European Pharmaceutical Review

DECEMBER 1, 2022

In order to speed up the regulatory process for advanced medicinal therapy products (ATMPS), the European Union (EU) implemented the priority medicines (PRIME) scheme in 2016. Robust analytical methods are needed to establish safety, potency, and purity of mRNA therapeutics in large-scale manufacturing.

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Medicine Marketing Safety Pharmaceutical 98

European Pharmaceutical Review

JANUARY 19, 2023

Adverse events (AEs) observed in the ixazomib arm were consistent with reported safety profiles for the individual agents.

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Consulting Patients Safety Pharmaceutical 96

World of DTC Marketing

DECEMBER 10, 2020

SUMMARY: (JAMA) The median drug wholesale list price (as defined by Average Wholesale Price) increased by 129% from 2010-2016, while median patient out-of-pocket costs increased by 53% and median insurance payments after rebates and discounts increased by 64%. Say goodbye to all the supposed goodwill.

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Insurance Pharma Manufacturing Retail 181

European Pharmaceutical Review

JUNE 12, 2024

The main objective was to evaluate the efficacy and safety of MBK-01 compared to fidaxomicin, providing significant insights into the potential of MBK-01 as a treatment for primary or recurrent CDI and contributing to the advancement of microbiome-based therapies. 2016; 46: 479–93. Intern Med J. Clin Microbiol Infect. Song JH, Kim YS.

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Safety Patients Side effects Management 111

European Pharmaceutical Review

JULY 4, 2024

2 It was first approved as Fulyzaq in December 2012 and in October 2016, Napo Pharmaceuticals launched the new brand, Mytesi. 10 Evidence of safety, adherence to appropriate manufacturing standards and provision of appropriate product information to users is also required to gain registration under the scheme. 3 Is two too few?

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Marketing Food and Drug Administration Medicine Prescription 103

European Pharmaceutical Review

DECEMBER 20, 2022

In 2016, the companies signed a first natural killer (NK) cell engagers collaboration to generate and evaluate up to two bispecific NK cell engagers, using technology from Innate Pharma and Sanofi’s proprietary bispecific antibody format as well as tumour targets. “By Building on Sanofi’s and Innate Pharma’s original license agreement.

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Pharma Manufacturing Sales Safety 98

European Pharmaceutical Review

OCTOBER 27, 2023

Benefits of The Future Clinical Trials Bill Chiefly, the Bill’s goal is to increase patient participation and overall, ensure clinical trials have the highest levels of safety while enabling greater regulatory pragmatism, the author explained. This is according to a 2016 paper published in Clinical and Translational Oncology.

Ethics 105

Ethics Medicine Education Competition 105

Pharmaceutical Technology

JULY 25, 2022

According to GlobalData, the number of mentions of ‘Artificial Intelligence’ in the company filings of pharmaceutical organizations increased 105% between 2016 and 2021. Datwyler has already rolled out a VR tool as a new way to train operators without risking their safety or pausing production.

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Pharmaceutical Engineering Healthcare Provider Healthcare 114

European Pharmaceutical Review

AUGUST 22, 2022

This motivated the biopharma sector to devise smart approaches to develop and manufacture vaccines without compromising on their safety and efficacy. This can drive informed decisions and strategies to enhance the safety, quality and efficiency of the manufacturing process. Novel biotechnology platforms for vaccine development.

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Manufacturing Biopharma Engineering Safety 98

Pharmaceutical Technology

MARCH 24, 2023

However, it has taken over six years for Amjevita to launch, after first being FDA-approved in 2016. Many other biosimilars have also been FDA-approved since 2016. Further, there remains scepticism on the efficacy and safety of biosimilars. Sometimes the settlement of a patent dispute involves agreeing to defer entry.

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Competition Marketing FDA Physicians 59

Pharmaceutical Technology

NOVEMBER 3, 2022

A targeted tenofovir prodrug, Vemlidy had priorly received FDA approval in 2016 as a once-a-day treatment in adults for chronic HBV infection with compensated liver disease. At 24 weeks, 21% of the participants who received 25mg Vemlidy attained HBV DNA less than 20IU/ml versus 0% in the placebo arm.

