BC Extra | Jan 17, 2020
Company News

Jan. 17 Company Quick Takes: FDA expands label of Novo’s Ozempic; plus Intercept, Durect, Coherus-Innovent, CoImmune-Formula and Momenta

Label expansion for Novo’s Ozempic  FDA approved Ozempic subcutaneous semaglutide from Novo Nordisk A/S (CSE:NOVO B; NYSE:NOVO) to reduce the risk of major adverse cardiovascular events in adults with Type II diabetes and heart disease....
BC Extra | Jan 7, 2020
Company News

Management tracks: New director for CMS’s CMMI, plus FibroGen, Turning Point, Akcea, Antengene, Biocon and more

CMS appointed Brad Smith as director of the Center for Medicare & Medicaid Innovation , through which HHS plans to implement the Trump administration’s proposed International Pricing Index model for Medicare Part B drugs. Smith, who...
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 | Nov 5, 2019
Company News

Sandoz to launch third Neulasta biosimilar

Sandoz has received FDA approval for Ziextenzo pegfilgrastim-bmez and plans to price it at a monthly wholesale acquisition cost of $3,925, a 37% discount to the WAC for Amgen neutropenia drug Neulasta. The entry of...
BioCentury | Sep 6, 2019
Regulation

Lackluster U.S. biosimilars market sparks radical recommendations

The lackluster U.S. biosimilars market has led to calls for a new regulatory paradigm that could slash the cost of development. Biosimilars developers and critics of the sector agree on one thing: as it has...
BC Week In Review | Feb 15, 2019
Company News

Samsung Bioepis partners with AffaMed, expands biosimilar development in China

Samsung Bioepis Co. Ltd. (Incheon, South Korea) partnered to develop four of its biosimilars with AffaMed Therapeutics (Shanghai, China). The partners will initially collaborate on clinical development, regulatory registration and commercialization Ontruzant, SB11, SB12 and...
BC Extra | Feb 5, 2019
Company News

Management tracks: Amazon-Berkshire Hathaway-JPM venture hires Kutan as CTO

Serkan Kutan started in January as the CTO of the healthcare venture from J.P. Morgan (NYSE:JPM), Berkshire Hathaway Inc. (NYSE:BRK-A; NYSE:BRK-B) and Amazon.com Inc. (NASDAQ:AMZN). He was CTO of Zocdoc Inc. (New York, N.Y.), a...
BC Week In Review | Feb 1, 2019
Company News

AbbVie loses $8B in market cap on steeper Humira erosion

AbbVie Inc. (NYSE:ABBV) lost $5.34 to $80.54 on Jan. 25, representing a loss of almost $8 billion in market cap, after announcing it expects a higher rate of erosion in ex-U.S. sales on autoimmune drug...
BC Extra | Jan 25, 2019
Company News

AbbVie loses $8B in market cap on steeper Humira erosion

AbbVie Inc. (NYSE:ABBV) lost $5.34 to $80.54 on Friday, representing a loss of almost $8 billion in market cap, after announcing it expects a higher rate of erosion in ex-U.S. sales on autoimmune drug Humira...
BioCentury | Jan 12, 2019
Finance

JPM jump-starts 2019

About three quarters of the more than 200 biopharma companies presenting at the 2019 J.P. Morgan Healthcare Conference saw their stock prices rise last week. Leading the pack was the 53% jump by Insmed Inc....
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