Alnylam Pharmaceuticals Inc., of Cambridge, Mass., said it started a phase I/II trial of ALN-HBV, a subcutaneously administered RNAi therapeutic for the treatment of chronic hepatitis B virus (HBV) infection. Read More
Pharmathene Inc., of Annapolis, Md., said it received a $20 million payment from Siga Technologies Inc., of New York, to extend by 90 days, until Oct. 19, the date by which Siga must satisfy the Pharmathene judgment. The payment is creditable against final satisfaction of the judgment in favor of Pharmathene of about $205 million plus interest and is not refundable. The judgment was awarded following a long-running dispute between the companies over smallpox antiviral tecovirimat. (See BioWorld Today, Aug. 12, 2014.) Read More
Tesaro Inc., of Waltham, Mass., said it closed its underwritten public offering of common stock, selling 5.34 million shares at $81 per share, which included 697,500 shares of common stock sold as a fully exercised overallotment option. The company estimates that the net proceeds from the offering will be approximately $409 million. Read More
In briefing docs released ahead of Tuesday's meeting of the FDA's Arthritis Advisory Committee, reviewers appeared favorable toward Thousand Oaks, Calif.-based Amgen Inc.'s ABP-501, a biosimilar version of Humira (adalimumab), the top-selling drug from Abbvie Inc., of North Chicago. Read More
Jedd Wolchok is apparently not one to rest on his laurels. As the principal investigator on the 024 study that led to approval of the first commercially successful cancer immunotherapy, CTLA-4 checkpoint inhibitor Yervoy (ipilimumab, Bristol-Myers Squibb Co.) as well as several phase III trials investigating the combination of Yervoy and PD-1 checkpoint blocker Opdivo (nivolumab, Bristol-Myers Squibb Co.), Wolchok has done as much as anyone currently working in oncology for patients. Read More
Life sciences patents have not fared well in recent case law, including several cases ruled on by the U.S. Supreme Court, but the Court of Appeals for the Federal Circuit has returned a verdict in the case of Rapid Litigation Management v. Cellzdirect, a case that is seen by some as favorable toward patents that invoke natural law and, by extension, favorable to commercial activity in the life sciences. Read More
Conditional capture of a $22.5 million milestone payment from Roche Holding AG sent Eleven Biotherapeutics Inc. shares climbing Friday, triggered by effectiveness of an IND for its interleukin-6 antagonist, EBI-031. Read More
Officials at Galena Biopharma Inc. are still in the dark on data from the phase III PRESENT trial of cancer vaccine Neuvax (nelipepimut-S), company president and CEO Mark Schwartz revealed Friday on a conference call with analysts. Read More
As backers of other drug developers with CAR T cell therapies in the works scrambled to downplay the hitch met by Juno Therapeutics Inc. and gain distance from it, CEO Hans Bishop outlined what he called "a clear path forward" with JCAR015 in acute lymphoblastic leukemia, held up by the FDA because three patients died in phase II trials. Read More