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...
00:23 , Jan 12, 2019 |  BioCentury  |  Finance

We all fall down

After an exuberant third quarter that put biotech indexes near their 2015 highs, all market cap tiers fell in 4Q18, eliminating the first nine month’s gains and losing $291.2 billion in aggregate value. Median losses...
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...
02:49 , Jan 5, 2019 |  BioCentury  |  Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
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....
00:48 , Oct 6, 2018 |  BioCentury  |  Finance

Seeking validation

The final stretch of the year offers clinical catalysts and early launch data that could validate investments in hot immuno-oncology targets and large untapped markets. Late-stage readouts from Vertex Pharmaceuticals Inc. in cystic fibrosis and...