The U.S. Supreme Court Monday added Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc. to the cases it will hear in its next term, calling into question the Federal Circuit's interpretation of the "on-sale bar" when it comes to drug patent law. Read More
Biotime Inc., of Alameda, Calif., licensed one of its pluripotent cell lines to Nantes, France-based Goliver Therapeutics SAS, a company focused on addressing liver diseases with regenerative technologies. The commercial license will allow Goliver to build on its preclinical work to produce cells for commercial use, Biotime said. Read More
Kiniksa Pharmaceuticals Ltd., of Hamilton, Bermuda, said the underwriters of its IPO exercised their option to purchase an additional 1 million class A common shares at $18 each, bringing the total sold to 9.48 million for gross proceeds of approximately $170.7 million. Read More
Merrimack Pharmaceuticals Inc. is moving forward without MM-141 (istiratumab) after top-line data from the phase II CARRIE study in front-line metastatic pancreatic cancer showed that adding the bispecific, tetravalent monoclonal antibody (MAb) to standard-of-care (SOC) nab-paclitaxel/gemcitabine failed to beat the SOC regimen plus placebo in the primary efficacy endpoint of progression-free survival (PFS). The study also missed secondary efficacy endpoints: objective response rate, disease control rate, duration of response and overall survival. Read More
Gossamer Bio Inc.'s co-founder, president and chief operating officer, Sheila Gujrathi, told BioWorld that by signing a potential $420 million deal with Aerpio Pharmaceuticals Inc., her firm hopes to pursue "higher-hurdle endpoints of mucosal healing" in inflammatory bowel disease (IBD) and use Aerpio's hypoxia induced factor (HIF)-1 alpha stabilizer, AKB-4924, and related compounds to bring about longer-term remissions in such patients. Read More
A man with prostate cancer has died after receiving a second dose of Sophiris Bio Inc.'s topsalysin during a trial testing the inactivated pore-forming protein therapy. Investigators are now holding off on administering second doses to two additional patients as they seek further details of the death. Meanwhile, company shares (NASDAQ:SPHS) fell 40.3 percent to $2.24 on Monday, amid initial uncertainty about how soon the cause of the death would become clear. Read More
An upsurge in research on fibroblast growth factor 21 (FGF21) during the past decade or so – along with the advance of drug candidates targeting nonalcoholic steatohepatitis (NASH) through that mechanism and others – helped Akero Therapeutics Inc. nail down its handsome $65 million series A round as the field evolves. Read More
DUBLIN – Shares in Erytech SA took a hammering Monday on news that the company is halting development of its lead program, eryaspase, in acute lymphoblastic leukemia (ALL) and withdrawing a marketing authorization application (MAA) in Europe for relapsed and refractory (r/r) ALL. Read More
The FDA's approval of GW Pharma plc's liquid Epidiolex – the first pharmaceutical formulation of purified, plant-based cannabidiol (CBD) to reach the market – in Dravet syndrome (DS) and Lennox-Gastaut syndromes (LGS) opens the door to a new therapeutic and regulatory world. Read More
