The pace of consolidation within the European biotech sector quickened on 27 September as Biotie Therapies Corp of Finland announced plans to acquire Newron Pharmaceuticals SpA of Italy for €45 million, creating a group with two late-stage assets in neurology.
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.
Corporate venture capitalists increasingly are looking for early biotech investment opportunities that will support the strategic objectives of their parent companies. And they are reserving funds to support these companies until the assets in question mature. This was one conclusion from a panel discussion among venture capitalists that took place at the Sachs Investor Forum in Zurich, Switzerland on 13 September 2011.
Seven new medicines, including a new diabetes treatment, an antibiotic for C. difficile, two drugs for HIV, and combination treatments for hypertension, have received positive opinions from the European Medicines Agency.
The US Food and Drug Administration has approved the monoclonal antibody, Soliris (eculizumab), for a rare paediatric blood disorder called atypical hemolytic uremic syndrome while the EMA has recommended approval of the same indication.