European Pharmaceutical Review

JULY 5, 2022

It can lead to painful attacks of oedema (swelling) in various parts of the body, including the abdomen, face, feet, genitals, hands and throat. The SPRING study data reinforce the safety and efficacy of Takhzyro across a broad range of patients living with HAE,” commented Ming Yu, Global Clinical Lead at Takeda. “We

Safety 90

Safety Patients Leads Pharmaceutical 90

pharmaphorum

OCTOBER 26, 2022

The drug failed a futility test in a pivotal trial and was also placed under a partial clinical hold by the FDA while it probed the drug’s safety. Palovarotene was acquired by Ipsen under the tenure of its former chief executive David Meek as part of its $1 billion upfront acquisition of Clementia Pharma in 2019.

FDA 57

FDA Safety Marketing Pharma 57

European Pharmaceutical Review

AUGUST 29, 2023

The paper highlighted an Article 31 referral into medicine safety which began in the EU in September 2019. therefore concluded that the finding “is another major simplification and a valuable lead in the development of effective mitigation strategies for the prevention of NDSRI formation”. Cioc et al.

Medicine 86

Medicine Manufacturing Safety Healthcare 86

pharmaphorum

JULY 4, 2022

Two weeks after reporting disappointing results for its lead coeliac disease therapy, 9 Meters Biopharma will draw some comfort from a mid-stage trial of its candidate for short bowel syndrome (SBS), although its share price remains under pressure. Some children are born with an abnormally short small intestine.

Biopharma 82

Biopharma Leads Food Safety 82

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.

Side effects 52

Side effects Medicine Safety Healthcare 52

Pharmaceutical Technology

JANUARY 10, 2023

Many of the current existing therapies are often viewed by physicians as not optimal to addressing the needs of patients, and challenges remain such as improving patient compliance, safety profile, and addressing comorbidities of T2D. billion in sales in 2019, increasing to $136.2

Marketing 52

Marketing Physicians Leads Sales 52

pharmaphorum

NOVEMBER 24, 2022

The opportunity is open to academic, government, and industry organisations anywhere in the world, with a lead partner based in the UK. Dr Catherine Kettleborough, lead of the LifeArc Chronic Respiratory Infection Translational Challenge, said: “Repurposing an existing drug or compound is a faster way of getting new treatments to patients.

Government 57

Government Leads Safety Medical 57

Pharmaceutical Technology

FEBRUARY 10, 2023

Countries with a high willingness for performance-based models, such as the UK, saw this RSA type peak in 2019 before continually declining. Access to oncology medicines varies across countries, and their cost against safety/efficacy is generally perceived as being low, such as in the US.

Marketing 105

Marketing Medicine Leads Safety 105

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

Legacy MEDSearch

APRIL 17, 2023

(NASDAQ: POCI ), a leading designer and manufacturer of advanced optical instruments for the medical and defense industries, today announced the appointment of medical device and aerospace/defense industry manufacturing veteran, Mahesh Lawande, as the Company’s Chief Operating Officer effective April 24, 2023.

Engineering 52

Engineering Manufacturing Electronics Medical 52

European Pharmaceutical Review

APRIL 11, 2024

He leads Siemens’ efforts to optimise and improve processes for clients within the pharmaceutical, biopharmaceutical and medical device sectors. 2019 Mar;214:185–94. This allows a more detailed understanding of exactly how different variables affect the outcomes. References Belkhir L, Elmeligi A.

Manufacturing 91

Manufacturing Pharmaceutical Engineering Pharmaceutical manufacturing 91

European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” Takeaways from ISPE’s GAMP 5 Second Edition update.

Manufacturing 83

Manufacturing Pharma Food and Drug Administration Safety 83

Clarivate

DECEMBER 15, 2022

of fatal traffic accidents in 2019 [5]. 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. Furthermore, road freight vehicles were involved in 4.9% 6] Rai, H.B., Verlinde, S.,

Transportation 59

Transportation Retail Engineering Food 59

European Pharmaceutical Review

DECEMBER 19, 2022

1 However, as most biosimilars are developed by means of a complex biotechnological process in living organisms, this inevitably leads to differences between the biosimilar and the reference product. Marie Manley leads Sidley’s Life Sciences team in London and is a distinguished thought leader and adviser on EU and UK regulatory law.

Medicine 52

Medicine Biopharma Safety Food 52

Healthcare Success

JANUARY 25, 2023

Porath also found that technology overuse leads to increased exposure to negativity and misinformation. And you don’t have to search long to find stories like this: A hospital in Missouri gave their staff panic buttons after hospital staff assaults rose from 40 in 2019 to 123 in 2020—more than a 200% increase. Technology overuse Ms.

Patients 105

Patients Healthcare Healthcare Management 105

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 94

Pharmaceutical Food and Drug Administration Medicine FDA 94

Pharmaceutical Technology

AUGUST 16, 2022

In 2019, Daiichi Sankyo entered a global development and commercialisation agreement with AstraZeneca for Daiichi Sankyo’s lead antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), in a deal worth $6.9bn.

Food and Drug Administration 59

Food and Drug Administration Sales Patients Food 59

PM360

NOVEMBER 29, 2022

The effects of climate change represent an additional danger for the health, safety, and quality of life of people all over the world, as evidenced by the recent heat waves plaguing the northern hemisphere. Extreme temperatures lead to more cases of heat stroke, which can be fatal or lead to chronic health issues.

