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...
23:46 , Nov 20, 2018 |  BC Extra  |  Company News

ICER to review peanut allergy therapies from Aimmune, DBV

The Institute for Clinical and Economic Review (ICER) will review peanut allergy therapies AR101 from Aimmune Therapeutics Inc. (NASDAQ:AIMT) and Viaskin Peanut from DBV Technologies S.A. (Euronext:DBV; NASDAQ:DBVT). ICER announced the review in a scoping...
00:39 , Nov 20, 2018 |  BC Extra  |  Clinical News

Aimmune down on safety concerns for peanut allergy therapy

Aimmune Therapeutics Inc. (NASDAQ:AIMT) was off $3.33 (11%) to $26.29 on Monday after the New England Journal of Medicine published full data from the Phase III PALISADE trial of the company's peanut allergy therapy AR101,...
00:48 , Oct 6, 2018 |  BioCentury  |  Finance

Seeking validation

The final stretch of the year offers clinical catalysts and early launch data that could validate investments in hot immuno-oncology targets and large untapped markets. Late-stage readouts from Vertex Pharmaceuticals Inc. in cystic fibrosis and...
20:49 , Aug 29, 2018 |  BC Innovations  |  Emerging Company Profile

Meta(bolite) analysis

ClostraBio Inc.’s preclinical gut microbiome-derived metabolites could yield a pan-allergen therapy for food allergy, eschewing the need for multiple allergen-specific treatments. Director of Operations John Colson said research from co-founder and President Cathryn Nagler suggests...