President Trump recently announced four Executive Orders that direct the Secretary of the Department of Health and Human Services (HHS) to implement policy changes to reduce out-of-pocket costs and the price of prescription drugs. All but one of the Executive Orders has been issued with the remaining order on hold…
The life sciences industry affects a substantial portion of the U.S. and European economies, in terms of both GDP and the number of individuals employed. And in the context of a global pandemic, the life sciences sector obviously plays an existential societal role. Accordingly, ensuring the safe and continuous functioning…
Investments in early stage life sciences companies often provide that payments are tranched over time, subject to satisfying agreed milestones. This is normal, but in this abnormal market, stakeholders are approaching tranched investments with more caution. As a starting point, where milestones and other completion conditions are met, the investor…
A new draft amendment to Chinese Patent Law was submitted to the National People’s Congress Standing Committee on June 28, 2020. Key provisions include the establishment of patent term adjustment (PTA) caused by delays in the patent office and patent term extension (PTE). Under the new draft amendment, a Patentee…
The urgent needs of the COVID-19 pandemic have more squarely brought into focus the role real-world evidence (RWE) can play in analyzing and informing product development and clinical and public health decisions. Specifically, the U.S. Food and Drug Administration (FDA) is participating in the COVID-19 Evidence Accelerator, in partnership with…
Life science companies have been among the biggest users of convertible debt financing in the first half of 2020. As highlighted in our recent Client Insight article, life science, technology and other traditional high-yield debt issuers were the biggest participants in the record issuance of convertible bonds. Through June 30,…
The patient voice is recognized as one of the most critical sources of data in drug development, and patients play an increasingly important role in these efforts by teaching us about their experience with their condition and its impact. A common way sponsors can leverage the patient experience is by…
Healthcare companies are facing unprecedented challenges as a result of the COVID-19 crisis. This includes heightened enforcement risks. A key area of risk is the federal False Claims Act (FCA), a powerful tool for the DOJ to seek substantial penalties including three times the amount of money a company received…
The United States Patent and Trademark Office (USPTO) is accepting requests for prioritized examination or “fast track” of patent applications that claim a product or process subject to FDA approval for COVID-19 use, without the payment of additional fees. The USPTO will advance accepted patent applications out of turn, aiming…
For life sciences companies who are or are looking to become publicly traded in the U.S., one of the most frequent comments that we see from the SEC as part of their review process is the following: You make several assertions regarding the safety and efficacy of certain of your…