European Pharmaceutical Review

MAY 22, 2024

The agencies holding this status have been approved and validated as compliant and committed to upholding the “highest level of regulatory standards and practices for quality, safety and efficacy of medicines and vaccines ”.

Vaccines 69

Vaccines FDA 69

Pharmaceutical Technology

NOVEMBER 9, 2022

In August 2020, the agency had rejected an approval application, suggesting the company complete its Phase III Gener8-1 study and include two-year follow-up safety and efficacy data. In the EU however, two years later, the European Commission awarded a conditional marketing authorisation for Roctavian. million price tag.

FDA 111

FDA 111

pharmaphorum

JANUARY 21, 2022

Access to medicines is “one of the most challenging policy areas in every country in the European region” – it’s time to develop a solution that works for everyone. Balancing the incentivisation of innovation against affordable access to revolutionary new medicines is an age-old conundrum in the biopharmaceutical industry.

Insurance 52

Insurance Vaccines 52

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 62

FDA Labelling 62

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.

Labelling 105

Labelling Data Entry Communication FDA 105

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.

FDA 98

FDA 98