Alkermes plc's decision – against the advice of the FDA – to use an abbreviated, six-item version of the 10-item Montgomery-Asberg Depression Rating Scale (MADRS) in Study 207, one of the main trials with ALKS-5461 (buprenorphine/samidorphan), became a bone of contention in briefing documents made public ahead of Thursday's adcom meeting. Read More
DUBLIN – One of the main priorities for Ivan Coulter, newly appointed CEO of Atxa Therapeutics Ltd., is to raise additional capital to enable the early stage company to move its lead program into the clinic in 2020. Read More
Multiple myeloma (MM) wasn't exactly a headliner at last week's European Society for Medical Oncology (ESMO) 2018 Congress, and maybe that was fortuitous for the space. Read More
LONDON – Angle plc reported it has succeeded in using its Parsortix system to separate whole fetal cells from maternal blood, opening the way for noninvasive prenatal detection of a far wider range of genetic disorders than is possible with current cell-free DNA testing. Read More
Medical cannabis companies developing pharmaceuticals have largely focused on using purified cannabinoids as monotherapies to treat neurological diseases. This year, for example, Cambridge, U.K.-based GW Pharma plc gained FDA approval for Epidiolex (cannabidiol) to treat two rare pediatric epilepsies, Dravet syndrome and Lennox-Gastaut syndrome, and others are on GW's heels, developing drugs for epilepsy and pain indications. Read More
NEC Corp., of Tokyo, and Transgene SA, of Strasbourg, France, plan to collaborate on an individualized immunotherapy for the treatment for solid cancers, including ovarian cancer and HPV-negative head and neck cancer, using NEC's artificial intelligence technology and Transgene's myvac MVA-based viral vector platform. Read More
Incyte Corp., of Wilmington, Del., reported that it recorded GAAP net product revenues of JAK inhibitor Jakafi (ruxolitinib) in the quarter ending Sept. 30 of $348 million, as compared to $304 million for the same period in 2017, representing 14 percent growth. For the nine-month period, net product revenues were $1 billion, as compared to $831 million for the same period last year, representing 21 percent growth. GAAP net product revenues of Iclusig (ponatinib) were $20 million in the third quarter, as compared to $18 million for the same period in 2017. For the nine-month period, net product revenues were $61 million, as compared to $47 million for the same period in 2017. Read More
Newron Pharmaceuticals SpA, of Milan, Italy, said it signed a financing agreement with the European Investment Bank, which will allow it to borrow up to €40 million (US$45.48 million) over the coming years, subject to achieving a set of agreed performance criteria. Read More
