Sometimes Speed Is Not The Best Answer
The expedited drug approval process by the U.S. Food and Drug Administration (FDA) is a double-edged sword. Designed to bring lifesaving treatments to market swiftly, particularly for severe conditions, this process has encountered significant criticism for its implications on patient safety and the integrity of drug efficacy data. Pharmaceutical and biotech companies eyeing this expedited […]
Venture Capital Update
The National Venture Capital Association (“NVCA”) has innovated again in venture capital. They’ve updated their standard template legal documents, a first since 2014. This refresh includes cryptocurrency and workplace conduct updates. It’s a modern twist on classic standards, aiming for progress and integrity. Crowley Law has deep venture capital and startup expertise. We are well-versed in […]
LIFE-SAVING HELP FOR INFANTS AND SENIORS
Great news for prevention of respiratory syncytial virus (“RSV”) infections! Here’s a quick summary of the article: RSV is a common respiratory virus that, in most children through adults, causes mild, cold-like symptoms. However, that’s not the case for infants and adults aged 65 and older. The disease causes approximately 58,000 hospitalizations in the United States […]
GOVERNMENT PROGRAMS ARE THE “TAR BABY”
Have you ever heard of a tar baby? In the 1946 Disney animated film “Song of the South” (now banned by Disney as “unwoke”), Brer Rabbit starts punching a figure made of coal tar by Brer Fox and Brer Bear, two of the other mischievous characters. Instead of resisting, the figure just adheres to its assailant […]
Corporate Transparency Act Ruled Unconstitutional!!!
Big news on the legal front! The U.S. District Court for Northern Alabama has just ruled that the Federal Corporate Transparency Act (“CTA”) is unconstitutional. This ruling came as a result of a lawsuit by National Small Business United, a trade group of over 40,000 members. Summary: · The Federal District Court for the Northern District of Alabama has ruled […]
NEW HONORS FOR PRESIDENT OF STEVENS INSTITUTE OF TECHNOLOGY
We are delighted to report a new recognition for Nariman Farvardin, President of Stevens Institute of Technology. He is to be awarded the Ellis Island Medal of Honor. This award is intended to recognize individuals who have made it their mission to share with those less fortunate, their wealth of knowledge, indomitable courage, boundless compassion, unique […]
BEWARE: CYBER ATTACKS ON AI SYSTEMS
Artificial intelligence systems will be the savior of mankind! Artificial intelligence systems will doom mankind! Which statement is true?? Who knows at this point? But one thing is certain, this new powerful technology will have a tremendous impact on the work we do and how we interact with one another. Artificial intelligence (“AI”) systems are indeed powerful […]
NJ BIOTECH IMPACT ON PATIENTS
The BioNJ 31st Annual Dinner Meeting and Innovation Celebration, held on February 8, 2024, was a significant event that showcased the vibrant life sciences industry in New Jersey. Under the theme “Toasting New Jersey’s Amazing Life Sciences Industry,” this gathering highlighted the State’s role as a leading innovation powerhouse, especially in the field of medical […]
TO ROBOT OR NOT TO ROBOT – THERE’S THE QUESTION!
Sometimes a technical innovation fails to deliver improved patient outcomes. An example may be robotic-assisted knee replacements. Robotic-assisted knee replacements, especially using Stryker’s Mako system, have become increasingly common in the U.S. This surge in robotic surgeries signifies a major leap in medical practices. The promise was to provide improvements in surgical outcomes. However, the transition […]
WILL THE FEDERAL GOVERNMENT “MARCH IN” TO YOUR PATENT RIGHTS?
Did you know that the Federal government could be your “partner” in ownership of your patent rights? That could happen if your patented technology resulted from research sponsored by a government grant. The National Institute of Standards and Technology (“NIST”) recently released a draft framework that has garnered significant attention, particularly for its implications on the U.S. government’s exercise […]
Help for Startup Founders
Stage2Startups has a wonderful focus. It seeks to help “mature” entrepreneurs who have had a lot of “life experience” start new businesses. I had an opportunity to present to many mature startup entrepreneurs on a Stage2Startups webinar on issues that are important to the success of startup ventures. One of the key issues we covered was […]
PENN WEALTH PLANNING ROCKS!
