05:22 , Feb 8, 2019 |  BC Week In Review  |  Clinical News

Olumiant meets Phase III endpoints for atopic dermatitis

Eli Lilly and Co. (NYSE:LLY) and Incyte Corp. (NASDAQ:INCY) said Olumiant baricitinib met the primary endpoints of the Phase III BREEZE-AD1 and BREEZE-AD2 trials to treat moderate to severe atopic dermatitis. In the double-blind, international...
01:49 , Feb 8, 2019 |  BC Week In Review  |  Clinical News

CTI withdraws MAA for myleofibrosis therapy

CTI BioPharma Corp. (NASDAQ:CTIC) withdrew its MAA for pacritinib to treat myelofibrosis following interactions with EMA's CHMP suggesting the committee was likely to issue a negative opinion. CTI said CHMP indicated the risk-benefit profile of...
21:12 , Feb 1, 2019 |  BC Extra  |  Company News

CHMP recommendations include Ajovy, Vizimpro, Humira biosimilars

EMA's CHMP recommended a basket of approvals and label extensions on Friday, including Ajovy fremanezumab, Vizimpro dacomitinib and two Humira biosimilars. CHMP also backed an expanded label for Forxiga dapagliflozin to include Type I diabetes....
03:03 , Jan 26, 2019 |  BioCentury  |  Product Development

Target wide, test narrow in lupus

While last year’s spate of clinical misses in lupus leave the field still in search of optimal targets, the 2019 outlook isn’t all doom. Companies with shots on goal are using sharper endpoints and aiming...
19:05 , Jan 4, 2019 |  BC Week In Review  |  Company News

New Year splash as BMS to acquire Celgene in $74B deal

The biggest biotech takeout in a decade brings a tumultuous 15 months for Celgene Corp. (NASDAQ:CELG) to an end as Bristol-Myers Squibb Co. (NYSE:BMY) proposed on Jan. 3 to acquire the bellwether for $74 billion....
14:08 , Jan 3, 2019 |  BC Extra  |  Company News

New Year splash as BMS to acquire Celgene in $74B deal

The biggest biotech takeout in a decade brings a tumultuous 15 months for Celgene Corp. (NASDAQ:CELG) to an end as Bristol-Myers Squibb Co. (NYSE:BMY) proposed Thursday to acquire the bellwether for $74 billion. BMS cited...
04:43 , Dec 15, 2018 |  BioCentury  |  Product Development

O’Day’s expansive task at Gilead

A fresh executive team and a track record of building deep portfolios could allow incoming Gilead Sciences Inc. chairman and CEO Daniel O’Day to do what his predecessors couldn’t: make Gilead a leader outside of...
16:03 , Nov 16, 2018 |  BC Week In Review  |  Clinical News

Concert's hair loss product meets in Phase IIa, but with slower onset than Pfizer's

Concert Pharmaceuticals Inc. (NASDAQ:CNCE) reported Phase IIa data suggesting that its JAK inhibitor CTP-543 may have a later onset in treating alopecia areata than competing Phase IIa products from Pfizer Inc. (NYSE:PFE). Twice-daily 8 mg...
00:38 , Nov 13, 2018 |  BC Extra  |  Clinical News

Concert stock falls as hair loss product meets in Phase IIa, but with slower onset than Pfizer's

Concert Pharmaceuticals Inc. (NASDAQ:CNCE) lost $3.47 (22%) to $12.59 on Monday after reporting Phase IIa data suggesting that its JAK inhibitor CTP-543 may have a later onset in treating alopecia areata than competing Phase IIa...
17:59 , Oct 26, 2018 |  BC Week In Review  |  Clinical News

FDA grants Priority Review to Incyte's Jakafi for acute GvHD

Incyte Corp. (NASDAQ:INCY) said FDA accepted and granted Priority Review to an sNDA seeking approval for Jakafi ruxolitinib to treat acute graft-versus-host disease (GvHD) in patients with inadequate response to corticosteroids. The PDUFA date was...