19:07 , Dec 15, 2017 |  BC Week In Review  |  Company News

Federal Appeals Court rules that Biosimilars Act preempts state law

In a ruling issued in the case of Amgen Inc. v. Sandoz Inc. concerning biosimilars, the U.S. Court of Appeals for the Federal Circuit (CAFC) held that the federal Biologics Price Competition and Innovation Act...
20:40 , Dec 14, 2017 |  BC Extra  |  Politics & Policy

Appeals court: Federal biosimilars act preempts state law

In a ruling issued in the case of Amgen Inc. v. Sandoz Inc. concerning biosimilars, the U.S. Court of Appeals for the Federal Circuit (CAFC) held that the federal Biologics Price Competition and Innovation Act...
23:21 , Nov 30, 2017 |  BC Week In Review  |  Company News

Amgen buys out Kyowa JV

In October, Amgen Inc. (NASDAQ:AMGN) and Kirin Holdings Co. Ltd. terminated their JV Kirin-Amgen, which now becomes a wholly-owned subsidiary of Amgen. Kirin is the parent company of Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151). Kirin will...
03:19 , Nov 17, 2017 |  BC Week In Review  |  Company News

CAFC affirms Apotex biosimilars do not infringe Amgen patent

The U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a district court ruling that two biosimilars from Apotex Inc. (Toronto, Ontario) do not infringe a patent held by Amgen Inc. (NASDAQ:AMGN). Amgen sought...
23:16 , Nov 13, 2017 |  BC Extra  |  Company News

CAFC affirms Apotex biosimilars do not infringe Amgen patent

The U.S. Court of Appeals for the Federal Circuit affirmed a district court ruling that two biosimilars from Apotex Inc. (Toronto, Ontario) do not infringe a patent held by Amgen Inc. (NASDAQ:AMGN). Amgen sought a...
22:24 , Sep 15, 2017 |  BC Extra  |  Politics & Policy

U.S. government asserts biosimilars act preempts state law

On Monday, the U.S. government submitted an amicus brief to the U.S. Court of Appeals for the Federal Circuit (CAFC) in the case of Amgen Inc. v. Sandoz Inc. arguing that the federal Biologics Price...
20:27 , Sep 15, 2017 |  BC Week In Review  |  Clinical News

FDA accepts Adello's BLA for Neupogen biosimilar

FDA accepted for review a BLA from Adello Biologics LLC (Piscataway, N.J.) for its biosimilar candidate of neutropenia drug Neupogen filgrastim from Amgen Inc. (NASDAQ:AMGN). Adello did not disclose the user fee action goal date....
23:37 , Sep 12, 2017 |  BC Extra  |  Company News

Regulatory round-up: Array, Sandoz, Sorrento, Adello

FDA accepted for review a number of applications, including NDAs from Array BioPharma Inc. (NASDAQ:ARRY) and BLAs for two biosimilar candidates. FDA assigned a June 30, 2018 PDUFA date to a pair of NDAs from Array...
16:47 , Aug 4, 2017 |  BC Week In Review  |  Company News

Express Scripts releases 2018 formulary exclusions

Express Scripts Holding Co. (NASDAQ:ESRX) posted a list of drugs it will not cover in its 2018 National Preferred Formulary, along with preferred alternatives in each drug category. The new formulary excluded 64 additional drugs...
21:17 , Jul 31, 2017 |  BC Extra  |  Company News

Radius Health scores with Express Scripts 2018 formulary

Radius Health Inc. (NASDAQ:RDUS) gained $1.90 to $44.03 Monday after Express Scripts Holding Co. (NASDAQ:ESRX) listed Radius' osteoporosis drug Tymlos abaloparatide-SC as a preferred alternative to Forteo teriparatide from Eli Lilly and Co. (NYSE:LLY). The...