LONDON – Boehringer Ingelheim GmbH has agreed to pay up €627.5 million (US$741.3 million) to buy Autifony Therapeutics Ltd.’s lead program, AUT-00206 and the associated ion channel modulation technology through which the compound was discovered. Read More
The Center for Drug Evaluation and Research at the FDA has issued a draft guidance for information requests and discipline review letters under the generic drug user fee agreement, stating that reviewers will ordinarily communicate their views of possible deficiencies in a generic drug application via a discipline review letter (DRL) as each discipline involved in the review completes its portion of the application. Read More
Aerie Pharmaceuticals Inc., of Irvine, Calif., said the FDA approved Rhopressa (netarsudil ophthalmic solution) 0.02 percent for the lowering of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Read More
DUBLIN – ISA Pharmaceuticals BV could earn well in excess of $500 million from a strategic collaboration in immuno-oncology with Regeneron Pharmaceuticals Inc., which marries its peptide-based therapeutic cancer vaccine, ISA-101, with Regeneron’s PD-1 inhibitor, cemiplimab (REGN-2810). Read More
Aptinyx Inc. continued to race down the track by completing a $70 million series B financing to continue advancing its pipeline of N-methyl-D-aspartate (NMDA) receptor modulators. Read More
PERTH, Australia – Belgium’s Tigenix NV licensed intellectual property from Australian stem cell company Mesoblast Ltd. the same day it announced approval of the EU’s first allogeneic stem cell therapy. Read More
With the age of the companion diagnostic fast approaching, the FDA recently issued a draft guidance dealing with the use of investigational in vitro diagnostics (IVD) in drug studies, highlighting the circumstances in which the use of that IVD rises from an insignificant to a significant risk, thus incurring a regulatory liability. Read More
PERTH, Australia – Investment in research and development fell sharply in the last decade in Australia, and the government can play an important role to improve framework conditions that support innovation, according to the Australian Innovation System Report 2017. Read More
Madrigal Pharmaceuticals Inc., of Conshohocken, Pa., said it launched a public offering of $100 million of its common stock, and intends to grant underwriters a 30-day option to purchase up to an additional 15 percent. Read More
La Jolla Pharmaceutical Co., of San Diego, started the phase II LJ401-HH01 trial testing LJPC-401 (synthetic human hepcidin) in approximately 60 patients with hereditary hemochromatosis. The trial will measure the change in transferrin saturation from baseline to the end of the 12-week treatment compared to placebo as the primary endpoint. Change in serum ferritin from baseline to end of treatment and the requirement for and frequency of phlebotomy procedures – removal of blood – during the study will be measured as secondary endpoints. Read More
