An antibiotic from AstraZeneca Plc is one of four new medicines to be recommended for marketing in Europe by the EMA’s Committee for Medicinal Products for Human Use. The drug, Zinforo, is a cephalosporin antibiotic.
In an unusual public rebuke, the European Medicines Agency has cited Roche for deficiencies in its medicine-safety reporting system. It has given the company until 27 June to submit a comprehensive plan for dealing with outstanding cases.
NicOx SA, which has shifted its strategy to focus on ophthalmology, is to in-license point-of-care diagnostics from Rapid Pathogen Screening Inc. The agreement, financial terms of which were not disclosed, was announced on 21 June 2012.
Venture capital-backed Heptares Therapeutics Ltd has extended a research collaboration with the UK Medical Research Council that is looking at the structure of G-protein coupled receptors (GPCRs) and other transmembrane proteins.
InDex Pharmaceuticals AB of Sweden said that data from a compassionate use programme of its experimental therapy for treating ulcerative colitis has been published in the journal, Inflammatory Bowel Diseases.
Noxxon Pharma AG has started a Phase 2a trial of an oligonucleotide-based drug for patients with diabetic nephropathy. The drug, NOX-E36, aims to bind and neutralise MCP-1, a protein that is involved in inflammation.
Bavarian Nordic A/S has received another vaccine contract from the US government, this time to develop candidate vaccine components and technologies for a combined smallpox and Marburg virus vaccine using the company’s vector technology.
Erytech Pharma SA has reported Phase 2 data for a new formulation of asparaginase, in combination with chemotherapy, showing the drug was safe and effective in older patients with acute lymphoblastic leukaemia (ALL) for whom no alternatives exist.
Wilex AG said that a Phase 2 proof-of-concept trial of its cancer therapy, Mesupron combined with capecitabine, was more effective than capecitabine alone in patients with HER2-receptor negative metastatic breast cancer.
The US Food and Drug Administration has approved a new combination vaccine for infants and children aged six weeks through 18 months for the prevention of two types of meningococcal disease and Haemophilus influenzae type b (Hib disease).