Last week the SEC issued a staff report seeking reaction to proposed amendments to the definition of an “accredited investor.” Regulation D is the most relied-upon exemption from SEC (and typically State) registration requirements for the sale of securities, and … Continue reading
Stephen Honig
The SEC has been entertaining, for several years, a rule requiring reporting companies to disclose political contributions. Yesterday, a compromise budget bill was announced by Speaker Ryan which includes a rider barring the SEC from finalizing, issuing or implementing any … Continue reading
Dealing with the FDA today is getting slightly easier, but it is nothing to write home about. Agency plans will attempt to improve the regulatory experience; success remains to be demonstrated. Presentations by a research firm and by the Regional … Continue reading
Where is health care going in the United States? Well, no big surprises: it is costing more, is on an upwards cost trend given demographics (e.g. we are getting older as a population), and it is harder to get reimbursement. … Continue reading
At the December 9 symposium on FDA issues for medical device companies sponsored in Waltham by MassMEDIC (the association of device manufacturers), legislation passed by the House of Representatives that would greatly assist the industry was outlined, for the benefit … Continue reading
Current literature is full of warnings about individual liability of directors when corporations violate governmental laws or regulations. I suggest that the practical risk for directors is minimal. The United States Attorney General’s Office is out to emphasize that individuals … Continue reading
A November 13 presentation at the Boston offices of DuaneMorris, by Japanese pharma giant Takeda, addressed to a group of life science and healthcare investors, contained stark facts concerning the cost and difficulty of creating new, significant drugs outside the … Continue reading
What should compensation committees consider when determining executive compensation? The answer, according to an expert panel convened by the National Association of Corporate Directors in Boston on November 10th, seems to be: just about everything. It is axiomatic that compensation … Continue reading
On October 30, the SEC at long long last promulgated final rules for true crowdfunding, a mere three and a half years after receiving instructions from Congress to do just that. Whether this Federal program will replace other crowdfunding solutions, some of … Continue reading
80% of mobile “wearable” medical devices today are focused on the treatment of chronic disease; some are good, some “garbage,” and in any event more than half of them will disappear in three years. This was the view expressed by … Continue reading