21:58 , May 24, 2019 |  BioCentury  |  Product Development

Why quizartinib hiccup at ODAC shouldn’t derail Daiichi’s 2025 cancer drug goals

FDA's ODAC may have given the thumbs down to Daiichi’s quizartinib, but a stocked pipeline and another ongoing trial of the candidate suggest it’s more of a hiccup than a hurdle in the Japanese pharma’s...
19:06 , May 22, 2019 |  BC Extra  |  Company News

Management tracks: Gottlieb re-joining NEA; plus Seattle Genetics, Celsius and more

Former FDA Commissioner Scott Gottlieb is joining New Enterprise Associates as a special partner. Gottlieb was a venture partner at the firm from 2007 to 2017. In his new role, Gottlieb will have a “deeper...
14:18 , May 20, 2019 |  BC Innovations  |  Distillery Techniques

RB1 alterations predict survival in mCRPC patients treated with Zytiga or Xtandi

TECHNIQUES CATEGORY: Biomarkers TECHNOLOGY: Gene profiling Alterations in RB1 could help predict survival in mCRPC patients treated with Zytiga or Xtandi. In 429 patients with mCRPC, analysis of whole-exome sequencing, gene expression, histopathology, survival and...
22:17 , May 17, 2019 |  BC Extra  |  Company News

Management tracks: AstraZeneca, Certara, Longas

AstraZeneca plc (LSE:AZN; NYSE:AZN) said Sunil Verma will become VP, head of breast cancer strategy and global clinical leader in R&D oncology. Verma was head of the department of oncology at University of Calgary and...
19:24 , May 17, 2019 |  BioCentury  |  Product Development

Pushing China to the forefront: When a first-in-China regulatory strategy makes sense

As reforms in China shorten clinical and regulatory timelines for biotechs across the board, the country has a growing chance to become the first stop for regulatory approvals of first-in-class drugs. The decision to do...
00:48 , May 17, 2019 |  BC Innovations  |  Tools & Techniques

Leaning on exosomes, model-informed drug development gets closer to tailoring doses to each patient

Model-informed drug development is poised to move into personalized dosing, with a little help from exosomes. An August FDA workshop aims to shed light on when and how to use these precision dosing models in...
00:16 , May 14, 2019 |  BC Extra  |  Financial News

Trade tensions sink biotech shares as markets skid

While biopharma products have largely escaped Beijing and Washington’s tariff lists, biotech indexes were dragged down with the rest of the U.S. market Monday as the U.S. and China escalated their trade war. But industry...
00:19 , May 11, 2019 |  BC Extra  |  Clinical News

FibroGen falls on U.S. safety data for roxadustat

FibroGen lost $9.28 (20%) to $36.39 on Friday after pooled safety analyses of Phase III data of anemia therapy roxadustat raised concerns for investors ahead of planned regulatory filings this fall. Omega Funds’ Otello Stampacchia...
23:09 , May 8, 2019 |  BC Extra  |  Company News

Management tracks: Immunocore, Kyn, Engitix

Immunocore Ltd. (Abingdon, U.K.) brought on a third ex-AstraZeneca plc (LSE:AZN; NYSE:AZN) executive, hiring Mohammed Dar as head of clinical development and CMO. Dar was VP, clinical development oncology, R&D at AZ's MedImmune LLC subsidiary....
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...