DUBLIN – Prosensa Holding NV hopped off the rollercoaster it's been traveling on for more than a year by agreeing to a cash acquisition deal with Biomarin Pharmaceutical Inc. worth about $680 million up front, with another $160 million to come in two near-term regulatory milestones. Read More
Patients are astonished when they learn that the development of most drugs has, historically, not incorporated human differences into the design equation. How and why age, ethnicity, gender and race haven't been woven into most clinical trial designs makes most people in the industry cringe because the issue is immensely complicated. Read More
Following up its March deal with Bristol-Myers Squibb Co. (BMS) centered on a pair of undisclosed checkpoint inhibitors, Five Prime Therapeutics Inc. entered a new arrangement with BMS that brings $30 million up front and may hold the key to getting around resistance problems. Read More
A class of HIV drugs could potentially be repurposed to treat dry age-related macular degeneration (AMD), as well as used as a research tool and possibly a therapeutic option, for diseases that are due to activation of the inflammasome. Read More
Genome engineering firm Transposagen Biopharmaceuticals Inc. will seek to segue into a long-planned run at drug development as it joins the increasingly crowded race to develop chimeric antigen receptor T cells (CAR-T) through a research collaboration and global license deal with Janssen Biotech Inc., a unit of Johnson & Johnson. Read More
Merck & Co. Inc. licensed global R&D and manufacturing rights for Newlink Genetics Corp.'s phase I Ebola vaccine, agreeing to pay the immunotherapy developer $30 million up front, plus $20 million more once efficacy testing begins early next year. Read More
strong>Oncore Biopharma Inc., of Doylestown, Pa., said it confidentially submitted a draft registration statement to the SEC for a proposed initial public offering. The date of the proposed offering and the number and price of the shares of common stock to be offered have not yet been determined. Read More
Insys Therapeutics Inc., of Phoenix, said the FDA granted orphan drug designation to its pharmaceutical cannabidiol candidate to treat pediatric schizophrenia, marking the fifth such designation for the company's cannabidiol program. Read More
Genmab A/S, of Copenhagen, Denmark, said partner Janssen Biotech Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson, plans to start enrolling patients in a phase II study of the CD38 monoclonal antibody daratumumab in high-risk smoldering multiple myeloma next year. Read More
Merck & Co. Inc., of Whitehouse Station, N.J., said it submitted a new drug application for omarigliptin, its once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes, to the Japanese Pharmaceuticals and Medical Devices Agency. Read More
