23:26 , May 14, 2019 |  BC Extra  |  Clinical News

Daiichi gets ODAC split, with FDA panel backing pexidartinib for rare cancer

Missing data and lingering safety questions dogged a pair of Daiichi Sankyo oncology agents that came before ODAC on Tuesday, but a lack of available treatment options for tenosynovial giant cell tumor and a clear...
21:57 , May 10, 2019 |  BC Extra  |  Company News

May 10 Company Quick Takes: Red flags for Daiichi ahead of ODAC; plus JHL/Genentech, J&J, Gilead

FDA reviewers raise concerns about Daiichi’s quizartinib, pexidartinib  Despite both pexidartinib and quizartinib meeting the primary endpoints in their pivotal trials, FDA reviewers raised concerns about each agent from Daiichi Sankyo Co. Ltd. (Tokyo:4568) in...
21:54 , May 8, 2019 |  BC Extra  |  Clinical News

AZ, Daiichi planning global submissions for breast cancer ADC

After AstraZeneca paid Daiichi $1.35 billion up front to jointly develop and commercialize the Japanese pharma’s trastuzumab deruxtecan (DS-8201), the partners reported Wednesday that the antibody-drug conjugate met the primary endpoint in the pivotal Phase...
16:25 , Apr 19, 2019 |  BioCentury  |  Finance

Earnings on deck

Earnings on deck At least 12 profitable biotechs and pharmas are slated to report earnings this week. (A) During trading hours in Europe; premarket on U.S. exchange; (B) Full-year EPS for fiscal year ended March...
18:59 , Apr 12, 2019 |  BC Week In Review  |  Company News

ODAC to discuss Daiichi Sankyo's pexidartinib, quizartinib NDAs

FDA’s Oncologic Drugs Advisory Committee will meet on May 14 to discuss two NDAs from Daiichi Sankyo, one for pexidartinib to treat symptomatic tenosynovial giant cell tumors and the other for quizartinib to treat relapsed...
00:06 , Apr 6, 2019 |  BioCentury  |  Finance

Big caps under pressure

Biogen’s fall in the wake of its decision to discontinue late-stage trials of Alzheimer’s therapy aducanumab is yet another reminder that large caps are in dire need of new pipeline products, and could serve as...
03:13 , Mar 29, 2019 |  BC Extra  |  Company News

Daiichi gets $1.35B up front from AZ in antibody-drug conjugate deal

AstraZeneca will pay Daiichi Sankyo $1.35 billion up front to bolster one of the four platforms of its oncology unit, ADCs. Daiichi Sankyo Co. Ltd. (Tokyo:4568) and AstraZeneca plc (LSE:AZN; NYSE:AZN) announced Friday that they...
17:36 , Mar 8, 2019 |  BC Week In Review  |  Company News

Esperion submits NDAs to FDA for LDL-C lowering products, EMA starts review

Esperion said it submitted two NDAs to FDA for bempedoic acid (ETC-1002) and a bempedoic acid/ezetimibe combination tablet to treat elevated LDL-C in patients who need additional LDL-C lowering despite the use of currently accessible...
01:29 , Feb 28, 2019 |  BC Innovations  |  Distillery Therapeutics

Infectious disease

INDICATION: Encephalitis Mouse studies suggest inhibiting CMA1 could help treat Japanese encephalitis (JE). In mice non-lethally infected with JE virus, serum levels of a mouse homolog of CMA1 were higher after infection with JE virus...
23:56 , Feb 26, 2019 |  BC Extra  |  Company News

Management tracks: Immunomedics, Daiichi, Notable Labs

Immunomedics Inc. (NASDAQ:IMMU) said Michael Pehl resigned as president, CEO and a board member due to personal reasons, just 15 months after he joined the antibody-drug conjugate company. The news comes a month after FDA...