BioCentury | Apr 28, 2020
Product Development

Blueprint stumbles in GIST race, clearing path for Deciphera

A Phase III miss for Blueprint’s Ayvakit avapritinib in third- and fourth-line GIST likely means the biotech won’t see its NDA approved in the indication, positioning Deciphera to claim a larger share of late-stage settings....
BioCentury | Apr 20, 2020
Product Development

Opdivo-Cabometyx combo improves PFS by 49%, OS by 40% in first-line RCC

Exelixis jumped $4.14 (21%) to $23.58 on Monday, pushing its valuation above $7 billion, after the biotech and partners Bristol Myers Squibb and Ipsen said the combination of Opdivo nivolumab plus Cabometyx cabozantinib generated positive...
BC Extra | Aug 29, 2019
Clinical News

Aug. 29 Clinical Quick Takes: Immunicum's off-the-shelf cell therapy misses in Phase II for kidney cancer; plus Acurx and Esperion

Immunicum's cell therapy misses survival endpoint in Phase II RCC trial  Immunicum AB (SSE:IMMU) lost SEK1.46 (14%) to SEK8.86 after reporting that ilixadencel plus Sutent sunitinib from Pfizer Inc. (NYSE:PFE) did not improve 18-month survival,...
BC Extra | Aug 13, 2019
Clinical News

Big gain for Deciphera as GIST readout portends face-off with Blueprint

New Phase III data in GIST burnished Deciphera's case for an upcoming regulatory submission, pushing the company's market cap to about $1.4 billion while also taking competitor Blueprint Medicines' shares down a few ticks in...
BC Extra | Jun 11, 2019
Company News

Ahead of Phase III data, Zai adds Deciphera's GIST candidate to gastric cancer franchise

With a Phase III readout imminent for Deciphera's kinase switch control inhibitor ripretinib in GIST, Zai Lab has obtained the compound's rights in Greater China, adding to a planned gastric cancer franchise it has built...
BioCentury | May 10, 2019
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...
BC Extra | Apr 22, 2019
Company News

Keytruda combo gains FDA approval in first-line RCC

FDA approved a BLA for Keytruda pembrolizumab in combination with Inlyta axitinib as a first-line therapy for advanced renal cell carcinoma. The decision, which arrived late Friday, came about two months ahead of the combo's...
BioCentury | Apr 5, 2019
Product Development

Pazdur on pandemonium: calls for collaboration, competition on PD-1 drugs

In separate sessions at AACR, FDA’s Oncology chief Richard Pazdur’s pointed comments and questions to PD-1/PD-L1 companies made it clear that he thinks patients are getting hurt from pharmas’ failure to collaborate and the high...
BC Extra | Apr 1, 2019
Company News

Pazdur grills PD-1/PD-L1 companies over lack of collaboration, trial redundancies

FDA's Oncology Center of Excellence Director Richard Pazdur pressed representatives from companies with marketed PD-1/PD-L1 inhibitors to explain why they aren't collaborating more in the clinic while questioning whether there are too many of these...
BC Week In Review | Mar 8, 2019
Clinical News

Keytruda, Inlyta combo improves OS by 47%, PFS by 31% in first-line RCC

Merck & Co. reported detailed data from the Phase III KEYNOTE-426 trial of Keytruda pembrolizumab plus Inlyta axitinib as first-line treatment of renal cell carcinoma. New data showed that the combination significantly improved overall survival...
Items per page:
1 - 10 of 396