GSK withdraws Tykerb application from the FDA
GlaxoSmithKline Plc announced that it has withdrawn an application from the US Food and Drug Administration for a new indication for its marketed cancer drug, Tykerb (lapatinib), a kinase inhibitor.
GlaxoSmithKline Plc announced that it has withdrawn an application from the US Food and Drug Administration for a new indication for its marketed cancer drug, Tykerb (lapatinib), a kinase inhibitor.
Actelion Ltd, the Swiss specialist in pulmonary arterial hypertension (PAH), said that will eliminate up to 135 research and administrative positions, mostly at its headquarters near Basel, in order to ensure that it has sufficient capital to maintain its PAH franchise.
Silence Therapeutics Plc has secured commitments from existing and new shareholders to raise up to £5.7 million (gross), extending its cash runway and enabling it to complete a second clinical trial of an RNAi treatment for solid tumours.
Genkyotex SA has raised CHF25 million (€20.8 million) in new money from its venture capital backers after showing promising data from a Phase 1 trial of a new class of molecules that inhibit enzymes implicated in oxidative stress. The funding was announced on 9 July.
The US Food and Drug Administration has approved the first genetic test that will detect whether patients with colorectal cancer are eligible for treatment with the antibody drug, Erbitux (cetuximab). The test was developed by Qiagen NV.
Wilex AG has elected to receive a final cash payment from Prometheus Laboratories Inc (Nestle SA) in connection with the out-licensing in 2011 of its cancer product Rencarex (girentuximab). The product is in a Phase 3 registration trial.
Oxford BioMedica Plc is about to extend its cash runway thanks to a decision by its pharmaceutical partner, Sanofi SA, to in-license two gene-based ophthalmology products. The decision enabled the company to ask its institutional investors for more support. And they have responded with a commitment to provide £11 million for additional working capital.
The US Food and Drug Administration has approved the first DNA test to help healthcare professionals evaluate the progress of anti-viral treatment in solid organ transplant patients undergoing cytomegalovirus (CMV) antiviral therapy.
Venture-capital backed Prosonix Ltd has entered into a research agreement with Imperial College London to accelerate development of technology that is intended to improve the delivery of respiratory medicines. Financial terms weren’t disclosed.
The US Food and Drug Administration has approved the first over-the-counter, self-administered test to detect the presence of antibodies to the human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2).