Pharmaceutical Technology

SEPTEMBER 30, 2022

After several setbacks, bluebird bio bounces back with two major FDA gene therapy approvals. Last month, Zynteglo (betibeglogene autotemcel), or beti-cel, was approved as a one-time potentially curative gene therapy for patients with beta-thalassaemia who require regular blood transfusions.

FDA 115

FDA Insurance Patients Marketing 115

pharmaphorum

AUGUST 25, 2022

The double-headed antibody binds to CD3 on T cells and redirects them to BCMA-expressing myeloma cells, with the aim of stimulating an immune attack on the tumour, which remains incurable despite a slew of new therapies reaching the market in recent years.

FDA 96

FDA Marketing Safety Patients 96

pharmaphorum

AUGUST 21, 2022

Shares in Axsome Therapeutics have rocketed on FDA approval of its depression therapy Auvelity (formerly AXS-05) – a year after its approval was held up by the regulator. In this product, bupropion is designed to increase levels of dextromethorphan in the blood and extend its half-life.

FDA 93

FDA Marketing Pharma Sales 93

pharmaphorum

JULY 25, 2022

The EMA’s human medicines committee has recommended approval of Johnson & Johnson’s Tecvayli as a fourth-line therapy for multiple myeloma , joining a growing group of BCMA-targeted therapies for the blood cancer.

Medicine 52

Medicine FDA Recruitment Patients 52

PM360

APRIL 22, 2024

In the rapidly evolving landscape of healthcare, where breakthrough therapies and treatments emerge at an unprecedented pace, conventional boundaries are rapidly shifting. Post-launch, the role of Medical Affairs groups continues to evolve, focusing on driving patient outcomes and optimizing the use of therapies in real-world settings.

Medical 52

Medical Healthcare Healthcare Education 52