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the offing for its Leber's hereditary optic neuropathy (LHON) drug Raxone (idebenone), Santhera Pharmaceuticals AG has withdrawn its marketing authorization application (MAA) from the European Medicines Agency's (EMA) re-examination process and will instead submit a new file with an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.
LONDON – The part of the immune system that deals with viruses and other pathogens can also delay the healing of bone fractures, a new study has found.
Underlining its ambitions in ophthalmology, Shire plc is acquiring SARcode Bioscience Inc. for $160 million up front, plus additional, undisclosed milestones based on the clinical, regulatory and commercial progress of its main asset, lifitegrast, which is undergoing a second pivotal Phase III trial in dry eye disease.
Start-up Helmedix Pty Ltd. has raised A$1.25 million (US$1.29 million) in seed funding, providing a springboard to the commercialization of molecules based on immune-modulating peptides used by helminth parasites to suppress the immune response of their hosts.
India's Drug and Cosmetics Act purports to keep clinical trials kosher under something called Schedule Y, but the law – which has not been amended since 2005 – lacks rules for mandatory practice and does not specify what recourse trial participants have when things go wrong.