Four years ago, the US Food and Drug Administration launched its “breakthrough designation” program, designed to speed the review and potential approval of new therapeutics deemed to offer the possibility of substantial improvement over existing options for patients with life-threatening or serious diseases. Since then, the FDA has approved more than 30 drugs in this category, many...
For many young biotech and pharma companies, the decision about how to take their first drug to Europe has been simple: just license the European marketing rights to a company that already is well established there, and collect milestone payments and a stream of royalties. For an inexperienced company, dealing with the European regulatory and...
We are looking forward to attending the JP Morgan Healthcare Conference again January 11-14, 2016, in San Francisco. Three of Bionest’s leaders, Alain J. Gilbert, Olivier Lesueur, and Bob Easton, will be available to meet one-on-one for 30 minutes in our private suite, between Monday Jan 11 and Thursday Jan 14. For Bionest,...
Bionest attended BIO Europe in Munich last month and witnessed firsthand the flurry of deal making activity. In many ways 2015 has been a landmark year for deal making. Companies big and small have made headlines, striking deals across every corner of the industry and for myriad reasons ranging from combination collaborations to the recent...