The Securities and Exchange Commission (SEC) has recently instituted new rules pertaining to cybersecurity disclosure. These are particularly relevant to Canadian issuers that are reporting issuers with the SEC. This latest regulatory shift marks a critical update for many international corporations and legal firms providing counsel on regulatory compliance. The new rules are found to…
The U.S. Food and Drug Administration (FDA) has initiated a priority review of Merck’s supplemental Biologics License Application (sBLA), according to a recent announcement made by Merck on 20th September. The application specifically involves the use of KEYTRUDA (pembrolizumab), an anti-PD-1 therapy that Merck is aiming to use as part of an innovative treatment plan…
The UK’s Financial Conduct Authority (FCA) and Prudential Regulation Authority (PRA) have recently unveiled their long-anticipated consulatations on diversity and inclusion (D&I) policy, linked to financial services firm misconduct. Detailed in separate but related papers from each authority (FCA CP23/20 and PRA CP18/23), these consultations follow a joint Discussion Paper issued in July 2021. The…
On the 13th of September 2023, Oliver Street Dermatology Management LLC, a renown dermatology practice manager, reached a settlement with the U.S. Attorney’s Office for the Northern District of Texas. According to the Public Report, Oliver Street agreed to a payment of $8.892 million to the United States to resolve self-reported allegations of violating multiple…
The Office of the Comptroller of the Currency’s (OCC) Committee on Bank Supervision has recently published its bank supervision operating plan for the fiscal year 2024. The plan, released on September 28, lays out the agency’s supervisory priorities along with several areas of increased attentiveness. The primary intention of this plan is to guide the…
With the rapid fusion of artificial intelligence (AI) and digital health, the landscape of the healthcare industry is taking a transformative turn. An example of this change can be seen in the AI & Digital Health, Digital Deep Dive webinar held recently, which was a part of more comprehensive series highlighting the intersection of AI,…
The Internal Revenue Service (IRS) has issued new guidelines for employers that have or are contemplating the implementation of leave-based programs. These programs permit employees to forfeit sick, vacation, or personal leave in order for their employers to make donations to charitable organisations, specifically those assisting victims of the 2023 Hawaii wildfires. The information came…
In a significant turn of events, Columbia University found itself with a remarkably favorable ruling in an ongoing Intellectual Property (IP) case involving NortonLifeLock Inc. A Virginia Federal Judge has notably elevated the penalty amount, nearly tripling the previous financial staking the jury had decreed NortonLifeLock Inc. to pay Columbia University. The court finds the…
The ongoing United Auto Workers (UAW) strike across 38 locations in 20 states threatens to cause sizable disruptions in the automotive supply chain. The strike is poised to particularly impact the supply of electronics for automotive manufacturers. According to an article by Reed Smith on JD Supra, potential disruptions could cause significant financial setbacks. This…
In a recent development on an intellectual property case, a Virginia federal judge increased the payment that NortonLifeLock Inc. is obligated to pay Columbia University almost threefold, due to deliberate infringement of anti-malware patents. Furthermore, the judge held the attorneys of the cybersecurity company, Quinn Emanuel Urquhart & Sullivan LLP as contempt. The litigant Columbia…
In an interesting analysis, Gillian Drake dives into the concept of the likable witness and discusses six personality archetypes to cultivate for a more effective representation in court. Tackling issues of trial witness preparation, she suggests a handful of key methods to identify and enhance a witness’s naturally likable personality type. These developed personalities, according…
The summer of 2023 ended with substantial developments in employment law, as reported by Michael Schmidt in his podcast, Employment Law Now VII-136. Noteworthy topics included the Equal Employment Opportunity Commission’s (EEOC) new harassment guidance and proposed regulations to actualize the Pregnant Workers Fairness Act, issues around federal AI legislation, and intriguing advancements in the…
Welcome back to our weekly roundup intended for legal professionals invested in the evolving landscape of marijuana legalization. Top on this week’s roundup is the significant progress of cannabis-related legislation in the Senate. For the first time in history, a cannabis bill, specifically the Secure and Fair Enforcement (SAFE) Banking Act, has received a markup…
In response to the COVID-19 pandemic, a number of sweeping legal changes have been observed in the field of telemedicine across the United States. This shift toward a more digitally enabled healthcare sector, though spurred by necessity amidst a global health crisis, could have long term ramifications for healthcare systems, legal professionals, and the public…
On September 20, 2023, during its first in-person open meeting since the COVID-19 pandemic, the U.S. Securities and Exchange Commission (SEC) adopted amendments to the Names Rule under Section 35(d) of the Investment Company Act of 1940, in a four-to-one vote. The details of the amendments show the SEC also adopted related disclosure and record…
When the US Congress missed agreeing on a new budget by midnight on September 30, 2023, it cast a long shadow of uncertainty over countless federal programs, many of which are now left in flux due to the subsequent government shutdown. Experts foresee significant impacts on the contracts for supplies and services, which fall under…
For legal professionals actively tracking consumer litigation, August reflected a significant spike in filings. Recentally, WebRecon published a report detailing an upward trend in court filings under the Fair Credit Reporting Act (FCRA), Fair Debt Collection Practices Act (FDCPA), and Telephone Consumer Protection Act (TCPA). WebRecon’s findings disclosed that the quantity of complaints filed with…
On August 22, 2023, the Federal Circuit issued a nonprecedential decision, a hallmark case between Sun Pharmaceuticals Industries, Inc. and Incyte Corp., that has stirred conversation amongst legal professionals in the pharmaceutical industry. The court held that claims directed to deuterated analogs of ruxolitinib, a powerful treatment option for diseases like myelofibrosis, were unpatentable as…
Customer Relationship Management (CRM) systems have progressed from being simple repositories of contact information to intelligent platforms that provide actionable insights and facilitate personalized customer experiences. These advancements have primarily been driven by the integration of artificial intelligence, machine learning and predictive analytics. A piece by ClientsFirst Consulting provides further detail on these expanding capabilities…
The potential of a government shutdown is looming large and a host of federal government programs and agencies are expected to feel the impact, notably immigration. The immigration-related programs, employers, and foreign workers could face significant implications due to such a shutdown. An insightful examination by Miles & Stockbridge P.C, sheds ample clarity on the…
In an aggressive week of enforcement actions by The Securities and Exchange Commission (SEC), Big Law firms and boutiques alike find themselves in a surge of work. Actions have been taken mainly against broker-dealers, corporate insiders and others. Previously in September, the SEC had already announced settlements or charges in more than three dozen matters….
The ‘Yes in God’s Back Yard’ (YIGBY) legislation, officially titled SB 4, holds the potential to significantly redefine the landscape of affordable housing development. This forthcoming change is courtesy of senator Scott Weiner and assemblymember Tina McKinnor’s bold efforts in pushing a unique initiative that could help combat the increasing housing crisis. More formally known…
The US Departments of Labor, Health and Human Services, and the Treasury (collectively referred to as ‘the Departments’) have issued a string of proposed regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA), which have sparked widespread interest across all corners of the legal profession. Our focus today revolves around the ‘Meaning of…
In a notable U.S. District Court for the Eastern District of New York decision on September 19, the courts allowed claims by two pro se plaintiffs against alleged inappropriate debt collection efforts to partly proceed. This lawsuit pertains to a balance due from a timeshare membership program which allegedly violated the Fair Debt Collection Practices…
The legal landscape in Luxembourg has seen recent adjustment due to the enactment of a new law on August 7, 2023. Eminent law firm Allen & Overy previously reported, in their article about hiring third-country nationals in Luxembourg, that this legislation has implications for Luxembourg employers intending to hire a third-country national (TCN) — defined…