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...
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...
20:21 , Sep 8, 2017 |  BC Week In Review  |  Financial News

Insmed prices $350M follow-on

On Sept. 7, Insmed Inc. (NASDAQ:INSM) raised $350 million through the sale of 12.3 million shares at $28.50 in a bumped-up follow-on underwritten by Goldman Sachs, Leerink, Evercore and Stifel. The price is a 6%...
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,...