The US Food and Drug Administration has approved an allogeneic cell therapy- the first of its kind – to treat vascular wounds caused by surgery to treat mucogingival conditions in adults. The product, Gintuit, was developed by Organogenesis Inc of Massachusetts, US.
ThromboGenics NV of Belgium has opened a new headquarters in the US ahead of the filing of a biologics license application with the Food and Drug Administration for its treatment of an eye disorder known as symptomatic vitreomacular adhesion.
A treatment for patients with glioblastoma multiforme, the most common form of brain cancer, exceeded its primary endpoint in a Phase-2 efficacy trial, the sponsor, Apogenix GmbH of Heidelberg, announced.
Bavarian Nordic A/S, the Danish vaccine-maker, reported higher sales and a lower loss in 2011, mainly as the result of increasing deliveries of its smallpox vaccine to the US health authorities.
InDex Pharmaceuticals AB, a privately-held Swedish immunotherapy company, is starting a Phase 3 trial of Kappaproct, which has performed well in earlier tests in treating steroid-resistant ulcerative colitis patients.
Intercell AG of said in its preliminary annual report for 2011 that restructuring should lead to profitability in 2014. The Austrian vaccine producer reported a €29.3 million loss for 2011, much lower than the €255.2 million deficit in 2010.
Oxford BioMedica Plc has reduced staff, appointed a new finance director, and closed an office in the US as it conserves cash in order to support the next phase of development of its candidate gene therapies and its therapeutic vaccine for cancer, TroVax.
Patients with two common eye diseases have been safely treated with cells derived from human embryonic stem cells (hESC), the first such treatment to be carried out in humans. The results were reported on 25 February 2012 in The Lancet.
MorphoSys AG reported a 16% increase in revenue in 2011 and a 24% rise in operating profit as its pharmaceutical partners paid significant sums for access to its antibody technology platform.
UCB SA achieved its revenue and earnings targets for 2011, while declaring that a period of sustained growth lies ahead as its off-patent medicines are replaced by new proprietary products.