The Medicines Co. (MDCO) moved Vabomere (meropenem and vaborbactam) across the goal line, garnering FDA approval to treat adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible Enterobacteriaceae – Escherichia coli, Klebsiella pneumoniae and Enterobacter cloacae species complex.
John Milligan, president and CEO of Gilead Sciences Inc., pronounced the company’s $11.9 billion acquisition of Kite Pharma Inc. as “a pivot to cellular therapy as our main strategy going forward” but promised that “we’re not going quiet after this deal.”
Efforts to stem the global tide of type 2 diabetes and its unrelenting sequelae have grabbed the lion’s share of attention, and money, for drug development in the space.
Given the implied value of just $3.41 per share (NASDAQ:DMTX) for the all-stock acquisition of Dimension Therapeutics Inc., Evercore ISI analyst Josh Schimmer asked Kenneth Mills, president and CEO of acquirer Regenxbio Inc., the question that likely was on everyone’s mind during a conference call to discuss the transaction. Could another suitor emerge with a competing bid?
Shares of Genmab A/S (CPH:GEN) shot up 11 percent Thursday after the company reported that the phase III ALCYONE study of daratumumab (Darzalex) met the primary endpoint of improving progression-free survival (PFS) as front-line treatment for newly diagnosed multiple myeloma (MM) patients.
Cowen and Co. analyst Eric Schmidt summed up the consensus of analysts on the phase III failure of Ultragenyx Pharmaceutical Inc. candidate aceneuramic acid extended release (Ace-ER) in patients with GNE myopathy (GNEM) as "disappointing, but not surprising." A win would have been a stunner, given tepid phase II findings and the company's withdrawal of a marketing authorization application (MAA) for the candidate in the fourth quarter of 2016.
Comparing the expansion of a young biopharma to the maintenance of a home, Terry Rosen, CEO of Arcus Biosciences Inc., pointed out that "If you think you're going to sell your house in six months, you put on a fresh coat of paint and new hardware on the doors. But if you're going to stay for 30 years, you fix everything inside the walls. Nobody can see it, but you've built a much stronger structure."
The legal, regulatory and marketing hurdles faced by companies with commercial cannabinoids have not deterred new entrants seeking to build better mousetraps. Although many companies in the field continue to rely on the cannabis plant as the starting point for their R&D efforts, some have turned to what they consider next-generation drug development to overcome concerns about pharmacokinetic consistency.
Comparing the expansion of a young biopharma to the maintenance of a home, Terry Rosen, CEO of Arcus Biosciences Inc., pointed out that "If you think you're going to sell your house in six months, you put on a fresh coat of paint and new hardware on the doors. But if you're going to stay for 30 years, you fix everything inside the walls. Nobody can see it, but you've built a much stronger structure." At Arcus, he told BioWorld, "We're building a special, unique, long-term place."
The cannabinoid story is hardly new to biopharma. The first cannabinoid therapeutics were approved roughly two decades ago, but only four drugs targeting the brain's cannabinoid receptors have made it to market, targeting narrow indications associated with cancer, neuropathic pain, chemotherapy-induced nausea and vomiting (CINV) or cachexia.
