Themis Bioscience GmbH is planning to begin clinical trials of viral vaccine candidates to protect against dengue virus and chikungunya virus infections before year-end, following successful preclinical proof of concept studies.
Following the FDA approvals of the first two antibody-drug conjugates (ADCs), the market is moving forward to develop enhanced products based on linker technologies that will make that new class of biopharmaceutical/small-molecule hybrids safer, more effective and easier to manufacture.
ReNeuron plc is planning to move its stem cell therapy ReN001 into a Phase I trial in critical limb ischemia (CLI), just as Aastrom Biosciences Inc., an erstwhile leader in the field, is stepping away from the fray.
• InteRNA Technologies BV, of Bilthoven, the Netherlands, closed an equity financing round, with participation from new investors Innovation and Investment Fund Gelderland and several angel investors.
Clavis Pharma A/S is facing a merger or an orderly shutdown following the Phase III failure of elacytarabine, its lipid-enhanced version of cytarabine, in the 380-patient CLAVELA trial in advanced acute myeloid leukemia (AML).
SEEK Ltd. has raised £25 million (US$37.9 million) to fund its spin-off, infirst Healthcare Ltd., toward an independent existence as a specialist in patent-protected over-the-counter (OTC) treatments.
Schizophrenia claimed another victim last week as shares of BioLineRx Ltd. plummeted after the company halted the Phase II/III CLARITY trial of BL-1020, its first-in-class, orally available GABA-enhanced antipsychotic and the lead program in the company's diverse pipeline.
With additional data in the offing for its Leber's hereditary optic neuropathy (LHON) drug Raxone (idebenone), Santhera Pharmaceuticals AG has withdrawn its marketing authorization application (MAA) from the European Medicines Agency's (EMA) re-examination process and will instead submit a new file with an expanded patient database.
The shape of the UK's new drug pricing regime became clearer when the government confirmed it is handing responsibility for assessing the value of medicines to the National Centre for Health and Clinical Excellence (NICE), a body that has repeatedly clashed with the industry over its decisions on whether drugs should be funded by the National Health Service.