Backed by positive data from two phase III studies, ABP 501 could become the first product from Amgen Inc.'s burgeoning yet close-to-the-vest biosimilars program, for which the Thousand Oaks, Calif.-based firm has anticipated five commercial launches between 2017 and 2019.
As widely expected, Pfizer Inc.'s cyclin-dependent kinase inhibitor palbociclib won a much-anticipated accelerated approval, with an FDA nod for use in advanced or metastatic breast cancer coming late Tuesday afternoon.
Wave Life Sciences, which began operations in 2013 following the combination of two small biotechs – one in Boston, one in Okinawa, Japan – emerged from stealth this week with an $18 million series A round and plans to lead "a revolution" in the field of nucleic acid therapeutics.
It's been more than six years since 2007 start-up Vaccinogen Inc. licensed rights to Oncovax, a cancer vaccine set to start a confirmatory phase III study in colon cancer. During that time, the immunotherapy space saw more than its share of highs and lows – the excitement surrounding the approval of Dendreon Corp.'s prostate cancer vaccine Provenge (sipuleucel-T) subsequently crushed by discouraging sales, followed by immunotherapy wins with Bristol-Myers Squibb Co.'s Yervoy (ipilimumab) and the new PD-1 checkpoint inhibitors.
While the PD-1 pathway has garnered most of the attention in the checkpoint inhibition space so far, thanks to last year's approvals of Keytruda (pembrolizumab, Merck & Co. Inc.) and Opdivo (nivolumab, Bristol-Myers Squibb Co.), a 2010 Israeli start-up is advancing what appears to be a first-in-class compound against a new immune checkpoint protein.
Just last week, Celgene Corp.'s head of business development, George Golumbeski, told a packed breakout session at the annual J.P. Morgan Healthcare Conference in San Francisco that the firm's long-term pipeline "can never be big enough."
Depomed Inc. said it expects its annual revenue to more than double in 2015 with the addition of U.S. rights to Janssen Pharmaceuticals Inc.'s Nucynta pain drug franchise.
SAN FRANCISCO – It's been a big week for billionaire physician and biotech veteran Patrick Soon-Shiong. He was awarded two separate presentation slots at the J.P. Morgan Healthcare Conference and his ambitious holding company Nantworks LLC launched new start-up venture Nantcell LLC, an immuno-oncology firm that began by licensing a late-stage monoclonal antibody from Amgen Inc.
SAN FRANCISCO – Opening his presentation during the J.P. Morgan Healthcare Conference Wednesday morning, Hospira Inc. CEO Michael Ball zipped through updates on the firm's injectable and device businesses and focused the majority of his talk on the firm's efforts in biosimilars, a space that finally appears to be opening up in the U.S.
SAN FRANCISCO – Shares of Pharmacyclics Inc. jumped 11.4 percent in afterhours trading Monday following a lively afternoon presentation during which the Sunnyvale, Calif.-based firm told attendees of the J.P. Morgan Healthcare Conference that it expected cancer drug Imbruvica (ibrutinib) to hit blockbuster status in 2015.
