Entries by Thomas Gabrielczyk

EMA recommends market approval of four biologics

The Europan Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended four biologics, among them three biosimilars, one monoclonal antibody as well as two targeted therapies for EU market authorisation.

Roche licenses Novimmune’s anti-TLR4 antibody

Roche’s US subsidiary Genentech has acquired an exclusive option to commercialise Novimmune’s TLR4 antibody NI-0101, the very first personalised approach to treat rheumatoid arthritis. The compound has already proved safety and drugability in a Phase I dose escalation trail.

Biopesticides: Of strawberries and antibodies

Over the last decade, therapeutic antibodies have fundamentally changed approaches in different areas of medicine, providing the impetus for a big leap forward in the treatment of cancers and autoimmune diseases. But could they also soon have a lasting impact on agriculture? Some pioneers predict that – in the near future – peptides, proteins and RNA will be driving markets in the fast-growing biopesticide and biostimulant sectors.

Real World Data: Beyond clinical trials

Only a small fraction of carefully selected patients are allowed to enroll in randomised controlled trials involving new compounds – the gold standard of drug assessment. But trying to acquire the most significant efficacy and safety results for a new drug is one goal, treating patients every day in hospitals or practices with it is something else entirely. Discrepancies are inevitable. Now real-world data that’s been gathered in large observational studies is attempting to close the gap between experimental, artificial study settings and clinical realities.