14:48 , Oct 22, 2018 |  BC Extra  |  Company News

Zai gains Hong Kong approval of PARP inhibitor Zejula

Zai Lab Ltd. (NASDAQ:ZLAB) is preparing for its first-ever product launch after Hong Kong's Department of Health approved its PARP inhibitor Zejula niraparib to treat adults with platinum-sensitive, relapsed ovarian cancer in adults who are...
23:32 , Oct 19, 2018 |  BC Extra  |  Company News

FDA, EMA delay review of Opdivo/Yervoy for first-line NSCLC

Bristol-Myers Squibb Co. (NYSE:BMY) said Friday that FDA and EMA have both pushed back their reviews of anti-PD-1 mAb Opdivo nivolumab plus anti-CTLA-4 mAb Yervoy ipilimumab for first-line non-small cell lung cancer. The company also...
22:46 , Oct 19, 2018 |  BioCentury  |  Politics, Policy & Law

CFIUS waiting game

Biotech and its investors must wait to find out how much of the industry will be caught up in the CFIUS dragnet of foreign investment in American companies, but the U.S. Treasury has given itself...
18:13 , Oct 19, 2018 |  BC Week In Review  |  Clinical News

Keytruda, Inlyta combo headed for first-line RCC submissions

Merck & Co. Inc. (NYSE:MRK) said Keytruda pembrolizumab in combination with Inlyta axitinib met the primary endpoints vs. Sutent sunitinib in the Phase III KEYNOTE-426 trial as first-line treatment of renal cell carcinoma. Merck plans...
17:46 , Oct 19, 2018 |  BC Week In Review  |  Financial News

Krystal raises $60M following Phase I/II gene therapy readout

On the heels of reporting data for its topical gene therapy, Krystal Biotech Inc. (NASDAQ:KRYS) raised $60 million late Oct. 18 through the sale 3 million shares at $20 in a follow-on underwritten by Cowen,...
17:38 , Oct 19, 2018 |  BC Week In Review  |  Clinical News

Eisai, Purdue insomnia candidate meets in second Phase III

Eisai Co. Ltd. (Tokyo:4523) and Purdue Pharma L.P. (Stamford, Conn.) said lemborexant met the primary and secondary endpoints in the Phase III SUNRISE 2 trial to treat insomnia. The trial is the second Phase III...
17:21 , Oct 19, 2018 |  BC Week In Review  |  Clinical News

Celgene's Otezla meets in Phase III for scalp psoriasis

Celgene Corp. (NASDAQ:CELG) said Otezla apremilast met the primary endpoint in the Phase III STYLE trial to treat moderate to severe plaque psoriasis of the scalp. A significantly greater proportion of patients who received twice-daily...
17:17 , Oct 19, 2018 |  BC Week In Review  |  Clinical News

Novo's oral GLP-1 analog meets in Japanese Phase IIIa for Type II diabetes

Novo Nordisk A/S (CSE:NOVO B; NYSE:NVO) reported that oral semaglutide met the primary safety endpoint in the Japanese Phase IIIa PIONEER 10 trial to treat Type II diabetes. The open-label trial evaluated once-daily 3, 7...
17:14 , Oct 19, 2018 |  BC Week In Review  |  Clinical News

Viking's VK5211 meets primary in Phase II for acute hip fracture

Viking Therapeutics Inc. (NASDAQ:VKTX) said VK5211 met the primary endpoint of increasing lean body mass from baseline to week 12 vs. placebo in a Phase II trial in patients recovering from acute hip fracture surgery....
17:12 , Oct 19, 2018 |  BC Week In Review  |  Clinical News

Genentech's Kadcyla meets in Phase III as breast cancer adjuvant

Genentech Inc. said adjuvant treatment with Kadcyla ado-trastuzumab emtansine met the primary endpoint of improving invasive disease-free survival (DFS) vs. Herceptin trastuzumab in the Phase III KATHERINE trial to treat breast cancer. The open-label, international...