Paion AG, which has pursued diversification in its drug development, is now opting for concentration, putting its efforts behind anaesthesia, and the drug candidate, remimazolam, a short-acting sedative that is ready to go into Phase 3 trials.
Alkermes Pharma Ireland Ltd has withdrawn its marketing authorisation application from the European Medicines Agency for the drug, megestrol, which was intended to be used to treat unexplained weight loss in patients with AIDS and cancer.
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.