Pharmaceutical Technology

NOVEMBER 9, 2022

On November 7, the company announced that the FDA has scheduled a pre-licensure inspection of BioMarin’s manufacturing facility, and required the company to submit three-year Phase III Roctavian data in the approval application. million price tag. The post Can gene therapies for haemophilia defend their high price tags?

Gene Therapy 278

Gene Therapy Gene FDA Approval Medicine 278

Cloudbyz

JUNE 1, 2023

Record Triggers: Flow can respond to changes in Salesforce data, initiating processes when records are created or updated. They’re typically initiated by a change in record data. Integration: Salesforce Flow can integrate with external systems through callouts, giving it the ability to interact with data outside of Salesforce.

Compliance 76

Compliance Development Branding Production 76

Rethinking Clinical Trials

AUGUST 30, 2023

The team collected focus group feedback from patients and clinicians and worked with IT professionals to pull data directly from the electronic health record and design an interface that could be used by all patients. They found the dashboard easy to use and discussed the lack of patient data that made it less useful.

Trials 141

Trials Clinical Research Coordinator Medicine Clinical Trials 141

Intouch Solutions

APRIL 11, 2024

Pharmacovigilance : Early identification of adverse drug reactions, higher data integrity and faster response times. Precision engagement is a data-driven approach developed for marketing and sales needs. Some of them could be internal (CRM data and physicians profiling, etc.) So, what is precision engagement?

Compliance 52

Compliance Marketing Drugs Pharma Companies 52

XTalks

JUNE 28, 2023

The FDA said it will review the data from this trial “as quickly as possible to consider if further action, such as a revised indication or withdrawal of Elevidys, may be necessary.” million price tag of Elevidys, a one-time gene therapy. In a media call, Sarepta CEO Douglas Ingram revealed the $3.2

Gene Therapy 98

Gene Therapy Gene Protein FDA Approval 98

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

Pharmaceutical Technology

MARCH 22, 2023

The pharmaceutical industry began using radio frequency identification (RFID) tags in the early 2000s. Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. Twenty years ago, the cost of implementing RFID tags and the ecosystem (software) was much more expensive than today.

Production 264

Production Pharma Production Pharma Companies Drugs 264

pharmaphorum

NOVEMBER 27, 2022

Empowering labs with automated equipment that produces rich, traceable, and actionable data insights means pharmaceutical companies can ensure drug production runs smoothly – even under stress. Better communication with traceable data. End-to-end monitoring for maximum security. Automation can be such a solution.

Production 105

Production Manufacturing Drugs Marketing 105

Rethinking Clinical Trials

SEPTEMBER 22, 2022

Denmark also has registries tracking socioeconomic data such as income and level of education and other types of data that can be linked together for study. Denmark also has a mandatory electronic mailbox (e-BOKs) system that is required for all Danish citizens older than 18 and is linked to each citizen’s social security number.

Trials 130

Trials Cardiology Vaccination Vaccine 130

Rethinking Clinical Trials

NOVEMBER 21, 2023

Messages included PHI but the study followed the institutional security protocols that allowed the intervention to be approved. – How did the messages account for prescription dosage changes? Patients could reply with Done and the message reminders would stop. The study would then recalculate the gaps.

Clinical Trials 141

Clinical Trials Clinical Trials Trials Development 141

XTalks

AUGUST 19, 2022

Zynteglo’s hefty price tag of $2.8 Zynteglo’s approval was based on data from bluebird bio’s Phase III studies HGB-207 (Northstar-2) and HGB-212 (Northstar-3), and the long-term follow-up study LTF-303. The cells are prepared outside of the body ( ex vivo ) and then infused into the patient.

Gene Therapy 95

Gene Therapy FDA Approval Gene Clinical Trials 95

XTalks

NOVEMBER 3, 2022

The company is currently conducting a study to demonstrate Mounjaro’s weight loss effects and secured an FDA Fast Track tag in the obesity indication. The company said it hopes to complete its filing once Phase III data from its SURMOUNT-2 trial starts coming in, which it expects to be in April of next year.

