18:06 , Apr 10, 2019 |  BC Extra  |  Company News

ICER draft report: Aimmune's peanut allergy therapy cost effective, DBV's falls short

ICER thinks Aimmune's peanut allergy therapy AR101 could be cost effective but found that DBV’s Viaskin Peanut exceeded standard cost-effectiveness ratios, according to a draft evidence report published Tuesday. The institute said both therapies may...
00:06 , Apr 6, 2019 |  BioCentury  |  Finance

Big caps under pressure

Biogen’s fall in the wake of its decision to discontinue late-stage trials of Alzheimer’s therapy aducanumab is yet another reminder that large caps are in dire need of new pipeline products, and could serve as...
20:02 , Mar 25, 2019 |  BC Extra  |  Clinical News

Aimmune on track for EU submission of peanut allergy therapy

A week after Aimmune said an FDA decision on approval of its peanut allergy therapy may come a month late, the company said Monday its timeline for an MAA submission remains on schedule following a...
20:13 , Mar 18, 2019 |  BC Extra  |  Company News

FDA accepts Aimmune's peanut allergy therapy for review

Aimmune said the recent government shutdown may add about a month onto the approval timeline for its peanut allergy therapy. On Monday, FDA accepted for review a BLA for AR101 to treat peanut allergy in...
19:42 , Feb 15, 2019 |  BC Week In Review  |  Clinical News

DBV to resubmit BLA for peanut allergy therapy 3Q19

DBV Technologies S.A. (Euronext:DBV; NASDAQ:DBVT) said on Feb. 13 it plans to resubmit a BLA for its peanut allergy therapy Viaskin Peanut in 3Q19. DBV said it withdrew the original BLA on Dec. 19 after...
16:41 , Feb 15, 2019 |  BC Extra  |  Politics & Policy

FDA to meet PDUFA goals despite shutdown bolus

FDA is on track to meet PDUFA goals for drug applications submitted before, during and after the government shutdown, Commissioner Scott Gottlieb told BioCentury Friday. “There is no backlog and no impact on goal dates”...
20:05 , Jan 18, 2019 |  BC Week In Review  |  Clinical News

Shutdown delays review of Aimmune peanut allergy therapy

Aimmune Therapeutics Inc. (NASDAQ:AIMT) said FDA notified the company it will not review a BLA for peanut allergy candidate AR101 until the government shutdown has ended. The company disclosed the news in an SEC filing...
02:49 , Jan 5, 2019 |  BioCentury  |  Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
01:28 , Jan 4, 2019 |  BC Week In Review  |  Clinical News

Aimmune submits BLA to FDA for peanut allergy therapy

Aimmune Therapeutics Inc. (NASDAQ:AIMT) submitted a BLA to FDA for AR101 to treat peanut allergy in children and adolescents ages 4-17. The BLA includes data from the Phase III PALISADE trial. In February, Aimmune said...
18:35 , Nov 30, 2018 |  BC Week In Review  |  Clinical News

Full data for Aimmune's peanut allergy therapy published in NEJM

The New England Journal of Medicine published full data from the Phase III PALISADE trial of peanut allergy therapy AR101 from Aimmune Therapeutics Inc. (NASDAQ:AIMT), including detailed safety showing a higher rate of rescue epinephrine...