Pharmaceutical Technology

JULY 14, 2022

Despite this high number, orphan diseases are rare by definition, affecting around one in 2,000 people as defined by the European Union. Historically, the pharmaceutical industry has failed to meet the needs of this patient population. But where does this leave patients outside of these preferred markets?

Drugs 147

Drugs Medicine Marketing Development 147

Rethinking Clinical Trials

APRIL 18, 2023

There are many hypothesized causes that may co-exist in the same patient, such as persistent virus or antigens, reactivation of other viruses, uncontrolled immune responses, damage to a wide range of organs and tissues, and injury to blood vessels and abnormal blood clotting. It’s all over the place. No, there are no signs PASC is going away.

Clinical Trials 219

Clinical Trials Clinical Trials Trials Immune Response 219

Rethinking Clinical Trials

DECEMBER 12, 2023

For the Jumpstart trial, a number of refinements were made to make it more pragmatic, including the creation of Jumpstart using EHR data rather than patient or family member surveys, delivering the intervention to clinicians only, automated population of Jumpstart guide fields, and automated Jumpstart delivery to clinicians by email.

Trials 130

Trials Medicine Clinical Trials Clinical Trials 130

pharmaphorum

OCTOBER 18, 2022

Medtech giant Beckton Dickinson (BD) has signed a deal with France’s Biocorp to use the latter’s near-field communication (NFC) tags in injectable devices. The Injay tag can confirm a complete injection and transfer that information via an NFC reader to a smartphone or tablet for review by a healthcare professional.

Drug Delivery 52

Drug Delivery Manufacturing Drugs Marketing 52

Pharmaceutical Technology

MAY 2, 2023

Immuno-oncology (IO) agents have transformed the cancer therapeutics landscape, driving long-term remissions in a subset of patients who historically had limited options. Although a subset of patients derives long-term benefits from IO therapies, a high percentage of patients still fail to respond or develop resistance to IO therapy.

Genetic Engineering 130

Genetic Engineering Antibody Clinical Trials Clinical Trials 130

Roots Analysis

MARCH 1, 2024

In order to effectively combat the problems related to counterfeit medicines, several companies have come up with innovative technologies to provide the necessary tools to manufacturers, healthcare professionals and patients to authenticate pharmaceutical products. Such technologies have been shown to have highly secured features.

Packaging 52

Packaging Packaging Production Manufacturing 52

Rethinking Clinical Trials

FEBRUARY 13, 2023

All patients could receive inhalation NO during/after surgery if considered indicated by the treatment team. The primary outcome was ventilator-free days (VFD) from start of cardiopulmonary bypass to day 28, with a number of secondary outcomes. 1,371 patients were randomized with 1,364 in the final analysis.

Trials 130

Trials Clinical Trials Clinical Trials Research 130

Rethinking Clinical Trials

MAY 19, 2023

Colwill Professor and Vice Chair Department of Family and Community Medicine University of Missouri Slides Keywords Electronic Health Record, Pragmatic Clinical Trial Key Points Patients bring patient-generated home blood pressure data into the clinical workflow. The primary outcome is blood pressure at 6 months.

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130

Rethinking Clinical Trials

OCTOBER 26, 2023

Many people do not know they have Hepatitis C (about 40% of patients). PCORnet has been an important resource by executing a query to identify the volume of HCV tests conducted by participating health systems and the number of co-infections with Hepatitis B virus. A manuscript is under development.

Clinical Research 143

Clinical Research Clinical Trials Clinical Trials Research 143

Rethinking Clinical Trials

FEBRUARY 16, 2023

ICD-Pieces studied patients with chronic kidney disease (CKD), diabetes and hypertension. The study used a patient-information sheet to inform patients about the research, how patient data would be handled, and an option to opt-out of including their data in the study. The study had a waiver of informed consent.

Clinical Trials 130

Clinical Trials Clinical Trials Medicine Trials 130

pharmaphorum

JANUARY 9, 2023

Zolgensma meanwhile is now approved in 45 countries, with over 2,500 patients treated globally across clinical trials, managed access programs, and in the commercial setting. ” Zolgensma is one of the most expensive therapies available, with a price tag of around $2.1 Pause in UK access. Pause in UK access.

Gene Therapy 119

Gene Therapy Genetics Gene Clinical Trials 119

Rethinking Clinical Trials

MARCH 6, 2024

The dietician met with the patient to share education about nutrition, portion size, recipes to make food taste good, and information via an optional diabetes self-management program. 500 patients were randomized to intervention or control groups, with a utilization of 465 and 349 participants completing the 6-month HbA1c lab sample.

