The US Food and Drug Administration has approved Lucentis (ranibizumab injection) for the new indication of diabetic macular edema, an eye disease that can occur in people with diabetes. The developer is Genentech (Roche).
Roche said that its angiogenesis inhibitor, Avastin (bevacizumab), has shown a significant improvement in progression-free survival in newly diagnosed glioblastoma when added to radiation and temozolomide. Overall survival data are expected in 2013.
4SC AG has been taking scientific advice from regulators about the design of a prospective Phase 3 study of its HDAC inhibitor for liver cancer, resminostat. Pending the conclusion of a partnership, a study could start in the 2013 first half, according to management.
Amgen has stopped a Phase 3 trial of its monoclonal antibody for metastatic pancreatic cancer after the independent data monitoring committee concluded the drug was unlikely to show improved overall survival compared with gemcitabine.
Novo Nordisk A/S, which now claims 25% of the global diabetes market, posted a 17% gain in sales to DKK 37.2 billion (€5 billion) in the 2012 first half year, powered by a 20% increase in local currency sales of synthetic insulins and an 82% rise in sales of Victoza (liraglutide), a glucagon-like peptide-1 analog for Type-2 diabetes.
Paion AG has given further details of its new strategy for growth which will focus on developing and distributing specialised products in anaesthesia. This follows the sale of all remaining rights to desmoteplase, the candidate stroke product that was its lead asset.
H. Lundbeck A/S reported a slump in sales and a loss in the second quarter because of higher marketing costs, generic competition and a charge for dismissing personnel. However, the Danish company is renewing its portfolio to secure long-term growth.
A second experimental treatment for severe sepsis, a significant area of unmet medical need, has been discontinued following the failure of a proof-of-concept trail. AstraZeneca Plc has stopped development of AZD9773, an anti-TNF-alpha antibody fragment.
Evotec AG has confirmed plans to invest more than €10 million in new technology this year in order to expand the range of services it offers its pharmaceutical partners. The expansion in capacity is expected to be largely financed from cash generated from the business- leaving liquidity at year-end above €60 million.
Agennix AG is set to restructure after the surprise failure of a Phase 3 trial of its lead product for non-small cell lung cancer, talactoferrin alfa (talactoferrin). The trial did not meet its primary endpoint of improving overall survival, despite promising earlier data.