On December 20, 2021, a group of emergency medicine physicians in California filed suit against a private equity-backed health care services company, claiming that (among other things), the company has run afoul of the state’s prohibition on the corporate practice
Lannett Company, Inc. (“Lannett”) announced Friday that the FDA has completed its safety review of Lannett’s Investigational New Drug application for Lannett’s insulin glargine biosimilar, a product Lannett is co-developing with its strategic alliance partners within the HEC group of
To assist public companies with their securities compliance obligations, Goodwin’s Public Company Advisory Practice has prepared a Form 10-K Compliance Checklist and Form 10-K Compliance Guide. Form 10-Ks are one of the most important disclosure documents that companies file
Our recent client alert discusses the SEC’s recent securities lending proposal, which, if adopted, would create a new reporting and disclosure framework for the securities lending market. Rule 10c-1 would require any person who loans a security on behalf of
On January 7, 2022, the Massachusetts Appeals Court issued a decision concerning whether two insurance companies provided sufficient and timely notice to its Insured regarding the exclusion of coverage for Telephone Consumer Protection Act (TCPA) violations. In Addison Automatics, Inc.
On January 12, the International Generic and Biosimilar Medicines Association (IGBA) announced that Vivian Fritelli, Chief Executive of Generic and Biosimilar Medicines of Southern Africa, will be the next IGBA Chair for 2022. The IGBA represents manufacturers of generic and
To assist companies with their securities compliance obligations, Goodwin’s Public Company Advisory Practice has prepared an Earnings Release Compliance Checklist and Earnings Release Compliance Guide. Quarterly earnings releases are one of the most important disclosure documents that companies publish.
On January 11, 2022, the Centers for Medicare and Medicaid Services (CMS) released a proposed National Coverage Determination (NCD) decision memo limiting Medicare coverage for Biogen’s new Alzheimer’s drug, Aduhelm. Under the terms of the NCD – despite FDA’s 2021
During the COVID-19 public health emergency, the United States Food and Drug Administration (FDA) has issued hundreds of Emergency Use Authorizations (EUAs) and numerous enforcement policies to facilitate the availability of important medical devices. On December 23, 2021, FDA published
On January 10, 2022, tZERO’s ATS settled a matter with the SEC in which it agreed to an $800,000 fine. Given the size of the penalty and substantial attention on the SEC’s approach to regulating digital asset securities, readers may
