Almost nine months of talks gave birth to the potential $1 billion deal disclosed Monday morning by MacroGenics Inc., which will deploy the company's Dual‐Affinity Re‐Targeting (DART) technology for drugs directed at up to four targets in an agreement with Gilead Sciences Inc. Read More
SAN FRANCISCO – Improving economic indicators portending a positive year for biotech was the early theme of the 31st annual J.P. Morgan Healthcare Conference. Read More
SAN FRANCISCO – With positive Phase III data in hand from European trials and more due this year from U.S. pivotal studies, Kythera Biopharmaceuticals Inc. offered attendees of the J.P. Morgan Healthcare Conference the company's game plan for earnings as "a new entrant into the established market of facial injectables," said Keith Leonard, co-founder, president and CEO. Read More
Peregrine Pharmaceuticals Inc.'s internal review of vial coding discrepancies from a Phase II trial of bavituximab in non-small-cell lung cancer (NSCLC) showed that the errors were isolated to placebo and 1-mg/kg treatment arms, leaving the 3-mg/kg treatment arm unaffected. Read More
Heptares Therapeutics Ltd. convinced another partner of the power of its G protein-coupled receptor (GPCR) technology, sealing a deal with Cubist Pharmaceuticals Inc. around one – or possibly two – targets to be nominated by the quoted U.S. biotech. Read More
ISA Pharmaceuticals BV raised €8 million (US$10.5 million) in an internal financing round to fund a Phase II trial of its therapeutic vaccine for cervical cancer, ISA-HPV. Read More
• BioTime Inc., of Alameda, Calif., created subsidiary BioTime Acquisition Corp. (BAC), for an agreement with Geron Corp., of Menlo Park, Calif., to acquire Geron's human embryonic stem cell (hESC) program, including its Phase I hESC-derived oligodendrocytes for acute spinal cord injury and its autologous cellular immunotherapy program. Read More
• Edison Pharmaceuticals Inc., of Mountain View, Calif., said it started a Phase IIb study testing EPI-743 in patients with Friedreich's ataxia. The six-month study, expected to be followed by an extension phase, will enroll patients between the ages of 18 and 45 who possess genetic confirmation of Friedreich's ataxia. Read More
• Merck & Co. Inc., of Whitehouse Station, N.J., said its resubmitted new drug application for sugammadex sodium injection was accepted for review by the FDA. Merck expects the agency's review to be completed in the first half of this year. Read More
• Baxter International Inc., of Deerfield, Ill., said it submitted an investigational new drug application for hemophilia A candidate BAX 855, a full-length longer-acting recombinant Factor VIII developed to increase the half-life of ADVATE (Antihemophilic Factor [Recombinant] Plasma/Albumin-Free Method). Read More
