DUBLIN Ablynx NV took in €74.2 million (US$82.8 million) in an upsized share placing that adds about an extra year's cash to its balance sheet and extends its strategic options across multiple facets of the business.
DUBLIN – Even as Biomarin Pharmaceutical Inc.'s dwindling hopes for its exon-skipping pipeline in Duchenne muscular dystrophy (DMD) turned to ash this week, with the withdrawal of its marketing authorization application (MAA) for drisapersen from the EMA, there was also some positive news for DMD patients and their families.
DUBLIN – In one of the most baffling decisions the EMA has made in recent years, the agency's Committee for Human Medicinal Products (CHMP) last week issued a negative opinion in response to Takeda Pharmaceutical Co.'s application for approval of Ninlaro (ixazomib) in relapsed or refractory multiple myeloma.
DUBLIN – Xenikos BV is on track to complete recruitment in a phase I/II trial of T-Guard, a combination of two antibody-drug conjugates in development for treating steroid refractory graft-vs.-host disease (GvHD), in the coming months. The company expects to report survival data early next year, but, based on what it has seen so far, it is already contemplating a potentially pivotal phase II trial as its next step, which could lead to an application for conditional marketing authorization.
DUBLIN – Sanofi SA ratcheted up the tension in its takeover battle with Medivation Inc. by seeking to oust the Medivation board and replace it with its own slate of candidates. It disclosed Wednesday that it had filed preliminary consent solicitation materials with the Securities and Exchange Commission (SEC) in a bid to replace Medivation’s directors with what it described as “eight independent and highly-qualified candidates who are willing to fully and fairly evaluate all of Medivation’s strategic options.” San Francisco-based Medivation quickly responded by unveiling plans to file consent revocation materials with the SEC.
DUBLIN – Bavarian Nordic A/S picked up a second bulk supply order for its Imvamune smallpox vaccine from the U.S. government, a $100 million deal that comes on top of the $133 million contract it secured last year. It's further evidence that the transition from liquid-frozen formulation to longer-lasting freeze-dried vaccine is under way.
DUBLIN – An evaluation of the first nine projects funded by the Innovative Medicines Initiative (IMI), the multibillion-euro public-private partnership involving the European Commission and the pharmaceutical industry, recommends that it broaden its focus from a "linear" approach to tackling pharma R&D bottlenecks to a "system-of-innovation" approach that can better identify pathways to socio-economic impact for individual projects.
DUBLIN – Asit Biotech SA put a little color into Europe's anemic IPO market, raising €23.5 million (US$26.5 million) on the Euronext Exchange in Brussels and Paris last week.
DUBLIN – Novimmune SA closed a CHF30 million (US$31 million) funding round, taking the total cash it has raised this year to CHF60 million and its lifetime total to more than CHF300 million.