Halozyme Corp. CEO Helen Torley told BioWorld that she expects the latest news about the firm's subcutaneous (subcu) hyaluronidase technology "on the heels of the Rituxan Hycela approval in June of this year by the FDA [will] spark even more rapid growth of companies wanting to sign an Enhanze deal."
Nanology LLC's strategy is "almost like having a new molecular entity, in terms of the broadness of the intellectual property [IP] around it, but on a more streamlined path to potential approval" if safety and efficacy pan out, Marc Iacobucci, managing director of DFB Pharmaceuticals Inc. told BioWorld, with a nod to the 505(b)(2) regulatory pathway that the Fort Worth, Texas-based firm intends to trod.
Shingrix (varicella zoster vaccine [recombinant], adjuvanted) from Glaxosmithkline plc (GSK) sailed through a hearing by the FDA's Vaccines and Related Biological Products Committee, with panelists voting 11-0 in favor of the product's efficacy and safety in people 50 years of age and beyond.
Achillion Pharmaceuticals Inc.'s chief commercial officer, Joseph Truitt, said the firm "will certainly assess all the options for the hepatitis C virus [HCV] portfolio" after the ending of the deal by Johnson & Johnson (J&J) unit Janssen Pharmaceuticals Inc., but had no further guidance.
Adaptimmune Therapeutics plc CEO James Noble said Glaxosmithkline plc (GSK) exercised its option "much earlier than they needed to," exclusively licensing rights to research, develop and commercialize Adaptimmune's NY-ESO SPEAR T-cell therapy program.
"I'd hate for people to just assume, 'Oh, this is another cancer vaccine, therefore it's going to fail like so many others have failed in big clinical trials,'" Gritstone Oncology Inc. CEO Andrew Allen told BioWorld. Investors in the company's individualized, tumor-specific neoantigen strategy – able to sort the plethora of mutations in cancer for key ones – apparently made no such assumption, as they put a handsome $92.7 million into the series B round.
Eagerly awaited data from Verastem Inc.'s phase III DUO study should "more than satisfy the skeptics," CEO Robert Forrester told BioWorld as the firm unveiled positive top-line data with duvelisib for relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). "This drug, as we saw from the [earlier] DYNAMO study, is clearly active," he added, referring to a phase II experiment in non-Hodgkin's lymphoma (NHL), results from which investors deemed less than thrilling.
Nightstar Therapeutics Ltd. filed to raise about $86.2 million in an IPO to advance its gene therapy candidate, NSR-REP1, for choroideremia (CHM), due to enter phase III trials in the first half of next year.
With Insmed Inc.’s phase III Convert trial expected to read out any day, onlookers are busying themselves with guesswork about success for amikacin liposome inhalation suspension, formerly called Arikayce but now known by the acronym ALIS, in non-tuberculous mycobacterium (NTM) infection.
