Goodwin

Put a Fork in it: What’s Happening with the DAO?

If you have an interest in bitcoin, you’ve undoubtedly heard people refer to “The Blockchain.” Because the term “blockchain” can refer to any distributed ledger where “blocks” are added to the ledge by solving complex…more
| Business Organizations, Finance & Banking, Personal Injury, Science, Computers, & Technology, Securities Law

FTC Settles with Fraudulent Debt Collectors for Millions as Operation Collection Protection Continues

On July 14, 2016, the FTC announced that, as part of an ongoing crackdown on deceptive collection practices, it reached a settlement with two debt collectors and three companies charged with using illegal collection tactics…more
| Antitrust & Trade Regulation, Consumer Protection, Finance & Banking

CFPB Orders National Bank to Pay $10 Million for Overdraft Practices

On July 14, 2016, the CFPB announced that it ordered a bank to pay $10 million in fines for its overdraft service practices. According to the CFPB, the bank’s telemarketing vendor used allegedly deceptive marketing and sales…more
| Communications & Media Law, Consumer Protection, Finance & Banking

OCC Hosts Forum on Responsible Innovation

On June 23, 2016, the Office of the Comptroller of the Currency (OCC) hosted a daylong forum, “Supporting Responsible Innovation in the Federal Banking System.” The purpose of the forum was to encourage a dialogue among…more
| Civil Rights, Commercial Law & Contracts, Consumer Protection, Finance & Banking, Science, Computers, & Technology

Financial Services Weekly News - July 2016 #3

Regulatory Developments - SEC Proposes Amendments to Update and Simplify Disclosure Requirements as Part of Overall Disclosure Effectiveness Review - On July 13, the Securities and Exchange Commission (SEC) proposed…more
| Business Torts, Constitutional Law, Consumer Protection, Finance & Banking, Securities Law

Amgen v. Apotex: District Court Decides that the ’138 Patent is Not Invalid on Some Grounds; Enablement is Still an Open Issue

As we previously reported, on July 5, the Federal Circuit affirmed the district court’s grant of a preliminary injunction enjoining Apotex from launching its biosimilar version of Amgen’s Neulasta (pegfilgrastim) until it…more
| Civil Procedure, Intellectual Property, Science, Computers, & Technology

FDA Issues Complete Response Letter for Sandoz’s Neulasta® Biosimilar

As we’ve previously reported, Sandoz is seeking approval of an aBLA for its proposed biosimilar to Neulasta® (pegfilgrastim), which is currently the subject of a BPCIA litigation (Civil Action No. 3:16-cv-02581 (N.D. Cal.)) …more
| Intellectual Property, Science, Computers, & Technology

The Blockchain: Beyond Bitcoin

Blockchain - While many people in the U.S. are still skeptical that bitcoin will become a mainstream currency, both private and public sectors are gaining interest in the idea that the underlying blockchain technology…more
| Finance & Banking, Insurance, International Law & Trade, Military Law, Science, Computers, & Technology

Busy Week for Biosimilars Worldwide

United States: On July 13, an FDA advisory committee voted to recommend approval of Sandoz’s biosimilar to Enbrel® (etanercept). The recommendation was to approve the biosimilar for all indications for which Enbrel® is…more
| Commercial Law & Contracts, Intellectual Property, International Law & Trade, Science, Computers, & Technology

Nasdaq Adopts “Golden Leash” Director Compensation Disclosure Requirement

The Nasdaq Stock Market LLC (Nasdaq) has adopted a new rule that will require each Nasdaq-listed company to publicly disclose compensation or other payments by third parties to any current director or nominee for director in…more
| Business Organizations, Commercial Law & Contracts, Finance & Banking, Labor & Employment Law, Securities Law

EU Proposal to Address Virtual Currency Exchanges & Wallet Providers in Anti-Money Laundering Laws

The European Commission recently published a proposal to amend the Fourth Anti-Money Laundering Directive, the legislation that specifies the anti-money laundering, or AML, and counter terrorist financing rules for EU Member…more
| Criminal Law, Finance & Banking, International Law & Trade, Science, Computers, & Technology, Securities Law

Missouri Governor Signs Biosimilar Substitution Law

Last month, Missouri Governor Jay Nixon signed into law Senate Bill 875, allowing pharmacists filling prescriptions for brand name biological products to substitute a less expensive biosimilar product if the biosimilar has been…more
| Elections & Politics, Health, Science, Computers, & Technology

Financial Services Weekly News - July 2016 #2

Regulatory Developments - Client Alert: Volcker Rule Conformance Period for Legacy Covered Fund Activities Extended One Year - On July 7, the Board of Governors of the Federal Reserve System announced that it has…more
| Business Organizations, Finance & Banking, Securities Law

BREAKING NEWS: FDA Denies Citizen Petitions Regarding Biosimilar Labeling

FDA denied citizen’s petitions from Abbvie, the UAW Retiree Medical Benefits Trust, and the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Industry Organization (“BIO”) trade associations…more
| Communications & Media Law, Consumer Protection, Science, Computers, & Technology

FDA Advisory Panels Considering Approvals of Two Biosimilars This Week

An FDA advisory panel unanimously voted to recommend approval of Amgen’s ABP501 biosimilar of AbbVie’s Humira (adalimumab) on July 12, 2016. Likewise, an FDA advisory panel is scheduled to consider approval of Sandoz’s…more
| Consumer Protection, Science, Computers, & Technology
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