Drug Discovery World

DECEMBER 20, 2022

Concerns about the high price tag have been raised in an article in Nature, particularly whether it will be affordable for low to middle-income countries. . Thank you to all for the role you have played in helping us reach this regulatory milestone in Europe.” . World’s most expensive drug.

Gene Therapy 52

Gene Therapy Gene Clinical Trials Clinical Trials 52

pharmaphorum

APRIL 20, 2021

The cost-effectiveness agency has said that anti-CD20 antibody Kesimpta (ofatumumab) can be prescribed via the NHS in England and Wales as a treatment for adults with RMS with active disease, as either a first-line therapy or after alternative drugs have been tried.

Sales 109

Sales Medicine Drugs Marketing 109

Rethinking Clinical Trials

AUGUST 23, 2022

There is a national priority to increase diversity in clinical trials, from regulatory, funding agencies, industry, and others, so that the participant population reflects the U.S. Duke University School of Medicine. Diversity, Inclusion. Key Points. population at large, which is steadily becoming more diverse. Learn more.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Medicine 130

pharmaphorum

SEPTEMBER 15, 2020

“Digitally native brands are typically agile businesses from the ground up, and agility and flexibility are part of their core makeup,” says Joe Holmes, vice president, marketing services, US at Tag. Jeremy Richter, Tag. Joe began his life at Tag in the UK, bringing efficiencies to his clients, working across all conceivable channels.

Branding 106

Branding Marketing Pharma Companies Life Science 106

Rethinking Clinical Trials

JULY 6, 2023

The European Medicines Agency (EMA) released a separate guidance around DCTs in December 2022. Additional considerations are needed for the data management plan, monitoring plan, safety plan, task log, and case report forms in the FDA draft guidance.

Trials 130

Trials Clinical Trials Clinical Trials Licensing 130

Drug Discovery World

OCTOBER 31, 2023

The UK Medicines and Healthcare Products Regulatory Agency (MHRA), Research Ethics Committee (REC), and Health Research Authority (HRA) have all approved the clinical trial application that was submitted by The University of Manchester in August 2022.

Gene Therapy 52

Gene Therapy Gene Trials Clinical Trials 52

World of DTC Marketing

JUNE 23, 2021

One agency FDA adviser, resigning from his committee post in protest, called it “probably the worst drug approval decision in recent U.S. Not to mention the $56,000 annual price tag. sales alone, which is above consensus estimates of around $7 billion to $8 billion, the team said.

Drugs 218

Drugs FDA Approval Doctors Doctor 218

pharmaphorum

NOVEMBER 16, 2021

The cost-effectiveness agency has backed Ontozry (cenobamate) as an option for treating focal onset seizures with or without secondary generalised seizures in adults with drug-resistant epilepsy that has not been adequately controlled with at least two prior antiseizure medicines. .

Drugs 87

Drugs Medicine Clinical Trials Clinical Trials 87

pharmaphorum

JUNE 12, 2022

The verdict on beti-cel is due from the agency by 19 August. Beti-cel has already been approved for marketing in Europe as Zynteglo, with a price tag of around $1.8 million price tag, saying its ability to help patients reach sustained transfusion independence justified its high price.

Gene Therapy 57

Gene Therapy Gene Marketing Trials 57

XTalks

MAY 2, 2024

Day 1 Highlights Pamela MacDonald from the Canadian Food Inspection Agency (CFIA) kicked off the conference with insights into future trends in food inspections and the value of collaborative efforts with inspectors. Read on to gain valuable insights from top industry leaders and learn more about the exciting innovations in food safety.

Compliance 108

Compliance Regulation Production Containment 108

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. Joanna Carlish, managing director, financial services, Tag Americas. Virtual connections.

Regulation 79

Regulation Marketing Sales Branding 79

pharmaphorum

NOVEMBER 19, 2020

Because Roche has never applied for Avastin to be used in wet AMD, clinics in the US have had to choose between the peace of mind offered by the regulatory process and Lucentis’ higher price tag, or the unapproved off-label formulation of Avastin at a lower price.

