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). The...
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). The...
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 of...
17:57 , Jun 22, 2018 |  BC Week In Review  |  Clinical News

FDA panel to review Paratek antibiotic

FDA's Antimicrobial Drugs Advisory Committee scheduled an Aug. 8 meeting to discuss two NDAs for omadacycline from Paratek Pharmaceuticals Inc. (NASDAQ:PRTK). The agency is reviewing oral and IV versions of the amniomethylcycline antibiotic to treat community-acquired...
19:50 , Jun 20, 2018 |  BC Extra  |  Company News

FDA panel to review Paratek antibiotic

FDA's Antimicrobial Drugs Advisory Committee has scheduled an Aug. 8 meeting to discuss two NDAs for omadacycline from Paratek Pharmaceuticals Inc. (NASDAQ:PRTK). The agency is reviewing oral and IV versions of the amniomethylcycline antibioitic to treat...
19:42 , May 18, 2018 |  BC Week In Review  |  Clinical News

FDA accepts NDA for Insmed's ALIS

Insmed Inc. (NASDAQ:INSM) said FDA accepted and granted Priority Review to an NDA for ALIS (amikacin liposome inhalation suspension) to treat non-tuberculous mycobacterial lung disease caused by Mycobacterium avium complex (MAC). The PDUFA date is...
21:10 , May 16, 2018 |  BC Extra  |  Company News

Priority Review for Insmed’s ALIS in rare lung infection

Insmed Inc. (NASDAQ:INSM) said FDA accepted and granted Priority Review to an NDA for ALIS (amikacin liposome inhalation suspension) to treat non-tuberculous mycobacterial lung disease caused by Mycobacterium avium complex (MAC). The PDUFA date is...
20:34 , Feb 23, 2018 |  BC Week In Review  |  Clinical News

Akari's Coversin meets in Phase II for PNH

Akari Therapeutics plc (NASDAQ:AKTX) said subcutaneous Coversin met the primary endpoint of reducing lactic dehydrogenase (LDH) to ≤1.8 times the upper limit of normal (ULN) at day 28 in the open-label Phase II COBALT trial...
19:30 , Oct 13, 2017 |  BioCentury  |  Product Development

Eyeing complement data

Clinical studies of four complement inhibitors in patients with age-related macular degeneration suggest the best target in the pathway may be complement 3. However, differences between study populations and methods and durations of treatment also...
23:53 , Sep 21, 2017 |  BC Extra  |  Clinical News

Akari gains on Phase III PNH plans for C5 inhibitor

Akari Therapeutics plc (NASDAQ:AKTX) gained $3.15 (56%) to $8.74 on Thursday after the company announced plans to start Phase III testing in 1Q18 of lead candidate Coversin to treat paroxysmal nocturnal hemoglobinuria. The announcement appears to...