Pharmaceutical Technology

SEPTEMBER 13, 2022

Since the approval of the first ICI – Bristol-Myers Squibb's (BMS) Yervoy (ipilimumab) in 2011 for unresectable metastatic melanoma – multiple checkpoint inhibitors have been approved in this disease setting. Of the 107 evaluable patients, 98% of patients underwent timely surgery, meeting this critical safety endpoint.

Patients 69

Patients Physicians Safety Pharma 69

pharmaphorum

AUGUST 22, 2022

They just published Phase 1A last week, which is the safety profile. Jack graduated BA in Middle Eastern Studies from the University of Exeter in 2011 and speaks fluent Arabic. This is the sort of hypothesis behind it,” Torrance states. “It’s now in humans for the first time. About the author .

Healthcare 103

Healthcare Healthcare Healthcare Provider Specialization 103

European Pharmaceutical Review

FEBRUARY 1, 2024

That will be our pivotal trial for not just LDL lowering, but also for safety in Phase III, because it is a very large trial. Michael served as President of the National Lipid Association from 2010 to 2011. The patients are on maximum tolerated statins and they have predominantly atherosclerotic cardiovascular disease (ASCVD).

Pharma 97

Pharma Patients Pharmaceutical Leads 97

Clarify Health

AUGUST 26, 2020

Prior to 2011 when the Affordable Care Act (ACA) was passed, many insurance companies were spending a large portion of premium dollars on administrative costs and profits. Implementing best practices designed at improving patient safety. Since the ACA, health plans are required to meet minimum MLR standards.

Insurance 52

Insurance Medical Networking Management 52

pharmaphorum

JULY 6, 2022

And how can regulators balance timely access with robust safety? A European Federation of Pharmaceutical Industries and Associations (EFPIA) report published earlier this year, for example, compared the timelines of six regulatory agencies between 2011 and 2020. The post Are timely access and robust safety mutually exclusive?

Safety 98

Safety FDA Medicine Patients 98

Evolve Your Success

MAY 10, 2022

I spit myself out of the hospital system in 2011. Patient safety and probably the medical system when they know that they can demand better staff ratios, “I’m not bringing my mom here. I was done clinical nursing in 2014. That’s when my practice became full-time for me. Private patient advocacy. Are you kidding?

Education 130

Education Patients Medical sales reps Medical sales 130

Cadensee

JULY 26, 2021

And it also goes to safety, which not surprisingly, was the number one concern with parents. So also want to make sure that our branding and our packaging really communicates the safety of the product. Liron Fendell: Again, it really goes back to the safety and to the fact that people are used to getting fooled.

Retail 52

Retail Marketing Doctors Food 52

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. 2011 Dec;12(4):1248-63. Eur Pharm Rev.

Pharmaceutical 111

Pharmaceutical Food and Drug Administration Medicine FDA 111

European Pharmaceutical Review

DECEMBER 14, 2023

Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. But from a safety point of view, observational studies can be more representative of the population the drug will serve. Meta-analyses contributed least frequently (31.4

Medicine 116

Medicine Safety Competition Medical 116

European Pharmaceutical Review

SEPTEMBER 22, 2022

11 have recently conducted an analysis of international HTA submissions from 2011-2019 to determine the acceptability of single arm clinical studies and ECs as part of the drug reimbursement process. 2011 May; 46(3): 399–424. Patel et al. FDA presentation. Available at: [link]. Multivariate Behav Res. doi: 1080/00273171.2011.568786.

Food and Drug Administration 122

Food and Drug Administration Patients Distribution FDA 122

European Pharmaceutical Review

OCTOBER 17, 2024

World Allergy Organization (WAO) White Book on Allergy 2011-2012: Executive Summary. neffy, Epinephrine Nasal Spray, Demonstrates a Positive Efficacy and Safety Profile for the Treatment of Allergic Reactions in Pediatric Patients at Risk of Anaphylaxis: Phase 3 Study Results. Hand (N Y). 2007; 2(1):5-11.

