There's no stopping Mother Nature when she gets going. The striking force of a tornado recently tore through a Pfizer factory in Rocky Mount, N.C. This weather event offers a poignant reminder of the intricate threads that weave their way through the pharmaceutical supply chain. On July 19, 2023...
Newsletters & Blogs
Unveiling the Power and Pitfalls of Real-World Evidence (“RWE”) in Drug Testing
Pharmaceutical regulators are open to new kinds of data to support new drug applications. However, that doesn't mean that applicants can ignore the quality of that data. That's the topline message of a recent report from Cardinal Health that highlights the challenging journey from RWE to U.S. Fo...
LEARN ABOUT ARTIFICIAL INTELLIGENCE IMPACTS IN BUSINESS
Expand your knowledge about how artificial intelligence (“AI”) is impacting business. Phil Crowley is serving as moderator for an informative seminar “Understanding Intellectual Property in Generative AI” by the NJ Chapter of the Licensing Executives Society (“LES”). The event will be held from ...
PROPOSED FED LAW WOULD CRUSH BIOTECH INDUSTRY
Recently proposed Federal legislation would have a very damaging effect on the biotech industry. Those are the conclusions of a recent report by industry analysts at Vital Transformation . The report modelled the effects of the Inflation Reduction Act (“IRA”), President Biden's proposed 2024 Budg...
Comparing State Data Privacy Laws
Maintaining the privacy of data received online is a significant concern for many businesses. Unlike many other countries, the United States does not currently have a single Federal law that governs privacy rights for individuals.[1] At this point, there exists a patchwork of privacy laws enacted...
Unleashing Innovation in New Jersey
Introduction New Jersey is leading the charge in promoting clean energy and sustainability through its Clean Tech R&D Voucher Program. As attorneys committed to supporting clean tech ventures, Crowley Law is here to guide and assist clients in navigating this groundbreaking initiative. In this bl...
IMPROVEMENTS TO NEW YORK HEALTH INSURANCE: BIOMARKER TESTING
Testing for biomarkers in patients is the state of the art in assessing effectiveness of therapies. The New York State legislature recently recognized that and passed a bill requiring health insurers, including Medicaid, to cover biomarker testing, a diagnostic tool for cancer and other medical c...
Discovering New Horizons for Companies Outside the USA
For businesses located outside the United States, expanding your business focus to the USA is a bold choice towards growth and success. As you venture into the promising realm of the U.S. market, it's essential to be well-informed about the legal and other intricacies that come with it. In this b...
The Rapid Rise of the Machines
Artificial Intelligence is Transforming the Medical and Healthcare Industries Just about every industry is experiencing a dramatic evolution with the sudden rise of artificial intelligence (AI). Healthcare and pharmaceuticals are no different. As we recently wrote, the area of oncology is showing...
COMPREHENSIVE HELP FOR CANCER PATIENTS
Today's cancer care is incomplete. Cancer affects not only the body of the patient but also his or her emotional well-being. And it has tremendous impact on the emotional health and financial well-being of the patient's family as well. It's those other effects that are ignored in current treatm...
“Say No to Non-compete Clauses!?”
Watch out for those boiler-plate post-employment non-compete clauses!! The General Counsel of the National Labor Relations Board (“NLRB”) has issued a memo that addresses non-compete clauses in employment agreements for non-supervisory employees. It provides her guidance on their potential viola...
ARE PUBLIC COMPANIES DISAPPEARING?
Where did all the public companies go?? A recent report by the Center for Research in Securities Prices indicates that the number of publicly traded companies has decreased dramatically since 1996. Back then, 8,000 companies were traded on U.S. stock exchanges. Now, the number is only about 3,7...
BEWARE OF THOSE HYPERLINKS!
Pacta sunt servanda (Latin lawyers' maxim: Agreements must be kept!) A recent case in the New York appellate court underscored this principle in a proceeding involving a hyperlink in an online document. The plaintiff or claimant in that case was attempting to avoid settling his claim through arb...
Investment in Medical Technology Startups Falling
Introduction Investment in medical technology startups has been a driving force behind innovation in the healthcare industry. However, recent trends demonstrate a downtrend in investment in medical technology startups in the United States. Why is that? There are many reasons. Based on our analy...
NEW JERSEY LOVES ITS LIFE SCIENCES INNOVATORS
The State of New Jersey has an affinity for life sciences innovators. That's the message of last week's meeting sponsored by the NJ Economic Development Agency (“NJEDA”) at the Hackensack Meridian Health System Center for Discovery and Innovation in Nutley, NJ. The meeting was headlined by Judit...
WATCH OUT! AI IS COMING!
Watch out! Artificial intelligence (“AI”) is coming! AI is coming to healthcare and drug discovery! Oops!! It's already here!! Google's DeepMind project is an AI research organization that has been involved in several groundbreaking projects in recent years. One of the areas where the technology...
EDUCATION ON CENTER STAGE
Hope Through Education's Spring Gala was a great success. Nearly 300 people attended the event last week at the lovely Hamilton Farm Golf Club in Peapack-Gladstone, NJ. Hope Through Education is a 501(c)(3) qualified charity focused on providing scholarships to families seeking to send their chi...
WE ARE THE CHAMPIONS!!!
I am so proud of the Men's Volleyball Team at my alma mater, Stevens Institute of Technology (https://stevens.edu ). They've just won the National Collegiate Athletic Association Division III (“D3”) championship. Why is that significant? D3 schools are those universities and colleges that do no...
NEW HOPE FOR PARKINSON’S DISEASE SUFFERERS
This week boasted announcement of a monumental achievement in the fight against Parkinson's disease. Parkinson's disease is a progressive neurodegenerative disorder that affects millions of people worldwide. It is caused by the degeneration of dopamine-producing neurons in the brain, leading to t...
The Importance of Partnering with Outside Counsel on Strategic Planning
Why Entrepreneurs Should Rely on a Trusted Advisor to Forecast What Lies Ahead Founders of startups and leaders of young companies have plenty on their plates. It's tempting for entrepreneurs to focus their attention on immediate priorities. Others prefer to spend their time scratching their inna...
CRITICAL POINT: Putting Together a Winning Team
Valuation of life sciences companies has been battered and the IPO window has closed, for now. But there are still plenty of strategic partners looking for promising new technology and life sciences companies to fill their pipelines. If you want to be one of them, having the right team put togeth...
5 Startup Equity Mistakes and How to Avoid Them
Keeping to the fundamentals can be tough. As an overtasked and overwhelmed startup founder, it's tempting to look for DIY stop-gap solutions for equity issues with a mantra of “we can deal with this later.” It's like going after that vending machine Snickers bar (or two!!) when your stomach is gr...
The Hidden Risks of Nondisclosure Agreements
What Life Sciences and Technology Startups Need to Know “The brands that innovate best do so with an exceptional embrace of collaboration.” ~Stephen Nowak Innovation rarely happens in a silo. But collaboration can also be a double-edged sword. Working with potential investors, creditors, clients,...
Representations and Warranties: What Life Sciences and Technology Startups Need to Know
Time and money. Innovative business ventures are often short on both. So, in the face of competing priorities, it can be tempting to gloss over standard contractual terms—like representations and warranties—with the assumption that they are boiler-plate and relatively unimportant. “We don't have...
Cybersecurity: What Medical Device Manufacturers Need to Know
A hostile authoritarian government launches a coordinated ransomware attack on computers across the globe. In less than 24 hours, more than 200,000 computers in over 150 countries are infected, shutting down everything from MRI scanners to blood-storage refrigerators. Patient-filled ambulances ar...