Antibiotics development underwent “a bad period, and probably the low point was around 2009,” Melinta Therapeutics Inc. Chief Scientific Officer Erin Duffy told BioWorld Today.
Pointing to a "brand-new ball game" with vasodilator Orenitram (treprostinil extended-release tablets) in pulmonary arterial hypertension (PAH) and "tough competition" in the prostacyclin receptor agonist Uptravi (selexipag) from Actelion Ltd., United Therapeutics Inc. CEO Martine Rothblatt said that being able to promote her firm's therapy for reduction in morbidity and mortality – as well as improvements in exercise, as the label now proclaims – could boost sales.
"Are there too many [immuno-oncology programs]? People with cancer are dying every day – we have a lot of work to do," Incyte Corp. CEO Hervé Hoppenot told BioWorld Today as his firm kicked off Echo-301, a phase III trial testing the oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor epacadostat in combination with Merck & Co. Inc.'s approved anti-PD-1 drug Keytruda (pembrolizumab) as first-line treatment for patients with advanced or metastatic melanoma.
"People know we're low on cash," Immune Pharmaceuticals Ltd. CEO Daniel Teper told BioWorld Today, but the company is "working on transactions that will allow us to refinance the company by the end of the summer."
Savara Pharmaceuticals Inc. CEO Rob Neville told BioWorld Today the all-stock buyout of Serendex Pharmaceuticals A/S brings aboard a pair of orphan products, one of them "already enrolling phase II/III" trials in Europe and Japan for pulmonary alveolar proteinosis (PAP). "Being able to pull off an acquisition of a company like Serendex for a private company like us was a big win," he said.
Hoping to fill what chief medical officer (CMO) Evan Loh called "a vacuum of unmet need" created by the FDA's recent edict on the dangers of fluoroquinolone antibiotics, Paratek Pharmaceuticals Inc. aims to build on success with the first of two phase III registration trials comparing its once-daily, broad-spectrum antibiotic, omadacycline, to linezolid (Zyvox, Pfizer Inc.) for acute bacterial skin and skin structure infection (ABSSSI).
With immuno-oncology (IO) revving faster than even optimists predicted and chemotherapy for non-small-cell lung cancer (NSCLC) fated to become an image in the rearview mirror, research continues to grope for the just-right levels of programmed death-ligand 1 (PD-L1) expression that lets programmed cell death-1 (PD-1) inhibitors work best.
Coming off a preliminary settlement with the U.S. government for alleged misbranding that would take about $40 million from its coffers, Aegerion Pharmaceuticals Inc. agreed to a merger with QLT Inc. that gives the combined company a pair of marketed products plus phase III-ready QLT091001, awarded ultra-orphan fast track status by the FDA for IRDs.
The pharma-to-spinout-to-pharma course traveled by Afferent Pharmaceuticals Inc. in Merck & Co. Inc.'s buyout worth up to $1.25 billion is not the first time and likely won't be the last in neurology, New Leaf Venture Partners managing director Liam Ratcliffe told BioWorld Today. "Despite headwinds in the space and many big companies getting out, we continue to see opportunities," he said.
