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.
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.
Disregarded for decades, extracellular vesicles are now understood to be a key element in communication between cells. Discoveries around the nano-sized bubbles are revolutionising not only the field of diagnostics. With their ability to mimic stem cells, EVs could also help open the doors to novel therapeutic concepts.
For over three decades, attempts among drug developers to target the inflammatory pathways and symptoms of sepsis have been fruitless. New rapid diagnostics, rigourous patient stratification and drugs with novel modes of action are now on the horizon for treating the most costly cause of death in the industrialised world. Biotechs are pushing new ideas towards clinical testing, but there just isn’t enough funding available in the EU. Will US investors again pick up European innovation on the cheap?
Although most people still view carbon dioxide (CO2) as a climate killer, industry is beginning to realise that CO2 could actually provide an abundant, low-cost feedstock for carbon-based processes. A number of Carbon Capture and Utilisation (CCU) schemes are evaluating the many different pathways that could play a role in the field in the future.
The European Medicines Agency’s new, accelerated route to approval for innovative drugs seems to be especially attractive for biotech companies. But Health Technology Assessment institutions warn that the lack of substantial data might interfere with reimbursement.
The US has opened the floodgates to cheaper versions of biologic medicines, and analysts predict that by 2020, biosimilar protein meds could seize a significant share of a projected €390bn market. That’s good news for national health services and insurers, which stand to save billions in payouts. As expensive biologics begin to go off-patent, competitors with knockoffs are planning their onslaughts. But for biosimilars to have a future, both physicians and patients have to be sold on the idea – and many of them remain uninformed and unconvinced. The field is at a crucial juncture.
Amgen’s Imlygic was approved last year – a move that finally added oncolytic viruses (OVs) to the healthcare toolkit. Although the treatment’s scope of application as a stand-alone therapy is limited, many are viewing the event as Ground Zero for an explosive new age in medicine. Evidence is mounting that the full potential of virotherapies can only be realised in combination with other immunotherapies, chemotherapies or small-molecule therapies. A number of other European drug developers have now jumped on Amgen’s bandwagon.
Early January saw a few indicators that stock markets might deliver some solid biotech results in 2016, even if it wasn’t destined to be a hallmark year for the industry. But then, in the weeks that followed, the situation began to deteriorate. Now it looks like European biotech companies might have to start coming to terms with a closing IPO window.