BC Extra | Jan 11, 2020
Company News

Jan. 10 Company Quick Takes: Nektar gains on expanded BMS deal; plus Nurix-Sanofi, Amunix-Roche, Sorrento, Alderaan, Keytruda, Akari, Moderna

BMS, Nektar adding more combo trials to bempeg/Opdivo deal  Bristol-Myers Squibb Co. (NYSE:BMY) and Nektar Therapeutics (NASDAQ:NKTR) will start two new registrational trials under an expanded partnership in which they are developing Nektar's bempegaldesleukin (NKTR-214)...
BC Extra | Oct 30, 2019
Company News

Oct. 29 Company Quick Takes: Incyte’s JAK inhibitor beats expectations; plus Sumitomo-Intercept, Merck KGaA-Pfizer, AMAG, Regeneron-Sanofi

Incyte surges on Jakafi sales, guidance  On the strength of 3Q19 sales of Jakafi ruxolitinib that beat estimates and resulted in an increase in full-year guidance, Incyte Corp. (NASDAQ:INCY) climbed $3.49 to $83.35 Tuesday, adding...
BC Extra | Sep 20, 2019
Company News

Xospata poised for EU approval under accelerated assessment

EMA's CHMP recommended approval of Xospata for acute myelogenous leukemia in its September roundup. Under accelerated assessment, the agency backed Xospata gilteritinib from Astellas Pharma Inc. (Tokyo:4503) as monotherapy for relapsed or refractory AML in...
BC Extra | Jul 27, 2019
Company News

Vitrakvi set to become EU’s first tissue-agnostic cancer drug

EMA's CHMP delivered its first positive recommendation for a tissue-agnostic cancer therapy to Vitrakvi in its monthly basket of positive opinions, which also included one for GW’s Epidyolex. CHMP backed approval of an MAA from...
BC Extra | May 21, 2019
Company News

Merck bets on HIF2As with Peloton takeout ahead of planned listing

Days before Peloton was to price an IPO that would fund Phase III testing of its HIF2A program to treat kidney cancer, the biotech has elected instead to take a buyout offer from Merck &...
BC Extra | May 15, 2019
Company News

May 15 Company Quick Takes: Approvals for Bavencio in RCC, Venclexta-Gazyva combo; plus Adaptimmune, Alpine, Advaxis

Bavencio gets RCC approval with Inlyta  FDA approved Bavencio avelumab from Merck KGaA (Xetra:MRK) and Pfizer Inc. (NYSE:PFE) for first-line treatment of advanced renal cell carcinoma in combination with Pfizer's Inlyta axitinib, making Bavencio the...
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 | Mar 25, 2019
Emerging Company Profile

China Oncology Focus: funding combinations

China Oncology Focus aims to differentiate itself from other Chinese in-licensing plays by leveraging the diversity of its pipeline to develop in-house combination therapies, with its PD-L1 therapy as a backbone. The company is seeking...
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...
BC Week In Review | Feb 15, 2019
Clinical News

Priority Review for Keytruda in RCC, head and neck cancer

FDA accepted and granted Priority Review to two sBLAs for anti-PD-1 mAb Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK). The agency assigned a June 10 PDUFA date to an sBLA for Keytruda as a...
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