United States FDA gets serious about biosimilars

The most significant advances in medical treatments are being made with biological products.  As biological medicines are significantly more expensive than traditional small molecule drugs, upward pressure is being placed on health spending. For example, in the United States, biological medicines accounted for 40% of all prescription drugs spending and 70% of the increase in read more...
Subjects: Patents

The future is now: Gene therapy lands in the United States

The United States Food and Drug Authority (FDA) has just given the green light to America’s first ever gene therapy treatment. It’s called Kymriah and it’s a genetically-modified autologous T-cell immunotherapy (CAR-T cell therapy).  For the layman: individually customised, cancer-killing white blood cells. This is why it’s a big deal, and what the future could read more...
Subjects: Patents

US Food and Drug Administration releases draft guidances about social media and online communications

On 17 June 2014, the United States’ Food and Drug Administration (FDA) released two draft guidances relating to the promotion of prescription drugs or medical devices online or on social media. Designed with patients in mind, the FDA is aware that patients and health care providers often get information about FDA-regulated products through social media read more...