Fujifilm Kyowa Kirin Biologics Announces Successful Adalimumab Biosimilar Trial Results

On October 19, Fujifilm Kyowa Kirin Biologics (a joint venture between Fujifilm and Kyowa Hakko Kirin), announced successful results in the global Phase 3 study of its Humira® (adalimumab) biosimilar candidate, FKB327. …more
| Business Organizations, Commercial Law & Contracts, Science, Computers, & Technology

FINRA Announces Effective Date of New Capital Acquisition Broker Rules

FINRA has announced the adoption of the new Capital Acquisition Broker (CAB) rules. CABs, which will be able to act as brokers for merger and acquisition transactions and agents in private placements to institutional investors,…more
| Business Organizations, Commercial Law & Contracts, Finance & Banking, Mergers & Acquisitions, Securities Law

Norwegian Study Concludes Infliximab Biosimilar Not Inferior To Remicade

A study conducted by the Norwegian government compared Johnson & Johnson’s Remicade (infliximab) to Celltrion’s approved biosimilar Remsima. The “NOR-SWITCH” study, which cost $2.5 million, was a 52-week Phase IV study that…more
| Science, Computers, & Technology

UPDATE: Mylan Files Amicus Brief in Support of Apotex’s Petition in Amgen v. Apotex

Earlier this week, we reported on the amicus curiae brief filed by the Biosimilars Council in support of Apotex’s petition in Amgen v. Apotex. Mylan Pharmaceuticals Inc. has also filed an amicus brief in support of Apotex…more
| Civil Procedure, Intellectual Property, Science, Computers, & Technology

Massachusetts Gaming Update: The Mashpee Wampanoag Tribe’s Revised Game Plan

Tribal gaming may have endured a setback, but perhaps not a complete elimination in the Massachusetts gaming arena. When a U.S. District Court judge determined the federal government erred in approving the Mashpee Wampanoag…more
| Art, Entertainment, & Sports Law, Indigenous Peoples

Treasury Targets Tax Deferral in Leveraged Partnership Structures with New Regulations

The Treasury issued new final, temporary and proposed regulations that take aim at, and significantly reduce the effectiveness of, leveraged partnership structures intended to achieve tax deferral to the contributing partner…more
| Business Organizations, Commercial Law & Contracts, Finance & Banking, Taxation

Economic Times of India: Report Suggests that Indian Biosimilars Market May Reach $40 Billion USD by 2030

The Economic Times of India has reported on a study of the Indian biosimilars market conducted by the Jawaharlal Nehru Institute of Advanced Studies (JNIAS). The study reports that the Indian biosimilars industry was close…more
| Science, Computers, & Technology

Financial Services Weekly News - October 2016 #2

Editor's Note - Never Satisfied. Despite the Securities and Exchange Commission’s announcement that, in its just completed fiscal year 2016, it filed a record 868 enforcement actions reprimanding misconduct by companies and…more
| Antitrust & Trade Regulation, Business Organizations, Consumer Protection, Finance & Banking, Securities Law

PTAB Denies Institution on Biogen’s Tysabri® Patent

On October 17, the PTAB denied institution of IPR2016-000912, IPR2016-00915, IPR2016-00916. The Petitions in these cases were filed by Swiss Pharma International AG on U.S. Patent Nos. 8,815,236; 8,349,321; and 8,900,577,…more
| Intellectual Property, Science, Computers, & Technology

BREAKING NEWS: Pfizer Announces Upcoming U.S. Launch of Biosimilar INFLECTRA® (infliximab-dyyb)

Pfizer announced today that it will begin shipping INFLECTRA® (infliximab-dyyb) for injection, a biosimilar of REMICADE® (infliximab), to wholesalers in the United States (U.S.) in late November 2016. INFLECTRA® received FDA…more
| Health, Science, Computers, & Technology

Janssen v. Celltrion: District Court Schedules Hearing on Motion to Dismiss

As we previously reported, Celltrion has moved to dismiss Janssen’s claim of infringement of the ’083 patent, the sole remaining patent in the case since the district court entered partial final judgment with respect to the ’471…more
| Civil Procedure, Intellectual Property, Science, Computers, & Technology

Biosimilars Council Files Amicus Brief in support of Apotex’s Petition for Certiorari in Amgen v. Apotex

As we covered in a previous post, Apotex has filed a cert. petition asking the Supreme Court to review the Federal Circuit’s ruling on the BPCIA’s notice provision in Amgen v. Apotex. Last week, the Biosimilars Council filed…more
| Civil Procedure, Intellectual Property, Science, Computers, & Technology

Regulatory Update: SEC Adopts New Requirements for Fund Liquidity Risk Management and Amendments to Permit the Use of “Swing Pricing”

On October 13, 2016, the U.S. Securities and Exchange Commission (SEC) unanimously adopted regulatory changes that require open-end funds, including mutual funds and exchange-traded funds (ETFs), to establish liquidity risk…more
| Business Organizations, Commercial Law & Contracts, Finance & Banking, Securities Law

Amgen v. Hospira (epoetin alfa): District Court Lets in New Infringement Theories, Not New Defendants

As we previously reported, Amgen has sought to amend its complaint regarding Hospira’s planned epoetin alfa biosimilar to add three new defendants and two theories of infringement. On October 3, 2016, Judge Andrews…more
| Civil Procedure, Intellectual Property, Science, Computers, & Technology

MedPAC Meets to Discuss Biosimilars

On October 6-7, 2016, the Medicare Payment Advisory Commission (MedPAC), a federal agency that advises Congress on Medicare pay policies, held a public meeting, with one session titled “Biosimilars in Medicare Part D.” This…more
| Health
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