Scientists at the University of Salamanca have demonstrated that free radicals or reactive oxygen species (ROS) produced by astrocytes had a beneficial effect on brain metabolism. Read More
Large-molecule drugs such as insulin and other proteins require delivery via injection or intravenous infusion. That typically limits their routine use to the most dire circumstances, given the associated inconvenience, expense and pain. To address that, drug delivery guru Robert Langer and other MIT researchers have teamed up with Novo Nordisk A/S to enable the delivery of injectable drugs via an ingestible pill that delivers a shot into the lining of the stomach. Read More
Researchers have shown that T cells produced the neurotransmitter acetylcholine to affect blood vessel dilation, which helped them control chronic infections. The work was published in the Feb. 8, 2019, issue of Science. Read More
Developing a new administration route for an existing FDA-approved drug is a classic drug development strategy. That's precisely what Incarda Therapeutics Inc. has long been doing; it's in the midst of a phase II study for Inrhythm, an inhaled flecainide drug-device combo to treat recent-onset paroxysmal atrial fibrillation (PAF). Read More
Alnylam Pharmaceuticals Inc., of Cambridge, Mass., reported its global net product revenues for the fourth quarter were $12.1 million for Onpattro (patisiran), to treat hereditary transthyretin-mediated amyloidosis, and $12.5 million for the full year. Read More
Pulmatrix Inc., of Lexington, Mass., entered a securities purchase agreement with certain institutional investors, providing for the purchase and sale of about 1.7 million shares of common stock at a price of about $1.46 per share in a registered direct offering priced at the market, resulting in total gross proceeds of about $2.5 million. Read More
Eli Lilly and Co., of Indianapolis, initiated an exchange offer to divest its remaining interest in Elanco Animal Health Inc., of Greenfield, Ind. Elanco completed its IPO in September 2018, with Lilly retaining an 80.2 percent ownership interest in Elanco. Read More
The FDA disclosed briefing documents for the meeting Tuesday of the Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management (DSaRM) Advisory Committee meeting. Panelists from PDAC and DSaRM will take up the matter of the NDA for the esketamine 28-mg single-use nasal spray device, submitted by New Brunswick, N.J.-based Johnson & Johnson company Janssen Pharmaceuticals Inc., as a therapy for treatment-resistant depression. Read More
DUBLIN – The mood music coming out of Uniqure NV's phase IIb trial for its hemophilia B gene therapy, AMT-061, remains positive. A second interim readout last week, after an initial peek at the data sparked a share-buying frenzy last November, showed continued improvement in levels of factor IX (FIX) expression in two of the three patients enrolled in the study. The third patient has plateaued but has maintained his response to the therapy, which comprises an adeno-associated virus 5 (AAV5) vector encoding the highly active Padua variant of FIX. Read More
