Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AGG Talks: Cross-Border Business Podcast - Episode 22: What Global Companies Need to Know About Navigating FDA Regulations and U.S. Market Entry
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
GLP-1 Drugs and Cultivated Meat: What’s the Impact on the Food and Agriculture Industry?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
The $100B+ Weight-Loss Drug Market Is Red Hot—But So Are the Legal, Regulatory, and Compliance Risks. As the GLP-1 revolution reshapes the future of metabolic health, life sciences companies face mounting scrutiny from...more
As we previously discussed (here and here), the biotech mergers and acquisitions market currently faces significant headwinds. These challenges include frozen capital markets, regulatory uncertainty at the Food and Drug...more
The biotech mergers and acquisitions market faces significant headwinds in the first half of 2025. These challenges include frozen capital markets, regulatory uncertainty at the Food and Drug Administration (FDA) and...more
With companies constantly developing new therapies and technologies, the biotech industry is a hotbed of innovation. This dynamic environment often leads to mergers and acquisitions (M&A) as a vehicle for larger companies to...more
In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community. The value of merger and...more
Several members of our firm’s life sciences team were on the ground at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco from January 13 to 16, 2025. It was an exciting and sunny four days, during which key...more
DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more
The life sciences industry is well positioned for growth in 2025, fueled by strong investor interest and technological advancements, especially in AI. Life sciences venture capital (VC) funding and IPOs have picked up in...more
To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more
Wilson Sonsini’s inaugural Biotech Summit will address topics of critical importance to Biotech and Biopharmaceutical companies, including early and late-stage venture financing, partnering strategies, current and future AI...more
The Fenwick life sciences team recently returned from the 2024 JP Morgan Healthcare conference. As we reflect back on the week, there were several key themes and trends that we expect will continue to resonate and evolve over...more
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
Originally published in Genetic Engineering News on October 10, 2023. Reprinted with permission. The biotechnology sector has long been characterized by its constant innovation, rapid technological progress, and unyielding...more
For years, the antitrust enforcement agencies have indicated their antipathy toward resolving competition issues in proposed mergers by entering into consent decrees that prohibit certain conduct, rather than stopping the...more
While the ability to market medical products is bound by the claims that can be lawfully made, it does not mean the claims available at acquisition are all your company will have. Consider developing a plan to create...more
Join Gardner Law and colleagues live from Lord Fletcher's on Lake Minnetonka, Minnesota for a complimentary CLE event. Hear from a panel of experts on compliance, data breaches, FDA regulations, privacy, and more....more
McDermott is pleased to bring our Life Sciences Boot Camp for In-House Counsel back to the Bay Area! Amid turbulent economic forces, life sciences companies continue to grapple with increasingly complex legal and business...more
Note From the Editors - With this Summer 2020 issue of Vital Signs, we take a moment to again applaud the remarkable actions of all the health care and life science organizations around the globe working tirelessly on our...more
On March 27, 2020, Congress approved the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to provide financial assistance to individuals and businesses, which in aggregate greatly exceeds the financial package...more
The life sciences industry faces a wide range of legal, regulatory and business challenges, along with constantly evolving trends that impact leadership priorities. McDermott’s cross-functional team of life sciences...more
Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more
On December 18, 2019, Chancellor Andre G. Bouchard of the Delaware Court of Chancery ruled that defendant Boston Scientific Corporation was not entitled to terminate its merger agreement with plaintiff Channel Medsystems,...more
In the first case following Akorn v. Fresenius to rule on a party’s entitlement to terminate a merger agreement on the basis of a material adverse effect (MAE), the Delaware Court of Chancery ordered Boston Scientific...more
On December 28, 2018, Vice Chancellor Sam Glasscock III of the Delaware Court of Chancery declined to dismiss a breach of contract claim brought by former stockholders of Ception Therapeutics, Inc. (“Ception”) against...more
On October 1, in Akorn v. Fresenius Kabi, the Delaware Court of Chancery for the first time found that a material adverse effect — or MAE — had occurred in a merger transaction, which, combined with other breaches of the...more