Infuse Medical

FEBRUARY 4, 2025

Difficulty in Mastering Complex Procedures The complexity of modern medical devices and procedures often leads to steep learning curves. Inadequate training can result in increased procedural errors, slower adoption of new technologies, and compromised patient safety.

Training 130

Training Medical Healthcare Healthcare 130

European Pharmaceutical Review

MARCH 11, 2025

BIMZELX is the first and only approved medicine designed to selectively inhibit both interleukin 17A IL-17A and IL-17F. These results lead the way to the start of the first head-to-head study intended to demonstrate superiority of a pill versus injectable biologic in moderate-to-severe plaque psoriasis, according to Johnson & Johnson.

Safety 52

Safety Leads Medicine Patients 52

European Pharmaceutical Review

JUNE 29, 2022

How does that impact the safety of the biologics? Safety is key to the development of any medicine, but the safety considerations linked to bioproduction are more complex because biologics are more sophisticated medicines than small molecules. This could lead to false positives or, even worse, false negatives!

Ethics 98

Ethics Safety Manufacturing Medicine 98

European Pharmaceutical Review

DECEMBER 22, 2022

Advances in mRNA technologies and cellular delivery systems coupled with their cost effectiveness, manufacturing simplicity and ability to target previously-undruggable pathways has limitless potential that could revolutionise medicine. Manufacturing time for mRNA therapeutics is also fast compared to antibodies or protein-based drugs.

Medicine 116

Medicine Food and Drug Administration Transportation Distribution 116

European Pharmaceutical Review

NOVEMBER 28, 2024

This dual-layer certification process can create significant delays, as each framework involves extensive assessments for safety and performance under separate requirements specific to medical device and AI-specific criteria. If successful in other jurisdictions, such product will eventually make their way to Europe for approval.

Medical 105

Medical Government Safety Management 105

Healthcare Success

MAY 9, 2022

In this blog post, you’ll learn: Why QR codes have made a comeback, When to use them, And, 8 ways to improve the patient experience and drive leads with QR codes. . Suddenly the safety of contactless, hygienic interactions became a necessity. 8 Ways to Improve the Patient Experience & Drive Leads with QR Codes.

Leads 109

Leads Patients Healthcare Provider Healthcare 109

European Pharmaceutical Review

JUNE 13, 2024

Tell us about Ocugen’s lead programme, OCU400. Shortly thereafter, the European Medicines Agency (EMA) reviewed the study design, endpoints, and planned statistical analysis, and deemed the US-based trial acceptable for a Marketing Authorisation Application (MAA). What’s the latest and what’s next?

Manufacturing 145

Manufacturing Food and Drug Administration Engineering Safety 145

European Pharmaceutical Review

FEBRUARY 27, 2024

The Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), Dame June Raine, will step down in the Autumn following five years in the role. While she is stepping down from her current role, Dame June shared that she still hopes to contribute “to patient safety and public health in other ways.”

Safety 111

Safety Pharmacology Medicine Management 111

European Pharmaceutical Review

FEBRUARY 21, 2025

Only one eye was treated to mitigate any potential safety issues. Each of the children with retinal dystrophy were given the new treatment via subretinal injection. The team conducted observations over a three- to four-year period. They found that the participants lost sight in their untreated eye during this time.

Manufacturing 52

Manufacturing Medicine Specialization Consulting 52

World of DTC Marketing

MARCH 23, 2022

Accelerated Approval allows for early access to drugs and biologics based on initial evidence of safety and effectiveness, while confirmatory studies required to verify clinical benefits are ongoing. The program was codified into law under the Food and Drug Safety and Innovation Act (FDASIA) in 2012. Do patients care?

Patients 200

Patients FDA Doctors Physicians 200

MedCity News

OCTOBER 16, 2023

” A Microsoft customer, Doug King, Northwestern Medicine’s senior vice president and CIO, was on hand to sing praises of this unified data capability. The report reads like this: “Left anterior chest wall dual-lead pacer stable from prior examination. Lungs hyperinflated to clear. No pneumothorax or pleural eltusion.

Healthcare 313

Healthcare Healthcare Patients Doctors 313

European Pharmaceutical Review

SEPTEMBER 20, 2022

The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have announced that biosimilar medicines authorised in the European Union (EU) can now be interchanged with their reference medicine or an equivalent biosimilar product. New regulatory guidance could lead to UK biosimilar boom.

