PharmaShots

FEBRUARY 3, 2023

4D Molecular Therapeutics Receives the US FDA’s IND Clearance of 4D-150 for the Treatment of Diabetic Macular Edema Date: Feb 03, 2023 | Tags: 4D Molecular Therapeutics, 4D-150, Diabetic Macular Edema, Regulatory, US, FDA, IND AstraZeneca and Amgen Receive the US FDA’s Approval of Tezspire (tezepelumab) for the Treatment of Severe Asthma (..)

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PharmaShots

JUNE 2, 2023

Impact Therapeutics Entered into a License and Collaboration Agreement with Eikon Therapeutics to Develop and Commercialize IMP1734 Date: June 02, 2023 | Tags: Impact Therapeutics, Eikon Therapeutics, IMP1734, Pharma, China, Hong Kong, Macau, Taiwan BMS’ Mavacamten Receives the NICE Recommendation for the Treatment of Obstructive Hypertrophic (..)

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PharmaShots

FEBRUARY 17, 2023

Iveric Bio Reports the US FDA Acceptance of NDA and Granted Priority Review of Avacincaptad Pegol for Geographic Atrophy Date: Feb 17, 2023 | Tags: Iveric Bio, Avacincaptad Pegol, Geographic Atrophy, Regulatory, US, FDA, NDA, Priority Review ALX Oncology Reports the First Patient Dosing of Evorpacept in the P-I Study (ASPEN-07) for the Treatment of (..)

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Viseven

MAY 24, 2023

During her speech, Viseven CEO Nataliya Andreychuk, emphasized the importance of content marketing in pharma and the related software tools and techniques, such as tagging for better navigation, content reuse with modules, and overall production optimization. The post Viseven at Reuters Pharma EU appeared first on Viseven.

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Roots Analysis

MARCH 1, 2024

Examples of such technologies include DNA Taggants (a unique DNA tag used in the product / packaging that can be scanned using a designated instrument / equipment), invisible printing technologies, digital watermark technologies and hidden markers / print technologies.

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Pharmaceutical Technology

NOVEMBER 9, 2022

In the EU however, two years later, the European Commission awarded a conditional marketing authorisation for Roctavian. Reimbursement has been a major obstacle in the EU for expensive gene therapies, including bluebird bio’s beta-thalassemia therapy Zynteglo. million price tag. million ($1.5 million ($1.8 million at the time).

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Pharmaceutical Technology

JULY 14, 2022

Centralised incentives are also in place across Europe, as well as at the national level in some EU states. Due to the high price tags associated with these speciality medicines, innovators have naturally favoured big markets with high GDP such as the US and EU-5 (Germany, France, Spain, Italy, and the UK).

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pharmaphorum

APRIL 5, 2022

It’s the first treatment for mUM in the EU, as well as the first BiTE drug to treat a solid tumour. The post Immunocore gets EU nod for TCR cancer therapy Kimmtrak appeared first on. Uveal melanoma is a rare cancer of the eye, which in the majority of patients is localised. ” Image by Pexels from Pixabay .

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pharmaphorum

NOVEMBER 19, 2021

Evrysdi was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in May, a couple of months after the drug also got a green light in the EU. million price tag make it is the most expensive treatment ever approved for NHS funding.

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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.

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Pharmaceutical Technology

DECEMBER 5, 2022

Collectively, cannabinoid receptors (CB1 and CB2) are currently the most popular targets in preclinical stage of development, with 391 drugs tagged in total. In most EU and Commonwealth countries, including the UK, New Zealand and Australia, cannabinoids are legal for medical use.

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pharmaphorum

NOVEMBER 16, 2021

“We look forward to the full technology appraisal guidance (TAG) which is due to be published in early December 2021,” he added. The drug was eventually cleared in the EU in April, with the UK giving it a green light in June.

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Documentation 96

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.

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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.

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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.

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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.

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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.

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Documentation Communication 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.

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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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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.

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PharmaShots

MARCH 9, 2023

She developed various mobile technologies and pioneered early electronic labels including NFC tags, which helped Thin Film Electronics win the Wall Street Innovation Award and the Global Technology Award. LinkedIn Total experience: 16 yrs. Present company and time period: Johnson & Johnson (13 yrs.

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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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