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. 2018; 8(1). EMA/95098/2010.

Safety 113

Safety Medicine Competition Networking 113

pharmaphorum

JANUARY 23, 2023

It is the first time that a treatment has improved on Abraxane plus gemcitabine when used first-line in mPDAC, according to lead investigator Zev Wainberg of the University of California, Los Angeles (UCLA), in the US. billion in 2018. As a privately-held company, Servier does not break down its quarterly sales figures.

Safety 52

Safety Sales Leads 52

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. If achieved, this would boost the UK’s competitiveness as a leading international site for trials.

Ethics 88

Ethics Medicine Education Competition 88

pharmaphorum

DECEMBER 8, 2022

The pair – who were at one time in a romantic relationship – were initially placed on trial together, but went down separate legal avenues after Holmes accused Balwani of emotional and physical abuse during their time leading the biotech. The company folded in 2018.

Doctors 103

Doctors Media Safety Patients 103

European Pharmaceutical Review

FEBRUARY 21, 2023

After the substance became legal in the UK in 2018, pharmaceutical companies have faced numerous obstacles to attain a fairer position in the industry. He founded Celadon in 2018. Prior to leading the firm McKinsey, Arthur was an M&A investment banker at Lazard.

Medicine 130

Medicine Manufacturing Specialization Pharmaceutical 130

European Pharmaceutical Review

AUGUST 31, 2023

Overcoming challenges in patient safety, manufacturing and supply of radiopharmaceuticals As clinical trials progress and the first results are published, companies’ best candidates will emerge in the next five years. Hospital staff must also be protected from radiation while handling the agent. Through its longer half-life of 12.7

Food and Drug Administration 80

Food and Drug Administration Manufacturing Safety Transportation 80

pharmaphorum

DECEMBER 9, 2022

Novartis seems to be leading the pack with TNO155, which has advanced to phase 2 testing as a monotherapy and is also in combination studies with adagrasib. The initial data from the Lumakras combination study was reported earlier this year and demonstrated the safety of the duo, but did not show convincing evidence of efficacy.

Medicine 57

Medicine Safety Pharma Leads 57

Pharmaceutical Technology

MARCH 24, 2023

For example, the cost of Humira biosimilars in Denmark decreased by 82% from September 2018 to December 2018. Many experts have concerns that only a few Humira biosimilars will have access to the US market, while the rest will not be listed, thereby leading to lower savings than expected.

Competition 59

Competition Marketing FDA Physicians 59

European Pharmaceutical Review

MARCH 4, 2024

Therefore, biologics identification and characterisation poses unparalleled challenges, as does their manufacturing processes and routes of administration while maintaining patient safety and clinical efficacy. A Robotic Pill for Oral Delivery of Biotherapeutics: Safety, Tolerability, and Performance in Healthy Subjects. References 1.

Food and Drug Administration 90

Food and Drug Administration Transportation FDA Medical 90

Healthcare Success

JANUARY 25, 2023

The rate of injuries from violent attacks against medical professionals grew by 63% from 2011 to 2018. Porath also found that technology overuse leads to increased exposure to negativity and misinformation. To be clear, workplace violence experienced by healthcare workers predates the pandemic. Why are people so angry and rude?

Patients 108

Patients Healthcare Healthcare Management 108

PM360

OCTOBER 28, 2022

Likewise, it enables them to predict the effect of the compound on the target and the compound’s safety risks. Clinical trials: Evaluating the safety and efficacy of new drugs consumes up to half of the total cost of the drug development process. According to a Deloitte report , pharmaceutical investment ROI has declined from 10.1%

Pharma 105

Pharma Food and Drug Administration Government Medicine 105

European Pharmaceutical Review

JUNE 29, 2023

In 2018, even before the number of global manufacturing inspections fell off precipitously, the industry was alarmed by the FDA’s report that angiotensin receptor blockers (ARBs) containing the active pharmaceutical ingredient (API) valsartan were found to contain nitrosamine impurities that sparked a series of recalls. Internet] 2023.

