The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MITA announces new health care supplier standard; Laggardly patient record response costs provider $75k; New med-tech resource platform now includes logistics; Spectrascience the subject of speculation, SEC action; HC nudging along with regulatory modernization plan.
U.S. federal government enforcement of the Foreign Corrupt Practices Act (FCPA) might not draw the attention that other matters draw, but the Securities and Exchange Commission (SEC) has made extensive use of the FCPA in 2020. SEC actions related to the FCPA may have accounted for only about 2% of the agency’s actions over the past year, but nonetheless accounted for nearly 80% of the penalties collected by the agency, and health care was second only to the oil and gas industries as the targets of FCPA action by the agency.
When entrepreneurs and emerging businesses raise seed capital for a new business or generate funding for business growth, they often turn to the exempt offering framework under the Securities Act. However, when doing so, they are faced with a confusing and complex system that must be navigated. To simplify the process, the SEC has announced that it is amending its rules that govern offering exemptions, which small and medium-sized business rely on to raise capital.
Public drug and device companies may want to think twice before eagerly jumping on the COVID-19 bandwagon with announcements overselling their efforts to develop or repurpose products to treat patients infected with the coronavirus.
Another volatile day of trading in health care stocks unfolded March 13, after a trebling of broader market carnage the day before and the declaration of a national emergency by U.S. President Donald Trump Friday afternoon. Substantial declines hit shares of Moderna Inc., Vaxart Inc. and Inovio Pharmaceuticals Inc., all of which had recently rallied on optimism over coronavirus-fighting efforts. Biopharma shares saw some recovery, with both the S&P 500 Health Care Sector and Nasdaq biotechnology indices each rising a bit more than 2% each before Friday's close.
The U.S. Securities and Exchange Commission (SEC) Thursday extended the public on-ramp for small companies that take longer than five years to generate $100 million in annual revenue, as well as some of the business development companies that invest in them.
Quarterly financial reporting for public companies is costly and ties up senior management and board members for several days before each quarterly earnings report is released and the 10-Q is filed. Could this process be made more efficient and less frequent, such as a semi-annual filing like many reporting companies based in Europe have implemented? That was one of the questions considered by a roundtable hosted by the SEC's Division of Corporation Finance where key stakeholders delved into the impact of short-termism on U.S. capital markets and whether the SEC's current reporting system needs to be changed to ease administrative and other burdens on reporting companies.
Quarterly financial reporting for public companies is costly and ties up senior management and board members for several days before each quarterly earnings report is released and the 10-Q is filed. Could this process be made more efficient and less frequent such as a semi-annual filing like many reporting companies based in Europe have implemented?
With a new year, old impatience is growing among small companies and investors eager to see the potential of federally sanctioned crowdfunding take off. In January, biotech hotbed Massachusetts, as well as Oregon and Maine, joined a growing list of states taking matters into their own hands. Irritated by the SEC's sauntering approach to finalizing proposed rules it drafted to implement crowdfunding provisions in the 2012 Jumpstart Our Business Startups (JOBS) Act, they joined a growing roster of states that have adopted their own rules for governing the offerings. (See BioWorld Insight, Aug. 11, 2014.) Massachusetts' new rules, like all...
It’s been 16 years since I first reported in BioWorld Today that David Blech was charged with securities fraud. In April 1997, I reached him at his New York office a few days after his arraignment in a U.S. District Court. Though he wouldn’t comment on the case, he chided me repeatedly for using the word “arrested,” insisting that I tell our readers he “appeared voluntarily” for the arraignment, still worried about his reputation ‑ as if it wasn’t already rubbish. Frankly, I’m satisfied he’s going to serve time. Angry that our judicial system can’t penalize him with a longer...
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