21:52 , Sep 18, 2018 |  BC Extra  |  Company News

Management tracks: BioTime, Immune-Onc

Degenerative disease company BioTime Inc. (NYSE-A:BTX; Tel Aviv:BTX) named Brian Culley CEO, to replace co-CEOs Adi Mohanty and Michael West. Most recently, Culley was CEO of infectious disease company Artemis Therapeutics Inc. (OTCQB:ATMS). Immunotherapy company Immune-Onc...
17:50 , Sep 14, 2018 |  BC Extra  |  Politics & Policy

Gottlieb releases FDA's plan to combat antibiotic resistance, calls for funding

FDA Commissioner Scott Gottlieb reiterated the call for new funding mechanisms to combat antimicrobial resistance during remarks made at a Pew Charitable Trusts meeting Friday. Gottlieb also revealed FDA's 2019 strategic plan to address AMR,...
22:19 , Jul 19, 2018 |  BC Innovations  |  Translation in Brief

Public Funding Highlights: 2Q18

Public Funding Highlights: 2Q18 Selected developments and initiatives in 2Q18 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) and the Canadian...
21:57 , Jul 10, 2018 |  BC Extra  |  Company News

Management tracks: G1, Collegium, Nimbus

Cancer company G1 Therapeutics Inc. (NASDAQ:GTHX) hired John Demaree as chief commercial officer and Stillman Hanson as general counsel. Demaree was VP of oncology marketing at Astellas Pharma Inc. (Tokyo:4503). Hanson was associate general counsel...
03:05 , Jun 30, 2018 |  BioCentury  |  Finance

Hidden in the rough

Judicious stock picking was especially important in the second quarter, as 57% of global biotech stocks saw their equity values decline. Volatility continued to roil global markets during the period and additional uncertainty looms with the...
03:04 , Jun 30, 2018 |  BioCentury  |  Finance

Eyes on launches

The annual summer slowdown isn’t restricted to just the stock market this year, as the clinical catalyst calendar also appears to be on holiday in 3Q18. Buysiders are therefore turning their attention to a spate of...
00:59 , Jun 30, 2018 |  BioCentury  |  Regulation

Not a test

Antibiotics developers shouldn’t read too much into FDA’s rejection of the first drug to be reviewed under a new limited-use pathway that is supposed to make it easier to develop treatments for rare and resistant...
17:42 , Jun 29, 2018 |  BC Extra  |  Politics & Policy

Bill seeks to introduce ‘pull’ incentive for antibiotics

Two members of the House Energy and Commerce Committee introduced legislation that would create a new “pull” incentive pathway for priority antibiotics, providing manufacturers a transferable award that could be worth $1 billion or more....
15:03 , Jun 29, 2018 |  BC Week In Review  |  Clinical News

FDA approves plazomicin for cUTI, but not blood infections

Achaogen Inc. (NASDAQ:AKAO) said FDA approved Zemdri plazomicin to treat complicated urinary tract infections (cUTIs), but issued a complete response letter for the same candidate to treat bloodstream infections. The mixed decision is in line...
15:30 , Jun 26, 2018 |  BC Extra  |  Company News

FDA approves plazomicin for cUTI, but not blood infections

Achaogen Inc. (NASDAQ:AKAO) said FDA approved Zemdri plazomicin to treat complicated urinary tract infections (cUTIs), but issued a complete response letter for the same candidate to treat bloodstream infections. The mixed decision is in line...