00:47 , Jun 29, 2019 |  BioCentury  |  Finance

All eyes on new modality launches, cancer and rare disease data in 3Q19

While the typical summer lull means fewer catalysts in the third quarter, investors will be keeping a close eye on launches of new modality drugs. Of special interest to multiple buysiders is the launch of...
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...
00:19 , 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...
20:22 , May 1, 2019 |  BC Extra  |  Preclinical News

May 1 Preclinical Quick Takes: MD Anderson, Sana, Sigilon

MD Anderson findings could make radiation possible for pancreatic cancer  Researchers at University of Texas MD Anderson Cancer Center reported findings suggesting that HIF-PH inhibition could help prevent radiation-induced GI injury, the main factor that...
20:54 , Apr 15, 2019 |  BC Extra  |  Clinical News

Invokana reduces composite endpoint by 30% in Type II diabetics with CKD

After years of failures in the CKD space, two agents have now shown efficacy in the indication. The latest is Invokana canagliflozin from Janssen, which said Sunday that Invokana is the only drug in nearly...
17:44 , Mar 15, 2019 |  BC Week In Review  |  Clinical News

Mitsubishi Tanabe planning Japanese submission for vadadustat

Akebia said partner Mitsubishi Tanabe plans to submit a regulatory application in Japan this year for vadadustat to treat anemia due to chronic kidney disease (CKD) after reporting that the product met the primary endpoints...
18:03 , Jan 11, 2019 |  BC Week In Review  |  Clinical News

Following China approval, FibroGen's anemia drug meets in five additional Phase III trials

FibroGen Inc. (NASDAQ:FGEN) and AstraZeneca plc (LSE:AZN; NYSE:AZN) reiterated plans to submit an NDA to FDA this half for roxadustat to treat anemia in patients with chronic kidney disease (CKD) after the compound met the...
20:45 , Dec 21, 2018 |  BC Week In Review  |  Clinical News

China gives FibroGen its first approval for roxadustat

After over a decade of development, FibroGen Inc. (NASDAQ:FGEN) said China's National Medical Products Administration (NMPA) approved an NDA for roxadustat to treat anemia caused by chronic kidney disease (CKD) in patients who are dialysis-dependent....
01:01 , Dec 18, 2018 |  BC Extra  |  Company News

China gives FibroGen its first approval for roxadustat

After over a decade of development, FibroGen Inc. (NASDAQ:FGEN) said China's National Medical Products Administration (NMPA) approved an NDA for roxadustat to treat anemia caused by chronic kidney disease (CKD) in patients who are dialysis-dependent....
16:37 , Sep 21, 2018 |  BC Week In Review  |  Clinical News

Roxadustat meets in Phase III for CKD patients with anemia not on dialysis

Astellas Pharma Inc. (Tokyo:4503) said roxadustat (ASP1517, FG-4592) met both primary endpoints in the Phase III ALPS trial to treat anemia in patients with chronic kidney disease (CKD) who were not receiving dialysis. On the...