01:14 , Oct 6, 2018 |  BioCentury  |  Finance

Large cap comeback

The biotech sector continued to be a stock pickers’ market for investors through 3Q18 as there was a near even split between global biotech stocks that gained and lost value in the quarter. While 1H18...
20:17 , Sep 7, 2018 |  BioCentury  |  Strategy

Thinking beyond Bi

Following the resignation of Jingquan Bi, early signs for continued biopharma regulatory reform in China remain positive. But the IP reforms spearheaded by Bi look to have fallen off the government’s priority list, and there...
16:53 , Aug 20, 2018 |  BC Extra  |  Company News

China approves Roche’s Alecensa for NSCLC

Roche (SIX:ROG; OTCQX:RHHBY) said China’s State Drug Administration approved Alecensa alectinib as monotherapy to treat anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer. FDA and EMA approved the drug for the indication in November...
21:52 , Jul 13, 2018 |  BioCentury  |  Strategy

Roche’s partnering priority

As James Sabry gets set to lead partnering for all of Roche pharma, his first order of business might be to build out the company’s late-stage pipeline ahead of an impending patent cliff that puts...
16:35 , Mar 9, 2018 |  BioCentury  |  Strategy

Accelerating Flatiron

Roche isn’t saying much about how it approached the decision to shell out $1.9 billion to acquire the 87% of Flatiron Health Inc. it didn’t already own. But it appears that Flatiron would have needed...
20:42 , Nov 10, 2017 |  BC Week In Review  |  Clinical News

FDA approves Genentech's Alecensa for first-line NSCLC

The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) said FDA approved an sNDA for Alecensa alectinib (AF802, CH5424802, RG7853, RO5424802) as first-line treatment of anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). FDA...
19:02 , Oct 24, 2017 |  BC Innovations  |  Distillery Therapeutics

Infectious disease

INDICATION: Sepsis Patient sample and mouse studies suggest inhibiting the ALK-STING axis could help treat sepsis. In patient peripheral blood mononuclear cells (PBMCs), levels of ALK and STING were higher than in PBMCs from healthy volunteers....
00:35 , Oct 20, 2017 |  BC Week In Review  |  Clinical News

CHMP recommends Roche's Alecensa for first-line NSCLC

EMA's CHMP recommended approval of Alecensa alectinib (AF802, CH5424802, RG7853, RO5424802) from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) as monotherapy for first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell...
23:10 , Oct 6, 2017 |  BioCentury  |  Finance

Coasting on catalysts

While buysiders do not expect any sector-moving milestones in the wake of a catalyst-heavy third quarter, they will have at least 21 Phase III milestones and 23 PDUFA dates on their radar. But the biggest...
15:00 , Oct 6, 2017 |  BC Week In Review  |  Clinical News

Roche reports detailed Phase III data for Alecensa in previously treated NSCLC

Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit reported additional data from the Phase III ALUR trial in 107 patients with non-small cell lung cancer (NSCLC) showing that twice-daily 600 mg oral Alecensa alectinib (AF802,...