13:00 , Nov 14, 2018 |  BC Extra  |  Clinical News

Bayer's Stivarga first to enter adaptive brain cancer trial

Bayer AG (Xetra:BAYN) and the Global Coalition for Adaptive Research (GCAR) said Stivarga regorafenib will be the first therapy to enter the adaptive Phase II/III GBM AGILE trial, which has been designed to more rapidly...
00:11 , Nov 10, 2018 |  BioCentury  |  Finance

Earnings on deck

Earnings on deck...
18:27 , Nov 9, 2018 |  BC Week In Review  |  Clinical News

Adverum reviewing capsid after discontinuing AAT gene therapy

Adverum Biotechnologies Inc. (NASDAQ:ADVM) will discontinue development of gene therapy ADVM-043 to treat α-1 antitrypsin (AAT; A1AT; SERPINA1) deficiency. The company said that although ADVM-043 was well tolerated among six patients in the open-label, U.S....
00:34 , Nov 3, 2018 |  BioCentury  |  Finance

Part B exposure

HHS Secretary Alex Azar's proposed changes to Medicare Part B have put at least four large biopharmas at risk of substantial U.S. revenue losses. But the lack of market reaction and the views of VCs...
23:28 , Nov 2, 2018 |  BioCentury  |  Finance

Bye-bye, build-to-buy

As another Inception Sciences Inc. company secures an exit, Versant Ventures plans to move away from its build-to-buy model to focus on creating stand-alone companies with broader portfolios and investor syndicates. On Oct. 31, Ophthotech...
19:52 , Nov 2, 2018 |  BC Week In Review  |  Clinical News

Eylea meets 52-week endpoint in Phase III for diabetic retinopathy subset

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said both dosing schedules of Eylea aflibercept met the 52-week primary endpoint in the Phase III PANORAMA trial for early intervention of non-proliferative diabetic retinopathy without diabetic macular edema (DME). The...
19:52 , Nov 2, 2018 |  BC Week In Review  |  Clinical News

Bayer's darolutamide meets in Phase III for non-metastatic CRPC

Bayer AG (Xetra:BAYN) said darolutamide (ODM-201, BAY1841788) met the primary endpoint of improving metastasis-free survival vs. placebo in the Phase III ARAMIS trial to treat non-metastatic castration-resistant prostate cancer (CRPC). The company did not disclose...
19:50 , Nov 2, 2018 |  BC Week In Review  |  Clinical News

Syndax's entinostat misses PFS endpoint in Phase III for breast cancer

Syndax Pharmaceuticals Inc. (NASDAQ:SNDX) reported that entinostat (SNDX-275) missed the primary endpoint of improving progression-free survival (PFS) in the Phase III E2112 trial to treat breast cancer. The company said the trial will continue as...
14:45 , Nov 2, 2018 |  BC Extra  |  Clinical News

Adverum reviewing capsid after discontinuing AAT gene therapy

Adverum Biotechnologies Inc. (NASDAQ:ADVM) sank $1.21 (27%) to $3.34 on Friday after it said it will discontinue development of gene therapy ADVM-043 to treat α-1 antitrypsin (AAT; A1AT; SERPINA1) deficiency. The company said late Thursday...
22:38 , Nov 1, 2018 |  BC Extra  |  Company News

Management tracks: CuraSen names Vargas CMO; plus Sosei, Casebia

Neurodegenerative disease start-up CuraSen Therapeutics Inc. (San Mateo, Calif.) hired Gabriel Vargas as its first CMO. Vargas led early development of migraine prophylactic Aimovig erenumab at Amgen Inc. (NASDAQ:AMGN), where he was most recently executive...