Biotie Therapies Oyj closed out the year exactly as planned – with a product undergoing regulatory review in Europe. Development partner H. Lundbeck A/S disclosed on Dec. 21 that the European Medicines Agency (EMA) had accepted for review its marketing authorization application (MAA) for nalmefene to treat alcohol dependence.
Biotie Therapies Oyj closed out the year exactly as planned – with a product undergoing regulatory review in Europe. Development partner H. Lundbeck A/S disclosed on Dec. 21 that the European Medicines Agency (EMA) had accepted for review its marketing authorization application (MAA) for nalmefene to treat alcohol dependence.
Shares in Sygnis Pharma AG plunged more than 62 percent Friday on news that its lead drug AX200 failed to demonstrate efficacy in a 328-patient Phase IIb trial in acute ischemic stroke.
Clinuvel Pharmaceuticals Ltd. plans to complete a European regulatory filing for its lead drug Scenesse (afamelanotide) in the coming weeks, following a Phase III trial in patients with erythropoietic protoporphyria (EPP), which met its primary endpoint.
Clinuvel Pharmaceuticals Ltd. plans to complete a European regulatory filing for its lead drug Scenesse (afamelanotide) in the coming weeks, following a Phase III clinical trial in patients with erythropoietic protoporphyria (EPP), which met its primary endpoint.
Shares in Sygnis Pharma AG plunged more than 62 percent Friday on news that its lead drug AX200 failed to demonstrate efficacy in a 328-patient Phase IIb trial in acute ischemic stroke.
Actelion AG's potential acquisition of Trophos SA is off the table, following the failure of the latter firm's lead drug olesoxime to demonstrate efficacy in a pivotal Phase III trial in amyotrophic lateral sclerosis (ALS) or Lou Gehrig's disease.
As crunch time looms for TopoTarget A/S's lead pipeline molecule belinostat, which is undergoing a pivotal Phase II trial in 129 patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), the company is cutting almost 40 percent of its Danish workforce in order to conserve cash and focus its resources.
Molecular Partners AG entered a strategic alliance with Janssen Biotech Inc., under which it will team up with the Johnson & Johnson subsidiary to develop a broad pipeline of drugs, based on its Darpin scaffold technology, for a range of immunology indications.
EMBL Ventures GmbH took in €40 million (US$53.5 million) in a first closing of its second fund, bringing an additional tranche of early stage investment to Germany's cash-starved biotechnology sector. And it hopes to add at least another €10 million in a second closing.
