LONDON – Ablynx NV has formed a second partnership with Merck & Co. Inc, which will see the two collaborate to develop cancer immunotherapies in a deal with a headline value of $2.3 billion, almost quadruple that of their first agreement in neuroscience. Read More
LONDON – Pharma’s dependence on biotechs and academics for innovation is highlighted in an analysis of the 94 novel drugs approved in Europe from 2010 to 2012, which shows that while 87 percent of the approvals were granted to pharmaceutical companies, more than half of the products had their origins outside corporate laboratories. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) is ramping up efforts to make certain that clinical trials include wide enough breadths of patient populations, and don’t unnecessarily keep out subjects with multiple chronic conditions (MCCs) who could turn up important data that would otherwise be missed. Read More
With an eye on enhancing biologic competition, the FTC is diving into some of the issues that will shape the biosimilar market in the U.S. But the Congressional Research Service (CRS) isn’t holding its breath as it waits for the competition to hit. Read More
Last week, the news that exposing mature cells to stressful environments such as low pH can induce a stem cell-like state was greeted with much excitement, as stimulus-triggered acquisition of pluripotency cells (STAP cells) joined embryonic stem cells (ES cells) and induced pluripotent stem cells (iPS cells) as a cell type that might ultimately provide materials for autologous cell transplants. Read More
Endo Health Solutions, of Malvern, Pa., said its Qualitest subsidiary completed the acquisition of Boca Pharmacal, of Coral Springs, Fla., a specialty pharmaceutical company, for approximately $225 million in cash. Read More
Cel-Sci Corp., of Vienna, Va., said the institutional review board of the U.S. Navy’s Naval Medical Center, of San Diego, approved the start of a Phase I dose-escalation study of immunotherapy Multikine (leukocyte interleukin, injection) in HIV/human papillomavirus co-infected men and women with perianal warts. Read More
Alimera Sciences Inc., of Atlanta, said it closed a private placement of common stock on Jan. 31, with gross proceeds from the offering totaling about $37.5 million. Read More
Forest Laboratories Inc., of New York, said it, along with Merz Pharma GmbH & Co. KgaA, of Frankfurt, Germany, and Adamas Pharmaceuticals Inc., of Emeryville, Calif., jointly filed a lawsuit in the U.S. District Court for the District of Delaware against several companies for the infringement of some or all of the patents relating to Forest’s Namenda XR (memantine HCl extended-release capsule) product. Read More
Pfizer Inc., of New York, said the randomized Phase II (PALOMA-1) of palbociclib achieved its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in progression-free survival for the combination of palbociclib and letrozole compared to letrozole alone in postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or newly diagnosed metastatic breast cancer. Read More
