One of the issues that will rise again to the surface as the 114th Congress convenes is tax reform; the medical device tax is back in play as well. One big question is whether these will be handled separately, but one line of thinking is that the pressure to find offsets for the device tax may force the House and Senate to package any repeal legislation into a larger bill in order to address the pay-for question. Read More
Another biotech squeaked through the initial public offering (IPO) door Wednesday, as Xenon Pharmaceuticals Inc. priced 4 million shares at $9 to raise a smallish $36 million. But the IPO queue remained at three dozen companies after Inotek Pharmaceuticals Corp. entered as fast as Xenon could exit. The Lexington, Mass.-based biotech, which is developing a small molecule eye drop therapy to treat glaucoma, is seeking to raise up to $86 million, including overallotments, and plans to offer another $46 million in five-year convertible debt concurrent with the IPO. Read More
FRANKFURT – With a maturing clinical pipeline and big ambitions for creating a new paradigm for translational research in Germany, Oryx GmbH & Co. KG, a company that has flown under the radar since its formation, finally set out its stall at Bio-Europe. Read More
Amid the rising rate of multidrug-resistant infections, The Medicines Co. launched a pivotal program testing Carbavance, a combination anti-infective, against carbapenem-resistant Enterobacteriaceae (CRE), which the Centers for Disease Control and Prevention has called one of the most deadly gram-negative pathogens. Read More
The treatment of hepatitis C has undergone profound shifts for the better in recent years with the advent of first targeted therapies and then all-oral regimens. Read More
LONDON – One of Europe's leading medical institutes, the Karolinska in Sweden, has secured $128 million for its spin-out companies from Thailand's Charoen Pokphand Group (CP Group), in an unprecedented investment by an Asian company in European university technology. Read More
Micreos BV, of Wageningen, The Netherlands, said it has developed Staphefekt, a bacteria-killing enzyme, or endolysin, specific to Staphylococcus aureus, which is equally effective in killing methicillin-resistant S. aureus. This is the first endolysin available for human use on intact skin. Read More
Ranbaxy Laboratories Ltd., of Mumbai, India, said it received FDA approval to manufacture and market Fenofibrate capsules USP, 43 mg and 130 mg indicated for primary hypercholesterolemia, mixed dyslipidemia and severe hypertriglyceridemia. The FDA's Office of Generic Drugs has determined the formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Antara capsules, 43 and 130 mg, respectively, of Lupin Atlantis. Read More
Biolinerx Ltd., of Jerusalem, reported final results from the phase I/II study of BL-7010, showing the co-polymer, designed to treat celiac disease, was safe and well-tolerated in single- and repeated-dose administrations. Pharmacokinetic analyses across all cohorts revealed no systemic exposure of BL-7010 in plasma and urine samples. The study also enabled the company to determine the optimal safe dose of 1 gm, three times daily, for future development. Read More
Tolero Pharmaceuticals Inc. closed the second tranche of its series B financing, bringing its total amount raised to $22.4 million. Fred Alger Management Inc. led the round, with investments from other institutional and individual investors. Read More
Corcept Therapeutics Inc., of Menlo Park, Calif., said it recognized $7.3 million in net revenue for the third quarter of 2014 compared to $5.9 million in the second quarter. Revenue increased 177 percent over the prior year comparable period on continued uptake of Korlym for the treatment of Cushing's syndrome. Read More