Food and Drug Administration 121

Food and Drug Administration Medicine Consulting Food 121

Cadensee

OCTOBER 19, 2021

By the way, with a very attractive safety profile so far. Her previous venture PolyTouch Medical was acquired back in 2011. So, you can think about it as bio convergence. But if you think about it, BrainQ is a medical device that goes by a medical device regulation. We're using AI; we're using cloud. Yoav Fisher.

Patients 52

Patients Medical Networking Marketing 52

Legacy MEDSearch

JANUARY 13, 2023

The IDE Study is being conducted to determine the safety and effectiveness of the HIT Reverse HRS in Primary Total Hip Arthroplasty (THA). Safety will be assessed through the collection of device-related adverse events and patient quality of life metrics. About Hip Innovation Technology, LLC.

FDA 98

FDA Safety Recruitment Patients 98

PM360

DECEMBER 20, 2023

The content of the value dossier should consist of product introduction, effectiveness, novelty, safety, economic value, and equity. Trends and Characteristics of New Drug Approvals in China, 2011-2021.” References: 1. Su L, Liu S, Li G, Xie C, Yang H, Liu Y, Yin C, Chen X. Ther Innov Regul Sci. 2023 Mar;57(2):343-351. Epub 2022 Nov 2.

Marketing 105

Marketing Insurance Medical Manufacturing 105

Legacy MEDSearch

JULY 21, 2023

This first-in-female procedure was approved by the National Agency for the Safety of Medicines and Health Products (or ANSM, the French equivalent to the U.S. Food and Drug Administration). “It’s magic,” the patient stated, as the first woman to activate the novel UroActive device.

Food and Drug Administration 52

Food and Drug Administration Patients Safety Recruitment 52

Pharmaceutical Technology

MAY 11, 2008

For example, Turkey will require track and trace by 1 January 2009 and California is requiring the technology by 1 January 2011. The trial allowed end-to-end traceability of haemophilia medication, which promoted secure deliveries, stock optimisation and greater patient safety.

Electronics 40

Electronics Transportation Pharmaceutical manufacturing Pharmaceutical 40

Pharmaceutical Technology

AUGUST 9, 2022

Thus, committing to climate action, reducing gender inequalities and ensuring workplace safety within supply chains is rising on investors’ agendas as a way to build resilient supply chains, promote the achievement of the SDGs and generate sustainable economic growth.

Transportation 52

Transportation Electronics Government Consulting 52

Clarivate

MAY 24, 2022

Approval pathways have been established that allow manufacturers to bring innovative therapies to market without conducting trials in Mainland China, provided the safety and efficacy of the drugs have been demonstrated through real world data (RWD) in other markets. 2011; 6:81-82. [3] 10] [11] [12]. 2] Ma R, Li DG, Zhang X, He L.

Patients 52

Patients Food and Drug Administration Marketing Pharma 52

European Pharmaceutical Review

JULY 4, 2024

The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. 6 Thus, it is critical to ensure the consistency of therapeutic effect across batches (see box).

Marketing 103

Marketing Food and Drug Administration Medicine Prescription 103

Celeritas

DECEMBER 30, 2022

On this basis, let us inspect the pillars that shall concretize a hydrogen-fueled future: infrastructure and safety regulations. Safety and Regulation. The first priority is addressing the safety concerns and threats posed by hydrogen transport and distribution. IoT Monitoring.

Engineering 52

Engineering Distribution Transportation Safety 52

European Pharmaceutical Review

DECEMBER 23, 2024

14 This in turn has led to the introduction of safety-based limits, 15 eg, permitted daily exposures (PDEs), etc. ICH Q6A 1 states that specifications should focus on those characteristics found to be useful in ensuring the safety and efficacy of the drug substance and drug product. EMA/CHMP/ICH/425213/2011. November 2012.

Safety 52

Safety Pharmaceutical Manufacturing Management 52