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Food and Drug Administration FDA Physicians Food 52

European Pharmaceutical Review

JUNE 13, 2023

In addition, atrasentan revealed a significant reduction in proteinuria versus baseline in a Phase II study, with good tolerability, including liver safety profile. This then leads to progressive loss of renal function, according to a 2016 paper published in Nature Reviews Disease Primers. The post £2.5b

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Biopharma Safety Leads Pharmaceutical 52

Medgadget

NOVEMBER 8, 2022

There are also potential safety concerns about the use of general anesthetics in very young children, which prompted an FDA Safety Alert in 2016. It is reported that 57% of children with ear tube procedures experience post-general anesthetic emergence delirium (e.g.,

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PM360

JUNE 26, 2023

For example, the Access Accelerated initiative was launched by 22 pharmaceutical companies in 2016 to help improve access to non-communicable disease medicines in emerging markets. In a shareholder meeting, Merck & Co.

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Medicine Marketing Pharma Manufacturing 98

pharmaphorum

AUGUST 11, 2022

In 2016, the estimated annual cost of drug-related morbidity and mortality resulting from non-optimised medication therapy was $528.4 These drugs have been rigorously tested by regulatory bodies around the world before they’re made available to ensure they work as labelled, but despite that, adverse events crop up.

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Side effects Medical Prescription Patients 98

European Pharmaceutical Review

MAY 26, 2023

For clinical trials, this is obviously even more complicated with the need for extra safety data. The administrative burden is not really something that the regulatory bodies make any effort in addressing, as they are solely interested in safety. In 2016, he joined the directorate of the National Center for Tumor Diseases in Dresden.

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Safety Patients Management Manufacturing 98

European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. Importantly, we believe the safety, reliability, and pharmacokinetic data that we collected through both parts of the Phase I study support the initiation of a Phase II trial of RT-102 in osteoporosis,” Hashim said.

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Food and Drug Administration Manufacturing Safety Pharmaceutical 105

Medgadget

MAY 2, 2023

Hendler in 2016 and we were fascinated with both her, the technology, and the paradigm shift we can drive with her in psychiatry. Throughout 2016 and until mid-2019 we conducted a deep technology due diligence, as well as market research, and met and spoke with dozens of mental healthcare providers. My co-founders and I met with Prof.

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Side effects Prescription Healthcare Healthcare 86

Pharma Marketing Network

MAY 15, 2023

Additionally, by analyzing data from completed clinical trials, companies can gain insights into the safety and effectiveness of their products, which can inform the development of new drugs. 1 (2016) 3. However, the use of big data in pharmaceutical marketing also poses significant challenges. . 8 (2018) 2. Hardoon and Susan E.

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Pharmaceutical Marketing Electronics Media 59

Referral MD

MAY 19, 2023

In 2016, US healthcare fraud cost $30 million. Blockchain will improve healthcare safety and transparency. Innovation and Security Implications of Blockchain in Health Care Innovation and Safety Blockchain’s impact on innovation and security depends on what it adds to a non-blockchain environment.

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Healthcare Healthcare Medical Patients 62

Pharma Marketing Network

MARCH 23, 2023

Additionally, by analyzing data from completed clinical trials, companies can gain insights into the safety and effectiveness of their products, which can inform the development of new drugs. 1 (2016) 3. However, the use of big data in pharmaceutical marketing also poses significant challenges. . 8 (2018) 2. Hardoon and Susan E.

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Pharmaceutical Marketing Electronics Media 52

pharmaphorum

JANUARY 4, 2023

General Data Protection Regulation 2016/679. providing personalised healthcare consisting in assessing, maintaining, or restoring the state of health of individuals. References. European Health Data Space: Regulation 2022/0140. Explanatory Memorandum, Section 2 of the Proposal. Explanatory Memorandum, Section 1 of the Proposal.

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Pharmaceutical Electronics Healthcare Healthcare 98

European Pharmaceutical Review

JUNE 27, 2022

As the complexity of molecules increases the probability of impurities with safety concerns, the development of biologically relevant activity assays during downstream purification and process development will become increasingly important. 2016; 8(4):828-838. 2016; 1455:9-19. Tustian AD, Endicott C, Adams B, et al. Antib Ther.

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Recruitment Manufacturing Media Leads 98

Clarify Health

MARCH 1, 2023

As one of the largest trials ever conducted testing the impact of nudges on opioid prescribing, this study demonstrated the potential for health systems to change clinicians’ behavior and improve patient safety by using scalable nudge interventions.[5] Healthcare (2016), [link] [2] Parikh, R. Manuscript in Preparation]. [3]

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Physicians Prescription Medicine Management 52

PM360

DECEMBER 14, 2023

Combined, they are having a lasting effect on the reputation of the healthcare sector and the safety and durability of its products and services. Hospitals, Clinics, and Other Health Care Delivery Organizations, 2016-2021.” So how should marketers prepare? References: 1. Neprash HT, McGlave CC, Cross DA, et al. JAMA Health Forum.

