The biopharma sector has had quite a year. Under FDA Commissioner Scott Gottlieb, the regulator approved a record number of drugs and helped usher in innovative gene therapy treatments. Behavioral health drugs also marked a milestone with the approval of Otsuka Pharmaceutical’s Abilify MyCite, embedded with a sensor developed by Proteus Digital Health to remotely monitor medication adherence for people with schizophrenia and bipolar disorders.
The FDA has released a range of decisions regarding the agency’s role in regulating digital health technologies since Scott Gottlieb, MD, assumed the role of commissioner in May.
Here are three highlights from the FDA’s year in digital health.
In covering the D.C. innovation economy comes the inevitable: funding news. Trust us, there’s a lot of it floating around the D.C. metro area. Here’s a roundup of all of the major funding news from the region in December:
Dr. David Feinberg has served as president and CEO of Danville, Pennsylvania-based Geisinger since 2015. Previously, he was president of UCLA Health System, CEO of UCLA’s hospitals and associate vice chancellor of UCLA Health Sciences.
New Enterprise Associates made the most venture deals for the second year in a row in 2017, with 125 investments totaling $914 million, according to VCJ’s analysis of preliminary Thomson Reuters data through mid-December.
Precision Medicine Group announced it had raised $275 million. The round was led by Berkshire Partners and TPG Growth, with participation from its co-founders and management team, as well as original investors Oak Investment Partners and J.H. Whitney.
When the University System of Maryland set its strategic plan for the next 10 years in 2010, it hoped to double the system’s externally sponsored research and development funding from $1.2 billion to $2.4 billion. Instead, as federal dollars have dried up, that number has remained relatively flat, up to just $1.27 billion with three years
Global pharmaceutical company Mallinckrodt Plc (NYSE: MNK) has entered an agreement to buy Rockville’s Sucampo Pharmaceuticals Inc. (NASDAQ: SCMP) for $1.2 billion including debt.
Shanghai-based pharmaceutical company WuXi AppTec Group is partnering with Merck Serono, a subsidiary of company Merck KGaA, to launch a pharma and biotech startup incubator in Israel in early 2018. Israel-born businessman Mori Arkin and life sciences-focused venture capital fund Pontifax Ltd. will also be part of the venture. The plans were declared last week in an event held by the partners in Tel Aviv.
Swiss pharma giant Roche has given itself a pricey holiday gift and deepened its oncology product portfolio with its $1.7 billion acquisition of immuno-oncology business Ignyta. Based in San Diego, the company tests, identifies, and treat patients with cancers that come with rare mutations.
