News

Wilex rises after FDA agreement
Enlarge image

BusinessGermany

Wilex rises after FDA agreement

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.

© laborwelt.de/pd

http://www.european-biotechnology-news.com/news/news/2012-04/wilex-rises-after-fda-agreement.html

DiabetesFrance

01.09.2015 Sanofi is partnering up with Google’s life sciences team with an ambitious goal: to change the face of diabetes management.

M&ASwitzerlandFrance

31.08.2015 In order to boost its active cosmetic ingredients business, the Swiss flavour and fragrance giant Givaudan has acquired Volketswil-based Induchem Holding and all its subsidiaries.

BioeconomyEU

26.08.2015 In its second call for proposals, the Bio-Based Industries Joint Undertaking has earmarked €106m for the research and development of useful bio-based products.

OncologyNorway

25.08.2015 Oslo Cancer Cluster is inaugurating its NOK1bn (€107m) Innovation Park. None other than Norwegian prime minister Erna Solberg officially opened the doors to the research park on August 24th.

LicensingUKSwitzerland

21.08.2015 Novartis Pharma AG has secured all remaining rights to antibody hopeful ofatumumab. Seller GlaxoSmithKline is set to receive up to US$1bn (€919m) for the treatment for MS and other autoimmune indications.

LicensingDenmark

18.08.2015 Danish Novo Nordisk is climbing on the antibody therapeutics bandwagon in a US$500m licensing agreement with antibody-specialist Genmab.

M&ASwitzerland

13.08.2015 Roche is stepping up its commitment in the fight against drug resistant “superbugs” with its takeover of US diagnostics play Geneweave, for up to US$425m.

M&AUK

11.08.2015 Biotech bug controllers Oxitec has been bought by US biotech Intrexon Corporation for $160m (€145m). The Oxford University spin-out specialises in environmentally friendly technology to control pests such as mosquitoes, which cause dengue fever and other diseases.

Research and DevelopmentFranceGermany

07.08.2015 In a deal worth more than €300m, Sanofi has partnered up with German drug discovery and development company Evotec in order to develop beta cell-modulating diabetes therapies.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • TIGENIX (B)1.28 EUR25.49%
  • BIOTECH PHARMACON (N)14.35 NOK13.89%
  • BIOFRONTERA (D)2.25 EUR10.29%

FLOP

  • NEUROVIVE PHARMACEUTICAL AB (S)14.00 SEK-39.13%
  • BIOTIE THERAPEUTICS (FI)0.20 EUR-9.09%
  • MEDIGENE (D)7.58 EUR-5.60%

TOP

  • KARO BIO (S)39.40 SEK2378.0%
  • TRANSGENE (F)5.02 EUR74.9%
  • TIGENIX (B)1.28 EUR62.0%

FLOP

  • CHRONTECH PHARMA (S)0.01 SEK-50.0%
  • THROMBOGENICS (B)2.99 EUR-40.7%
  • BIONOR PHARMA (N)1.25 NOK-39.0%

TOP

  • KARO BIO (S)39.40 SEK4704.9%
  • ADOCIA (F)86.21 EUR408.0%
  • GALAPAGOS (B)53.99 EUR328.5%

FLOP

  • CHRONTECH PHARMA (S)0.01 SEK-85.7%
  • EVOCUTIS (UK)0.19 GBP-80.2%
  • NEUROVIVE PHARMACEUTICAL AB (S)14.00 SEK-78.5%

No liability assumed, Date: 01.09.2015