Biomedical Company Avoids DOJ Prosecution After First Ever Voluntary Corporate Self-Disclosure of Fraud Under NSD Enforcement Policy - On May 22, the US Department of Justice (DOJ) announced that it will not prosecute a...more
A preliminary injunction is one of the most potent weapons in a patent plaintiff's arsenal, being capable of shutting down an accused infringer's continued infringement, prohibiting the infringing product from the stream of...more
On November 1, 2023, a jury in the U.S. District Court for the Central District of California awarded damages to Skye Orthobiologics, LLC (“Skye”) and Human Regenerative Technologies, LLC (“HRT”) for breach of contract,...more
The food and ag sectors are tied to nearly a quarter of all global greenhouse gas emissions. However, those sectors receive disproportionately less climate tech venture funding. Beatriz Franco and Maya Benami of Vita Vera...more
With the ever-growing adaptation of software in all realms of health care, the market for software for medical devices (SaMD) is forecasted to grow 16.7% per year over the next decade and surpass $5 billion by 2032....more
Despite a strong start last year, venture capital funding for life sciences totaled $35.8 billion in 2022, down 28% from 2021, according to Cushman & Wakefield (C&W). Initial public offering activity also fell 90% from $14.5...more
As part of the Biden Administration’s ongoing efforts to spur innovation and research, it has championed the creation of a new sub-agency within the Department of Health and Human Services, the Advanced Research Projects...more
Caribou Biosciences, Inc., a Berkeley, California-based CRISPR genome-editing biopharmaceutical company, raised $304M in an initial public offering, one of the most lucrative IPOs in gene-editing. In June 2021, Gene editing...more
The health care industry is taking it on the chin these days. As DOJ increases False Claims Act prosecutions, the primary targets are pharmaceutical, medical device and health care providers. ...more
On January 11, 2020, the Broad Institute, Verily Life Sciences, and Microsoft announced a strategic partnership to accelerate biomedical innovations through the Terra platform. Terra was originally developed by the Broad...more
Report on Research Compliance 18, no. 1 (January 2021) - As the pandemic continues to not only drag on but intensify, the toll on institutions and staff is becoming more evident. To get a sense of what was happening, and...more
Report on Research Compliance 17, no. 11 (November 2020) - In light of the ongoing COVID-19 pandemic, the HHS Office for Human Research Protections has issued an exception to the single institutional review board...more
Former U.S. attorney Jessie K. Liu recently joined Skadden from her role overseeing the U.S. Attorney’s Office in Washington, D.C., which is not only the largest in the country but also home to one of the busiest Civil...more
Notable regulatory amendments and COVID-19-related inspection guidelines, described below, will impact Animal Welfare Act (AWA) licensees and registrants New rules, finalized in May, 2020, amended the long-standing...more
Care provided to chimpanzees at Project Chimps, a sanctuary for chimpanzees located in Georgia, has come under fire by “[m]ore than 20 former staffers and volunteers,” as reported by Rachel Fobar in Animal Wildlife Watch on...more
...On Monday, House Speaker Nancy Pelosi, Majority Whip James Clyburn, Transportation & Infrastructure Committee Chairman Peter DeFazio, and Energy & Commerce Committee Chairman Frank Pallone held a press conference on a...more
ART 2: EFFORTS TO CLARIFY PATENT ELIGIBILITY UNDER § 101 - In this four-part series, we take a look forward at the cases, legislation, and other trends that are likely to have a significant impact on intellectual property...more
On October 10, 2019, an NIH team, led by Ian Hutchins, published their exciting new work, "Predicting Translational Progress in Biomedical Research." The team built a machine learning system that detects whether a paper and...more
The Israel Securities Authority (ISA) recently published a proposal for amending the Securities Law as to the supervision of underwriters and distributors. The ISA aims to add a section to the law that would authorize it to...more