Bad news came on Good Friday for Incyte Corp. and Eli Lilly and Co. in the form of a complete response letter (CRL) from the FDA related to once-daily, oral baricitinib for moderate to severe rheumatoid arthritis (RA).
As the company unveiled positive topline phase II results with topical gel SB-208, Novan Inc. CEO Nathan Stasko told BioWorld Today that "we're really at the infancy of this platform and the nitric-oxide era," with more news due about other compounds this year.
"It's a lab-ready system – that's really critical," Geraldine Hamilton, president and chief scientific officer of Emulate Inc., told BioWorld Today, detailing the firm's cooperative research and development agreement with the FDA for use of the Boston-based firm's Organs-on-Chips technology, which will be placed "in [the FDA's] lab, so they can get first-hand experience" with it.
Investors may not have cherished high hopes for Allergan plc's phase II effort with Botox (onabotulinumtoxin type A) in major depressive disorder (MDD), nor are the results uniformly positive, but the company is forging ahead anyway with plans for a phase III experiment.
Intezyne Technologies Inc. should find itself “on an IPO trajectory for late 2018 or early 2019,” its chief financial officer (CFO), Russell McAllister, told BioWorld Today, “coinciding with potential licensing deals for both” lead candidates owned by the Tampa, Fla.-based company.
With clinical news pouring from pharma giants matching up the indoleamine 2,3-dioxygenase 1 (IDO1) blocker mechanism with PD-1 immune checkpoint inhibitors, Newlink Genetics Corp.'s interim results from NLG2103 – a phase II study evaluating its IDO pathway blocker indoximod as a combo candidate in advanced melanoma – seemed to take a back seat.
As Johnson & Johnson (J&J) tied the bow on its all-cash tender offer takeover of Actelion Ltd. to gain an impressive franchise in pulmonary arterial hypertension (PAH), an expected decision grew near on the device portion of United Therapeutics Corp.’s drug-device combo Remosynch – an implantable pump system for delivery of the PAH drug Remodulin (treprostinil).
