Geron Corporation said it has received clearance from the Food and Drug Administration to proceed with a human trial of an embryonic stem cell-based therapy in patients with acute spinal cord injury.
NicOx SA will be seeking a meeting with the Food and Drug Administration to discuss the agency’s refusal to approve its lead product, naproxcinod, for marketing, the company’s chief executive, Michele Garufi, told analysts in a conference call on 30 July.
The management of Wilex AG is asking shareholders not to accept an offer for the company from dievini Hopp BioTech holding GmbH. The venture capital firm was obliged to make the offer after its stake in Wilex moved above 30%.
Sanofi-Aventis managed to offset the impact of generic competition for some of its major products in the quarter and half year ended June 2010. However, it changed its guidance for profit per share at constant exchange rates.
For the second time this year, AstraZeneca Plc has raised its guidance for earnings per share in 2010 even as it anticipates a slight decline in revenue and downward pressure on prices in Europe from healthcare reforms. The Anglo-Swedish multinational also said that it is raising its target for the repurchase of its shares on the market to $2 billion, up from $1 billion, and will be paying an interim dividend of $0.70 per share.
Addex Pharmaceuticals Ltd said it is prepared to take a more opportunistic approach to out-licensing its allosteric modulator compounds- even if this means opening discussions with potential licensors for very early-stage programmes.
The antibody business of MorphoSys AG generated a substantial increase in sales and profits for the quarter and half year ended June 2010, giving it an unusual problem of how best to deploy its large cash holdings.
Merck Serono said that its new small molecule drug for relapsing-remitting multiple sclerosis, which is an oral formulation of cladribine, has been granted priority review by the FDA, which means a decision can be expected in about six months.
A cannabis medicine developed by GW Pharmaceuticals Plc for the treatment of spasticity due to multiple sclerosis has been approved by the Spanish regulator. This follows its approval in June, 2010, by the UK regulator, the MHRA.
The European Medicines Agency’s main scientific committee has recommended that Boehringer Ingelheim’s new combination pill for hypertension, Twynsta, be approved for marketing.