Algeta ASA said it expects to make regulatory filings in the US and Europe by mid-2012 for its radiopharmaceutical, Alpharadin, following a Phase 3 trial which showed improved survival in patients with prostate cancer and bone metastases.
Roche and its partner, ImmunoGen Inc, said Phase 2 data for their antibody-drug conjugate, T-DM1, in patients with metastatic breast cancer showed better progression-free survival than those on trastuzumab and chemotherapy.
The Japanese regulatory authority has approved Faslodex (fulvestrant), an oestrogen receptor antagonist, for metastatic breast cancer which has recurred or progressed following prior endocrine therapy, according to the developer, AstraZeneca Plc.
Scientists from the Roche group have reported generating the first draft genome sequence of the cynomolgus monkey, Macaca fascicularis, the most frequently used nonhuman primate in drug safety studies.
The US Food and Drug Administration has approved the tumour necrosis factor blocker, Remicade (infliximab), for the treatment of ulcerative colitis in children older than six years who have had inadequate response to conventional therapy.
The US Food and Drug Administration has issued a ‘complete response letter’ to GlaxoSmithKline Plc, effectively rejecting its application to market a new combination vaccine for children against three types of bacteria.
The European Medicines Agency is recommending approval of a new macrocyclic antibiotic for Clostridium difficile, Dificlir (fidaxomicin). Developed by Optimer Pharmaceuticals Inc, the antibiotic was approved by the FDA in May 2011.
Sinclair IS Pharma Plc, which was created through the merger of two UK speciality pharmaceutical companies, has ended its 2011 financial year with a pre-tax loss, but a rise in like-for-like sales and plans for several product launches.
Privately-held NovImmune SA of Geneva, Switzerland has announced the start of a proof-of-concept study of a monoclonal antibody intended to neutralise the activity of the chemokine, IP-10, in order to treat patients with primary biliary cirrhosis.
Anticipating the start of Phase 3 trials of a stem-cell therapy for heart failure, Cardio3 BioSciences SA has set up a US subsidiary in Rochester, Minnesota, the home of its minority shareholder – the Mayo Clinic. The trials are set to begin in 2012.