09.10.2012 - German antibody specialist Wilex AG has reached an agreement with the FDA on the further development for its Redectane diagnostic.
According to Wilex, the US regulatory authority accepted the positive vote of an expert committee regarding the clinical usefulness of the test detecting renal tumours. The FDA however demands a second Phase III trial to confirm the diagnostic performance and safety of Redectane. WILEX assumes that an approval can be expected after successful conclusion of this second trial. Originally, the FDA had suggested to run a complex clinical outcomes study to prove the value of Redectane. Dr Paul Bevan, Head of Research and Development, said “eliminating the need for an outcomes-based study – which in our opinion was not a feasible option - will enable us to move forward with our strategy as the regulatory pathway for marketing approval of this innovative imaging agent is now clear. We are delighted with the result.“
Redectane is intended to assist in the detection or exclusion of clear cell RCC during diagnostic workup of an intermediate renal mass. Wilex is already conducting preparatory work for the second trial called REDECT 2 and plans to submit the results to the FDA. German antibody specialist Wilex AG has reached an agreement with the FDA on the further development for its Redectane diagnostic. At the Frankfurt Stock Exchange, Wilex was up more than 5% on Monday.
29.08.2014 Just a week ago, Glaxosmithkline defused the WHO’s claim that an Ebola vaccine could be ready by 2015. Now, the British company’s own candidate vaccine is to be rushed to human trials with the help of funding from an international consortium.
24.08.2014 Germany's Morphosys is licensing a preclinical bi-specific antibody for the treatment of prostate cancer from Emergent Biosolutions. The US developer will rake in up to €138m for the commercialisation rights to the compound.
20.08.2014 Biopharmaceutical contract manufacturer Fujifilm Diosynth Biotechnologies is expanding its cell culture manufacturing capacity further with a new 2,000l single-use bioreactor at the company’s site in Billingham, UK.
08.08.2014 Boehringer Ingelheim is walking away from Swedish Orexo's prostaglandin inhibition project OX-MPI. Germany's largest researching pharmaceutical company had been responsible for the project's research and development since 2005.