FDA approves first cord blood product
The US Food and Drug Administration has approved the first haematopoietic progenitor cell-cord cell therapy. Called Hemacord, the product is manufactured by the New York Blood Center Inc of New York.
The US Food and Drug Administration has approved the first haematopoietic progenitor cell-cord cell therapy. Called Hemacord, the product is manufactured by the New York Blood Center Inc of New York.
Evotec has confirmed its guidance that revenue for 2011 will grow by about 40% and revealed for the first time that orders for its drug discovery services look strong going into 2012. The company expects to end the current year with an operating profit.
Galápagos NV said that it is maintaining its full-year guidance for an operating and net profit this year subject to achieving certain unspecified research and development income. Group revenue is expected to be more than €146 million.
H. Lundbeck A/S posted a 9.8% increase in revenue to DKK 3.97 billion (€0.53 billion) in the third quarter of 2011 compared with the year-earlier period but its operating profit fell by 22% to DKK 660 million due to an exceptional charge.
Paion AG reduced its loss in the first nine months of 2011 but said that difficult conditions on the capital markets and restrained investment by the pharmaceutical industry had delayed the planned out-licensing of two products.
Merck Serono is set to pay Ablynx NV €20 million upfront as part of a new agreement to co-discover and co-develop antibody-derived therapeutic proteins against two targets in osteoarthritis. This is an expansion of an existing partnership.
The Committee for Advanced Therapies (CAT) was set up at the European Medicines Agency in 2009 in order to give expert advice on whether advanced therapy medicinal products should be approved or not. These therapies include gene and cell therapies and products engineered from human and/or animal tissue.
The first of four Phase 3 trials which are investigating a new compound as an adjunct therapy to antidepressants has failed to meet its primary endpoint, according to AstraZeneca Plc and Targacept Inc, the sponsors.
Intercell AG, the Austrian vaccine developer, reported higher revenue for the third quarter and the first nine months of 2011 and a sharply lower operating loss following a restructuring programme that involved setting new priorities for research and development.
The US Food and Drug Administration has approved Erbitux (cetuximab) for use with chemotherapy to treat patients with metastatic head and neck cancer. The drug is already approved to treat epidermal growth factor receptor-positive colon cancer.