The US Food and Drug Administration has issued a ‘complete response letter’ to Biodel Inc of Danbury, Connecticut rejecting its new drug application for Linjeta, a rapid-acting injectable regular human insulin for Types 1 and 2 diabetes.
Researchers from the Institute for Regenerative Medicine at Wake Forest University’s Baptist Medical Center have seeded human liver cells in a laboratory and reportedly maintained them in a specialised bioreactor for up to one week.
The US Food and Drug Administration has approved the Novartis cancer drug, Afinitor (everolimus), for a new indication which is to treat patients with a benign brain tumour but who are not candidates for surgery.
MorphoSys AG increased its proprietary research and development spending by 40% in the first nine months of 2010 – an indicator of the growing importance of its portfolio of internally-generated therapeutic antibodies.
Financial results from Sanofi-Aventis for the third quarter and first nine months indicate that the French pharmaceutical company’s strategy of diversifying into developing countries while cutting costs is working well.
The US Food and Drug Administration has approved a new indication for the cancer drug, Sprycel (dasatinib), enabling it to be administered to patients with a rare blood cancer when it is first diagnosed.
Novo Nordisk A/S, the Danish specialist in diabetes products, raised its guidance for 2010 sales and earnings following strong results for the third quarter.
Despite revenue and profit declines in the 2010 third quarter, AstraZeneca Plc has confirmed that core earnings per share for the year as a whole should show an increase from 2009. Restructuring and legal costs depressed the Q3 results.
The UK drug-device company, Biocompatibles International Plc, is in advanced talks with another party which may or may not lead to an offer being made for the company. The talks were disclosed on 28 October to the London Stock Exchange.
Index Ventures, the Geneva-based venture capital company, is providing the initial funding of €1.5 million for a company that has been set up to exploit a new technology for treating serious brain diseases.