BioCentury | Apr 16, 2020
Product Development

April 15 Quick Takes: TScan, Novartis team up on TCR therapies and a first for UroGen; plus Aligos, Leo, Madrigal, Merck

TScan, Novartis partner to develop TCR therapies  TScan Therapeutics Inc. entered an agreement with Novartis AG (NYSE:NVS; SIX:NOVN) to discover and develop TCR-engineered T cell therapies. Novartis will pay a technology access fee and research...
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...
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 | 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...
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...
BC Extra | Jun 15, 2019
Company News

June 13 Company Quick Takes: ISS rebuffs Takeda’s Weber; plus Sage, Blueprint, Tetraphase, Celgene and more

ISS weighs in on Weber  Institutional Shareholder Services recommended Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) shareholders oppose President and CEO Christophe Weber at the June 27 shareholder meeting because “top management is responsible for the...
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 Week In Review | Jan 25, 2019
Clinical News

Samsung's Herceptin biosimilar gains U.S. approval

FDA approved a BLA for Ontruzant trastuzumab-dttb from Samsung Bioepis Co. Ltd. (Incheon, Korea), a biosimilar of Herceptin. The biosimilar is Samsung Bioepis' first approved in the U.S. to treat cancer. Ontruzant received approval for...
BC Extra | Jan 22, 2019
Company News

Samsung's Herceptin biosimilar gains U.S. approval

FDA approved a BLA for Ontruzant trastuzumab-dttb from Samsung Bioepis Co. Ltd. (Incheon, Korea), a biosimilar of Herceptin. The biosimilar is Samsung Bioepis' first approved in the U.S. to treat cancer. Ontruzant received approval for...
BC Week In Review | Dec 21, 2018
Clinical News

FDA approves Celltrion's Herceptin biosimilar

FDA approved a BLA for Herceptin biosimilar Herzuma trastuzumab-pkrb from Celltrion Inc. (KOSDAQ:068270) to treat HER2-positive breast cancer. In April, Celltrion received complete response letters from FDA for Herzuma and Truxima rituximab-abbs, its Rituxan biosimilar....
Items per page:
1 - 10 of 86