Sales 98

Sales FDA Approval Production Insulin 98

pharmaphorum

MAY 17, 2021

Apellis Pharma has secured FDA approval for its complement C3 inhibitor Empaveli as a treatment for paroxysmal nocturnal hemoglobinuria (PNH) – with a label that will allow it to challenge Alexion’s established therapies directly. . billion and $1.1 billion respectively last year, although Soliris could lose patent protection next year.

Drugs 52

Drugs FDA Approval Marketing Clinical Trials 52

XTalks

DECEMBER 21, 2022

Bluebird bio is a notable mention as it secured FDA approvals for two of its gene therapies, Zynteglo and Skysona. The multi-million-dollar price tags are largely attributable to the high R&D and manufacturing costs associated with making a gene therapy, as the raw materials for producing the therapy can be expensive.

Life Science 52

Life Science Gene Therapy Gene Clinical Trials 52

XTalks

APRIL 29, 2022

According to Our World in Data , 13 percent of adults in the world are obese (classified as a body mass index [BMI] greater than 30) and 39 percent are overweight (BMI greater than 25). Wegovy had a price tag of $1,297 a month when it was first launched. Since 1975, obesity rates have almost tripled worldwide.

Trials 98

Trials Drugs FDA Approval Clinical Trials 98

Delveinsight

JULY 22, 2020

The Internet of Things is the interconnection of available medical devices, software applications and other resources to collect and exchange data to provide a reliable, efficient, and smart healthcare service to the patients. Sensors/Devices are the primary data collection point in IoT. New Insight/Data For Research.

Doctors 59

Doctors Doctor Marketing Production 59

XTalks

MARCH 22, 2023

Check out the infographic that accompanies this article for more pharmaceutical industry data, along with statistics that demonstrate Xtalks as the go-to source for professionals in the life science industry. How has Pfizer secured their spot? Click on the infographic to explore the data.

Life Science 97

Life Science Drugs FDA Approval Vaccination 97

pharmaphorum

NOVEMBER 28, 2022

Substra is the software that powered the MELLODDY platform, a collaboration in which Amgen, Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, GSK, Janssen, Merck, Novartis, and Servier all agreed to share drug discovery data — but not with each other directly, nor with Owkin. Open source is undoubtedly the future of AI research.”.

Pharma Companies 72

Pharma Companies Life Science Research Development 72

pharmaphorum

AUGUST 26, 2022

It’s a major step forward for BioMarin after its first attempt to secure approval for Roctavian in the US was knocked back, with the FDA rejecting its application in 2020 with a request for more data on the durability of its effects. BioMarin has said Roctavian will be available at a ‘net’ price of around €1.5

Gene Therapy 111

Gene Therapy Gene Antibody Marketing 111

pharmaphorum

OCTOBER 4, 2022

Central to the initiative is the aim to gather data from willing participants that can provide greater insights into cancer development and treatment over time. The Moonshot was started with three aims: to accelerate scientific discovery in cancer, foster greater collaboration between stakeholders, and to improve the sharing of cancer data.

Biobanking 105

Biobanking Clinical Trials Clinical Trials Trials 105

The Pharma Data

MAY 15, 2021

Click here to get PentagonFit Fitness Tracker at discounted price while it’s still available… All orders are protected by SSL encryption – the highest industry standard for online security from trusted vendors. At the end of the day, this data is sent to various computers which give you a detailed report to look at.

Production 52

Production Containment Medicine Vaccination 52

Drug Discovery World

OCTOBER 21, 2022

The main principle involves a well-defined light source such as that produced by lasers that excites fluorescent tags bound to the cells or particles present in a sample. Representative data for antibodies of interest from trusted manufacturers can also provide valuable information regarding fluorophore brightness and antigen expression. .

Reagent 52

Reagent Antibody Drugs Protein 52

The Pharma Data

MAY 4, 2021

Safety data from the Phase 3 study has also been collected from more than 12,000 vaccinated participants who have a follow-up time of at least six months after the second dose, demonstrating a favorable safety and tolerability profile. Safety data will also be collected during the study. Pfizer recorded $1.0 Regulatory Developments.

Vaccination 40

Vaccination Vaccine Production Sales 40