News

Nanoparticle device to be tested in cancer patients

Country
France

A Paris-based life science company, Nanobiotix SA, has received clearance to start a Phase 1 safety study of a new nanoproduct in patients with soft-tissue sarcoma. The product has been classified as a device in Europe, but as a drug in the US.

Hypha in drug discovery deal with Ferrer Grupo

Country
United Kingdom

Hypha Discovery Ltd of the UK has entered into a discovery collaboration with Ferrer Grupo of Spain to identify new low-molecular weight natural products that could be used to treat microbial infections. Financial terms were not disclosed.

Biotie to acquire Newron for €45 million

Country
Finland

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 to make regulatory filings by mid-2012

Country
Norway

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.

Data from T-DM1 breast cancer trial released

Country
Switzerland

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.

AstraZeneca’s Faslodex approved in Japan

Country
United Kingdom

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 sequence the macaque genome

Country
Switzerland

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.

FDA approves Remicade for children

Country
United States

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.

GSK receives ‘complete response letter’ for vaccine

Country
United Kingdom

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.