15:16 , Oct 26, 2018 |  BioCentury  |  Regulation

Learning the limits of limited use

While it’s too soon to tell if FDA’s limited-use pathway for anti-infectives will boost development in the underserved field, the pathway’s first approval has helped clarify the amount of uncertainty the agency is willing to...
01:14 , Oct 6, 2018 |  BioCentury  |  Finance

Large cap comeback

The biotech sector continued to be a stock pickers’ market through 3Q18 as there was a near even split between global biotech stocks that gained and lost value in the quarter. While 1H18 saw investors...
19:49 , Oct 5, 2018 |  BC Week In Review  |  Clinical News

Insmed antibiotic is first approved via FDA's LPAD pathway

FDA granted the first expedited approval of an antibiotic under its limited population pathway for antibacterial and antifungal drugs Sept. 28. The agency granted accelerated approval to Arikayce amikacin liposome inhalation suspension from Insmed Inc....
23:20 , Sep 28, 2018 |  BC Extra  |  Company News

Insmed antibiotic is first approved via FDA’s LPAD pathway

FDA granted the first expedited approval of an antibiotic under its limited population pathway for antibacterial and antifungal drugs Friday. The agency granted accelerated approval to Arikayce amikacin liposome inhalation suspension from Insmed Inc. (NASDAQ:INSM)...
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...
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...
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...
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...
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 antibiotic to...
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...