Medicine 98

Medicine Side effects Safety Doctors 98

Pharmaceutical Technology

FEBRUARY 3, 2023

The field of genomic medicine has reached a true turning point. After years of safety-related setbacks and development challenges, recent progress in gene therapy is especially exciting. More efficient, suspension-based cell culture processes are urgently needed in the now fast-developing genomic medicine space.

Medicine 97

Medicine Manufacturing Safety Management 97

European Pharmaceutical Review

OCTOBER 20, 2022

Apogenix’s lead immunotherapy candidate, asunercept is a fully human fusion protein, consisting of the CD95 receptor and an IgG1 antibody. The Phase II trial investigated efficacy and safety of asunercept in 435 patients with moderate to severe COVID-19 disease.

Patients 105

Patients Safety Medicine Leads 105

Pharmaceutical Technology

NOVEMBER 1, 2022

Intrinsic Medicine has signed a definitive business combination agreement with special purpose acquisition (SPAC) firm Phoenix Biotech Acquisition to create a public company. To be named Intrinsic Medicine following closing, the combined company will be led by current Intrinsic CEO Alexander Martinez and president and COO Jason Ferrone.

Medicine 59

Medicine Safety Specialization Leads 59

European Pharmaceutical Review

SEPTEMBER 22, 2022

EBT-101, a CRISPR-Cas9 gene editing system delivered by adenovirus-associated virus vector serotype 9 (AAV9) has been administered to the first individual in a Phase I/II trial designed to establish its safety and efficacy. Biodistribution, pharmacodynamic, and efficacy assessments will also be conducted. “It

Patients 145

Patients Safety Medicine Physicians 145

European Pharmaceutical Review

MAY 29, 2023

A neurosteroid drug was one of two medicines recommended for approval at the Committee for Medicinal Products for Human Use (CHMP) ’s May 2023 meeting. This medicinal product has potential to diagnose this cancer in high risk patients in early stages and for patients with suspected recurrence.

Medicine 98

Medicine Marketing Leads Safety 98

European Pharmaceutical Review

JANUARY 27, 2023

The UK will be the first country to introduce a tailored framework for the regulation of innovative medicines manufactured at the point where a patient receives care, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced.

Manufacturing 105

Manufacturing Medicine Consulting Engineering 105

European Pharmaceutical Review

AUGUST 22, 2024

billion” last year, two key players in the market, namely Novo Nordisk and Eli Lilly and Company, are set to lead the market, the analytics company forecasts: “collectively capturing 94 percent of the total 2030 GLP-1R sales”. The treatment was also shown to hold a “good safety and tolerability” profile. Internet] GlobalData.

Medicine 59

Medicine Marketing Manufacturing Sales 59

European Pharmaceutical Review

APRIL 17, 2024

Roche multiple sclerosis subcutaneous injection: late-breaking data “Updated results from OCARINA II further underline the potential benefits of subcutaneous OCREVUS for patients with both relapsing and progressive forms of MS,” shared Scott Newsome , DO, lead author, Johns Hopkins University School of Medicine.

Food and Drug Administration 93

Food and Drug Administration Safety Medicine Food 93

Pharmaceutical Technology

APRIL 3, 2023

Hyrimoz has been approved for use in all the indications covered by the reference medicine Humira, including plaque psoriasis, rheumatic diseases, ulcerative colitis, Crohn’s disease, uveitis and hidradenitis suppurativa. Its reference medicine, Humira, initially received approval with an adalimumab 50 mg/mL concentration.

Marketing 105

Marketing Food and Drug Administration Medicine Food 105

European Pharmaceutical Review

OCTOBER 20, 2023

This cytokine drives the type-2 inflammatory loop in the skin, which leads to skin barrier dysfunction, itch, skin thickening and infection. The safety profile of lebrikizumab in ADjoin was found to be consistent with previous lebrikizumab studies in patients with moderate-to-severe atopic dermatitis.

Safety 105

Safety Pharmaceutical Patients Medicine 105

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. 6 Thus, it is critical to ensure the consistency of therapeutic effect across batches (see box).

Marketing 103

Marketing Food and Drug Administration Medicine Prescription 103

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. They are vital to ensuring the safe and effective use of medicines, making them an integral part of healthcare in Europe. percent as EU average with some Member States as high as 25 percent).

