News

FDA Panel backs Ocriplasmin
Enlarge image

BusinessBelgium

FDA Panel backs Ocriplasmin

30.07.2012 - Nail-biter with Happy End: An expert panel of the FDA has backed Belgian Thrombogenics eye disease drug Ocriplasmin.

FDA advisors ruled on July 26 that Ocriplasmin helped enough people in clinical trials to warrant a favourable review. The injectable drug is a truncated form of the human serine protease plasmin which retains its enzymatic properties. It’s used for the treatment of symptomatic vitreomacular adhesion, which occurs when vitreous gel detaches at the back of the eye but adheres to the retina as it pulls away, distorting vision and causing small breaks to develop in the macula.

The panel decided in an 6-3 split decision, that  there is no need for additional studies despite evidence of adverse effects including eye pain, swelling and impaired vision. Nevertheless, Michael Repka, Chairman of the panel said, that post-market studies on this topic „would be nice“, reported Bloomberg.

A regulatory review published a day before the panel’s decision has sent the drugmaker’s stock price rollercoasting. A warning on serious adverse events in the report sent down the quotation by 19% at NYSE Euronext in Brussels. The Belgian Biotech Company tried to pour oil on troubled waters. "We have evidence that these things are all transient. There is nothing that is really sustained. Of course, we will address this during the discussion," ThromboGenics CFO Chris Buyse told Reuters. On July 27, the first day after the panel’s favourable decision, stock quotes raised by 13% to 26.37 Euro.

ThromboGenics, based in Heverlee, has already sold rights to the drug outside the U.S. to Swiss drugmaker Novartis AG. Its Alcon unit paid $99m upfront and promised close to $400m more in milestones to gain the rights to commercialise the drug.

http://www.european-biotechnology-news.com/news/news/2012-03/fda-panel-backs-ocriplasmin.html

R&DUKIreland

12.02.2016 The promise of the microbiome as the basis of new treatments has caught the attention of many. Now, UK biotherapeutics maker 4D pharma plc has padded its microbiome pipeline with the acquisition of Irish Tucana Health.

CommercialisationEU

10.02.2016 In future, meds will come in packages sporting a unique barcode and an anti-tampering device. These measures are part of the EU’s new regulation to safeguard against falsified medicines.

Clinical ResearchFrancePortugalEU

05.02.2016 It is not yet clear why a man died during a first-in-man clinical trial in January. A preliminary report found several “major shortcomings” by responsible CRO Biotrial. However, all regulations were complied with.

M&ASwitzerland

04.02.2016 After having dodged multiple takeover attempts by Monsanto last year, agrobusiness giant Syngenta has now agreed to be acquired by chemical corporation ChemChina. The Swiss company also announced plans to go public within a few years.

FinancingEUUKBelgium

01.02.2016 Newly formed Medicxi Ventures, a life sciences-dedicated VC firm based in London, Geneva and Jersey, has closed a €210m investment fund to reinvest in European early-stage assets.

ResearchUKEU

01.02.2016 Altering human DNA with the efficient gene editing method CRISPR/Cas9, especially germline modifications, was long considered a taboo. Now, however, UK scientists have received official approval to tinker with embryo DNA.

M&ASwedenIceland

28.01.2016 Swedish infectious disease specialist Enzymatica has bagged Icelandic company Zymetech, who produces the patent-protected enzyme used in Enzymatica’s own common cold blocker ColdZyme.

R&DUK

27.01.2016 Three UK universities have teamed up with three pharma companies to create the Apollo Therapeutics Fund. With the tech transfer fund, the consortium aims to develop scientific research into medicines.

Clinical TrialsGermany

25.01.2016 Affimed means to put a promising drug combination to the test. With support from MSD, the German biopharma will carry out clinical trials for an immunotherapy combining treatments of both companies.

AMREU

21.01.2016 Stop squandering antibiotics and make research profitable again: at the World Economic Forum in Swiss Davos, 83 pharmaceutical companies have called for a unified approach towards the threat of antimicrobial resistance.

Quick news provided by GlobeNewswire

View more stock news

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • PAION (D)1.77 EUR63.89%
  • 4SC (D)2.95 EUR11.32%
  • BIONOR PHARMA (N)0.86 NOK8.86%

FLOP

  • STENTYS (F)2.83 EUR-26.30%
  • BIOTIE THERAPEUTICS (FI)0.14 EUR-22.22%
  • KARO BIO (S)24.60 SEK-16.04%

TOP

  • VERONA PHARMA (UK)3.40 GBP23.6%
  • IXICO (UK)35.75 GBP21.2%
  • SERODUS (N)2.71 NOK15.8%

FLOP

  • STENTYS (F)2.83 EUR-49.0%
  • BIONOR PHARMA (N)0.86 NOK-46.2%
  • MOLMED (I)0.24 EUR-35.1%

TOP

  • CHRONTECH PHARMA (S)0.34 SEK3300.0%
  • KARO BIO (S)24.60 SEK3053.8%
  • 4SC (D)2.95 EUR243.0%

FLOP

  • NEUROVIVE PHARMACEUTICAL AB (S)8.65 SEK-86.0%
  • BIOTEST (D)13.79 EUR-85.3%
  • EVOCUTIS (UK)0.08 GBP-69.2%

No liability assumed, Date: 12.02.2016