BioCentury | Feb 14, 2020
Finance

On heels of reimbursement, Innovent raises $303M to ready Tyvyt rollout

Within one month of its stock reaching an all-time high, Innovent priced its second follow-on offering on the Hong Kong exchange early Thursday, raising HK$2.4 billion ($303.2 million) to expand manufacturing capacity in preparation for...
BC Extra | Jan 25, 2020
Company News

Pfizer seeking to dent market share with trio of discounted biosimilars

Pfizer is hoping that discounts of 22-24% from reference drugs’ wholesale acquisition costs (WACs) will help it gain market share for three new or soon-to-be launched biosimilars, each of which will compete with at least...
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 19, 2019
Company News

Nov. 19 Company Quick Takes: Medicines Co. gains on buyout rumor; plus Samsung's biosimilar under review and Zelluna-Glycostem

Medicines Co. mum on Novartis takeout rumor  The Medicines Co. (NASDAQ:MDCO) declined to comment to BioCentury on a Bloomberg report that said Novartis AG (NYSE:NVS; SIX:NOVN) is among several companies exploring an acquisition of the...
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...
BC Extra | Sep 18, 2019
Financial News

Hong Kong’s first IPO in months values Shanghai Henlius at $3.4B

Amid market concerns due to recent Hong Kong protests, Shanghai Henlius became the first company to list on the exchange’s biotech chapter in four months Wednesday, raising HK$3.2 billion ($409.9 million) in an IPO that...
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 Extra | Jul 19, 2019
Company News

July 19 Company Quick Takes: First biosimilars of Avastin, Herceptin launched; plus Gilenya, Celltrion-Nan Fung and Celgene

Amgen, Allergan launch pair of biosimilars  Amgen Inc. (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) launched Mvasi bevacizumab-awwb and Kanjinti trastuzumab-anns in the U.S.; they are the first biosimilars of Avastin bevacizumab and Herceptin trastuzumab available in...
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