I’m happy to send congratulations to my friend and colleague, Lisa Policare, CEO of Penn Wealth Planning on being recognized in the 2024 Forbes Best-in-State Wealth Management Teams list. The list, compiled by Shook Research based on hundreds of interviews, focuses on advisors with demonstrated track records of success over many years. Lisa has been […]
WATCH OUT! SERIOUS NEW COMPLIANCE REQUIREMENTS ARE COMING
Small privately-held companies will have new compliance burdens starting in the new year. The Federal Corporate Transparency Act (“CTA”) will require substantial disclosures of company and personal information and updates of that information with severe penalties for non-compliance. The following summary provides an overview of key considerations. For questions about how your unique situation impacts compliance, contact […]
Bio NJ Loves Life Sciences Startups
Bio NJ has some tremendous opportunities for C-suite executives at life sciences companies. Bio NJ has established a networking and discussion group exclusively for founders and C-Suite executives of life sciences companies. It provides leaders of those companies with opportunities to compare notes, ask questions and benefit from the experience of similarly situated entrepreneurs in a […]
BIOMEDICAL ENGINEERING ON PARADE
Here’s a great opportunity for those interested in biomedical research and entrepreneurship. The Biomedical Engineering Department at Stevens Institute of Technology in Hoboken, NJ is hosting its BME Day event on Friday, February 2, on its beautiful campus. The event will feature a keynote address by Dr. Martha J. Connolly, the former Director of the Maryland Industrial Partnerships, an award […]
ORPHAN DRUGS TO THE RESCUE
Orphan drug development is a crucial and complex area of pharmaceutical research. It’s dedicated to creating treatments for rare diseases. These drugs are designated as ‘orphan’ because, without government assistance, the pharmaceutical industry has little financial incentive to develop treatments. The markets are small but the costs to develop treatments are still large. Here’s an overview […]
PROGRESS IN PREVENTING BLINDNESS
Losing one’s sight is one of the cruelest types of disabilities. We depend on that sense for so much of what we do. So, it’s always encouraging to see advances that limit or eliminate causes of severe vision loss and/or blindness – and the types of corporate and commercial transactions that can accelerate that effort. […]
WHAT IS A FINCEN ID NUMBER AND HOW DO I GET ONE?
A significant new reporting requirement started on January 1, 2024. The Federal Corporate Transparency Act requires that most small limited liability companies and corporations must disclose the beneficial owners of equity interests in those entities. Failure to comply can result in substantial financial and potential criminal penalties. So, what should companies, their officers and directors, […]
Congratulations to Ralph Selitto and John Kim
I’m sending congratulations to my friends and fellow lawyers, Ralph Selitto and John Kim. Both are experienced intellectual property lawyers who have just joined the international legal powerhouse Clark Hill. Ralph and John will be working in the Clark Hill offices in Phoenix and Scottsdale, Arizona. See the Clark Hill announcement here. Ralph and I are […]
MEDICAL DEVICE INNOVATIONS YOU NEED TO KNOW ABOUT
The realm of medical devices has seen remarkable advancements in 2023. Innovators need to be aware of these advancements to assess the opportunities they provide for making healthcare more efficient, more effective and more patient-centric. Let’s explore three of these significant developments: 1. Enhanced Robotic Surgical Systems: Offering unprecedented precision in surgeries. 2. Breakthrough Non-Invasive Diagnostic Devices: […]
CRISPR Eyes Autoimmune Disease: What are the implications?
Key Highlights: · Strategic Shift: CRISPR Therapeutics is pivoting from cancer drug development to cell-based medicines for autoimmune diseases. · Potent Alternatives: The company focuses on advancing two newer, more potent cell therapy candidates, with lupus as a primary target. · Regulatory Milestone: Anticipation builds for FDA’s potential […]
Harnessing the Power of Cell and Gene Therapy
It’s not just your hometown physician’s travel bag anymore! In the dynamic field of life sciences, cell and gene therapy have emerged as revolutionary forces. It redefines our approach to treating complex diseases. This blog post delves into the latest advancements in these therapies, exploring how they are transforming patient care and what the future may […]
New Approaches in Cancer Drug Development
One of the features that excites me about representing life sciences and other technology innovators is the impact they can have on our society. I enjoy using the skills I learned in over 30 years of working with business leaders at a global health products company to help those innovators navigate the pathway to the […]
CRISPR GENE EDITING FOR SICKLE CELL DISEASE: A NEW ERA OF HOPE
We live in an extraordinary time. It’s a time where technology in life sciences is peeling back the curtain on the underlying causes of disease. In this note, I’ll cover recent developments in gene editing therapies: Crowley Law LLC is devoted to helping life sciences and other technology entrepreneurs realize their dreams – taking ideas […]
STEVENS INSTITUTE HAS GOOD NEWS ON CANCER THERAPEUTICS
Stevens Institute of Technology (“Stevens”) has announced some great results impacting cancer therapies. In this note, I’ll describe Crowley Law is delighted to be supporting innovators in the life sciences and other technology areas. If you are a life sciences or other technology innovator with an idea you’re developing into products, services and a business, my […]
