European Pharmaceutical Review

MARCH 16, 2023

The combination modulator therapy tezacaftor (TEZ) and ivacaftor (IVA) for cystic fibrosis (CF) has demonstrated long-term safety and clinical benefit in a four-year trial. While this clinical trial was still being conducted, a three-part regimen composed of TEZ/IVA plus elexacaftor (Trikafta) was approved in 2019.

Patients 98

Patients Safety Leads Medical 98

European Pharmaceutical Review

OCTOBER 5, 2022

An industry that is among the world’s biggest polluters is caught in a balancing act between satisfying the health and safety demands of industry regulators and meeting the needs of modern eco-conscious consumers. However, when it comes to pharmaceutical products, health and safety remains the primary consideration.

Pharma 98

Pharma Safety Pharmaceutical Manufacturing 98

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 98

Medicine Manufacturing Safety Healthcare 98

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. 2019; 13(1):16-24. Clin Microbiol Infect. 2012; 18 (6): 21-27.

Safety 111

Safety Patients Side effects Healthcare 111

European Pharmaceutical Review

SEPTEMBER 22, 2023

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline. Treatment with the mAbs delayed cognitive decline by 2.6 months for lecanemab and 5.5

Food and Drug Administration 97

Food and Drug Administration Safety Patients Leads 97

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. Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. 2019 [cited 2023Feb]. the enteric coating and the capsule dissolve. 2021;12(1):294–305.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Safety Pharmaceutical 105

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 98

Manufacturing Pharma Food and Drug Administration Safety 98

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. 2019 ;42:385-406.

Safety 98

Safety Pharmacology Engineering Medical 98

European Pharmaceutical Review

JULY 13, 2023

A new therapeutic antibody class, bispecific antibodies, was engineered to build on the classic antibody design and bind to two different proteins, demonstrating how incremental changes in protein design can lead to entirely new therapies. 2019; 1(1): 100001. Engineering the next-generation of car T-cells with CRISPR-Cas9 gene editing.

Engineering 98

Engineering Food and Drug Administration Patients Safety 98

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 109

Patients Healthcare Healthcare Management 109

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 59

Government Leads Medical Safety 59

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

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

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

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

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 105

Manufacturing Pharmaceutical Engineering Pharmaceutical manufacturing 105

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 Pharmaceutical 98

Pharmaceutical Technology

SEPTEMBER 22, 2022

Invossa has demonstrated the efficacy and safety of a single shot for up to three years, as outlined by Lew in a 2019 study published in Osteoarthritis and Cartilage (NCT03383471). Similarly, ReNu also showed positive efficacy and safety for up to 12 months from a single intra-articular injection (NCT02318511, NCT03063099).

Marketing 59

Marketing Safety Physicians Management 59

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 132

Medicine Manufacturing Specialization Pharmaceutical 132

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 105

Patients Medicine Marketing Medical 105

European Pharmaceutical Review

JULY 25, 2022

A significant advancement in worldwide standards for mass serialisation on packaging came in 2019 when two important regulations came into force – the EU’s False Medicines Directive (FMD) and the US’ anti-counterfeiting protocol, ‘The Drug Quality and Security Act’ or DQSA. Supply-chain visibility.

Pharmaceutical 104

Pharmaceutical Medicine Pharmaceutical manufacturing Manufacturing 104

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

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 104

Patients Food and Drug Administration Side effects Safety 104

European Pharmaceutical Review

AUGUST 15, 2024

Chronic lymphocytic leukaemia (CLL) is the most prevalent adult leukaemia in Western countries with more than 100,000 incidences and more than 40,000 deaths reported globally in 2019. for patients with del(17p)/ TP53 mutation) and a favourable safety profile, including cardiac events, compared to ibrutinib ( ALPINE study ).

Safety 52

Safety Patients Medical Medicine 52

pharmaphorum

AUGUST 22, 2022

Health Innovation Fund concentrates its investments on highly productive technologies, hoping to create more personalised care that will lead to better outcomes. They just published Phase 1A last week, which is the safety profile. Investment strategies. It currently hosts 40 companies in its portfolio. ” About the interviewee.

Healthcare 102

Healthcare Healthcare Healthcare Provider Specialization 102

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

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 111

Patients Pharmaceutical Medical Physicians 111

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 98

Recruitment Manufacturing Media Leads 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 98

Medicine Pharmacology Healthcare Healthcare 98

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

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

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

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 116

Medicine Food and Drug Administration Transportation Distribution 116

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 98

Food and Drug Administration Manufacturing Food Medicine 98

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

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