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 | Jan 1, 2020
Regulation

Fewer FDA approvals in 2019, but a basket of firsts

While the year held fewer approvals of new molecular entities than 2018, it was not short of major achievements. FDA greenlit several drugs with innovative modalities, against novel targets and for diseases that have long...
BC Extra | Dec 21, 2019
Company News

Efficacy data set trastuzumab ADC up for fast approval for third-line breast cancer

Less than two weeks after establishing a new threshold for efficacy in HER2+ breast cancer, Enhertu fam-trastuzumab deruxtecan-nxki has gained accelerated approval from FDA in the indication a mere two months after receiving Priority Review....
BC Extra | Dec 11, 2019
Clinical News

AstraZeneca, Daiichi’s trastuzumab ADC sets new efficacy bar in breast cancer

Trastuzumab deruxtecan from AstraZeneca and Daiichi Sankyo may have established a new threshold for efficacy in HER2+ breast cancer based on pivotal Phase II data. The data were better, in a sicker patient population, than...
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 | Dec 6, 2019
Company News

Management tracks: Cancer therapy pioneer Desmond-Hellmann leaving Gates Foundation; plus CStone, Janssen, Akcea, insitro and more

Sue Desmond-Hellmann is stepping down after five years as CEO of the Bill & Melinda Gates Foundation . Before joining the foundation, she spent 14 years at Genentech Inc., where she helped develop cancer drugs Herceptin...
BC Extra | Nov 6, 2019
Company News

Biogen expanding biosimilars deal for eye therapies, anti-TNFs

As it continues to rely on biosimilars as a growth driver, Biogen has expanded its deal with Samsung Bioepis to include two new ocular biosimilars in certain major markets, as well as rights in China...
BC Extra | Nov 6, 2019
Company News

Nov. 5 Company Quick Takes: Takeda licenses MD Anderson CAR NK cell portfolio; plus Myriad, Canbridge, BioCryst-Torii and Strongbridge

MD Anderson, Takeda partner for CAR NK cell therapies  The University of Texas MD Anderson Cancer Center partnered with Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) to develop and commercialize up to four allogeneic CAR NK...
BC Extra | Nov 4, 2019
Clinical News

Halozyme to focus on Enhanze partnering after Phase III oncology miss

With the failure of Halozyme's lead cancer program in a Phase III trial, the company intends to exit the oncology R&D field entirely and focus on deriving partner revenue from its subcutaneous drug delivery technology...
BC Innovations | Oct 24, 2019
Tools & Techniques

Driving safely into solid tumors with CAR exosomes

Therapeutic exosomes derived from CAR T cells could avoid the cytotoxic side effects of the engineered cells and overcome barriers in the tumor microenvironment that limit the cells’ efficacy. The obstacles to deploying CAR T...
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