pharmaphorum

SEPTEMBER 14, 2022

SparingVision’s lead candidates are both targeting inherited retinal diseases (IRDs), a group which already has a gene therapy on the market in Novartis’ Luxturna (voretigene neparvovec), which was approved by the FDA in 2017 for biallelic RPE65 mutation-associated retinal dystrophy, a group which includes a small group of RP patients.

Safety 52

Safety Leads Patients FDA 52

pharmaphorum

SEPTEMBER 16, 2022

The week 16 data of lebrikizumab […] points towards a drug with robust efficacy with hardly any safety trade-offs. The findings from the phase 3 trial of lebrikizumab noted that the most adverse side effects reported had been “nonserious and did not lead to treatment discontinuation”. However, side effects do happen.

Management 100

Management Side effects Patients Safety 100

Pharmaceutical Technology

FEBRUARY 8, 2023

Blank acknowledged that in many cases, an exclusively paediatric patient population could lead to difficulties with drawing consent for early phase trials. Still, Blank suggested that companies enroll the patient population that is most likely to benefit, because early phase studies contain the most safety risks.

FDA 105

FDA Patients Pharmacology Pharmaceutical 105

Legacy MEDSearch

SEPTEMBER 27, 2023

Its flagship product, the Personal Cardiac Assistant (PCA 500) , is the only hospital-grade, resting 12-lead ECG device cleared by the FDA and CE marked for both professional and patient use. Resting 12-lead ECG is the most used medical test for screening, diagnosing, and monitoring heart disease.

Medical 52

Medical Recruitment Leads Management 52

European Pharmaceutical Review

MAY 8, 2024

Based on the growing evidence of positive outcomes seen with full ecosystem products, mbiomics has developed a proprietary techbio platform that aims to combine the disease-modifying potential of large consortia with the safety and scalable manufacturability of GMP-manufactured non-engineered microbial strains isolated from healthy individuals.

Manufacturing 98

Manufacturing Safety FDA Patients 98

pharmaphorum

AUGUST 18, 2022

VMS are reported by up to 80% of women at some point during menopause and is the leading cause for seeking medical attention during this phase of their lives. Astellas has high hopes for the new drug, so much so that it has used a priority review voucher to reduce the FDA’s review time from ten months to six, which resulted in a 13.1

FDA 52

FDA Safety Marketing Pharma 52

Pharmaceutical Technology

JANUARY 23, 2023

The few approvals within paediatrics can be seen to be contributing to the numerous challenges associated with these studies; the smaller patient population, in addition to special measures required to ensure the ethics and safety of these trials, which all leads to trial delays, extended studies, and higher costs.

Medical 59

Medical Ethics Specialization Physicians 59

European Pharmaceutical Review

DECEMBER 11, 2023

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. 7 Their safety profiles have also shown to be unfavourable for broad applicability as treatment options for many diseases including chronic diseases. 2017; 376:86-88.

Safety 98

Safety Pharmacology Engineering Medical 98

pharmaphorum

SEPTEMBER 11, 2022

Hard on the heels of a new $575 million partnership with GSK, US biotech SpringWorks Therapeutics has reported phase 3 data at ESMO that sets up regulatory filings for its lead drug nirogacestat in a rare and aggressive form of soft tissue cancer.

Side effects 52

Side effects Leads Safety Patients 52

pharmaphorum

DECEMBER 6, 2022

Live data is critical for patient safety and for good operations in clinical trials,” Peleg says. “It He calls out a particular opportunity in the United Kingdom, where COVID-19 and other factors have reduced patient access to clinical trials by 44% since 2017. It makes everything more efficient and more accurate.”.

Electronics 98

Electronics Patients Medical Marketing 98

Clarivate

NOVEMBER 10, 2022

The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. In 2017, the Clarivate COA team began working with a sponsor to develop COAs for evaluating key clinical trial endpoints in alopecia areata clinical trials. The regulatory landscape around COAs is fast evolving.

