Just ahead of its Nov. 13 PDUFA date, revefenacin won FDA approval, becoming the first once-daily nebulized bronchodilator cleared for chronic obstructive pulmonary disease in the U.S.
Briefing documents released ahead of Friday's meeting of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) suggest Acelrx Pharmaceuticals Inc. might have better luck the second time around with its sublingual 30-mcg tablet version of sufentanil given by way of a non-invasive, single-dose applicator.
Top-line results from the phase III PREVENT study testing Soliris (eculizumab) in rare disease neuromyelitis optica spectrum disorder (NMOSD) "far exceeded our expectations," said Ludwig Hantson, CEO of Alexion Pharmaceuticals Inc., which is now moving to engage regulators on submissions to expand use of the complement inhibitor in NMOSD, a complement-mediated disorder for which there currently are no approved therapies.
Cambridge, U.K.-based Astrazeneca plc and its Medimmune unit will introduce the first new drug for hairy cell leukemia (HCL) in more than two decades, with the FDA's approval Thursday for Lumoxiti (moxetumomab pasudotox-tdfk). The CD22-targeted cytotoxin is indicated for adults with relapsed or refractory disease who have received at least two prior systemic therapies, including a purine nucleoside analogue.
You could say Invenra Inc. has been working toward bispecific antibodies for years. Founded in 2011, the University of Wisconsin-Madison spin-off launched with the aim of making antibody drug discovery more efficient, eventually developing a platform based on ultra-high-throughput technology capable of synthesizing hundreds of thousands of full-length antibodies using cell-free expression, with a screening platform that allows researchers to pinpoint those with the most promising biological activity.
The team at Bellerophon Therapeutics Inc. intends to further analyze data after an unexpectedly disappointing interim look at the phase III INOvation-1 study testing its inhaled nitric oxide delivery system in pulmonary arterial hypertension (PAH) failed to show sufficient improvements in the six-minute walk distance (6WMD), the primary endpoint. That review prompted the data monitoring committee (DMC) to recommend the study be stopped for futility and sent shares of the Warren, N.J.-based company (NASDAQ:BLPH) falling more than 68 percent Tuesday.
Progenics Pharmaceuticals Inc.'s newly approved Azedra (iobenguane I 131) arrives on the market with a nod for ultra-orphan neuroendocrine tumors, a hefty price tag and a label the New York-based firm hopes will lay the foundation for its broader radiopharmaceutical efforts.
Hoping to repeat its phase II success, Aldeyra Therapeutics Inc. enrolled the first patient in its pivotal phase III trial testing a topical version of its aldehyde trap, reproxalap, in ichthyosis associated with Sjögren-Larsson syndrome (SLS), a rare disease for which there are no approved therapies.
For Dermira Inc., winning the FDA's nod for Qbrexza (glycopyrronium cloth) as the first once-daily, topical treatment for primary axillary hyperhidrosis is only step one in its commercialization challenge. The Menlo Park, Calif.-based dermatology-focused firm now is tasked with reaching the nearly 10 million people estimated to suffer from the condition, more commonly known as excessive underarm sweating, many of whom have given up on ever finding a treatment.
