21:11 , Feb 28, 2019 |  BC Innovations  |  Distillery Therapeutics

Infectious disease

INDICATION: Escherichia; Gram-negative bacterial infection Cell culture and mouse studies identified a deoxystreptamine-based inhibitor of the ribosomal 30S subunit that could help treat E. coli and other Gram-negative bacterial infections. Chemical synthesis and in vitro...
06:12 , Aug 10, 2018 |  BC Week In Review  |  Clinical News

FDA panel backs Insmed lung infection compound in narrow population

FDA's Antimicrobial Drugs Advisory Committee voted that ALIS (amikacin liposome inhalation suspension) from Insmed Inc. (NASDAQ:INSM) is effective and safe in the treatment of non-tuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC)....
22:31 , Aug 7, 2018 |  BC Extra  |  Company News

FDA panel backs Insmed lung infection compound in narrow population

FDA's Antimicrobial Drugs Advisory Committee voted that ALIS (amikacin liposome inhalation suspension) from Insmed Inc. (NASDAQ:INSM) is effective and safe in the treatment of non-tuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC)....
21:10 , Apr 17, 2018 |  BC Innovations  |  Distillery Therapeutics

Infectious disease

INDICATION: Bacterial infection; sepsis Cell culture and mouse studies identified an odilorhabdin-based bacterial ribosomal 30S subunit inhibitor that could help treat bacterial sepsis and other bacterial infections. Screening of small molecules derived from 80 strains...
17:43 , Jan 5, 2018 |  BC Week In Review  |  Clinical News

Paratek begins rolling NDA of omadacycline for ABSSSIs and CABP

Paratek Pharmaceuticals Inc. (NASDAQ:PRTK) began submission of a rolling NDA to FDA for omadacycline (ZL-2401) to treat acute bacterial skin and skin structure infections (ABSSSIs) and community-acquired bacterial pneumonia (CABP). The company expects to complete...
19:02 , Dec 8, 2017 |  BC Week In Review  |  Clinical News

Bayer's Amikacin Inhale misses in Phase III for Gram-negative pneumonia

Bayer AG (Xetra:BAYN) reported data from the double-blind, international Phase III INHALE program in 725 intubated and mechanically-ventilated patients with Gram-negative pneumonia showing that Amikacin Inhale (BAY41-6551, NKTR-061) plus standard of care (SOC) missed the...
20:46 , Oct 10, 2017 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Chronic myelogenous leukemia (CML) Patient sample, cell culture and mouse studies suggest combining ribosomal 30S subunit inhibitors or other inhibitors of oxidative phosphorylation with Gleevec imatinib could help treat CML. In leukemic hematopoietic stem...
16:15 , Sep 8, 2017 |  BC Week In Review  |  Clinical News

Insmed's ALIS meets in Phase III for rare lung infection

Insmed Inc. (NASDAQ:INSM) reported top-line data from the Phase III CONVERT trial in 336 patients with treatment-refractory non-tuberculosis mycobacterial (NTM) lung infection caused by Mycobacterium avium complex (MAC) showing that ALIS (amikacin liposome inhalation suspension,...
22:34 , Sep 5, 2017 |  BC Extra  |  Clinical News

Insmed jumps on Phase III success in rare lung infection

Insmed Inc. (NASDAQ:INSM) soared $14.70 (120%) to $26.99 on Tuesday and ended the day with about $1.7 billion in market cap after reporting that ALIS ( amikacin liposome inhalation suspension , Arikayce) met the primary...
00:59 , Jul 21, 2017 |  BC Week In Review  |  Clinical News

Paratek planning regulatory submissions for omadacycline antibiotic

Paratek Pharmaceuticals Inc. (NASDAQ:PRTK) reported top-line data from 720 patients with acute bacterial skin and skin structure infections (ABSSSIs) in the modified intent-to-treat (mITT) population of the Phase III OASIS-2 trial showing that once-daily oral...