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19185 items
3:55 PM, Jan 05, 2018  |  BioCentury | Politics, Policy & Law

Seeking odd couples

When Sen. Orrin Hatch retires in December, the U.S. Congress will lose the last living link to the lawmakers who collaborated across party lines to transform the FDA into the gold standard for medical product...
3:33 PM, Jan 05, 2018  |  BioCentury | Finance

BioNTech bonanza

BioNTech AG is the latest billionaire-backed German biotech to diversify its shareholders by adding U.S. investors, a move that could help support an eventual IPO. On Jan. 4, the mRNA and immuno-oncology company raised $270...
2:50 PM, Jan 05, 2018  |  BioCentury | Emerging Company Profile

Against radical pain

CerSci Therapeutics thinks that by neutralizing peroxynitrite and other free radicals it can treat acute pain and prevent it from becoming chronic, without the potential for abuse and addiction. CerSci was founded in 2014 to create...
2:25 PM, Jan 05, 2018  |  BioCentury | Finance

Building Sosei’s base

Sosei Group Corp. (Tokyo:4565) is tipping the scales towards international, institutional investors as it looks to build a shareholder base that can support the biotech as it begins to bring its first internally discovered candidates...
2:24 PM, Jan 05, 2018  |  BioCentury | Finance

Scholar goes to the clinic

While Scholar Rock LLC’s series C round will bring the biotech’s lead program into the clinic, investors also want continued investment in the company’s growth factor modulation platform to maximize its value. On Jan. 3, Scholar...
5:29 PM, Dec 22, 2017  |  BioCentury | Regulation

Prioritizing preferences

The realization that patients have distinct preferences about the trade-offs and risks inherent in medical decisions -- and that their choices are frequently different from those physicians or regulators would make -- has mobilized FDA,...
3:39 PM, Dec 22, 2017  |  BioCentury | Regulation

Preference pioneers

Rituxan Hycela subcutaneous rituximab provides the first example of how companies can get patient preference data on an FDA-approved drug label. The new formulation is intended to reduce the treatment burden of rituximab therapy, which was...
2:34 PM, Dec 22, 2017  |  BioCentury | Finance

Less to gain

While most of the stock market partied in 4Q17 as the tax reform bill approached the goal line, biotech stocks have sulked in the corner. Republicans turned their full attention to tax reform in late September...
1:04 PM, Dec 22, 2017  |  BioCentury | Finance

Flying high

Flagship Pioneering has expanded its LP base with its sixth fund to meet its goal of launching six to eight newcos per year out of its VentureLabs unit. Flagship Pioneering Fund VI L.P. closed on...
12:45 PM, Dec 22, 2017  |  BioCentury | Product Development

Beyond PD-L1 assays

Data from Genentech Inc.’s Phase III IMpower150 trial of Tecentriq atezolizumab in first-line non-small cell lung cancer provides the company with its first hard data showing what work lies ahead before it will be ready...