Rethinking Clinical Trials

FEBRUARY 22, 2023

In Heartline, patients will be reimbursed for effort to complete patient reported outcomes and interacting with the app. Tags #pctGR, @Collaboratory1 The post Grand Rounds February 17, 2023: The Heartline Trial: A New Paradigm in Conducting Virtual Clinical Trials (C. But for outcomes and others you can do virtually.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Nurses 130

XTalks

AUGUST 19, 2022

Zynteglo’s hefty price tag of $2.8 Zynteglo’s weighty price tag posed to be an issue in Europe, with bluebird having to pull the drug shortly after it was approved in the EU due to both issues with securing reimbursement payment plans, and manufacturing problems.

Gene Therapy 95

Gene Therapy FDA Approval Gene Clinical Trials 95

pharmaphorum

MAY 10, 2022

The FDA awarded a fast-track designation to lecanemab in December and has also given the drug breakthrough tag as a treatment for early-stage Alzheimer’s, and Biogen and Eisai will be hoping the drug can sidestep the controversy that engulfed Aduhelm from the moment it was approved.

FDA Approval 40

FDA Approval Trials Clinical Trials Clinical Trials 40

pharmaphorum

APRIL 14, 2022

million price tag. bluebird pulled it off the market last year however and retreated from the European market, saying the pricing and reimbursement environment was too hostile to make its business there viable. The gene therapy has already been approved for marketing in the EU and UK, where it was launched at a cost of around $1.7

Gene Therapy 63

Gene Therapy Gene Marketing Clinical Trials 63

pharmaphorum

AUGUST 18, 2022

The US approval comes three years after Zynteglo (betibeglogene autotemcel) was approved for the same indication in Europe, and subsequently withdrawn after bluebird concluded that it wasn’t possible to build a commercially viable business for the gene therapy as the pricing and reimbursement environment there was too “hostile.”

Gene Therapy 52

Gene Therapy FDA Approval Gene Clinical Trials 52

pharmaphorum

DECEMBER 17, 2021

Aduhelm (aducanumab) was approved by the FDA in June, but has been held back by a glacial rollout as clinicians have questioned the data on which the decision to clear the drug was based, plus a $56,000 per year price tag, which has in turn led to pushback by payers.

Trials 52

Trials Sales Marketing FDA Approval 52

XTalks

SEPTEMBER 27, 2022

The record-breaking price tag of Skysona is not surprising for one-time gene therapies like it. Case in point, bluebird had to pull both Zynteglo and Skysona and cease commercial activities in Europe after it failed to reach reimbursement agreements with local governments.

FDA Approval 52

FDA Approval Gene Therapy Drugs Gene 52

pharmaphorum

JUNE 2, 2022

And of course, in many cases, these drugs have higher than average price tags compared to the wider market which is due to the limited – or in most cases – non-existent competition within a treatment area.”. Raising questions.

Drugs 52

Drugs Sales Marketing Development 52

Pharmaceutical Technology

JANUARY 27, 2023

To qualify for a warranty reimbursement, there are three forms that must be filled out and specifically asks for multiple lab values to demonstrate patient response,” he said in an email to Pharmaceutical Technology. Furthermore, he said extracting data to validate the criteria for a warranty reimbursement could be an onerous process.

Manufacturing 130

Manufacturing Drugs Research Analyst FDA Approval 130

pharmaphorum

NOVEMBER 16, 2022

Yet, in the space of a decade, certain treatments have come along that have raised important questions over the future of treatment, reimbursement, and the value of the quality of life for patients. However, with a price tag of €1.58 How to navigate the new climate. At more than $2.1

Gene Therapy 130

Gene Therapy Gene Marketing Development 130

pharmaphorum

AUGUST 26, 2022

For now, the list price hasn’t been set and will depend on discussions with reimbursement authorities, according to the biotech. million spread over five years.

Gene Therapy 110

Gene Therapy Gene Antibody Marketing 110

XTalks

AUGUST 23, 2021

With a $56,000 price tag for a year’s worth of treatment, Aduhelm is far from the most expensive drug on the market. While the drug is likely to be covered by Medicaid, Blue Cross Blue Shield has already announced that, for the time being, it won’t reimburse patients under certain plans for the cost of aducanumab. “A

Clinical Trials 52

Clinical Trials Clinical Trials Trials Drugs 52

pharmaphorum

JUNE 15, 2021

The adoption of New Science – a unique combination of the best in science and health technology that address significant unmet patient needs – is delivering more precise and effective treatments, but often at a higher price tag, according to new research. But there is a silver lining.

Clinical Trials 90

Clinical Trials Clinical Trials Development Marketing 90

Pharmaceutical Technology

MARCH 17, 2023

On 16 March, Watt spoke at GlobalData webinar titled “Pharma [POLI]: Market Access Risk Outlook”, providing a current outlook on the pharmaceutical pricing and reimbursement environments around the world, including key reforms, risks and opportunities. GlobalData is the parent company of Pharmaceutical Technology.

Marketing 257

Marketing Drugs Research Analyst Manufacturing 257

The Pharma Data

MAY 4, 2021

federal or state legislation or regulatory action and/or policy efforts affecting, among other things, pharmaceutical product pricing, intellectual property, reimbursement or access or restrictions on U.S. The information contained on our website or any third-party website is not incorporated by reference into this earnings release.

Vaccination 40

Vaccination Vaccine Production Sales 40