As Wall Street mulled fourth-quarter sales numbers for Regeneron Pharmaceuticals Inc.'s macular degeneration drug Eylea (aflibercept), which beat expectations but disappointed some investors, CEO Leonard Schliefer spoke to the J.P. Morgan Healthcare Conference, outlining the future of the drug as it faces competition on two fronts.
Almost nine months of talks gave birth to the potential $1 billion deal disclosed Monday morning by MacroGenics Inc., which will deploy the company's Dual‐Affinity Re‐Targeting (DART) technology for drugs directed at up to four targets in an agreement with Gilead Sciences Inc.
SAN FRANCISCO – With positive Phase III data in hand from European trials and more due this year from U.S. pivotal studies, Kythera Biopharmaceuticals Inc. offered attendees of the J.P. Morgan Healthcare Conference the company's game plan for earnings as "a new entrant into the established market of facial injectables," said Keith Leonard, co-founder, president and CEO.
SAN FRANCISCO – At the lectern and away, talks at the 31st Annual J.P. Morgan Healthcare Conference are sure to concern the steadily worsening revenue shortfall, and how major pharma firms might satisfy profit-hungry shareholders as more casualties topple down the patent cliff.
With most investor eyes focused on the waited-for FDA approval of Biogen Idec Inc.'s BG-12 for early stage multiple sclerosis (MS), the market hardly flinched at news that dexpramipexole failed in a Phase III trial for amyotrophic lateral sclerosis.
Investor enthusiasm for Gradalis Inc.'s autologous vaccine platform, Furin-ANd-GMCSF (FANG), boosted what began as a $10 million or so Series B round to an amount more than twice that much, and the firm will use the $24 million to move the Phase II ovarian cancer therapy along while expanding manufacturing capabilities.
Equivocal results from its first pivotal Phase III trial with OMS103HP in knee surgery shaved Omeros Corp.'s stock, but gave the company a roadmap for the next study, which will use postoperative pain – a secondary endpoint, met in the latest experiment – as the primary outcome goal.
Now that licensing partner Lux Biosciences Inc. has lifted the lid on short-of-the-mark Phase III results from another try with voclosporin for uveitis, Isotechnika Pharma Inc. is turning its attention fully to nephrology – especially kidney transplants, the indication for which the calcineurin inhibitor originally was designed.
Spectrum Pharmaceuticals Inc.'s endpoint-beating success in the pivotal Phase II study with belinostat for relapsed/refractory peripheral T-cell lymphoma (PTCL) keeps the firm on track potentially to pair the pan-histone deacetylase (HDAC) inhibitor with Spectrum's antifolate Folotyn (pralatrexate), already approved for the condition.
Chronic fatigue syndrome (CFS) patients willing to take Ampligen if it's approved – and accept the risks, because it has worked for them in trials – faced off against charges of inadequately done studies with less than satisfying overall efficacy signals, during a meeting of the FDA's Arthritis Advisory Committee.
