The US Food and Drug Administration has issued a final rule that clarifies what safety information must be reported by the developers of new investigational drugs and biologics during the clinical trials of these products.
Agennix AG of Germany has raised €76 million in a rights issue in order to support the Phase 3 development of its lead product for non-small cell lung cancer, talactoferrin, and other programmes.
H. Lundbeck A/S has changed its approach for researching new medicines by focusing on three areas of biology, rather than specific CNS indications. These areas are neurodegeneration, neuroinflammation and synaptic transmission.
Bavarian Nordic A/S has reorganised its vaccine business into two divisions and consolidated its management in order to deliver on two near-term targets: secure new US orders for its smallpox vaccine and advance its prostate cancer vaccine to Phase 3.
Privately-owned Okairos AG of Switzerland has raised €16 million in a Series B financing round to support development of its portfolio of T-cell vaccines against a range of infectious diseases. The round was led by Versant Ventures of the US.
In separate announcements, AstraZeneca Plc and Pfizer Inc said that trials of their respective treatments for prostate cancer, zibotentan and sunitinib malate, failed to show efficacy at Phase 3. Neither study threw up any unexpected safety issues.
Scientists at the Medical Research Council in the UK have identified a gene that they say plays a key role in the development of the central nervous system. The gene, Sox9, regulates the transformation of neuroepithelial cells into stem cells.
Sanofi Pasteur will pay $55 million upfront to acquire privately-owned, VaxDesign, which develops in vitro models of the human immune system. There is an additional $5 million payment linked to the achievement of certain, undisclosed goals.
The two-year-old Netherlands-based company, arGEN-X BV, has received a €1.5 million grant to accelerate preclinical development of an antibody that targets interleukin 6 (IL-6), a cytokine that plays a role in autoimmune indications.
The US Food and Drug Administration has approved a new combination oral contraceptive from Bayer Schering Pharma AG that contains a folate (levomefolate calcium), in order to protect against neural tube defects during a pregnancy.