21:21 , Mar 22, 2019 |  BioCentury  |  Regulation

Manufacturing new modalities

Cell and gene therapies won’t enter the mainstream of medicine until manufacturing processes become far more efficient, according to FDA Commissioner Scott Gottlieb and FDA Center for Biologics Evaluation and Research Director Peter Marks. The...
20:04 , Mar 6, 2019 |  BC Extra  |  Company News

Judge grants Genentech some relief as JHL trade secret case moves forward

A federal judge ruled in Genentech's favor on multiple issues in its civil suit against Taiwanese company JHL Biotech, but declined to halt JHL's biosimilars development. Judge William Alsup's order was unsealed late Tuesday, following...
19:01 , Feb 22, 2019 |  BC Week In Review  |  Company News

Judge skeptical of JHL's defense in Genentech case

U.S. District Judge William Alsup met with skepticism arguments made by lawyers for JHL Biotech Inc. (Zhubei, Taiwan) during a motion hearing Feb. 14 for Genentech Inc.'s civil case against the Taiwanese company. Genentech filed...
01:20 , Feb 16, 2019 |  BC Extra  |  Company News

Judge skeptical of JHL's defense in Genentech case

U.S. District Judge William Alsup met with skepticism arguments made by lawyers for JHL Biotech Inc. (Zhubei, Taiwan) during a motion hearing Thursday for Genentech Inc.'s civil case against the Taiwanese company. Genentech filed the...
22:49 , Feb 1, 2019 |  BioCentury  |  Politics, Policy & Law

Trading blows over trade secrets

Roche’s Genentech Inc. unit kept an employee on the payroll in its South San Francisco office for almost a year after it discovered she was stealing trade secrets, watching as she channeled proprietary data to...
00:35 , Feb 1, 2019 |  BC Innovations  |  Tools & Techniques

TMB needs company

Tumor mutation burden is looking less like a magic bullet and more like just one of at least three variables that could jointly predict responses to checkpoint inhibitors. Combining TMB measurements with markers of T...
21:46 , Jan 17, 2019 |  BC Innovations  |  Finance

Public funding highlights

Public funding highlights Selected developments and initiatives in 4Q18 from major sources of public funding including National Institutes of Health (NIH), the U.K.’s Medical Research Council (MRC), the Innovative Medicines Initiative (IMI), the Canadian Institutes...
21:20 , Dec 14, 2018 |  BC Week In Review  |  Financial News

Allen Insitute's immunology division launches with $125M, Lilly vet and five partners

The Allen Institute expects its latest research endeavor to generate knowledge about molecular drivers of immune-related diseases, paving the way for new diagnostics and therapies. The Allen Institute for Immunology launched on Dec. 12 with...
00:23 , Dec 13, 2018 |  BC Extra  |  Preclinical News

Allen Institute's immunology division launches with $125M, Lilly vet and five partners

The Allen Institute expects its latest research endeavor to generate knowledge about molecular drivers of immune-related diseases, paving the way for new diagnostics and therapies. The Allen Institute for Immunology launched Wednesday with $125 million...
00:05 , Dec 12, 2018 |  BC Extra  |  Company News

Management tracks: Merck creates new commercial roles to follow Schechter's exit

Merck & Co. Inc. (NYSE:MRK) said President of Global Human Health Adam Schechter will step down at the end of the year. The company will restructure his former position into two new roles effective Jan....