21:26 , Jul 27, 2018 |  BioCentury  |  Regulation

Biosimilar barriers

A coming showdown over anticompetitive contracting practices, coupled with an impending wave of patent expirations, could result in a wave of biosimilar approvals and launches in the U.S. over the next year, according to biosimilars...
03:05 , Jun 30, 2018 |  BioCentury  |  Finance

Hidden in the rough

Judicious stock picking was especially important in the second quarter, as 57% of global biotech stocks saw their equity values decline. Volatility continued to roil global markets during the period and additional uncertainty looms with the...
02:31 , May 18, 2018 |  BC Week In Review  |  Clinical News

FDA approves Pfizer's Retacrit, first epoetin alfa biosimilar in U.S.

FDA approved Retacrit epoetin alfa-epbx from Pfizer Inc. (NYSE:PFE), a biosimilar of anemia drugs Epogen from Amgen Inc. (NASDAQ:AMGN) and Procrit from the Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ). FDA said it...
23:16 , May 15, 2018 |  BC Extra  |  Company News

FDA approves Pfizer's Retacrit, first epoetin alfa biosimilar in U.S.

FDA approved Retacrit epoetin alfa-epbx from Pfizer Inc. (NYSE:PFE), a biosimilar of anemia drugs Epogen from Amgen Inc. (NASDAQ:AMGN) and Procrit from the Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ). FDA said it...
00:38 , Jan 6, 2018 |  BioCentury  |  Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to a...
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...
23:40 , Jul 7, 2017 |  BioCentury  |  Finance

Onward and upward

The top three market cap tiers continued to outperform smaller caps in 2Q17, led by companies valued between $1 billion and $9.9 billion. Companies valued below $1 billion failed to carry over their momentum from...
00:21 , Jun 23, 2017 |  BC Extra  |  Company News

Pfizer gets another CRL for biosimilar Retacrit

Pfizer Inc. (NYSE:PFE) said it received a second complete response letter from FDA for a BLA for Retacrit epoetin alfa. The candidate is a biosimilar of anemia drugs Epogen from Amgen Inc. (NASDAQ:AMGN) and Procrit...
20:24 , May 26, 2017 |  BC Week In Review  |  Clinical News

Akebia starts Phase II of vadadustat in CKD

Akebia Therapeutics Inc. (NASDAQ:AKBA) began the Phase II FO2RWARD trial to compare once-daily oral vadadustat vs. epoetin alfa to treat anemia in about 78 dialysis-dependent chronic kidney disease (CKD) patients who are hyporesponsive to erythropoiesis...
17:34 , May 26, 2017 |  BC Week In Review  |  Clinical News

ODAC backs Pfizer biosimilar Retacrit

FDA's Oncologic Drugs Advisory Committee voted 14-1 in favor of approval of Retacrit epoetin alfa from Pfizer Inc. (NYSE:PFE). The candidate is a biosimilar of anemia drugs Epogen from Amgen Inc. (NASDAQ:AMGN) and Procrit from...