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.
19.11.2014 It’s not every day that a company is pushed into the top ten of its sector, but that day has come for Actavis. Christmas came early for the new pharma giant after completing a US$66bn (€53bn) takeover battle for the Botox manufacturer Allergan.
18.11.2014 Merck KGaA and US rival Pfizer have signed a immuno-oncology alliance worth billions: Merck will share the development and commercialisation of its cancer antibody with its US partner – for €2.3bn.
14.11.2014 Cosily coinciding with World Diabetes Day on 14th November, French biopharma Les Laboratories Servier has struck a US$1bn deal with US pharma Intarcia Therapeutics for the exclusive rights to Intarcia’s unprecedented therapy for type 2 diabetes.
12.11.2014 Glitz and glamour are not words often used to describe science and mathematics. But once a year, celebrities from the science and showbiz world come together at the Breakthough Prizes, a glitzy television bash that honours scientists for their achievements. French life scientist Emmanuelle Charpentier was among this year’s winners.
04.11.2014 Galecto Biotech has entered an agreement with Bristol-Myers Squibb for the acquisition of the company and its lead drug, providing the Swedish company with the potential of reaching over US$400m.