DUBLIN – The International Society for Cellular Therapies (ISCT) has added its voice to those opposing the Regrow Act, a bipartisan bill introduced in the Senate in March, which aims to speed development of regenerative medicine and restore what its sponsors regard as America's lost prominence in the field.
DUBLIN – Shares in Auris Medical AG took a pounding Thursday on news that its lead drug, Keyzilen (AM-101, esketamine hydrochloride gel), failed the first of two phase III trials in acute inner ear tinnitus.
DUBLIN – Shares in Indivior plc rose more than 21 percent to an all-time high during early trading Wednesday on news that RBP-6000, a once-per-month depot injection of buprenorphine, hit the primary endpoint of a phase III trial in patients with opioid use disorder.
DUBLIN – Glaxosmithkline plc is adding a second cytokine-targeting antibody to its respiratory disease portfolio by in-licensing Johnson & Johnson's CNTO 7160, a phase I antibody that targets the interleukin-33 (IL-33) receptor. The deal is worth up to £175 million (US$229 million), comprising an undisclosed up-front payment plus milestones covering development and first commercial sales. J&J would also gain tiered sales royalties, should the product gain approval, plus additional payments tied to its sales performance.
DUBLIN – Immunoqure AG is parlaying an extensive auto-antibody characterization effort involving a cohort of patients with an ultra-rare autoimmune disease into an antibody discovery engine that has uncovered large numbers of highly active antibodies with the potential to address a swath of immunological conditions.
DUBLIN – Nextech Invest Ltd. missed the $100 million target it set for its Oncology Fund IV, closing with $64 million in the pot – enough to continue its focus on investing in high-quality firms focused on cancer.
DUBLIN – In the smoke-and-mirrors world of drug pricing in Europe, Ireland is claiming a little victory on foot of a new drug pricing agreement with the pharmaceutical industry which will help to keep a lid on rising drug prices between now and 2020.
DUBLIN – Pharming Group NV gave its weary investors a smidgen of hope Monday, with phase II trial news supporting the efficacy of its lead drug Ruconest (recombinant C1 esterase inhibitor) in treating acute attacks of hereditary angioedema (HAE).
DUBLIN – Shares in Santhera Pharmaceuticals Holding AG dropped 37 percent Thursday after the FDA blocked the company's bid to win accelerated approval for Raxone (idebenone) in Duchenne muscular dystrophy (DMD) patients not taking glucocorticoids.
DUBLIN – Ablynx NV's anti-interleukin-6-receptor (IL-6R) inhibitor, vobarilizumab (ALX-0061), demonstrated equivalent efficacy to the incumbent, Actemra (tocilizumab), in a phase IIb monotherapy trial in rheumatoid arthritis (RA). Some investors liked what they saw, pushing up the company's stock by as much as 17 percent early Thursday.