Patients 52

Patients Food and Drug Administration FDA Safety 52

Medgadget

MARCH 2, 2023

This leads to substantial damage to healthy tissues and too often results in poor outcomes. This will hopefully lead to an FDA approval for its first indication, after which Alpha TAU plans on expanding to other types of cancer and geographic regions such as Europe and Japan. Results from initial clinical trials were quite impressive.

Manufacturing 82

Manufacturing Leads Patients Medicine 82

Legacy MEDSearch

AUGUST 25, 2022

The primary safety endpoint is a performance goal for device and procedure related adverse events at 30 days. The FDA-approved randomized IDE trial has been designed to validate the safety and effectiveness of PiCSO.” Major adverse cardiac events and heart failure endpoints will be captured acutely and for up to 3 years.

Medical 52

Medical FDA Recruitment Pharmacology 52

Evolve Your Success

AUGUST 8, 2023

I’ve been in medical device for years starting in 2017. I got to say, for being in the game since 2017, you sound like you’ve mastered a lot in what you’re doing. He landed a territory manager role with a patient safety start-up right out of school where he cut his teeth, and has continued to grow and learn along the way.

Sales 130

Sales Medical Management Patients 130

Evolve Your Success

NOVEMBER 15, 2022

It was developing different audits, making sure that facilities were ready for regulatory visits, and making sure that patient safety was front of mind. I said, “Can I write for this magazine about the specific surgical product and how it can benefit patient safety?” Leads have been inbound. You did that for eight years.

Medical sales 130

Medical sales Medical Sales Medical sales reps 130

Pharmaceutical Technology

JUNE 22, 2023

The voucher approach was already debated in the months leading up to the announcement. The EU previously focused on AMR through the One Health Action Plan, which was released in 2017. Hence, some experts remain unsure of how the scheme will incentivise the development of new drugs to fight AMR.

Pharma 52

Pharma Pharmaceutical Government Marketing 52

pharmaphorum

NOVEMBER 27, 2022

Supply chain challenges take many forms in pharma – from capacity issues, to managing excess safety stock, and ensuring accurate supplier communication. These shocks can lead to unpredictable or even absent shipments, meaning drug production labs often aren’t dealing with a stable and regular volume of raw materials.

Pharma 105

Pharma Safety Pharmaceutical Manufacturing 105

European Pharmaceutical Review

OCTOBER 21, 2022

At week 28, the study assessed the vaccine’s safety and levels of anti-HBV surface antibodies (HBsAbs). A two-dose version of the vaccine was approved by the US Food and Drug Administration (FDA) in 2017. It causes severe hepatitis B infection that can lead to progressive liver disease.

Patients 96

Patients Food and Drug Administration Side effects Food 96

Pharmaceutical Technology

FEBRUARY 10, 2023

Access to oncology medicines varies across countries, and their cost against safety/efficacy is generally perceived as being low, such as in the US. Undoubtedly, this has played a factor in the success of market-leading PD-1 inhibitors, Merck & Co.’s

Marketing 105

Marketing Medicine Leads Pharmaceutical 105

European Pharmaceutical Review

JULY 5, 2022

7 In addition, the study supported the safety, tolerability and convenience of frequent low dosing, showing that Oncoral was well-tolerated and that the reported haematological toxicities were only mild to moderate (grade 1 or grade 2). 2017; 8(23):38022-38043. Cancer Chemother Pharmacol. 2019; 83(1):169-178. Oncotarget.

Patients 104

Patients Food and Drug Administration Side effects Safety 104

European Pharmaceutical Review

JULY 27, 2023

Cardiovascular diseases are the leading cause of death globally with over 18.5 Despite these trials varying in design, they confirmed the feasibility and safety of the procedure. Meta‑analyses of these trials have shown that the therapy is safe and can lead to a reduction in incidences of death and recurrent myocardial infarction.

Pharmacology 98

Pharmacology Manufacturing Leads Patients 98

European Pharmaceutical Review

JANUARY 29, 2024

4 The use of CPCA assessments allows for the assignment of scientifically justifiable higher acceptable intakes (AIs), without impacting patient safety. 16 Hydrazoic acid is a toxic, explosive gas and presents a significant worker-safety risk during manufacture of valsartan drug substance. However, there were some notable differences.

