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 | May 8, 2019
Company News

May 8 Company Quick Takes: Takeda selling Shire eye drug to Novartis in $3.4B deal; plus BioNTech, Third Rock’s Thrive and more

Takeda off-loads Xiidra, TachoSil  Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) will sell Xiidra lifitegrast to Novartis AG (NYSE:NVS; SIX:NOVN) for $3.4 billion up front, plus $1.9 billion in milestones. Takeda said divesting the dry eye...
BioCentury | Apr 19, 2019
Politics, Policy & Law

Thin U.S. biosimilars market fuels proposals to regulate biologics prices

Frustration over the failure of biosimilars to slash the costs of decades-old biologics has prompted a group of policy analysts to suggest abandoning attempts to copy biologics. Because the sole purpose of biosimilars is to...
BioCentury | Mar 28, 2019
Product Development

Contracting practices limiting U.S. biosimilars uptake

The U.S. biosimilars market lags Europe’s and won’t catch up until physicians understand and become comfortable with the concept of similarity, Sheila Frame, who heads up Sandoz’s North American biosimilars business, told BioCentury. To create...
BioCentury | Nov 16, 2018
Tools & Techniques

Benchtop manufacturing gets smaller

Publisher’s note: This story originally ran in the Nov. 15, 2018 issue of BioCentury Innovations , a comprehensive source of developments in translational research with knowledgeable perspectives on the key innovations, trends and opportunities in early...
BC Innovations | Nov 15, 2018
Tools & Techniques

Benchtop manufacturing gets smaller

MIT scientists continue to break new ground in benchtop manufacturing systems for biologics. Published in Nature Biotechnology last month, the latest advance from the institute centered on an automated, closed system capable of producing clinical-grade...
BioCentury | Oct 6, 2018

Large cap comeback

The biotech sector continued to be a stock pickers’ market through 3Q18 as there was a near even split between global biotech stocks that gained and lost value in the quarter. While 1H18 saw investors...
BioCentury | Sep 1, 2018
Politics, Policy & Law

Back to School: A pathway to Biopharma 3.0

As market and social forces continue to tighten around the biopharmaceutical industry, drug companies need to start evolving toward a new business model that both capitalizes on the potential of new technologies and accommodates society’s...
BioCentury | Jul 27, 2018

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...
BC Week In Review | Jul 27, 2018
Clinical News

FDA approves Pfizer Nivestym, second Neupogen biosimilar

FDA approved Nivestym filgrastim-aafi from Pfizer Inc. (NYSE:PFE), its biosimilar version of neutropenia drug Neupogen filgrastim from Amgen Inc. (NASDAQ:AMGN). The approval includes all indications on Neupogen's label. The July 20 approval followed July 18...
Items per page:
1 - 10 of 284