FDA Approval 62

FDA Approval Marketing Drugs Clinical Development 62

XTalks

JUNE 28, 2023

As such, the agency is requiring Sarepta to confirm the therapy’s clinical benefit as part of the confirmatory trial. million price tag of Elevidys, a one-time gene therapy. Additionally, the FDA said a “clinical benefit of Elevidys, including improved motor function, has not been established.”

Gene Therapy 98

Gene Therapy Gene Protein FDA Approval 98

XTalks

JANUARY 28, 2022

The company is expecting approval from the European Medicines Agency (EMA) soon as it prepares for a European launch in the second quarter of this year. Kimmtrak has a price tag of $18,760 per vial, which amounts to a weekly dose. The median treatment time is about 23 weeks (or 5.3

FDA Approval 98

FDA Approval Development Licensing Licensing 98

pharmaphorum

JANUARY 21, 2022

This evolution is leading to additional health benefits and health gains, but they are accompanied by major concerns, as very high price tags raise questions about their affordability.”. In recent years, revolutionary medicines have come with price tags to match, but this is simply a symptom of our current model. WHO is OMI?

Medicine 52

Medicine Marketing Manufacturing Production 52

XTalks

APRIL 18, 2024

According to the draft document, a reduction in amyloid levels could be used as a surrogate in clinical trials as a predictor of a drug’s potential benefits and could support an accelerated agency approval. However, the guidance doesn’t say whether it could serve as a study’s primary endpoint on its own.

Clinical Trials 52

Clinical Trials Clinical Trials In-Vitro Protein 52

XTalks

JULY 12, 2021

The US Food and Drug Administration’s (FDA) recent approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab) was met with a lot of backlash, prompting the health agency to narrow its recommendation of the drug for mild forms of the disease.

Drugs 98

Drugs Clinical Trials Clinical Trials Trials 98

pharmaphorum

NOVEMBER 24, 2022

One issue has been the cost of the drug, with health technology assessment agency NICE in the UK and the ICER organisation in the US both concluding its price tag means it is not a cost-effective option for health systems.

Trials 52

Trials Sales Drugs Marketing 52

pharmaphorum

JUNE 2, 2021

The cost-effectiveness agency’s initial assessment is that Evrysdi is simply too expensive at its current price to be provided to the roughly 1,500 people with the rare genetic disorder who might be eligible to receive it. Comments can be submitted until 23 June. — Spinal Muscular Atrophy UK (@SMA_UK_) June 2, 2021.

Gene Therapy 52

Gene Therapy Gene Drugs Medicine 52

Rethinking Clinical Trials

SEPTEMBER 22, 2022

The system is used for priority communications from government agencies, hospitals, banks, and others, and allows for rapid delivery of recruitment letters and implementation interventions. The system is used by approximately 5.8 million people, representing more than 95% of the population. Learn more. Read about DANFLU-1.

Trials 130

Trials Cardiology Vaccination Vaccine 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

XTalks

OCTOBER 26, 2021

Givlaari was approved by the European Medicines Agency (EMA) in March 2020 and by the US Food and Drug Administration ( FDA ) in 2019. The treatment came with an initial price tag of $39,000 per vial, which amounts to a total of $575,00 each year.

Gene Silencing 98

Gene Silencing Gene Clinical Trials Clinical Trials 98

XTalks

JUNE 8, 2021

With a price tag of over $2.5 Due to its high list price, both NICE and the Scottish Medicines Consortium also recommended that the NHS fund the treatment and came to an agreement with the government health agency over a confidential discount. million, Zolgensma is currently the world’s most expensive drug.

Gene Therapy 110

Gene Therapy Gene Protein Trials 110

Intouch Solutions

APRIL 11, 2024

Regulatory Acceptance: pharmaceutical companies need to ensure that AI-driven solutions are accepted and validated by regulatory agencies. This iterative process yields several benefits, including: Creating clusters of customers based on actual physician behavior. Interpretability: ensuring transparency in AI decision-making.

Compliance 52

Compliance Marketing Drugs Pharma Companies 52

Delveinsight

FEBRUARY 23, 2021

The company plans to use the capital to expand its pipeline of protein-based vaccines and biologic cancer therapies utilizing its innovative and proprietary Trimer-Tag technology platform. The company develops transformative biologics including vaccines and therapeutics for the world’s most debilitating diseases.