Food and Drug Administration 87

Food and Drug Administration Manufacturing Food Medicine 87

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 83

Management Side effects Patients Safety 83

pharmaphorum

DECEMBER 22, 2022

This will lead to more pre-protocol design discussions between sponsors and CROs and regulatory bodies seeking input on new and potentially acceptable approaches to, for example, measure digital endpoints. 2018 Jul 5;1:27. November 2, 2018. For new decentralised approaches, this is practically non-existent. NPJ Digit Med.

FDA 90

FDA Patients Electronics Medical 90

Pharmaceutical Technology

JANUARY 25, 2023

This is due to the complicated mechanism of induced protein degradation and due to large molecular weight and size, leading to issues associated with solubility, permeability, and bioavailability.” According to Syngene: “Although PROTACs are considered revolutionary, to date, the design and optimization of PROTACs remain empirical.

Side effects 52

Side effects Leads Safety Manufacturing 52

pharmaphorum

DECEMBER 1, 2022

A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine. She believes patients are the most important constituent in clinical development and provide the necessary information to assess the safety and efficacy of new medicines.

Patients 108

Patients Transportation Retail Recruitment 108

Pharmaceutical Technology

JANUARY 8, 2023

Today, approximately 384 million people around the globe have COPD and it is the third leading cause of death worldwide, the Global Initiative for Chronic Obstructive Lung Disease reports. In 2018, the FDA rejected the approval application for GSK’s Nucala (mepolizumab) in COPD. Better understanding of biologic efficacy.

Patients 119

Patients FDA Pharmaceutical Pharma 119

European Pharmaceutical Review

DECEMBER 22, 2022

While mRNA technologies still face long-term safety and efficacy evaluations, recent developments in new materials and delivery formulations are becoming effective solutions to enhancing therapeutic efficacy. Carsten Rudolph, PhD is the Chief Executive Officer and co‑founder of Ethris and the lead inventor of its SNIM® RNA Technology.

Medicine 107

Medicine Food and Drug Administration Transportation Distribution 107

European Pharmaceutical Review

JUNE 27, 2023

Hervé Affagard (HA): Developing microbiome therapeutics as well as every other new therapeutic modality comes with several challenges that need to be addressed carefully to ensure patient safety and maximise the potential benefits of these treatments. Science 2018 Available from: [link] Davar D. Internet] European Commission.

Food and Drug Administration 100

Food and Drug Administration Manufacturing Medicine Pharma 100

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). For more information about Oncoral, please visit www.ascelia.com/pipeline/oncoral. About the author.

Patients 85

Patients Food and Drug Administration Side effects Safety 85

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

Clarivate

DECEMBER 15, 2022

Intermodal transportation – the movement of goods in containers by using two or more different modes of transportation successively – plays the lead role in achieving sustainable logistics on the regional level. Road Safety: European Commission Rewards Effective Initiatives and Publishes 2021 Figures on Road Fatalities”. 4] Llano, C.,

Transportation 59

Transportation Retail Engineering Food 59

PM360

JULY 26, 2023

Even top AI developers from Google and OpenAI co-signed a statement at the end of May from non-profit the Center for AI Safety that said, “Mitigating the risk of extinction from AI should be a global priority alongside other societal-scale risks such as pandemics and nuclear war.” has fumbled trying to get to a standard national policy.

Government 95

Government Marketing Management Education 95

Clarify Health

JULY 13, 2020

The panel included Bhash Parasuraman, PhD, Vice President and BU Lead, Rare Disease Patient & Health Impact, Pfizer , Calum MacRae, MD, PhD, Professor of Medicine at Harvard Medical School , and Surya Singh, MD, President, Singh Healthcare Advisors. Approvals have spiked in recent years, with 59 new drugs approved in 2018.

Pharmaceutical 52

Pharmaceutical Pharma Patients Marketing 52

European Pharmaceutical Review

JUNE 27, 2022

Throughput Impurity Detection (HTID) platform for analysis of DNA enables rapid screening of different purification conditions delivering on-time analytical data leading to timeline reduction. 2018; 32(4):339-347. Tools such as the Lonza High?Throughput 2021; 12:626616. Available from: doi: 10.3389/fimmu.2021.626616. 2021.626616.

