00:23 , Jan 12, 2019 |  BioCentury  |  Finance

We all fall down

After an exuberant third quarter that put biotech indexes near their 2015 highs, all market cap tiers fell in 4Q18, eliminating the first nine month's gains and losing $291.2 billion in aggregate value. Median losses...
20:43 , Dec 21, 2018 |  BC Week In Review  |  Clinical News

CHMP backs Besremi for polycythemia vera, two Shionogi drugs

EMA's CHMP recommended a basket of approvals and label extensions on Dec. 14, including Orphan Drug Besremi ropeginterferon alfa-2b to treat polycythemia vera and a pair of treatments from Shionogi & Co. Ltd. (Tokyo:4507). The...
23:22 , Dec 14, 2018 |  BC Extra  |  Company News

CHMP backs Besremi for polycythemia vera, two Shionogi drugs

EMA's CHMP recommended a basket of approvals and label extensions on Friday, including Orphan Drug Besremi ropeginterferon alfa-2b to treat polycythemia vera and a pair of treatments from Shionogi & Co. Ltd. (Tokyo:4507). The agency...
21:06 , Dec 14, 2018 |  BC Week In Review  |  Clinical News

Adcetris improves PFS by 27.4 months in first-line PTCL

Seattle Genetics Inc. (NASDAQ:SGEN) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) reported detailed data from the Phase III ECHELON-2 trial to treat previously untreated CD30-expressing peripheral T cell lymphoma (PTCL) showing that Adcetris brentuximab vedotin plus...
04:32 , Nov 30, 2018 |  BC Week In Review  |  Clinical News

Adcetris gets speedy label expansion under FDA real-time pilot

FDA approved a label expansion for Adcetris brentuximab vedotin less than two weeks after Seattle Genetics Inc. (NASDAQ:SGEN) submitted the sBLA. The agency said Adcetris is the first U.S.-approved treatment for newly diagnosed peripheral T-cell...
00:10 , Nov 17, 2018 |  BC Extra  |  Company News

Adcetris gets speedy label expansion under FDA real-time pilot

FDA approved a label expansion for Adcetris brentuximab vedotin less than two weeks after Seattle Genetics Inc. (NASDAQ:SGEN) submitted the sBLA. The agency said Adcetris is the first U.S.-approved treatment for newly diagnosed peripheral T-cell...
22:08 , Oct 26, 2018 |  BC Extra  |  Company News

Seattle Genetics sags as Adcetris sales miss target

Seattle Genetics Inc. (NASDAQ:SGEN) lost $10.05 (15%) to $55.30 on Friday after 3Q18 sales of Adcetris brentuximab vedotin fell short of expectations, and the cancer company predicted relatively flat sales in 4Q18. Adcetris delivered $127...
20:34 , Oct 5, 2018 |  BC Week In Review  |  Clinical News

Adcetris meets in Phase III for first-line PTCL

Seattle Genetics Inc. (NASDAQ:SGEN) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) said Adcetris brentuximab vedotin plus chemotherapy met the primary and all key secondary endpoints in the Phase III ECHELON-2 trial to treat previously untreated CD30-expressing...
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...
03:04 , Jun 30, 2018 |  BioCentury  |  Finance

Eyes on launches

The annual summer slowdown isn’t restricted to just the stock market this year, as the clinical catalyst calendar also appears to be on holiday in 3Q18. Buysiders are therefore turning their attention to a spate...