AstraZeneca Plc has filed a lawsuit against the US Food and Drug Administration seeking to overturn the agency’s decision to deny the company’s petition to withhold approval of generic versions of its antipsychotic, Seroquel (quetiapine).
Circassia Ltd of the UK has completed a Phase 2 study of its T-cell vaccine for ragweed allergy showing a significant reduction in symptoms, the company said. The company is backed by venture capital with Imperial Innovations holding 18.4%.
Basilea Pharmaceutica Ltd of Switzerland said that its Phase 3 US trial for the investigational compound alitretinoin for severe chronic hand eczema achieved ‘clear’ or ‘almost clear’ hands for 40% of patients, thus meeting the trial’s primary endpoint.
Ablynx NV is exploring all options for its rheumatoid arthritis compound, ATN-103, which was returned to the company by Pfizer in late 2011 only months after it had achieved proof-of-concept in a Phase 2 clinical trial.
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.