Clinical Trials 143

Clinical Trials Clinical Trials Medicine Trials 143

Rethinking Clinical Trials

MARCH 1, 2023

S1800A was a Phase II randomized study of ramucirumab plus pembrolizumab versus standard of care for NSCLC patients previously treated with immunotherapy performed within the Lung-MAP platform. The study does not include tissue specimen collection, image submission, or patient-reported outcome instruments.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Packaging 130

World of DTC Marketing

SEPTEMBER 7, 2022

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. COVID-19 has not impacted the number of launches in the oncology space, as 2020 and 2021 have seen similar rates of drug launches as in 2019. ” The U.S.

Pharma Companies 210

Pharma Companies Marketing Drugs Production 210

Rethinking Clinical Trials

FEBRUARY 2, 2023

There are many choices clinicians must make for every emergency tracheal intubation for which the effect on patient outcomes is unknown. The data collector was not clinically taking care of the patient but familiar with the procedure and trained on data collection. It is an important procedure and is also challenging to research.

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130

Rethinking Clinical Trials

OCTOBER 13, 2022

There is an increasing frequency of surgical procedures and the need for anesthesia care, and the number of care transitions is increasing. The HandiCAP trial asked the question do intraoperative handovers of anesthesia care have an impact on patient outcomes? Learn more about the HandiCAP Trial. Discussion Themes.

Trials 130

Trials Clinical Trials Clinical Trials Nurses 130

Rethinking Clinical Trials

JULY 19, 2023

About 6-12 months after enrollment, patients were assessed for the primary outcome, which was the prescription of all 3 recommended therapies. of the patients ended up being prescribed all 3 therapies, and 37.9% of patients were prescribed all 3 therapies across the intervention sites. In the usual care arm sites, 14.5%

Trials 130

Trials Cardiology Medicine Nurses 130

Rethinking Clinical Trials

APRIL 13, 2023

The randomized controlled trial Effect of Nudges to Clinicians, Patients or Both to Increase Statin Prescribing published in JAMA found that the clinician nudge and the combined nudge interventions significantly increased the proportion patients prescribed a statin compared with usual care but the patient nudge had no impact.

Medicine 100

Medicine Trials Cardiology Development 100

Rethinking Clinical Trials

MAY 5, 2023

Yet, even though millions of patients have received oxygen during mechanical ventilation in clinical care for decades, the oxygen target that optimizes outcomes has been unknown. All patients in the ED and ICU were assigned together to an SpO2 target. The sample size was 2,250 patients over 36 months.

Trials 130

Trials Clinical Trials Clinical Trials Development 130

The Pharma Data

NOVEMBER 29, 2021

1.1.529 a variant of concern, named Omicron, on the advice of WHO’s Technical Advisory Group on Virus Evolution (TAG-VE). The number of people testing positive has risen in areas of South Africa affected by this variant, but epidemiologic studies are underway to understand if it is because of Omicron or other factors.

Vaccination 52

Vaccination Vaccine Genome Genomics 52

Rethinking Clinical Trials

FEBRUARY 9, 2023

This trial tested the hypothesis that the use of a platform-agnostic, EHR-embedded VTE risk model with integrated CDS would 1) increase rates of appropriate Thromboprophylaxis, and subsequently 2) reduce thromboembolism, compared to usual medical care in hospitalized, medically-ill patients.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

Rethinking Clinical Trials

SEPTEMBER 22, 2022

The Danish Nationwide Registries include the Danish Patient Registry (a registry of every inpatient and outpatient contact in the Danish free-for-all public healthcare system); the Danish Medicines Registry (a registry of every filed prescription at any pharmacy in Denmark including information on pill strength, pack size, etc.); Key Points.

Trials 130

Trials Cardiology Vaccination Vaccine 130

pharmaphorum

AUGUST 25, 2022

Johnson & Johnson has its first worldwide regulatory approval – in the EU – for Tecvayli, one of two much-anticipated bispecific antibodies the drugmaker has developed for patients with multiple myeloma. Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA.

Antibody 98

Antibody Marketing Drugs Medicine 98

pharmaphorum

OCTOBER 21, 2021

As it turned out, Aduhelm (aducanumab) made just $300,000 in the three-month period from July to September, against analysts’ estimates of $12 million, suggesting that few patients are being treated with the $56,000 a year therapy. Biogen reported $1.6 million in sales for the drug in the second quarter.

Sales 118

Sales Doctors Doctor Gene Therapy 118

XTalks

JUNE 8, 2021

Novartis’ Zolgensma (onasemnogene abeparvovec) gene therapy has been making significant strides as of late, including dosing of the first Spinal Muscular Atrophy (SMA) patient with the treatment in the UK last week. With a price tag of over $2.5 Baby Arthur: First UK Patient.

