Goodwin

Samsung Bioepis Seeks Regulatory Approval for an Adalimumab Biosimilar in Europe and South Korea

Samsung Bioepis is reportedly seeking regulatory approval to sell a biosimilar version of Humira® (adalimumab) in South Korea. Also, in July 2016, Samsung Bioepis reported that the EMA had accepted its Marketing Authorization…more
| Administrative Law, Science, Computers, & Technology

FDA Denies AbbVie Citizen Petition on Fifth Amendment Takings

On September 23, the FDA denied a citizen petition from AbbVie submitted to the FDA on April 2, 2012, requesting that the FDA not implement the BPCIA as to any applications for biosimilar products referencing Humira…more
| Constitutional Law, Intellectual Property, Science, Computers, & Technology

Advertising in MA: Can Consumers Bring Class Actions for ‘Deceptive’ Advertising that has Neither Deceived Nor Harmed Them?

If your company advertises and sells products in Massachusetts, it could be subjected to a class action lawsuit by Massachusetts consumers who purchased one of its products if the consumers can show that a reasonable person…more
| Civil Remedies, Communications & Media Law, Consumer Protection

CFPB Brings Administrative Lawsuits Against Five Arizona Title Lenders

On September 21, the Consumer Financial Protection Bureau (CFPB) announced that it filed five individual administrative lawsuits against Arizona title lenders. Each suit concerns allegations that the title lenders’ online…more
| Consumer Protection, Finance & Banking

Former Debt Collection Company VP Ordered to Pay Penalty and Stop Deceptive Debt Collection Practices

On September 21, the Department of Justice (DOJ) announced that the U.S. District Court for the Eastern District of Texas entered a stipulated order for a permanent injunction and civil penalty judgment against the vice…more
| Antitrust & Trade Regulation, Civil Remedies, Consumer Protection, Finance & Banking

CFPB Sues Credit Repair Company for Misleading Claims and Illegal Fees

On September 22, 2016, the Consumer Financial Protection Bureau (CFPB) filed a complaint in the U.S. District Court for the Central District of California against a credit repair company for allegedly making misleading…more
| Civil Remedies, Consumer Protection, Finance & Banking

FTC Secures $1.8M in Restitution From Debt Relief Scammers

On September 22, the Federal Trade Commission (FTC) announced that the U.S. District Court for the Central District of California issued a permanent injunction prohibiting five defendants involved in mortgage relief scams from…more
| Civil Remedies, Finance & Banking

CFPB Files Action Against Credit Repair Company, Seeking Injunction and Penalties

On September 23, the Consumer Financial Protection Bureau (CFPB) announced that it filed suit against a credit repair company in the United States District Court for the Central District of California, for alleged violations of…more
| Consumer Protection, Finance & Banking

BREAKING NEWS: FDA Expected to Approve Amgen’s Humira Biosimilar Today

According to a report this morning from Seeking Alpha, FDA is expected to approve Amgen’s application for a biosimilar version of AbbVie’s Humira (adalimumab) today. If approved, it will be the first biosimilar adalimumab…more
| Administrative Law, Health, Science, Computers, & Technology

Sanofi Sues Merck Over Proposed Insulin Glargine Biosimilar

Last week, Sanofi-Aventis U.S. LLC filed a complaint against Merck Sharp & Dohme Corp. over its proposed biosimilar to Lantus (insulin glargine injection). The complaint asserts that Merck will infringe 10 different U.S…more
| Civil Procedure, Intellectual Property, Science, Computers, & Technology

IRS Proposes Valuation Discount Regulations: Implications for Family-Controlled Businesses

IRS issues new proposed rules aimed at eliminating valuation discounts for transfers of interests in family-controlled entities. Clients considering making transfers of interests in such entities should act soon…more
| Business Organizations, Taxation, Wills, Trusts, & Estate Planning

Financial Services Weekly News - September 2016 #2

Editor's Note - In this edition. The NYDFS proposed a cybersecurity regulation governing New York-chartered banks and insurance companies, the OCC released its bank supervision priorities in its annual supervision operating…more
| Finance & Banking, Privacy, Real Estate - Residential, Science, Computers, & Technology

Deal Watch: Teva and Regeneron Announce Fasinumab Collaboration

On September 20, Teva Pharmaceutical Industries Ltd. and Regeneron Pharmaceuticals, Inc. announced an agreement to develop and commercialize fasinumab, an investigational NGF antibody currently under development by Regeneron as…more
| Business Organizations, Commercial Law & Contracts, Health, Science, Computers, & Technology

Litigation Update: Case Management Statement in Amgen v. Sandoz (filgrastim, pegfilgrastim)

The parties in Amgen v. Sandoz (N.D. Cal.) (filgrastim and pegfilgrastim) have submitted a joint case management statement regarding the two pending cases between the parties: Case No. 3:14-cv-04741-RS (accused product: Zarxio®…more
| Civil Procedure, Intellectual Property, Science, Computers, & Technology

The Aftermath of the Bitfinex Hack

In our August 9 blog post, we discussed the Bitfinex hack that rattled the bitcoin markets and raised serious questions about the security of bitcoin wallets and allocating risk in this new age of cyber theft. Through a simple…more
| Finance & Banking, Privacy, Science, Computers, & Technology
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