Healthcare 98

Healthcare Healthcare Safety Electronics 98

European Pharmaceutical Review

JANUARY 17, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorisation for Ximluci ® (ranibizumab), a biosimilar referencing Lucentis®, to help treat a leading cause of blindness globally. First bispecific antibody approved in EU to combat leading causes of vision loss.

Manufacturing 104

Manufacturing Marketing Medicine Leads 104

European Pharmaceutical Review

JANUARY 5, 2024

These results should lead to expediting the conduct of a placebo-controlled international trial to replicate these results,” Professor John Kane, Professor of Psychiatry and Molecular Medicine, The Donald and Barbara Zucker School of Medicine, Hempstead New York noted.

Food and Drug Administration 111

Food and Drug Administration Medical Safety Patients 111

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 Marketing 98

European Pharmaceutical Review

JUNE 16, 2023

According to Maximize Market Research , new technologies are expected to boost the clinical trials market between 2022 to 2029, especially as the industry and patients are shifting towards digitalisation approaches and personalised medicines. As the data landscape evolves, what is the most exciting innovation in clinical data management.

Safety 111

Safety Electronics Recruitment Patients 111

European Pharmaceutical Review

DECEMBER 14, 2023

Decisions to remove medicines from market are not taken lightly and are often based upon all evidence available to inform a benefit/risk balance. 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.

Medicine 116

Medicine Safety Competition Medical 116

European Pharmaceutical Review

MAY 15, 2023

HARMONIE investigated the efficacy and safety of a single intramuscular dose of nirsevimab. Agreed in March 2017, AstraZeneca leads development and manufacturing activities, and Sanofi leads commercialisation activities. The mAb demonstrated a reduction of 58.04 Participant follow-up will conclude at 12 months.

Safety 104

Safety Leads Manufacturing Medicine 104

European Pharmaceutical Review

AUGUST 24, 2023

Therefore “This could improve the overall safety and tolerability of risvodetinib.” “… compared to the capsules currently in use in the 201 clinical trial, the smaller tablets may overcome challenges patients have swallowing oral medication as a result of their disease.

Safety 98

Safety Medical Medicine Patients 98

Contrarian Sales Techniques

NOVEMBER 21, 2024

An essential part of this education is emphasizing evidence-based medicines. What is Evidence-Based Medicine? Evidence-based medicine (EBM) is a systematic approach to medical practice that integrates clinical expertise, patient values, and the best available research evidence.

Education 52

Education Medical Patients Doctors 52

European Pharmaceutical Review

AUGUST 29, 2023

Experts at the European Medicines Agency (EMA) have provided a regulatory perspective on risk factors and mitigation strategies for nitrosamine impurities in human drug products. The paper highlighted an Article 31 referral into medicine safety which began in the EU in September 2019. Cioc et al.

Medicine 98

Medicine Manufacturing Safety Healthcare 98

Pharmaceutical Technology

DECEMBER 15, 2022

Eisai has entered a comprehensive research partnership agreement with Washington University School of Medicine in St Louis, US, to develop potential new therapies for neurodegenerative ailments. By collaborating with world-leading research institutions such as Washington University in St.

Medicine 98

Medicine Safety Sales Leads 98

European Pharmaceutical Review

OCTOBER 26, 2023

PharmaKure has filed a Clinical Trial Application (CTA) with the UK’s Medicines and Healthcare Regulatory Agency (MHRA) to evaluate PK051, a combination drug targeting disaggregates of amyloid-β proteins. The submission includes comprehensive data from pre-clinical studies and thorough safety assessments, PharmaKure noted.

Safety 105

Safety Pharmaceutical Patients Medicine 105

pharmaphorum

SEPTEMBER 20, 2022

Findings from the litifilimab trial, undertaken by Northwell Health’s Division of Rheumatology and The Feinstein Institutes for Medical Research, have been published in the New England Journal of Medicine and show promise for those who have been diagnosed with systemic lupus erythematosus (SLE). Sponsored by Biogen Inc., Dr Kevin J.

Medicine 111

Medicine Leads Medical Patients 111

pharmaphorum

NOVEMBER 23, 2022

Dengue is a mosquito-borne virus endemic in more than 125 countries, including the US territories of Puerto Rico, the US Virgin Islands, and American Samoa, and is a leading cause of fever among travellers to Latin America, the Caribbean, and Southeast Asia. Takeda said last year that the vaccine could reach up to $1.6 billion in peak sales.

FDA 122

FDA Marketing Leads Safety 122