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 ...
Newsletters & Blogs
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 progres...
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 significant global health challenge, causing thousands of hospitalizations and deaths annually in the US, and many more worldwide, particularly among infants and ol...
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 ...
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: · ...
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 ...
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 ...
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 a...
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 ...
BIOMEDICAL ENGINEERING ROCKS
Last week I had the opportunity to attend the BioMedical Engineering Day at Stevens Institute of Technology in Hoboken, New Jersey. It reinforced for me the tremendous capabilities of this program and the opportunities for innovation that biomedical engineering provides. Summary Points The...
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 fram...
Help for Startup Founders
Hiring-$700-Per-Hour-Business-Attorney-Startups-Business-Formation-US-Guide-Phil-Crowley-Esq-Legal-Principles-Before-First-Sale-Company-Formation-LLC-Corporation-Operating-Agreement-Intellectual-Property-Tax-Implications-Stock-Vesting-Avoiding-Conflict
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 ...
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 followi...
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 n...
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 addr...
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 treatmen...
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 ca...
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 ...
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, Ar...
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: ...
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....
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...
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 nav...
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: A background on CRISPR The impact of CRISPR technology on sickle cell dise...