BioCentury | Oct 3, 2020
Product Development

Oral drugs and treatments for life-threatening diseases stand out among new product launches

Despite the challenge of introducing a drug to the market during the COVID-19 pandemic, sales of nearly all new product launches increased in 2Q20 versus 1Q, with drugs to treat life-threatening conditions and oral products...
BioCentury | Mar 21, 2019
Company News

FDA approves Jazz's Sunosi for daytime sleepiness

FDA approved late Wednesday Sunosi solriamfetol from Jazz to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. Jazz Pharmaceuticals plc (NASDAQ:JAZZ) expects to launch Sunosi following a...
BioCentury | Mar 9, 2018
Clinical News

Jazz gets PDUFA date for excessive sleepiness candidate

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) said FDA accepted for review an NDA for solriamfetol (JZP-110) to treat excessive sleepiness associated with narcolepsy or obstructive sleep apnea. The PDUFA date is Dec. 20. Solriamfetol is a phenylalanine...
BioCentury | Aug 31, 2017
Translation in Brief

Mouse model herds

With the publication of its first set of data, the International Mouse Phenotyping Consortium (IMPC) has demonstrated it's making strides toward generating and characterizing the phenotypes of knockout models corresponding to the entire mouse genome...
BioCentury | Sep 28, 2015
Company News

University of Minnesota, Oxis deal

Two researchers at the university granted Oxis exclusive, worldwide rights to develop and commercialize DT2219ARL . The researchers will receive an upfront payment and are eligible for milestones, plus royalties. The product is a bispecific single-chain...
BioCentury | Sep 28, 2015
Company News

University of Minnesota, Oxis deal

Two researchers at the university granted Oxis exclusive, worldwide rights to develop and commercialize DT2219ARL . The researchers will receive an upfront payment and are eligible for milestones, plus royalties. The product is a bispecific single-chain...
BioCentury | Jun 17, 2013
Clinical News

ADX-N05: Phase IIa data

A double-blind, placebo-controlled, crossover, U.S. Phase IIa trial in 33 patients with narcolepsy showed that once-daily ADX-N05 met the primary endpoint of increasing sleep latency from baseline to week 2 as measured by the MWT...
BioCentury | Dec 13, 2012
Distillery Therapeutics

Indication: Neurology

Indication Target/marker/pathway Summary Licensing status Publication and contact information Neurology Neurology Platelet derived growth factor A (PDGFA; PDGF1) A study in mice suggests lithium could help treat neonatal hydrocephalus, an expansion of the cerebral ventricles....
BioCentury | Sep 3, 2012
Clinical News

ARL-N05 regulatory update

FDA granted Orphan Drug designation to Aerial's ARL-N05 to treat narcolepsy. Aerial said it plans to begin Phase IIb testing of the compound this month, with data expected in mid-2013. ARL-N05, whose mechanism of action...
BioCentury | Aug 23, 2012
Distillery Therapeutics

Indication: Ophthalmic disease

Indication Target/marker/pathway Summary Licensing status Publication and contact information Ophthalmic disease Blindness Bardet-Biedl syndrome 12 (BBS12) Mouse studies suggest inhibiting the proapoptotic, unfolded protein response could help prevent retinal degeneration in Bardet-Biedl syndrome, which is...
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