19:15 , Sep 14, 2018 |  BC Week In Review  |  Clinical News

Novocure planning submission for TTFields in mesothelioma

Novocure Ltd. (NASDAQ:NVCR) reported final data from the Phase II STELLAR trial to treat previously untreated unresectable malignant pleural mesothelioma showing that its Tumor Treating Fields (TTFields) plus standard of care (SOC) chemotherapy significantly improved...
15:47 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

Keytruda combo gets regular approval for first-line non-squamous NSCLC

FDA granted regular approval to Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) in combination with Alimta pemetrexed and platinum chemotherapy as first-line treatment of metastatic, non-squamous non-small cell lung cancer (NSCLC) with no EGFR...
17:59 , Aug 3, 2018 |  BC Week In Review  |  Company News

China Medical gains Chinese product rights in trio of deals

China Medical System Holdings Ltd. (HKSE:867) announced a series of deals in July under which it gained rights to several products in China, including Hong Kong, Macao and Taiwan. China Medical obtained exclusive rights from Venus...
17:06 , Aug 3, 2018 |  BC Week In Review  |  Clinical News

CHMP positive on patisiran, Symkevi, Humira and Neulasta biosimilars

EMA's CHMP recommended a number of approvals July 26, including Onpattro patisiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY), Symkevi tezacaftor/ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), a handful of cancer therapies and three biosimilars. The committee recommended approval...
22:08 , Jul 27, 2018 |  BC Extra  |  Company News

CHMP positive on patisiran, Symkevi, Humira and Neulasta biosimilars

EMA's CHMP recommended a number of approvals Friday, including Onpattro patisiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY), Symkevi tezacaftor/ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), a handful of cancer therapies and three biosimilars. The committee recommended approval of...
16:34 , Jul 27, 2018 |  BC Week In Review  |  Clinical News

Tecentriq combo again meets PFS endpoint in Phase III for first-line NSCLC

The Genentech Inc. unit of Roche (SIX:ROG; OTCQB:RHHBY) said first-line treatment with Tecentriq atezolizumab plus chemotherapy met the co-primary endpoint of improving progression-free survival (PFS) vs. chemotherapy alone in the Phase III IMpower132 trial to...
18:57 , Jul 13, 2018 |  BC Week In Review  |  Clinical News

Keytruda under Priority Review for first-line squamous NSCLC

Merck & Co. Inc. (NYSE:MRK) said FDA accepted and granted Priority Review to an sBLA for Keytruda pembrolizumab plus carboplatin/paclitaxel or Abraxane nab-paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer regardless of...
17:57 , Jul 2, 2018 |  BC Extra  |  Company News

Keytruda under Priority Review for first-line squamous NSCLC

Merck & Co. Inc. (NYSE:MRK) said FDA accepted and granted Priority Review to an sBLA for Keytruda pembrolizumab plus carboplatin/paclitaxel or Abraxane nab-paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer regardless of...
03:05 , Jun 30, 2018 |  BioCentury  |  Finance

Hidden in the rough

Judicious stock picking was especially important in the second quarter, as 57% of global biotech stocks saw their equity values decline. Volatility continued to roil global markets during the period and additional uncertainty looms with the...
15:33 , Jun 8, 2018 |  BC Week In Review  |  Clinical News

Keytruda monotherapy benefit extended to low PD-L1 expression, though doubts linger

Detailed data from the Phase III KEYNOTE-042 trial showed that Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) given as monotherapy in the first-line setting could be further extended to treat non-small cell lung cancer...