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

FinancingUK

29.10.2014 British VC fundraiser Advent Life Sciences has raised €184m with its second fund. The money will help seed and build life sciences companies in the UK, Europe and the US, the company said.

BusinessSwitzerlandGermanyUK

28.10.2014 Swiss pharma company Novartis is selling its influenza vaccines business to Australian biopharma specialist CSL Ltd for US$275m.

PoliticsSwitzerland

23.10.2014 Just one day before its planned initial listing, Swiss Molecular Partners has cancelled its IPO. The reason: "unfavourable market conditions".

PoliticsEU

23.10.2014 Jean-Claude Juncker can breathe a sigh of relief as MEPs voted “yes” by a large majority to his team of European Union Commissioners. Previous to the vote, Juncker had shifted the EMA back to the health commissioner in response to protests.

FinancingFrance

21.10.2014 Yet another European company is looking for money on the US stock exchange – French DBV Technologies SA is all set up for its secondary listing on NASDAQ. The French biotech company hopes to rake in US$98m for its peanut allergy patches.

FinancingDenmark

18.10.2014 After raising US$220.5m (€172m) with its IPO, fast Forward Pharma’s lucky streak hits an obstacle on the road to success with shares falling 17% on its first day of trading.

M&AUKItaly

17.10.2014 Abandoned at the altar: Abbvie has dropped plans to acquire UK’s Shire following new US tax rules. This puts a stop to one of the biggest pharma mergers planned this year.

FinancingUKBelgium

15.10.2014 Bicycle Therapeutics wins €25m backing by major pharma venture capitalists for the development of a new class of oncology drugs.

FinancingGermanySwitzerlandNetherlands

13.10.2014 Biotechnology IPOs are back in fashion – German Probiodrug AG wants to raise €32m with its IPO, whilst Swiss Molecular Partners AG hopes the launch of its IPO will gain a revenue of €145m.

BusinessIreland

10.10.2014 Actavis has announced plans to merge with American pharma company Durata - a move that will strengthen their infectious diseases portfolio.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • THERAMETRICS0.08 CHF14.29%
  • CYTOS0.17 CHF13.33%
  • MORPHOSYS75.99 EUR4.89%

FLOP

  • EPIGENOMICS4.15 EUR-4.38%
  • EVONIK26.20 EUR-2.42%
  • PAION2.80 EUR-2.10%

TOP

  • BIOFRONTERA2.82 EUR28.2%
  • HBM91.50 CHF8.6%
  • EPIGENOMICS4.15 EUR8.4%

FLOP

  • MAGFORCE5.55 EUR-19.6%
  • CO.DON2.65 EUR-15.6%
  • PAION2.80 EUR-13.0%

TOP

  • SANTHERA89.00 CHF2318.5%
  • CO.DON2.65 EUR167.7%
  • WILEX2.25 EUR81.5%

FLOP

  • CYTOS0.17 CHF-95.7%
  • MERCK KGAA71.68 EUR-41.5%
  • 4SC0.98 EUR-41.0%

No liability assumed, Date: 30.10.2014