Gilead Sciences Inc. made a long-awaited M&A move with a deal to acquire Nimbus Apollo Inc., a wholly owned subsidiary of Nimbus Therapeutics, for $400 million up front and $800 million in development-related milestone payments. Read More
Despite a clinical hold that's been in place since December 2015, Zafgen Inc. continued to report promising findings with the full dataset from the bestPWS ZAF-311 study of beloranib, taking another step to put the asset back on track. Read More
AB Science SA's shotgun approach to drug development appears to have scored another late-stage win. Just months after reporting positive phase III data with tyrosine kinase inhibitor masitinib in mastocytosis, the Paris-based firm disclosed interim results from a phase III study in which the drug met the primary objective in amyotrophic lateral sclerosis (ALS), a condition that has been littered with failure in the past two decades. Read More
STOCKHOLM – After its fall meeting in Germany, EBD Group's BIO-Europe spring partnering meeting normally heads south to the warmer climes of Spain or Italy. This year, however, it headed north to Stockholm, where spring is still more a suggestion than a reality. Read More
STOCKHOLM – With pressures to provide ever greater value for money spilling out of Europe and into the U.S., interest in leveraging open innovation to access fresh ideas at the earliest possible moment is gaining increasing traction in all quarters of the industry, delegates at BIO-Europe said Monday. Read More
LONDON – A U.K. study into the pricing and reimbursement of potentially curative but very expensive regenerative therapies has called for a new payment-by-results approach and suggests that rather than buying products outright, there should be a system of lifetime leasing. Read More
HONG KONG — Japanese scientists from the Riken Center for Developmental Biology (CDB) have for the first time successfully grown complex skin tissue complete with hair follicles and oil-secreting sebaceous glands using reprogrammed induced pluripotent stem (iPS) cells. They then transplanted it into living mice, paving the way for growing functional skin grafts for use in regenerative medicine. Read More
Instead of its usual untitled letter, the FDA's Office of Prescription Drug Promotion (OPDP) stepped it up a notch in sending a warning letter to Shionogi Inc., of Florham Park, N.J., part of Shionogi & Co. Ltd., citing issues with a patient co-pay assistance voucher for the company's head lice lotion Ulesfia (benzyl alcohol). Read More
Entasis Therapeutics Inc., of Waltham, Mass., said it completed a $50 million series B financing to advance its pipeline of clinical and preclinical products for treating major gram-negative infections. The financing was led by Clarus and included Frazier Healthcare Partners, Novo A/S, and Eventide Funds, who joined founding investor Astrazeneca plc. Read More
Bristol-Myers Squibb Co., of New York, said it has completed the acquisition of Padlock Therapeutics Inc., which includes full rights to their protein/peptidyl arginine deiminase (PAD) inhibitor discovery program focused on the development of potentially transformational treatment approaches for patients with rheumatoid arthritis and other autoimmune diseases. Read More
Stealth Biotherapeutics Inc., of Newton, Mass., presented results from the phase I PREVIEW trial testing elamipretide (formerly Bendavia) in heart failure patients with reduced ejection fraction, showing that the drug appeared safe and well tolerated with demonstrated improvements in key secondary efficacy measures. Read More
Alexion Pharmaceuticals Inc., of New Haven, Conn., said researchers presented data showing children with perinatal- and infantile-onset hypophosphatasia (HPP) treated with Strensiq (asfotase alfa) had statistically significant improvements in bone healing as assessed radiographically, which were sustained through 3.5 years of treatment. Read More
Paratek Pharmaceuticals Inc., of Boston, completed enrollment in the pivotal phase III clinical study of intravenous and once-daily oral formulations of omadacycline, a broad-spectrum antibiotic, compared to linezolid to treat acute bacterial skin and skin structure infections. Read More