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 52

Food and Drug Administration FDA Side effects Prospecting 52

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 100

Food and Drug Administration Side effects Pharmaceutical Leads 100

Legacy MEDSearch

OCTOBER 25, 2022

Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System. Our goal is to bring this new therapy to patients as quickly as possible. The EndoStim System consists of an implantable neurostimulation device and lead placed via a quick, minimally-invasive laparoscopic procedure.

Food and Drug Administration 98

Food and Drug Administration FDA Side effects Recruitment 98

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 90

Food and Drug Administration Side effects Leads Patients 90

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 90

Food and Drug Administration Side effects Leads Patients 90

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). Due to this, adjunctive treatments are used as part of a patient’s treatment regimen.

Food and Drug Administration 52

Food and Drug Administration Side effects Safety Recruitment 52

pharmaphorum

AUGUST 11, 2022

The system did not only spend money and resources trying to address issues caused by those treatments, but patients also wasted time looking for answers; precious time that could have been spent receiving proper and effective treatment. billion in the United States alone.

Side effects 88

Side effects Medical Prescription Patients 88

World of DTC Marketing

APRIL 15, 2021

While patients have the right to full disclosure, misinformation and scare tactics could lead to more deaths from COVID. The major concerns for hesitancy included worries over side effects and that the vaccine is too new. Also cited was a lack of trust in the government to ensure the vaccines’ safety and effectiveness.

Food and Drug Administration 203

Food and Drug Administration Government Safety Side effects 203

Pharmaceutical Technology

JUNE 15, 2023

Food and Drug Administration approval. Clinical trials are divided into phases evaluating drug safety, side effects and effectiveness from increasingly larger pools of candidates and patients. AI also helps in interactions with patients, as it can be used for automating patient recruitment and data collection.

Food and Drug Administration 52

Food and Drug Administration Side effects Recruitment Safety 52

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. Today, we still can’t easily discern whether a patient took their pill or not and the reason why. Michael Oleksiw.

Medical 105

Medical Electronics Patients Healthcare 105

Pharmaceutical Technology

AUGUST 12, 2022

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. In these cases, patients often only have 3-5 years of life expectancy.

FDA 98

FDA Food and Drug Administration Physicians Side effects 98

European Pharmaceutical Review

NOVEMBER 4, 2022

tumour effects. Nevertheless, chemotherapy’s disadvantages, including substantial toxicities, combined with inconvenient hospital-based intravenous (IV) administration, impede patients’ ability to stay on treatment and their quality of life. The importance of taxanes in oncology.

Food and Drug Administration 77

Food and Drug Administration FDA Pharmaceutical Patients 77

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. Alzheimer’s is associated with neuronal organisational changes in brain.

Food and Drug Administration 52

Food and Drug Administration Medicine FDA Marketing 52

European Pharmaceutical Review

DECEMBER 18, 2023

After eight weeks of treatment, patients’ depression severity scores dropped by an average of 19.1 Treatment-related side effects included nausea and headache but were generally mild. “As The post Psilocybin-assisted therapy reduces depressive symptoms in cancer patients appeared first on European Pharmaceutical Review.

Food and Drug Administration 106

Food and Drug Administration Patients Side effects Safety 106

Evolve Your Success

FEBRUARY 13, 2024

— Watch the episode here Listen to the podcast here Surviving Cancer And Making An Impact To Cancer Patients’ Lives With Rob Ciaramitaro In this episode, we have with us another special guest and he goes by the name of Rob Ciaramitaro. Diagnostic products can change when patients discover their diseases.

Patients 64

Patients Sales Medical sales Doctors 64

pharmaphorum

OCTOBER 19, 2022

PKU is a rare genetic disease that manifests at birth and is marked by an inability to break down phenylalanine (phe), an amino acid that is commonly found in many foods. Left untreated, high levels of the amino acid become toxic to the brain and may lead to serious neurological and neuropsychological issues.

Side effects 97

Side effects Patients Engineering Sales 97

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. . We’ve shown that this type of model can work.

Food and Drug Administration 88

Food and Drug Administration Side effects Food Patients 88

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. at six months and 24 months, respectively, following infusion.

Food and Drug Administration 105

Food and Drug Administration FDA Side effects Food 105

World of DTC Marketing

SEPTEMBER 1, 2021

In a third trial, under a revised standard for measuring its effect, it showed minimal benefit. Overall, more patients died or had serious side effects on Nuplazid than after receiving no treatment. Food and Drug Administration approved both of these drugs — with a deadly aftermath. Nevertheless, the U.S.

FDA 165

FDA Food and Drug Administration Side effects Food 165

European Pharmaceutical Review

OCTOBER 19, 2023

These diagnostics have significantly progressed based on rigorous Phase III trial designs and because of the impact these diagnostics have had on patient management. These diagnostics are also paired with therapeutics and act as an imaging biomarker to identify patients who may benefit from the paired therapies.

Food and Drug Administration 84

Food and Drug Administration Side effects Manufacturing Doctors 84

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 percent and 14.3

Food and Drug Administration 73

Food and Drug Administration Safety Patients Leads 73

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.

FDA 83

FDA Food and Drug Administration Side effects Safety 83

Pharma Marketing Network

JUNE 11, 2020

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. But you’d have to have one click to the side effects. That was good because yeah, lots of patients don’t realize that.

Media 52

Media Pharma Ethics Consulting 52

European Pharmaceutical Review

DECEMBER 27, 2023

Due to shipping and manufacturing requirements, the time from a patient being included in the CAR T programme to receiving therapy can be several weeks. As a result, many patients waiting for the CAR T cells to be infused will need additional therapy (bridging therapy) against the malignance.

Manufacturing 80

Manufacturing Food and Drug Administration Patients Pharma 80

World of DTC Marketing

SEPTEMBER 28, 2020

Will it lead to an early approval with limited testing or will J&J ensure the vaccine goes thru thorough testing? ” The speedy vaccine development protects pharma companies from litigation if patients get sick from nasty side effects but morally this is a serious question of judgment. OK, NOW WHAT?

Food and Drug Administration 163

Food and Drug Administration Pharma Side effects Food 163

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