02:10 , Oct 20, 2018 |  BioCentury  |  Product Development

CVOT damage in diabetes

As FDA reconsiders its requirement for cardiovascular outcomes trials of new diabetes candidates, it’s clear that the development of new therapies has slowed since it was implemented. In December 2008, FDA issued guidance requiring diabetes...
23:32 , Oct 19, 2018 |  BC Extra  |  Company News

FDA, EMA delay review of Opdivo/Yervoy for first-line NSCLC

Bristol-Myers Squibb Co. (NYSE:BMY) said Friday that FDA and EMA have both pushed back their reviews of anti-PD-1 mAb Opdivo nivolumab plus anti-CTLA-4 mAb Yervoy ipilimumab for first-line non-small cell lung cancer. The company also...
18:13 , Oct 19, 2018 |  BC Week In Review  |  Clinical News

Keytruda, Inlyta combo headed for first-line RCC submissions

Merck & Co. Inc. (NYSE:MRK) said Keytruda pembrolizumab in combination with Inlyta axitinib met the primary endpoints vs. Sutent sunitinib in the Phase III KEYNOTE-426 trial as first-line treatment of renal cell carcinoma. Merck plans...
18:10 , Oct 19, 2018 |  BC Week In Review  |  Clinical News

After three deals, FDA approval, talazoparib joins PARP party

FDA approved Talzenna talazoparib from Pfizer Inc. (NYSE:PFE) to treat germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer, making it the second PARP inhibitor approved for the indication. The approval comes well ahead of...
18:00 , Oct 18, 2018 |  BC Extra  |  Clinical News

Keytruda, Inlyta combo headed for first-line RCC submissions

Merck & Co. Inc. (NYSE:MRK) said Keytruda pembrolizumab in combination with Inlyta axitinib met the primary endpoints vs. Sutent sunitinib in the Phase III KEYNOTE-426 trial as first-line treatment of renal cell carcinoma. Merck plans...
22:50 , Oct 16, 2018 |  BC Extra  |  Company News

After three deals, FDA approval talazoparib joins PARP party

FDA approved Talzenna talazoparib from Pfizer Inc. (NYSE:PFE) to treat germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer, making it the second PARP inhibitor approved for the indication. The approval comes well ahead of...
01:55 , Oct 13, 2018 |  BioCentury  |  Product Development

Bourla’s breadcrumbs to value

Incoming CEO Albert Bourla has spent only a few of his 25 years at Pfizer Inc. in the pharma’s innovative drugs business, but there are signs he already has laid the groundwork for innovating how...
20:53 , Oct 12, 2018 |  BC Extra  |  Tools & Techniques

iPS cell-derived models offer new opportunities for drug screening

New models for Down syndrome and amyotrophic lateral sclerosis harness patient-derived induced pluripotent stem (iPS) cells to overcome genetic and cell heterogeneities inherent to the disorders not adequately recapitulated by cell culture and animal models. In...
20:30 , Oct 12, 2018 |  BioCentury  |  Emerging Company Profile

Targeting GPCRs, Ab Initio

Ab Initio Biotherapeutics Inc. is using its biochemistry expertise and an integrated set of three platforms to purify GPCRs in clinically relevant conformations for producing anti-GPCR antibodies. Antibodies can act on their targets with better...
18:04 , Oct 12, 2018 |  BC Week In Review  |  Financial News

First-day pop for Allogene after year's largest biotech IPO on NASDAQ

Less than a year after it was founded, cell therapy company Allogene Therapeutics Inc. (NASDAQ:ALLO) raised $324 million late Oct. 10 in the largest IPO by a biotech on NASDAQ thus far in 2018. The...