Google Glass? Fitbit? DNA necktie? Again this year, BioWorld Today polled our staffers, biotech execs, PR folks, tweeps and others in the science world to bring our readers top finds for the holidays. Enjoy! Books and entertainment In February, the FDA met to consider whether and how to conduct trials to test gene manipulation techniques to prevent mitochondrial disease from occurring in offspring. “Are we heading to a world envisaged in Gattaca?” asked BioWorld Insight Editor Peter Winter, suggesting it might be time to substitute the 1997 movie for the even older holiday classic, Miracle on 34th Street. (Just...
After decades of foot-dragging, the FDA has put drugmakers on notice that greater inclusion in clinical trials – balanced gender enrollment, more cultural diversity and wider age spans – is coming.
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.
Checkpoint inhibitors (CIs) are among the hottest tickets in biopharma, with a handful of deals this year showing that no respectable oncology pipeline can be without one. Combined with traditional chemotherapy and radiation treatment, CIs made a big first impression in metastatic melanoma, thanks to the early success of Yervoy (ipilimumab, Bristol-Myers Squibb Co.).
In a major policy shift, the Department of Health and Human Services issued a Notice of Proposed Rulemaking (NPRM) requiring researchers to submit results from trials of investigational compounds that fail to meet clinical or safety endpoints – findings that often remain hidden under current practice.
Founded less than two years ago, Arcturus Therapeutics Inc. started from ground zero as a Johnson & Johnson Innovation tenant, with no assets, technology or pipeline in hand. That situation changed quickly. In June 2013, the San Diego-based company raised $1.3 million in seed funding from high net worth investors from the U.S. and Canada. Four months later, the company tapped most of those investors again and added interests from Japan in a $5 million series A round.
Drugmakers that complain about the growing cost to bring new molecular entities to market aren't exaggerating, according to a study released Tuesday by the Tufts Center for the Study of Drug Development (CSDD).
In the end, R&D sealed the deal. Allergan Inc. rejected the hostile overtures of one giant specialty pharma for a deal with another, fleeing from Valeant Pharmaceuticals International Inc. into the waiting arms of Actavis plc.
Fibrogen Inc. became the Street's new biotech sweetheart Friday, pricing its upsized initial public offering (IPO) of 8.1 million shares at $18 apiece, the high end of its range, to raise $145.8 million. The company could add another $21.9 million and become the largest U.S.-based biotech IPO this year, if underwriters fill a 30-day overallotment option to purchase an additional 1.2 million shares, eclipsing the $146.6 million raised by Santa Monica, Calif.-based Kite Pharma Inc. in its IPO.
