02:44 , Jun 3, 2019 |  BC Extra  |  Clinical News

Keytruda unlikely to face pushback from clinicians in HCC

Despite a Phase III miss for Merck & Co.'s Keytruda pembrolizumab to treat hepatocellular carcinoma, enthusiasm for the PD-1 inhibitor in the indication remains, according to comments made Sunday at the American Society of Clinical...
19:53 , May 13, 2019 |  BC Extra  |  Company News

May 13 Company Quick Takes: PeptiDream/JCR, Grail, Lilly, Onconova/HanX, Regeneron

PeptiDream, JCR deal produces drug carriers for CNS delivery  The 2016 partnership between PeptiDream Inc. (Tokyo:4587) and JCR Pharmaceuticals Co. Ltd. (Tokyo:4552) has led to the development of constrained peptides that bind TFRC and are...
23:09 , May 10, 2019 |  BioCentury  |  Product Development

Exelixis to fuel pipeline growth with Cabometyx cash flows

On the back of the successful launch of Cabometyx cabozantinib, Exelixis is not only using the increased free cash flow to expand the drug’s label, it also thinks it has the firepower to build out...
20:56 , Apr 11, 2019 |  BC Week In Review  |  Company News

Aveo could lose Fotivda's EU approval if August analysis confirms negative OS trend

EMA's CHMP will consider regulatory action should an interim overall survival analysis of Fotivda tivozanib, planned for August, confirms the negative OS trend that Aveo disclosed in an April 3 SEC filing. The European Commission...
17:16 , Feb 22, 2019 |  BC Week In Review  |  Clinical News

Keytruda misses survival endpoints in Phase III HCC trial

Merck & Co. Inc. (NYSE:MRK) said Keytruda pembrolizumab missed the co-primary endpoints of improving overall survival (OS) and progression-free survival (PFS) in the Phase III KEYNOTE-240 trial to treat advanced hepatocellular carcinoma. Merck declined to...
22:41 , Feb 20, 2019 |  BC Extra  |  Clinical News

Keytruda misses survival endpoints in Phase III HCC trial

Merck & Co. Inc. (NYSE:MRK) said Keytruda pembrolizumab missed the co-primary endpoints of improving overall survival (OS) and progression-free survival (PFS) in the Phase III KEYNOTE-240 trial to treat advanced hepatocellular carcinoma. Merck declined to...
01:32 , Feb 1, 2019 |  BC Week In Review  |  Clinical News

Aveo shares drop with uncertainty of NDA submission for Fotivda

Aveo Pharmaceuticals Inc. (NASDAQ:AVEO) lost $1.07 (60%) to $0.70 on Jan. 31 after the company said it will not submit an NDA to FDA based on preliminary survival data from the Phase III TIVO-3 trial...
00:46 , Feb 1, 2019 |  BC Week In Review  |  Clinical News

Cyramza leads to median OS of 8.5 months in AFP-high HCC population

Eli Lilly and Co. (NYSE:LLY) reported additional data from the Phase III REACH-2 trial to treat hepatocellular carcinoma (HCC) in patients with high α fetoprotein (AFP) levels showing that second-line treatment with Cyramza ramucirumab led...
19:23 , Jan 31, 2019 |  BC Extra  |  Company News

Aveo shares drop with uncertainty of NDA submission for Fotivda

Aveo Pharmaceuticals Inc. (NASDAQ:AVEO) lost $1.07 (60%) to $0.70 Thursday after the company said it will not submit an NDA to FDA based on preliminary survival data from the Phase III TIVO-3 trial for Fotivda...
22:53 , Jan 15, 2019 |  BC Week In Review  |  Clinical News

FDA approves Cabometyx for liver cancer

Exelixis Inc. (NASDAQ:EXEL) said Jan. 14 that FDA approved Cabometyx cabozantinib to treat hepatocellular carcinoma patients previously treated with Nexavar sorafenib. The approval comes two months after Exelixis’ partner Ipsen Group (Euronext:IPN; Pink:IPSEY) received approval...