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

AwardFinlandEU

27.05.2016 The Finnish Technology Academy has awarded US-American innovator Frances Arnold the 2016 Millennium Technology Prize, worth €1m. Arnold is a pioneer in the field of directed evolution.

OncologyUK

26.05.2016 BigDNA relaunches as Iceni Pharmaceuticals with the aim to develop repurposed and reformulated cancer therapies. First order of business: repurpose Merck Serono’s cilengitide as a multiple myeloma treatment.

MicrobiomeFranceDenmarkEU

24.05.2016 One of the pioneering companies developing pharmaceuticals and diagnostics based on the gut microbiome, Enterome Bioscience, has raised €14.5m in a Series C financing round. Among the investors were Seventure and Lundbeckfond as well as Nestlé.

AntibioticsEUUKItaly

20.05.2016 The long awaited global review on antimicrobial resistance by economist Lord Jim O’Neill has been published. It sets out an action plan to defeat superbugs with a huge awareness campaign and rapid diagnostics to be used before antibiotics are prescribed.

LicensingGermanyIrelandSwitzerland

18.05.2016 Bayer is deepening its involvement in CRISPR with a licensing agreement for genome editing patents. Irish partner ERS Genomics holds the rights to the CRISPR/Cas9 tech from Emmanuelle Charpentier, one of the inventors.

M&AGermany

17.05.2016 Newly rebranded Siemens Healthcare has entered the field of molecular testing for cancers with the acquisition of Cologne-based NEO New Oncology.

FinancingUK

11.05.2016 Newly spun out company OxStem has raised £16.9m (€21.5m) to develop regenerative meds for the treatment of age-related disease. It is the largest financing for an Oxford spin-out – or any UK academic spin-out – to date.

FinancingSwitzerland

09.05.2016 Swiss Genentech partner AC Immune has raised CHF42.7m (€38.6m) in order to advance its therapeutic and diagnostic product pipeline in Alzheimer’s disease. The news follows a recently announced R&D collaboration with Biogen.

FinancingSpain

04.05.2016 Barcelona-based epigenetics expert Oryzon Genomics has closed a debt funding round of €10.5m, bringing the total money raised since last year to €27m. The funds will serve to advance the company’s two LSD1 inhibitors in cancer and neurodegeneration.

Open InnovationFrance

03.05.2016 Ipsen is strengthening its ties to long-time development partner Oncodesign, a Dijon-based cancer treatment biotech. The French pharma is handing over the pre-clinical pharmacology for its oncology research programmes to Oncodesign.

Quick news provided by GlobeNewswire

View more stock news

Events

All Events

Partner-Events

Aachen

Biomedica 2016

Basel (CH)

Chemspec Europe 2016

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • BIOTIE THERAPEUTICS (FI)0.27 EUR92.86%
  • PLETHORA (UK)3.38 GBP12.67%
  • ALMIRALL (E)14.43 EUR7.93%

FLOP

  • 4SC (D)2.59 EUR-20.31%
  • NEUROVIVE PHARMACEUTICAL AB (S)5.25 SEK-4.55%
  • FORMYCON (D)20.15 EUR-4.37%

TOP

  • GALAPAGOS (B)51.86 EUR30.7%
  • NICOX (F)11.00 EUR28.7%
  • GENMAB (DK)1177.00 DKK22.2%

FLOP

  • MOBERG PHARMA (S)38.00 SEK-21.8%
  • 4SC (D)2.59 EUR-21.5%
  • FORMYCON (D)20.15 EUR-18.0%

TOP

  • KARO BIO (S)30.60 SEK1981.6%
  • CHRONTECH PHARMA (S)0.34 SEK1600.0%
  • NICOX (F)11.00 EUR491.4%

FLOP

  • NEUROVIVE PHARMACEUTICAL AB (S)5.25 SEK-89.0%
  • BB BIOTECH (D)44.03 EUR-84.5%
  • BIOTEST (D)17.15 EUR-78.1%

No liability assumed, Date: 28.05.2016