Healthcare 52

Healthcare Healthcare Marketing Ethics 52

Clarify Health

DECEMBER 13, 2022

The first is the 21st Century Cures Act signed into law in 2016 and the second is the COVID-19 pandemic, which drove the use of RWD and RWE, at scale. Mr. Gohil said, “When we look at the FDA, since 2016, the industry overall has seen a good amount of adoption. I think the pandemic sped that up a bit.

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Recruitment Retail Patients FDA 52

Pharmaceutical Technology

AUGUST 9, 2022

The study also states that mentions of “various SDGs set by the UN have been steadily increasing in companies ESG reports since 2016”. In addition, the data shows that companies tend to refer to different SDGs in their earnings calls depending on the sector in which they operate. What is the relationship between ESG and FDI?

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Transportation Electronics Government Consulting 52

European Pharmaceutical Review

JULY 22, 2024

It is not accurate to use ‘sterile’ to describe surfaces, methodologies, or environments such as biological safety cabinets and isolators. This term is best applied to drug substance or product, or items rendered sterile using a validated process such as sterile filtration. The term ‘sterile’ is not to be used casually.

Manufacturing 52

Manufacturing Medicine Management Pharmaceutical 52

PharmaKinnex

AUGUST 23, 2022

The pharmaceutical industry of 2022 is very different from the space that we all knew in 2012, 2016, or even 2020. More convenience and safety? The Traditional Pharma Model Isn’t Working – It’s Time to Evolve! August 23, 2022. dstansberry@costellocreativegroup.com. What’s not to love?

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Pharma Sales Sales Strategy Marketing 52

Pharmaceutical Technology

APRIL 6, 2023

Currently, Verismo Therapeutics is carrying out a Phase I multi-centre clinical trial to assess the anti-tumour activity, safety and feasibility of this investigational new drug. The company is leveraging its novel KIR-CAR technology, a dual-chain CAR-T cell therapy, to develop new treatments for life-threatening medical conditions.

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FDA Food and Drug Administration Medical Food 52

Clarify Health

DECEMBER 13, 2022

The first is the 21st Century Cures Act signed into law in 2016 and the second is the COVID-19 pandemic, which drove the use of RWD and RWE, at scale. Mr. Gohil said, “When we look at the FDA, since 2016, the industry overall has seen a good amount of adoption. I think the pandemic sped that up a bit.

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Recruitment Retail Patients FDA 40

Pharmaceutical Technology

NOVEMBER 30, 2022

In August 2016, the US Pharmacopeial Convention’s revision of Chapter <1207> prompted a new direction for CCIT. Patient safety and pharmaceutical product efficacy depends on container closure integrity, and container closure integrity testing (CCIT) is a crucial part of the manufacturing process. Time for change. Free Webinar.

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Food and Drug Administration Pharmaceutical products Manufacturing Pharmaceutical 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. 10] [11] [12].

Patients 52

Patients Food and Drug Administration Marketing Pharma 52

MedCity News

FEBRUARY 2, 2023

The percentage of respondents who know of a patient death being caused by nurses being assigned too many patients nearly doubled in the past seven years — from 22% in 2016 to 42% in 2023.

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Patients Safety 330

European Pharmaceutical Review

JULY 20, 2022

Withdrawing drugs over safety concerns requires careful analysis of the health benefits and risks by regulators. Monitoring and studying the side effects of licensed medicines is an essential part of drug development to ensure public safety. Six products were withdrawn or revoked for safety reasons during the study period.

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Medicine Safety Side effects Electronics 97

PM360

APRIL 25, 2023

Although AbbVie’s patent for Humira officially expired in 2016, the legal and regulatory delays paused competition for Humira until 2023. since the first biosimilar launched in 2016, with more than a dozen branded drugs now with biosimilar competitors. pharmaceutical industry.

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Marketing Competition Government Manufacturing 97

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). Gastric Cancer, Version 3.2016, NCCN Clinical Practice Guidelines in Oncology, JNCCN, 2016; 14(10).

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Patients Food and Drug Administration Side effects Safety 104