Healthcare 98

Healthcare Healthcare Manufacturing Distribution 98

European Pharmaceutical Review

MAY 2, 2023

Cancer remains a global threat with around 10 million people dying from the disease each year worldwide, making it the second leading cause of death. By collaborating with several stakeholders and authorities, multiple stages of development can take place concurrently to speed up R&D without compromising safety protocols.

Patients 98

Patients Medicine Marketing Medical 98

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.

Medicine 89

Medicine Pharmacology Healthcare Healthcare 89

Pharmaceutical Technology

NOVEMBER 4, 2022

According to GlobalData’s Social Media Analytics, supply chains were mentioned on Reddit and Twitter 1,908 times in 2019. As visibility diminishes, mismanagement of the supply chain can not only lead to revenue and reputational damage for manufacturers but more importantly, loss of life for patients. The tech solution.

Biopharma 52

Biopharma Manufacturing Media Pharmaceutical 52

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.” The PiCSO Impulse System received ‘Breakthrough Designation’ from the FDA in 2019 and the CE-Mark in 2020.

Medical 52

Medical FDA Recruitment Pharmacology 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 71

Management Side effects Patients Safety 71

Pharmaceutical Technology

APRIL 13, 2023

However, numbers are still much higher than 2019, indicating the use of telemedicine is set to remain post-Covid. Lower DCT usage for Phase I studies may be accounted for due to the heavier focus on safety and efficacy, and increased monitoring of trial participants in-person. For example, the patient completing an e-diary.

Food and Drug Administration 52

Food and Drug Administration Electronics Healthcare Healthcare 52

European Pharmaceutical Review

FEBRUARY 21, 2023

Celadon was the first company to work through the ‘chicken and egg’ situation with the Home Office and MHRA in 2019-20, as we weren’t prepared to break the law to grow medicinal cannabis in order to gain GMP! Prior to leading the firm McKinsey, Arthur was an M&A investment banker at Lazard. He founded Celadon in 2018.

Medicine 127

Medicine Manufacturing Specialization Pharmaceutical 127

Clarivate

OCTOBER 25, 2023

of fee-for-service beneficiaries having a type 2 diabetes diagnosis in 2019 , it is among the most widespread chronic conditions in the over-65 population. With monthly wholesale acquisition costs below $600, volume drove type 2 diabetic drugs Jardiance® and JANUVIA® onto the list. With 27.5%

Prescription 52

Prescription Physicians Manufacturing Healthcare 52

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). 2019; 83(1):169-178. Kümler I, Sørensen PG, Palshof J, et al. Cancer Chemother Pharmacol.

Patients 81

Patients Food and Drug Administration Side effects Safety 81

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. 2019 Aug;18(8):585-608. 2019; 1596:104-116. 2019; 164:105457. Tools such as the Lonza High?Throughput Nat Rev Drug Discov.

Recruitment 86

Recruitment Manufacturing Media Leads 86

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. I still feel that it is very important,” Dr Mullen said.

Patients 89

Patients Pharmaceutical Medical Physicians 89

European Pharmaceutical Review

JUNE 29, 2023

However, it is important to note that withdrawals and recalls are also a signal that ‘the system is working’ and that previously unidentified and undiscovered sources of contamination, like nitrosamines, are being removed from the supply chain, helping to improve patients’ safety. 2019; 74: 1275-1278. Internet] 2023.

Food and Drug Administration 83

Food and Drug Administration Manufacturing Food Medicine 83

pharmaphorum

OCTOBER 26, 2022

Chiesi has proven its dedication to global public health through its designation as a certified Benefit Corporation (B Corp) since 2019. We start our meetings by bringing to life a patient testimony and asking the team to reflect on how the goal of each meeting ultimately leads back to the needs of patients,” Chiesi says. “If

Patients 71

Patients Pharma Consulting Transportation 71

Cesare Ferrari

SEPTEMBER 12, 2022

In MedTech, branding was traditionally considered less important, since the purchasing mechanism is well structured and involves different stakeholders concerned only by clinical value, performance, safety, and cost. This belief is supported by an article published in 2019 by McKinsey & Company.

Marketing 52

Marketing Medical Insurance Training 52

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 103

Medicine Food and Drug Administration Transportation Distribution 103

Clarify Health

JULY 27, 2020

Now with the appropriate safety measures in place, they are urging patients to come back. Safety is the new quality,” Jennifer said. Ascension conducted 7k virtual visits between March and May 2019; this year, telehealth visits spiked to 700k during those same two months. However, maybe not all deferred care needs to return.

Healthcare 52

Healthcare Healthcare Safety Patients 52

Infuse Medical

MARCH 1, 2023

Anytime knowledge gets transferred to a sales rep, or a clinician, a physician or a patient, the purpose is to increase patient outcomes or to lower costs…Both of which ultimately leads to getting better healthcare solutions to as many people as possible.

Training 52

Training Education Leads Sales 52

Clarivate

OCTOBER 10, 2022

Fruquintinib was well-tolerated, with a safety profile consistent with that previously reported in other studies. The question of which KRAS inhibitor is most effective remains elusive, although being first to market in addition to strong efficacy and safety data could differentiate the more competitive agent. Market impact.

Marketing 52

Marketing Safety Patients Competition 52

PM360

MAY 25, 2023

And Mental Health America (MHA) found that between 2019 and 2020, 54.7% This is different from clinical trials which are really designed to look at efficacy and safety in a very controlled environment, so controlled trials are very good at answering those two questions. million people. above pre-pandemic levels by Q2 2022.

Side effects 95

Side effects Medical Patients Networking 95