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

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.

Government 105

Government Medical 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 317

Healthcare Healthcare Patients Doctors 317

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

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

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

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 Manufacturing 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

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

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

Pharmaceutical Technology

MAY 17, 2023

Under the deal, Prevail obtains exclusive rights to use Scribe’s CRISPR X-Editing (XE) technologies to develop the medicines. The deal will see the integration of Scribe’s new CRISPR by Design approach and Prevail’s expertise in developing genetic medicines for neurological disorders for specific genetic targets.

Medicine 52

Medicine Engineering Leads Safety 52

European Pharmaceutical Review

OCTOBER 20, 2022

City of Hope , one of the largest cancer research and treatment organisations in the US, announced that the first patient to receive novel cancer medicine AOH1996, is doing well. Its objective is to determine the maximum tolerated dose of the investigational pill, AOH1996, and to evaluate the medicine for preliminary efficacy.

Patients 98

Patients Medicine Medical Safety 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 Marketing Leads 98

European Pharmaceutical Review

MARCH 18, 2024

A Phase III trial has shown that compared oral drug delivery, administering levodopa through an infusion pump led to nearly two hours of day (1.72) of additional time in which the medicine reduced symptoms in Parkinson’s patients. There were 381 Parkinson’s patients enrolled in the trial. and Joan A.

Food and Drug Administration 98

Food and Drug Administration Medicine Physicians Food 98

European Pharmaceutical Review

JULY 26, 2022

Illuzyce (lutetium [ 177 lu] chloride), a radiopharmaceutical precursor, was recommended for the radiolabelling of carrier medicines that have been specifically developed and authorised for radiolabelling with lutetium chloride. It is not intended for direct use in patients.

Medicine 105

Medicine Marketing Patients Safety 105

European Pharmaceutical Review

MARCH 6, 2023

PAH is a rare, progressive blood vessel disorder that can lead to right heart failure. The safety profile of M/T STCT was consistent with the known safety profiles of macitentan and tadalafil monotherapies and no new safety observations were made.

Safety 96

Safety Patients Pharmaceutical Medicine 96

European Pharmaceutical Review

FEBRUARY 7, 2023

The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-A501, an adeno-associated virus (AAV)-based gene therapy for Danon disease. “RP-A501 Ultimately, this leads to heart failure and can be fatal for male patients.

Food and Drug Administration 105

Food and Drug Administration FDA Medicine Food 105

Pharmaceutical Technology

APRIL 4, 2023

The CLIMB-111 and CLIMB-121 trials are designed to evaluate the efficacy and safety of a single exa-cel dose in TDT or SCD patients aged 12 to 35 years. The US FDA granted regenerative medicine advanced therapy (RMAT), orphan drug, fast track, and rare paediatric disease designations to exa-cel for the treatment of SCD and TDT.

Food and Drug Administration 98

Food and Drug Administration FDA Medicine Pharmaceutical 98

Pharmaceutical Technology

SEPTEMBER 8, 2022

The expert services rendered by them help in improving patient outcomes, minimising costs of the healthcare system, improving medicinal adherence and persistency and saving clinicians’ time. Patient monitoring for safety and efficacy. The post Leading speciality pharmacies in pharma appeared first on Pharmaceutical Technology.

Specialization 45

Specialization Leads Pharma Side effects 45

European Pharmaceutical Review

JULY 25, 2022

As the world now looks to a post-pandemic future, despite the counterfeit medicine trade showing no signs of slowing, industry bodies must come together to tackle the production and trade of fake products. There is also the challenge of falsified medicines – the fake, unauthorised medical products that make their way into the market.

Pharmaceutical 104

Pharmaceutical Medicine Manufacturing Pharmaceutical manufacturing 104