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

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.

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Gene Therapy FDA Approval Gene Clinical Trials 95

pharmaphorum

JUNE 12, 2022

Beti-cel has already been approved for marketing in Europe as Zynteglo, with a price tag of around $1.8 million for each one-shot therapy, but bluebird decided to take it off the market and exit the EU market altogether, blaming reluctance by payers to fund treatment. Eli-cel was also previously approved in Europe as Skysona.

Gene Therapy 58

Gene Therapy Gene Marketing Trials 58

The Pharma Data

JANUARY 31, 2021

Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. About Trimer-Tag© Technology. Trimer-Tag© is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins. —- End —-.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

pharmaphorum

APRIL 20, 2021

NICE’s final appraisal document for Kesimpta will be followed by technology appraisal guidance (TAG) that will pave the way for NHS prescribing in England and Wales. The Scottish Medicines Consortium is expected to publish its final advice on the drug later this year.

Sales 110

Sales Medicine Drugs Marketing 110

XTalks

JUNE 28, 2023

million price tag of Elevidys, a one-time gene therapy. It is injected into a patient’s muscle tissue. It has taken Sarepta six years to develop Elevidys with several roadblocks in its journey, including two clinical holds due to safety concerns. In a media call, Sarepta CEO Douglas Ingram revealed the $3.2

Gene Therapy 98

Gene Therapy Gene Protein FDA Approval 98

pharmaphorum

APRIL 14, 2022

million price tag. 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 The FDA is currently reviewing beti-cel – also known as Zynteglo (betibeglogene autotemcel) – as a treatment for patients with beta thalassaemia who require regular blood transfusions.

Gene Therapy 63

Gene Therapy Gene Marketing Clinical Trials 63

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.

Medicine 52

Medicine Marketing Manufacturing Production 52

The Pharma Data

JANUARY 31, 2021

Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. About Trimer-Tag© Technology. Trimer-Tag© is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins.

Vaccination 52

Vaccination Vaccine Trials Protein 52

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, This includes the US, Canada and the EU. 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

pharmaphorum

JUNE 2, 2021

Evrysdi was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) on 20 May, almost two months after the drug go the go-ahead in the EU. million price tag make it is the most expensive treatment ever approved for NHS funding, as it provides “exceptional benefit” to babies with the disease.

Gene Therapy 52

Gene Therapy Gene Drugs Medicine 52

Delveinsight

FEBRUARY 9, 2021

Breyanzi will come with a price tag of USD 410,300 wholesale price, said the company, justifying it after taking into consideration several factors including medical and clinical value, patient value, and societal value.

FDA Approval 52

FDA Approval Marketing Research Protein 52

Pharmacy Checkers

JANUARY 30, 2020

Tagged the “pharma bro” for the cavalier attitude he fronted about his greed, Martin is actually currently behind bars. That would not include GlaxoSmithKline’s really cheap Daraprim from the EU. Martin Shkreli, who became famous overnight back in 2015 for raising the price of Daraprim 5000%, is back in the headlines.

Drugs 54

Drugs Generic Drugs Cosmetics FDA Approval 54

The Pharma Data

MAY 5, 2021

AbbVie’s Humira regains top pharma TV spender spot, while sibling brands Rinvoq and Skyrizi tag along ( Fierce ). The new EU AI regulation proposal, medical devices and IVDs ( Medicaldeviceslegal ). The new EU AI regulation proposal, medical devices and IVDs ( Medicaldeviceslegal ).

Vaccination 52

Vaccination Vaccine Gene Therapy Contract Packaging 52

pharmaphorum

AUGUST 26, 2022

BioMarin will no doubt have an eye on the earlier experience of bluebird bio, which secured EU approval for rare disease gene therapy Zynteglo (betibeglogene autotemcel) in 2019 for beta thalassaemia with a price tag of around €1.6 million spread over five years.

Gene Therapy 110

Gene Therapy Gene Antibody Marketing 110

pharmaphorum

DECEMBER 2, 2020

It has also been highly critical of parallel trade, and has been one of those militating for a pharmaceutical repackaging ban in the EU. For all the latest Pfizer news follow pharmaphorum’s Pfizer tag. The post A history of Pfizer appeared first on.

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Sales Production Drugs Marketing 128

pharmaphorum

MARCH 27, 2022

Johnson & Johnson is in course for approval of its multiple myeloma CAR-T therapy Carvykti in the EU the next few weeks, after getting a green light from the EMA’s human medicines committee. In the US, Abecma has a list price of around $420,00, while J&J has set its therapy a little higher at $465,000.

Antibody 94

Antibody Clinical Trials Clinical Trials Sales 94

pharmaphorum

NOVEMBER 19, 2021

Indeed, the price tags for Pfizer’s and Moderna’s jabs are substantial. in the EU, with Moderna charging $30 and $36 for two shots respectively. The market potential for any vaccine currently in trials is lower because the only markets really are the developing countries, which can’t pay the same prices.”.

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Sales Vaccination Vaccine Marketing 136

The Pharma Data

MAY 4, 2021

In February 2021, Pfizer and BioNTech announced an agreement with the European Commission (EC) to supply an additional 200 million doses of BNT162b2 to the 27 EU member states. First-quarter 2021 operational growth was primarily driven by: BNT162b2, which contributed $3.5 in December 2019; and. government to 300 million. Source: Pfizer Inc.

Vaccination 40

Vaccination Vaccine Production Sales 40