BioCentury | Dec 7, 2019
Product Development

U.S. biosimilars glass--half full or half empty?

Ten years after the U.S. created a pathway for biosimilars--and four and a half years after the first FDA approval--a few manufacturers have demonstrated that they can overcome the technical, regulatory and commercial barriers to...
BC Extra | Jul 10, 2019
Politics & Policy

CMS’s new CKD payment models could be mixed bag for drug companies

A set of five different payment models announced by the Centers for Medicare & Medicaid Services for patients with chronic kidney disease or end-stage renal disease could be a boon for companies that have taken...
BC Extra | May 11, 2019
Clinical News

FibroGen falls on U.S. safety data for roxadustat

FibroGen lost $9.28 (20%) to $36.39 on Friday after pooled safety analyses of Phase III data of anemia therapy roxadustat raised concerns for investors ahead of planned regulatory filings this fall. Omega Funds’ Otello Stampacchia...
BioCentury | Jan 5, 2019
Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
BC Week In Review | Nov 16, 2018
Clinical News

Pfizer launches U.S.’s first biosimilar epoetin

Pfizer Inc. (NYSE:PFE) launched the first biosimilar of anemia drug epoetin alfa in the U.S., priced at a 33.5% discount to the lowest priced reference product. Amgen Inc. (NASDAQ:AMGN) markets reference drug Epogen and Johnson...
BC Extra | Nov 15, 2018
Company News

Pfizer launches U.S.’s first biosimilar epoetin

Pfizer Inc. (NYSE:PFE) launched the first biosimilar of anemia drug epoetin alfa in the U.S., priced at a 33.5% discount to the lowest priced reference product. Amgen Inc. (NASDAQ:AMGN) markets reference drug Epogen and Johnson...
BioCentury | Jul 27, 2018
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...
BioCentury | Jun 30, 2018
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...
BC Week In Review | May 18, 2018
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...
BC Extra | May 15, 2018
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...
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