Recruitment 90

Recruitment Manufacturing Media Leads 90

European Pharmaceutical Review

MARCH 1, 2023

Since traditional visual inspection can already be replaced by automated camera systems, 8 CT could lead to reduction of failure by human inspection, cost savings and higher quality of freeze-dried products. As a result, rejected product vials can be reduced and the safety of the application is guaranteed. 2019; 260: 50–7 [[link] 6.

Distribution 85

Distribution Electronics Pharmaceutical Food 85

European Pharmaceutical Review

AUGUST 14, 2023

The company’s lead candidate, C21, is an angiotensin II type 2 receptor agonist (ATRAG). This data, together with a favourable safety profile, make C21 a potential game-changer for IPF patients, particularly those who are currently not treated due to the side effects of the available drugs, according to Dalsgaard.

Pharma 90

Pharma Side effects Patients Manufacturing 90

European Pharmaceutical Review

FEBRUARY 12, 2024

Liam Dunne, MSD Biotech Site Lead, explains that the site operates at the forefront of science and technology with 15,000L-scale, repeatable, robust manufacturing processes to produce highly sensitive monoclonal antibodies (mAbs). The downstream process ensures cell removal, virus safety, and impurity removal. How does it do this?

Manufacturing 91

Manufacturing Medicine Leads Media 91

pharmaphorum

DECEMBER 1, 2022

According to Diabetes UK, the prevalence of T2D is on the rise in Scotland – with a 40% increase in diagnosed cases recorded between 2008-2018 – and now, more than 300,000 people are living with T2D in Scotland, including those not yet diagnosed. The approval is based on the strength of results from Bayer’s phase 3 FIDELIO-DKD trial.

Consulting 57

Consulting Safety Medicine Patients 57

Pharmaceutical Technology

FEBRUARY 3, 2023

After years of safety-related setbacks and development challenges, recent progress in gene therapy is especially exciting. Researchers have relentlessly worked through the barriers to create lifechanging treatments for patients in need. This is already tricky at small scales but is getting close to impossible at really large scale.”

Medicine 97

Medicine Manufacturing Safety Management 97

PM360

MARCH 22, 2024

“For many years, our expertise in vision technology has been key in developing automotive solutions that improve driver safety,” said Neil Boehm, Chief Technology Officer at Gentex. Welcoming Kate and Denisa represents the culmination of a significant growth period since our inception in 2018.”

Media 52

Media Recruitment Education Medical 52

PM360

APRIL 7, 2023

Importance of Data Collection Many manufacturers fail to allocate sufficient time to obtain the safety and efficacy data needed to define critical endpoints. The accumulation of the right data—including safety, efficacy, and outcomes—are vital to negotiations with payers as opposed to what regulators are looking for.

Manufacturing 52

Manufacturing Marketing Patients Safety 52

PM360

DECEMBER 14, 2022

boasts 8,000 active licenses issued to cannabis businesses, leading the pack in countries with the largest markets. While projections are global, the U.S. is the major contributor to this rise with 30 states having legalized the use of cannabis, medicinally or for general adult use. Boston Scientific Acquires Gastro Device Company.

Manufacturing 52

Manufacturing Medical Healthcare Healthcare 52

Pharmaceutical Technology

SEPTEMBER 14, 2022

In 2018, the World Health Organisation (WHO) reported that 570,000 women were diagnosed with cervical cancer, of which 311,000 died of the disease. A phase II study of GX-188E, combined with Keytruda, also explored the safety and effectiveness of treatments in PD-L1+ and PD-L1-negative cervical cancer patients. .

Food and Drug Administration 59

Food and Drug Administration Patients FDA Pharmaceutical 59

Clarivate

AUGUST 9, 2022

The United States leads the world’s mass incarceration rate, which disproportionately affects Black Americans. This article received 281 citations since its publication in 2018. Police violence is a leading cause of death for young men, and young men of color face exceptionally high risk of being killed by police.

Government 98

Government Ethics Leads Media 98

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 52

Medical sales Medical Sales Medical sales reps 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 83

Manufacturing Leads Patients Medicine 83