Goodwin Procter

In September 2020, the Centers for Medicare & Medicaid Services (CMS) proposed a new rule that would expedite Medicare coverage for medical technology approved through the Food & Drug Administration’s (FDA’s) “Breakthrough Devices Program.”  CMS’s proposal – the Medicare Coverage of Innovative Technology, or MCIT, Pathway – was groundbreaking in that innovative medical technology would be afforded a new, expedited coverage avenue that would significantly reduce the time it takes for Medicare beneficiaries to gain…
On August 5, 2021, Formycon and Bioeq announced submission of the biologics license application for FYB201 to the U.S. Food and Drug Administration.  FYB201 is a biosimilar candidate to Lucentis(R)1 (Ranibizumab), which is used in the treatment of neovascular (wet) macular degeneration and other serious eye diseases.  If approved, Coherus Biosciences, Inc. will commercialize FYB201 (also known as CHS-201) in the United States according to the terms of a November 2019 license and development agreement…
Goodwin invites you to join us for our upcoming webinar on the NYDFS Cybersecurity Regulation. Now in its fifth year, the NYDFS Cybersecurity Regulation is a standout among state-level information security regulations.  This year, the NYDFS is investing additional resources into cybersecurity, with a new NYDFS Cyber Intelligence Unit formed in 2021, new ransomware guidance, and increasing enforcement.  Compliance with the NYDFS Cybersecurity Regulation requires financial institutions to adopt a risk-based approach to information…
On September 8, 2021 the Consumer Financial Protection Bureau (CFPB) announced that it filed a complaint against an online lender for alleged violations of a 2016 consent order, the Consumer Financial Protection Act (CFPA), 12 U.S.C. §§ 5564, the Equal Credit Opportunity Act (ECOA), 15 U.S.C. §§ 1691–1691f, and Regulation B (Reg B), 12 C.F.R. § 1002.9(a)–(b). In 2016, and as previously covered by Enforcement Watch, the CFPB entered a consent order to resolve alleged…
Many allied health professionals are subject to state-level licensing requirements that can vary from jurisdiction-to-jurisdiction. What may be required in New York to hold a medical professional license may differ dramatically from what is required in Illinois or Texas, for instance.  One state’s requirements may be onerous and administratively taxing; another state’s requirements to serve as the same type of medical professional may be quite simple.  Assessing licensing requirements for medical professionals from state to…
On September 10, 2021, Janet Woodcock, the acting FDA Commissioner of Food and Drugs at the FDA, sent a letter to Andrew Hirshfield, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office (USPTO) “pursuant to Executive Order 14036, and in the hope of further developing the [FDA’s] engagement with the [USPTO].” Executive Order 14036 was issued by President Biden on July 9, 2021 and focused on…
The use of telehealth continues to grow rapidly across the U.S.  Given legislative proposals and the Centers for Medicare & Medicaid Services efforts to expand access to telehealth, we can only anticipate that remotely engaging with healthcare providers is here to stay.   In fact, the National Center for Health Statistics and the Centers for Disease Control and Prevention reported that between April and July 2021, 24.5% of adults in the U.S. had a virtual care…
Recently, JHL Biotech co-founders Racho Jordanov and Rose Lin pled guilty and were convicted of conspiring to steal trade secrets related to Genentech’s cystic fibrosis drug Pulmozyme, and cancer drugs Rituxan, Herceptin, and Avastin.  Although Jordanov and Lin initially pled not guilty, the former JHL employees later admitted to hiring former Genentech employees and using those employees’ knowledge of Genentech’s confidential information to advance JHL’s own biosimilar program.  Related to their conviction for trade secret…
On September 2, 2021, the parties in the Amgen v. Hospira (D. Del., No. 18-1064) Neupogen®/filgrastim litigation submitted a stipulation and proposed order to dismiss all claims and counterclaims in the litigation, with prejudice.  The Court (Judge Connolly) has not yet entered the order of dismissal on the docket. The case has been pending since July 2018.  Pfizer/Hospira obtained FDA approval for their biosimilar filgrastim product Nivestym® (filgrastim-aafi) in July 2018 and launched the…
Debt collectors operating in California may now submit applications for licensure by the Department of Financial Protection and Innovation (DFPI) in compliance with the state’s newly enacted Debt Collection Licensing Act (DCLA). On September 1, 2021, the DFPI announced that it opened its license application for all debt collectors in California, representing the first step in the expansion of state oversight of the debt collection industry.  Debt collectors, debt buyers, and debt collection attorneys operating…