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...
08:00 , Dec 15, 2014 |  BC Week In Review  |  Clinical News

Amikacin Inhale regulatory update

FDA granted Qualified Infectious Disease Product (QIDP) designation to Amikacin Inhale from Bayer to treat Gram-negative pneumonia in intubated and mechanically ventilated patients receiving standard-of-care antibiotics. Bayer has rights to the second-generation nebulizer delivery of...
07:00 , Apr 29, 2013 |  BC Week In Review  |  Clinical News

BAY41-6551: Phase III started

Bayer started the double-blind, placebo-controlled, international Phase III INHALE 1 trial to evaluate 400 mg aerosolized BAY41-6551 given twice daily for 10 days in about 651 patients with Gram-negative pneumonia receiving standard of care IV...
08:00 , Dec 3, 2012 |  BioCentury  |  Regulation

Choice liberates

The judicious way in which FDA asked its Anti-Infective Drugs Advisory Committee whether to approve Theravance Inc.'s Vibativ telavancin to treat hospital-acquired pneumonia last week may reflect what the agency says is its renewed willingness...
08:00 , Nov 14, 2011 |  BioCentury  |  Regulation

Inching toward feasibility

Clinical work on compounds to treat community-acquired bacterial pneumonia and hospital-acquired or ventilator-associated bacterial pneumonia has been in limbo since 2008 when FDA began reassessing its requirements for clinical trial designs, which many companies said...
07:00 , Sep 28, 2009 |  BioCentury  |  Strategy

Nektar's Next Step

Nektar Therapeutics had expected to become profitable in mid-2007 based on royalties from Exubera inhaled insulin. Instead, partner Pfizer Inc. terminated the diabetes drug from its portfolio that October because it failed to gain acceptance...
07:00 , Oct 27, 2008 |  BC Week In Review  |  Company News

Nektar, Novartis deal

Novartis will acquire assets from the pulmonary drug delivery business of Nektar for $115 million in cash. The deal includes Nektar's dry powder and liquid pulmonary delivery technologies and manufacturing assets, plus all manufacturing and...
07:00 , Oct 27, 2008 |  BioCentury  |  Finance

Ebb & Flow

Drug delivery and infectious disease company Nektar (NASDAQ:NKTR) expects to end the year with about $440 million in cash, courtesy of the sale of part of its pulmonary delivery business to Novartis (NYSE:NVS; SWX:NOVN) for...
02:11 , Oct 22, 2008 |  BC Extra  |  Company News

Novartis acquiring Nektar pulmonary assets

Novartis (NYSE:NVS; SWX:NOVN) will acquire assets from the pulmonary drug delivery business of Nektar (NASDAQ:NKTR) for $115 million in cash. The deal includes Nektar's dry powder and liquid pulmonary delivery technologies and manufacturing assets and...
07:00 , May 26, 2008 |  BC Week In Review  |  Clinical News

NKTR-061 Amikacin Inhale: Phase II data

Preliminary data from a double-blind, placebo-controlled Phase II trial in 73 patients with hospital-acquired, Gram-negative pneumonia, showed that Amikacin Inhale had over 1,000 times the lung exposure than IV amikacin. Mean peak tracheal aspirate of...