Pharmaceutical 111

Pharmaceutical Food and Drug Administration Medicine FDA 111

European Pharmaceutical Review

MARCH 11, 2024

Self-stigma is also prevalent and hinders individuals from getting tested, starting pre‑exposure prophylaxis (PrEP) (if they’re HIV negative), seeking the lifesaving treatments they need (if they’re HIV positive), and can lead to isolation and depression. Internet] 2017. Lancet HIV. 2023;10(5):e295-e307.

Medicine 98

Medicine Pharmacology Leads Healthcare 98

European Pharmaceutical Review

MAY 15, 2023

HARMONIE investigated the efficacy and safety of a single intramuscular dose of nirsevimab. Agreed in March 2017, AstraZeneca leads development and manufacturing activities, and Sanofi leads commercialisation activities. HARMONIE compared nirsevimab treatment to no intervention (standard of care).

Safety 104

Safety Leads Manufacturing Medicine 104

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. These days, he is leading trials involving a system developed by the digital health company etectRx (pronounced as e-tect-are-ex), which works with investigators who can use such real-time data.

Food and Drug Administration 122

Food and Drug Administration FDA Medicine Patients 122

European Pharmaceutical Review

AUGUST 15, 2024

1 The cancer is a slow-growing but potentially life-threatening B-cell malignancy, in which increased activation of B-cell receptor signalling pathways leads to overgrowth of lymphocytes in bone marrow and other disease compartments. for all-comers; HR=0.52 for all-comers; HR=0.52

Safety 52

Safety Patients Medical Medicine 52

pharmaphorum

AUGUST 4, 2022

For instance, in pharmaceutical manufacturing, mistakes in training can lead to contamination or waste, which can cause businesses unnecessary headaches. She joined NSF in 2017. In addition, she worked as head of inspectorate and licensing for the MHRA from 2004-2006. appeared first on.

Recruitment 98

Recruitment Training Pharma Pharmaceutical manufacturing 98

pharmaphorum

JANUARY 3, 2023

A pharmacologist by training, Rawlins was the founding chairman of health technology assessment (HTA) agency NICE , leading the organisation from its inception in 1999 until 2013, and hired Sir Andrew Dillon to become the organisation’s founding chief executive.

Medicine 52

Medicine Side effects Safety Healthcare 52

pharmaphorum

JULY 26, 2022

Merck’s exit came after other companies including Pfizer, Eli Lilly and Roche all scrapped CETP development programmes following safety or efficacy issues. Others were let down not by safety but efficacy, with anacetrapib coming closest to showing value in a phase 3 trial. . Amgen licensed the rights to NewAmsterdam in 2020.

Side effects 52

Side effects Safety Pharma Patients 52

PM360

OCTOBER 22, 2024

A misstep here doesn’t just result in lost sales; it can lead to serious reputational damage, legal issues, and most importantly, a potential impact on patient health. Patients and consumers need to believe in the efficacy and safety of the products they use. Credibility and Trust In healthcare, trust is currency.

Media 52

Media Pharma Pharmaceutical Sales 52

pharmaphorum

JANUARY 27, 2023

Developing medicines – for people living with disease Dr Mullen’s current role involves providing medical monitoring support, as well as safety, pharmacovigilance, scientific, and medical advice across a range of client projects, including advanced therapies and orphan drugs.

Pharmaceutical 111

Pharmaceutical Patients Medical Physicians 111

pharmaphorum

SEPTEMBER 16, 2022

Pfizer is currently leading the race to bring an RSV vaccine to market for use by expectant mothers, which would transfer protection to newborns and infants, with phase 3 results due next year. Its closest rival GSK suffered a setback when it was forced to abandon phase 3 trials of its candidate on safety grounds earlier this year.

Marketing 59

Marketing Leads Safety Manufacturing 59

PM360

SEPTEMBER 15, 2022

In many of the states where abortion is banned, strictly regulated, or soon to be restricted, the procedure is legal only in instances of a life-threatening situation, but no regulations define what such a situation may be, leaving 70% of physicians unclear about when to intervene for maternal safety.

Healthcare 52

Healthcare Healthcare Doctors Physicians 52