European Pharmaceutical Review

AUGUST 11, 2023

Adakveo (crizanlizumab) received conditional authorisation by the EC in October 2020. This review started after results of a Phase III study (STAND) did not show a statistically significant difference between crizanlizumab and placebo in rates of pain crises leading to a healthcare visit over the first-year.

Marketing 98

Marketing Food and Drug Administration Medicine FDA 98

European Pharmaceutical Review

MAY 4, 2023

The agency’s approval is important, because according to the US Centers for Disease Control and Prevention, RSV leads to around 60,000-120,000 hospitalisations and 6,000-10,000 deaths in adults 65 years of age and older every year in the US. percent and reduced the risk of developing severe RSV-associated LRTD by 94.1

Food and Drug Administration 98

Food and Drug Administration Safety FDA Food 98

Clarivate

OCTOBER 28, 2021

That’s why trademark analysts also assess for patient safety. It can be a tricky business, and an important one not just for commercial reasons, but also for patient safety. Although used for very different indications, their similar names can lead to human error, resulting in potentially dangerous prescribing or dispensing mistakes.

Prescription 98

Prescription Safety Leads Marketing 98

pharmaphorum

SEPTEMBER 27, 2022

It comes after Johnson & Johnson’s Janssen Biotech division signed up to access the bispecific antibody technology in 2020, without revealing any financial details. 2 T cells, which have potent tumour-killing activity.

Safety 101

Safety FDA Sales Leads 101

World of DTC Marketing

AUGUST 12, 2022

He leads the Program on Regulation, Therapeutics, and Law at Brigham and Women’s Hospital in Boston. In 2020 JAMA found that the estimated median capitalized research and development cost per product was $985 million, counting expenditures on failed trials. After all, 90 percent of all drugs that enter human testing fail.

Pharma 255

Pharma Retail Pharmaceutical Pharmaceutical manufacturing 255

European Pharmaceutical Review

APRIL 12, 2023

The platform is “designed to cross the blood-brain barrier (BBB) and safely increase exposure of the therapeutic antibody in the brain and potentially lead to improved efficacy and/or safety,” stated Joseph Lewcock, PhD, Chief Scientific Officer of Denali. Denali will receive a one-time option exercise payment.

Transportation 102

Transportation Engineering Safety Sales 102

Pharma Marketing Network

JULY 19, 2023

For example, Pfizer, a leading pharmaceutical company, has a long history of sponsoring research into new drugs and treatments. In 2020, the company committed to investing $5 billion in research and development over the next five years. This could help to improve the lives of patients and make a real difference in the world.

Pharmaceutical 98

Pharmaceutical Healthcare Healthcare Education 98

pharmaphorum

SEPTEMBER 14, 2022

The French biotech said the cash injection – which follows a €45 million Series A in 2020 – will also help it bring forward the first development candidate in a collaboration signed with gene-editing specialist Intellia Therapeutics last year, currently in the early-discovery stage.

Safety 52

Safety Leads Patients FDA 52

Pharmaceutical Technology

JULY 4, 2022

In June 2020, Brii Bio exercised its option and acquired the exclusive rights for the further development and marketing of BRII-835 (VIR-2218) in Greater China. BRII-877 (VIR-3434) will be integrated into our innovative drug combination strategies that may lead to a higher functional cure rate across all patient groups.”.

Safety 111

Safety Medical Marketing Sales 111

Pharmaceutical Technology

APRIL 13, 2023

Biogen opted into Denali’s Antibody Transport Vehicle (ATV): Amyloid beta programme (ATV: Aβ) as part of a binding agreement signed by the companies in 2020, to co-develop and co-commercialise Denali’s small molecule inhibitors of leucine-rich repeat kinase 2 (LRRK2) for Parkinson’s disease.

Transportation 52

Transportation Safety Sales Leads 52

European Pharmaceutical Review

JANUARY 25, 2024

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. We note the Commission has not conducted an assessment on the impact of removing paper leaflets on patient safety. percent as EU average with some Member States as high as 25 percent).

Healthcare 98

Healthcare Healthcare Safety Electronics 98

pharmaphorum

JANUARY 4, 2023

MDS can lead to life threatening disease including acute myeloid leukaemia (AML), as well as anaemia and increased risk of bleeding and infections. Imetelstat also improved transfusion independence at 24 weeks and reduced the number of transfusions patients needed, both secondary endpoints, and raised haemoglobin levels.

