LONDON – Ten years after selling its U.K. chemistry development business for $64 million, Evotec AG is getting it back, as part of a $300 million acquisition of Aptuit Inc. (See BioWorld Today, Sept. 12, 2007.)
The FDA, in partnership with the Duke-Robert J. Margolis Center for Health Policy, will hold a public workshop Sept. 13 on creating a framework for the regulatory use of real-world evidence (RWE) in drug development.
Kuros Biosciences Ltd., of Schlieren, Switzerland, said Zürcher Kantonalbank fully exercised its overallotment option in connection with the company's recent offering, bringing total gross proceeds to CHF16.9 million (US$17.5 million).
LONDON – A new guideline for the conduct of phase I trials in Europe will come into effect in January 2018, two years after one man died and four others suffered neurological damage in the phase I study of BIA 10-2474.
Transgene SA, of Strasbourg, France, said the first patient was treated in a phase I/II trial evaluating the combination of oncolytic immunotherapy Pexa-Vec with Opdivo (nivolumab, Bristol-Myers Squibb co.) as a first-line treatment of advanced hepatocellular carcinoma.
Tenax Therapeutics Inc., of Morrisville, N.C., said the FDA requested an additional clinical trial for levosimendan after a pre-NDA meeting that reviewed the potential to submit a marketing application for the drug to treat patients undergoing coronary artery bypass grafting to reduce the risk of low cardiac output syndrome and for the treatment of patients with acute decompensated heart failure.
Intercept Pharmaceuticals Inc. reported $30.4 million in second-quarter global net sales of Ocaliva (obeticholic acid, or OCA), beating consensus estimates of $26 million to $27 million. Moreover, the phase II AESOP trial of OCA in individuals with primary sclerosing cholangitis (PSC) met its primary endpoint of statistically significant reduction in alkaline phosphatase (ALP), an accepted biomarker, while the phase II CONTROL trial also met its objective, confirming statin co-administration with OCA reduces LDL to levels below baseline in patients with nonalcoholic steatohepatitis (NASH).
Seattle Genetics Inc., of Bothell, Wash., reported second quarter revenues of $108.2 million, including $74.3 million in net sales of Adcetris (brentuximab vedotin) in the U.S. and Canada, compared to revenues of $95.4 million in the second quarter of 2016.
Idorsia Ltd., of Allschwil, Switzerland, reported that the phase II program of its dual orexin receptor antagonist (DORA), known as ACT-541468, met its primary endpoint in insomnia, using zolpidem as an active comparator.
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