In-Vitro 52

In-Vitro Vaccination Vaccine Licensing 52

Pharmaceutical Technology

JUNE 21, 2023

The high price tag may be hard to defend , but with lifetime treatment costs for haemophilia B reaching as high as $23m for some, the single-dose treatment could prove far more cost-effective. Despite the limited market, the price tags of haemophilia make it potentially lucrative. Haemophilia B is a rare condition.

Gene Therapy 246

Gene Therapy Gene Protein Sales 246

pharmaphorum

MAY 24, 2021

Robb DeFilippis, managing director, life sciences, for end-to-end global creative production and sourcing partner Tag in the Americas agrees. Robb has held leadership positions at major ad agency networks including Omnicom, WPP, Publicis and IPG across sectors such as CPG, Health and Beauty, Finance, Automotive and Fashion.

Marketing 80

Marketing Branding Sales Life Science 80

XTalks

FEBRUARY 27, 2024

Despite high price tags of a couple of million dollars, gene therapy makers say they are working to ensure patients are able to access the treatments through patient assistance programs developed in conjunction with the support of governments. Sarepta hopes to clarify Elvidys’ effectiveness in older children in a confirmatory trial.

Research 59

Research Drugs Gene Therapy Clinical Trials 59

pharmaphorum

SEPTEMBER 30, 2022

Over the years, pharmaceutical companies seeking product approvals have submitted increasingly vast amounts of information to regulatory agencies. Regulatory agencies are embracing standardized review processes (such as the FDA’s KASA project) that benefit from direct data collection and incorporate review metrics.

Compliance 52

Compliance Life Science Marketing Production 52

pharmaphorum

NOVEMBER 19, 2021

Indeed, the price tags for Pfizer’s and Moderna’s jabs are substantial. Moderna also launched an awareness campaign to encourage vaccinations, featuring a website with information and links to federal agency information and other resources. Pfizer is understood to have charged $19.50 per dose in the US and €19.50

Sales 130

Sales Vaccination Vaccine Marketing 130

XTalks

NOVEMBER 27, 2021

The technical advisory group on SARS-CoV-2 virus evolution (TAG-VE) met on Friday to discuss B.1.1.529, 1.1.529, two days after it was first reported to the global health agency by South Africa. The World Health Organization (WHO) has declared the new variant of SARS-CoV-2 found in South Africa, first referred to as B.1.1.529,

Vaccination 97

Vaccination Vaccine Protein Scientist 97

XTalks

MARCH 22, 2023

The FDA even managed to approve 53 new drugs in 2020, a remarkable feat considering the challenges imposed on the agency as a result of the COVID-19 pandemic. In addition, nearly half of all new drugs launched between 2020 and 2021 came with a price tag of $150,000 per year, or more.

Life Science 97

Life Science Drugs FDA Approval Vaccination 97

The Pharma Data

MAY 5, 2021

New Scottish Agency Would Ensure Supply Of Cost-Effective Drugs ( Pink Sheet ). AbbVie’s Humira regains top pharma TV spender spot, while sibling brands Rinvoq and Skyrizi tag along ( Fierce ). . Younger people filling up COVID-19 intensive care wards in Americas, PAHO says ( Reuters ).

Vaccination 52

Vaccination Vaccine Gene Therapy Contract Packaging 52

The Pharma Data

MAY 4, 2021

In March 2021, Pfizer and BioNTech announced that the European Medicines Agency (EMA) approved storage of BNT162b2 at -25°C to -15°C for a total of two weeks based on data showing the stability at these temperatures in standard pharmaceutical freezers. Regulatory Developments. View source version on businesswire.com : [link]. Source link.

Vaccination 40

Vaccination Vaccine Production Sales 40

XTalks

FEBRUARY 14, 2023

Spending on the nutrition title alone is expected to push the price tag for the next Farm Bill to more than $1 trillion over the next ten years. Rural development: The US Department of Agriculture (USDA) is the only federal agency with the explicit mandate of deploying programs to help the development of rural areas.

Packaging 98

Packaging Packaging Production Marketing 98