Gene Therapy 110

Gene Therapy Gene Protein Trials 110

Rethinking Clinical Trials

AUGUST 23, 2022

Participating organizations included FDA, NIH, academic institutions, pharmaceutical and device companies, patient advocacy groups, community groups, and data groups, and representatives from each organization had opportunity to extend invitation to others. This is an issue that a number of institutions have been thinking about for some time.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Medicine 130

XTalks

NOVEMBER 24, 2022

Hemgenix is approved for patients who currently use factor IX prophylaxis therapy or have serious hemorrhage or spontaneous bleeding episodes. The prevalence of Hemophilia B in the population is around one in 40,000 and 15 percent of patients with hemophilia have the B type. Hemophilia B primarily affects men.

Gene Therapy 52

Gene Therapy Gene FDA Approval Genetics 52

pharmaphorum

SEPTEMBER 15, 2020

As pharmaceutical marketers prepare their brands for the future, there are a number of important ways they can learn from digitally-native brands. As part of this, a number of big pharma companies are also racing to develop a safe and effective vaccine for the coronavirus. Jeremy Richter, Tag. About the interviewees.

Branding 114

Branding Marketing Pharma Companies Life Science 114

XTalks

SEPTEMBER 27, 2022

About half of patients who do not receive any treatment die within five years of symptom onset. The record-breaking price tag of Skysona is not surprising for one-time gene therapies like it. Patients were also required to have a neurologic function score (NFS) of less than one, indicating limited changes in neurologic function.

FDA Approval 52

FDA Approval Gene Therapy Drugs Gene 52

pharmaphorum

JULY 25, 2022

J&J filed for approval of the bispecific in the US in December based on the results of the phase 1b MajesTEC-1 study in myeloma patients who had been treated with a median of five lines of prior therapy. Most patients diagnosed with myeloma will relapse over the course of their disease, so the disease is still considered incurable.

Antibody 52

Antibody Medicine Drugs Trials 52

XTalks

FEBRUARY 27, 2024

The US Food and Drug Administration (FDA) has approved a number of new rare disease drugs in recent years, including gene therapies. Skyclarys (omobaloxone) was approved in 2023 for the treatment of adults and pediatric patients 16 years of age and older with Friedreich’s ataxia, a rare, neurological disease​​.

Research 59

Research Drugs Gene Therapy Clinical Trials 59

Rethinking Clinical Trials

SEPTEMBER 30, 2022

To be eligible, patients needed to be first-time mothers aged 15 and older who met the income-eligibility criteria for Medicaid and were no more than 28-weeks gestation at enrollment. The median number of visits is 9. The control group received standard of care in South Carolina. The median home visit length was 65 minutes.

Nurses 130

Nurses Trials Clinical Trials Clinical Trials 130

pharmaphorum

AUGUST 17, 2020

In this article Joanna Carlish, managing director of financial services at Tag Americas , and Robb DeFilippis, Tag Americas’ managing director, life sciences, go head-to-head to discuss marketing within a regulated industry. Virtual connections. Engagement channels. Regulated industry learnings.

Regulation 87

Regulation Marketing Sales Branding 87

XTalks

DECEMBER 21, 2022

This included greater adoption and acceptance of decentralized clinical trial models, emphasis on patient-centric approaches in trials, growing digitization of healthcare and dealing with drug manufacturing challenges. Gene Therapy Approvals. Manufacturer: Ferring Pharmaceuticals A/S. Manufacturer: bluebird bio, Inc.

Life Science 52

Life Science Gene Therapy Gene Clinical Trials 52

XTalks

MARCH 22, 2023

Drug Development is More Expensive than Ever Before It was once the aim of big pharma to develop small molecule drugs that collected indications like Pokémon cards in order to have the broadest possible patient population that would benefit. More potential patients equal more prescriptions which equals higher sales and bigger profits.

Life Science 97

Life Science Drugs FDA Approval Vaccination 97

XTalks

APRIL 18, 2024

Conversely, a negative result suggests a low probability of amyloid pathology, guiding healthcare providers in clinical decision-making and potentially ruling out Alzheimer’s disease in symptomatic patients. million people live with Alzheimer’s disease in the US with the number of cases expected to rise to 13 million by 2050.

Clinical Trials 52

Clinical Trials Clinical Trials In-Vitro Protein 52

XTalks

FEBRUARY 27, 2024

Since the activity of TILs can be suppressed by tumor cells, TIL therapies are designed to bolster the number of TILs. Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients.” percent) patients with a partial response.

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52