Safety 97

Safety Marketing Patients Pharma 97

pharmaphorum

JUNE 29, 2022

It is also being developed for use in pregnant women to prevent RSV in newborns, an indication for which it looks to be in the lead after GSK was forced to halt three clinical trials while it investigates a safety signal. For children younger than five years old in the US, the infection leads to approximately 2.1

Marketing 81

Marketing Leads Safety Sales 81

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

Healthcare Success

JANUARY 25, 2023

However, these numbers escalated in 2020, along with the COVID-19 pandemic. Negative or angry emotions According to her survey of 70,000 “The Mighty” readers and community members, the number of people choosing anger as their top emotion more than doubled from March to September 2020— rising from 20% to 45%. How did we get here?

Patients 109

Patients Healthcare Healthcare Management 109

pharmaphorum

JANUARY 27, 2023

It failed a futility test in a pivotal trial and was also placed under a partial clinical hold by the FDA in 2020 while a safety signal was investigated. Even if Ipsen can eventually get palovarotene over the line in the EU and US, any lead it may have enjoyed over rival FOP therapy developers is being winnowed away.

FDA 89

FDA Marketing Medicine Prospecting 89

European Pharmaceutical Review

NOVEMBER 1, 2023

It is one of the leading causes of death associated with AMR globally. Using this approach, our lead programme – RVX 001, a protein-based vaccine against invasive pneumococcal disease – has been designed with antigens common to all pneumococcus serotypes. 2020 Dec; 33(6): 517-529. Curr Opin Infect Dis. Lancet Glob Health.

Safety 115

Safety Marketing Manufacturing Leads 115

Infuse Medical

JULY 4, 2024

A 2020 study from Stanford University showed that VR training reduced maintenance errors by 35%. Brief Overview of the Importance of Medical Device Maintenance Medical device maintenance ensures patient safety, operational efficiency, and regulatory compliance in healthcare settings.

Training 52

Training Medical Healthcare Healthcare 52

European Pharmaceutical Review

MAY 4, 2023

Data announced at the European Lung Cancer Congress (ELCC) earlier this month revealed the long-term efficacy and safety of RYBREVANT ® (amivantamab) in patients with post-platinum EGFR Ex20ins-mutated advanced non-small cell lung cancer (NSCLC). 2020; 19(10): 2044–56. References 1. Garrido P et al. Oral Presentation JGN-75414.

Food and Drug Administration 98

Food and Drug Administration Safety Patients Medicine 98

European Pharmaceutical Review

MAY 8, 2024

Based on the growing evidence of positive outcomes seen with full ecosystem products, mbiomics has developed a proprietary techbio platform that aims to combine the disease-modifying potential of large consortia with the safety and scalable manufacturability of GMP-manufactured non-engineered microbial strains isolated from healthy individuals.

Manufacturing 98

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

Ethics 105

Ethics Medicine Education Competition 105

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. 2020; 8(1). Lopes J, Fisher J, Flick H, et al. J Immunother Cancer.

Engineering 98

Engineering Food and Drug Administration Patients Safety 98

European Pharmaceutical Review

OCTOBER 24, 2023

However, it also leads to a decline in the quality of life and the condition can be fatal. Therefore, the development of a drug that has a safety profile and can target the underlying causes of AD pathology to achieve a cure for AD has been an ongoing pursuit of researchers in this field. The process of Aβ aggregation.

Leads 103

Leads Patients Networking Safety 103

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. The disorder leads to impaired movement, as well as difficulty opening the mouth, affecting eating and speaking, and preventing normal breathing.

FDA 59

FDA Marketing Safety Pharma 59

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. 10,12 The THR scheme is also limited to products used for oral or external use and/or inhalation.

Marketing 103

Marketing Food and Drug Administration Medicine Prescription 103

pharmaphorum

AUGUST 18, 2022

VMS are reported by up to 80% of women at some point during menopause and is the leading cause for seeking medical attention during this phase of their lives. It acquired elinzanetant as part of its takeover of UK biotech KaNDy Therapeutics in 2020. billion yen ($97 million) charge as an R&D expense in its fiscal first quarter.

