 1, 2021

SUMMARY: Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and deputy director Phil Krause will exit the agency because the White House is getting ahead of the agency on COVID booster shots. I would argue, however, that the FDA is a bureaucratic mess with changes needed at all levels of leadership.

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FDA Food and Drug Administration Side effects Food 165

Pharmaceutical Technology

NOVEMBER 23, 2022

The US Food and Drug Administration (FDA) has granted approval for CSL Behring’s adeno-associated virus vector-based gene therapy, Hemgenix (etranacogene dezaparvovec), to treat haemophilia B (congenital Factor IX deficiency) in adult patients. Topic sponsors are not involved in the creation of editorial content.

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Food and Drug Administration FDA Side effects Food 105

European Pharmaceutical Review

DECEMBER 18, 2023

Treatment-related side effects included nausea and headache but were generally mild. “As As an oncologist for many years, I experienced the frustration of not being able to provide cancer care that treats the whole person, not just the tumour,” commented Manish Agrawal, MD, of Sunstone Therapies and lead author of the study.

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Food and Drug Administration Patients Side effects Safety 107

Pharmaceutical Technology

JANUARY 24, 2023

The US Food and Drug Administration (FDA) has granted clearance for Neurogene’s investigational new drug (IND) application for NGN-401 to treat Rett syndrome. Neurogene stated that the FDA IND clearance allows it to commence a Phase II/II trial of NGN-401 in female paediatric Rett syndrome patients.

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FDA Food and Drug Administration Side effects Safety 83

European Pharmaceutical Review

NOVEMBER 4, 2022

A new computer model has successfully simulated a clinical trial evaluating the efficacy of aducanumab and donanemab for Alzheimer’s disease (AD), establishing a gradual increase in dosage up to the maximum dose helps to minimise cognitive decline and limit side effects. .

Food and Drug Administration 90

Food and Drug Administration Side effects Food Patients 90

European Pharmaceutical Review

OCTOBER 19, 2023

Can you share an update on the clinical trial for your lead candidate? Like other cancer treatments, we must prove the effectiveness of radiopharmaceuticals through clinical trials, so they are more available and eventually implemented as a common standard of treatment to control tumours.

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Food and Drug Administration Side effects Manufacturing Doctors 86

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

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Food and Drug Administration Safety Patients Leads 75

Pharma Marketing Network

JUNE 11, 2020

Yeah, I even wanted to wear the shirt to this FDA meeting. You know, in November 2009, the FDA held a public hearing about the promotion of Food and Drug Administrative Related Regulated Medical Products, using the internet and social media tools. Don Langsdorf (EHS): You’d mentioned 14 letters that the FDA sent.

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Media Pharma Ethics Consulting 52

European Pharmaceutical Review

DECEMBER 27, 2023

Lessons learned The process of establishing point-of-care CAR T manufacturing was a learning curve, not just in managing the toxicities and side effects, but also in understanding the important difference between emerging CAR T-cell adoptive immunotherapy and traditional stem cell transplantation. US Food and Drug Administration.

Manufacturing 81

Manufacturing Food and Drug Administration Patients Pharma 81

Pharmaceutical Technology

FEBRUARY 23, 2023

Many compounds present sub-optimal pharmacokinetic (PK) data (either predicted from in-vitro and pre-clinical data or measured in the clinic), such as poor exposure (leading to high doses), large variability, short half-life requiring more than once-a-day dosing, or C max -related adverse events (AEs).

Food and Drug Administration 98

Food and Drug Administration Pharmaceutical Food Side effects 98