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. Read More
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. Read More
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. Read More
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). Read More
Pellepharm Inc. may have come up with a "Goldilocks drug" – just enough, not too much – to treat Gorlin syndrome, its chief medical officer (CMO), Ervin Epstein, told BioWorld, as the company finished the third closing of a $20 million series B financing and disclosed positive top-line data from a phase II trial with topical hedgehog inhibitor patidegib. Read More
Mateon Therapeutics Inc. said that, so far, five of 21 people with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome have achieved complete remissions after being treated with its vascular disrupting agent, Oxi-4503, in combination with cytarabine during a phase Ib dose-escalation study. Read More
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.) Read More
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. Read More
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). Read More
