NicOx SA’s candidate product for osteoarthritis, naproxcinod, has failed to get the support of a joint US Food and Drug Administration advisory committee which said the French’s company’s new drug application needs more data.
SkyePharma Plc said that it has applied to have its asthma treatment, Flutiform, approved for marketing in Europe, while preparations are underway to test the drug in Phase 3 trials in Japan. The UK company gave the product update on 12 May 2010.
Galapagos NV said that it has expanded a risk-sharing deal with Roche aimed at discovering new therapies against chronic obstructive pulmonary disease (COPD) to increase the number of targets for antibody drugs. The deal dates from January 2010.
CureVac GmbH, which is developing therapeutic vaccines against cancer, has raised €27.6 million from dievini Hopp BioTech holding GmbH, the investment company of Dietmar Hopp. The company has a compound for prostate cancer in Phase 2a.
More embryonic stem cell lines approved for US funding
Algeta ASA is expanding the clinical development programme for its radiopharmaceutical, Alpharadin (radium 223 chloride), to see if the product can be used for bone metastases from breast cancer as well as those from prostate cancer.
The US Food and Drug Administration has approved a new combination hormonal tablet for use as an oral contraceptive. The drug, Natazia (estradiol valerate and estradiol valerate/dienogest), is manufactured by the US division of Bayer AG.
Ark Therapeutics Group Plc and SkyePharma Plc have announced the resignations of their chief executive officers. The departures come after both companies encountered regulatory obstacles for their lead drugs.
The US National Institutes of Health have awarded $3.4 million to GlycoVaxyn AG of Switzerland and a researcher at the Harvard Medical School to carry out preclinical work on a new S. aureus vaccine for hospital-acquired infections.
The US Food and Drug Administration has issued its first-ever approval of a cellular immunotherapy. The product, Provenge (sipuleucel-T), is a therapeutic vaccine developed by Dendreon Corp of Seattle, Washington.