The European Commission has released its long-awaited revisions to the EU Clinical Trials Directive recommending that the procedures for getting approval for multi-state clinical trials be simplified and the supervision of trials strengthened.
The US Food and Drug Administration has approved a new use for the Gilead Sciences, Inc antiretroviral drug, Truvada (emtricitabine and tenofovir disoproxil fumarate), for use in individuals who are at high risk of HIV infection.
GlaxoSmithKline Plc has reached agreement to acquire Human Genome Sciences Inc following an increase in its per share offer to $14.25, up from $13 per share.
David Brennan has decided to waive a bonus payment for 2012 following his decision to retire as chief executive of AstraZeneca Plc effective 1 June. He did, however, receive a lump sum payment in lieu of his contractual notice, according to the company.
Edmond de Rothschild Investment Partners has launched a new fund to invest in life science companies in France and in Europe. Called BioDiscovery 4, the fund raised €125 million at its first closing. It is expected to achieve €200 million by year end.
Some 300 clinical trials are underway in Europe testing prospective cell, gene and tissue-engineered therapies. Known as advanced therapy medicinal products (ATMPs), these medicines are being investigated for a broad range of diseases- from macular degeneration to Parkinson’s disease.
Genmab A/S has secured a third commercial deal involving its new bispecific antibody technology, this time with Janssen Biotech Inc (Johnson & Johnson). The deal includes a $3.5 million upfront payment and milestones of $175 million.
Wilex AG, which is developing an antibody treatment and diagnostic for renal cancer, reported gross revenue of about €8.3 million for the fiscal half-year ended in 31 May 2012, up from about €2 million a year earlier.
GlaxoSmithKline Plc announced that it has withdrawn an application from the US Food and Drug Administration for a new indication for its marketed cancer drug, Tykerb (lapatinib), a kinase inhibitor.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.