FDA 52

FDA Safety Marketing Pharma 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. However, there were some notable differences.

Pharmaceutical 111

Pharmaceutical Food and Drug Administration Medicine FDA 111

European Pharmaceutical Review

SEPTEMBER 20, 2023

Conversely, poor analytical characterisation will likely lead to questions from regulators and, without sufficient product and process knowledge, an IND or BLA that is eventually deemed incomplete. Incorrect DNA sequences can also lead to high levels of SVs. While SVs are typically present at less than 0.1

Patients 98

Patients Manufacturing Leads Safety 98

European Pharmaceutical Review

DECEMBER 26, 2023

The increasing adoption of technologies promoting safety, efficacy and reduced production costs has been a persistent trend that will continue to benefit the industry and help to treat a broader patient population. million for Hemgenix [AAV5-hFIX-Padua]). This enhances the commercial viability of USP.

Manufacturing 98

Manufacturing Safety Patients Competition 98

European Pharmaceutical Review

FEBRUARY 1, 2024

In this Q&A, he explores the trends and challenges within the cardiovascular treatment space, as well as clinical development of the company’s lead candidate obicetrapib, a cholesterol ester transfer protein (CETP) inhibitor for lowering low-density lipoprotein-cholesterol (LDL-C) and ultimately reducing cardiovascular risk.

Pharma 97

Pharma Patients Pharmaceutical Leads 97

Legacy MEDSearch

AUGUST 8, 2022

The SkyWalker System has the technical advantages of precise operation and efficient coordination, while prioritizing safety. About MicroPort NaviBot MicroPort NaviBot International LLC was incorporated in 2020 and is headquartered in Foxborough, MA. NaviBot is subsidiary of MicroPort MedBot.

Food and Drug Administration 98

Food and Drug Administration Recruitment Medical Food 98

European Pharmaceutical Review

AUGUST 15, 2024

1 The cancer is a slow-growing but potentially life-threatening B-cell malignancy, in which increased activation of B-cell receptor signalling pathways leads to overgrowth of lymphocytes in bone marrow and other disease compartments. for all-comers; HR=0.52 for all-comers; HR=0.52

Safety 52

Safety Patients Medical Medicine 52

Pharmaceutical Technology

DECEMBER 14, 2022

By 2050, AMR is expected to become one of the leading causes of death worldwide, causing up to 10 million deaths per year by 2050 according to the World Health Organization (WHO). However, evidence from another study in 2020, led by Carmen Liu , found that phage resistance could also lead to antibiotic susceptibility.

Safety 52

Safety Manufacturing Government Leads 52

pharmaphorum

SEPTEMBER 28, 2022

Pheon’s lead ADC PHN-010 is directed at a novel, undisclosed cancer antigen that it says is highly expressed in a broad range of solid tumours. billion in 2020. ” The company says its ADC platform is designed to balance safety and efficacy for each target, and is already attracting interest from big pharma partners.

Biopharma 52

Biopharma Pharma Leads Safety 52

pharmaphorum

SEPTEMBER 20, 2022

The EU decision is based on the data from the phase 3 AURORA 1 and 2 studies, which showed that treatment with voclosporin in combination with MMF and low-dose corticosteroids achieved superior renal responses at 52 weeks compared to MMF and low-dose corticosteroids alone, with a comparable safety profile.

Marketing 52

Marketing Safety Patients Medicine 52

Clarify Health

AUGUST 26, 2020

While many plans did not meet their minimum medical loss ratio (or MLR Target) for 2020, in three steps, payers can better position themselves to meet these targets in 2021. Challenges to hitting MLR targets in 2020 The COVID-19 pandemic presented many unforeseen challenges to meeting MLR targets in 2020. billion last year.

Insurance 52

Insurance Medical Networking Management 52

Impetus Digital

AUGUST 2, 2024

In turn, this can support decision-making and lead to more efficient inventory management and faster delivery times, enhance supply chain visibility and transparency, and avoid overproduction and waste. Regulatory Compliance Regulatory frameworks are continuously evolving in the pharmaceutical industry.

Pharma 95

Pharma Manufacturing Medicine Marketing 95