GAITHERSBURG, Md. – The Nov. 13 U.S. FDA hearing on immune response to metal-containing implanted medical devices suggested that there are many more questions than answers about how to prevent the associated adverse events. However, a key hurdle is the absence of widely recognized tests for determining patient sensitivity to these metals.

Bayer AG led a $40 million series B financing for Informed Data Systems Inc. (IDS) and its One Drop diabetes management platform. The pharma giant also inked a licensing agreement to leverage IDS, which does business as One Drop, in therapeutic areas beyond diabetes and secured a seat on One Drop's board of directors.

Pharmaceutical and life sciences giant Bayer AG scored another indication for its MRI contrast agent, Gadavist (gadobutrol) injection, this time in adults with suspected coronary artery disease. The FDA nod makes Gadavist the first and only contrast agent approved for use in cardiac magnetic resonance (CMR) imaging.

Century Therapeutics Inc. came out of stealth mode Monday with $250 million in funding commitments from lead investor Bayer AG, founding investor Versant Ventures and strategic partner Fujifilm Holdings Corp. to develop next-generation allogeneic cell therapies for cancer, based on induced pluripotent stem cells (iPSCs).