BC Extra | Feb 6, 2018
Politics & Policy

EU court upholds EMA's decisions on transparency

The EU General Court upheld in three separate rulings EMA's decision to release documents -- including superiority data for an approved Orphan drug -- requested under EMA's transparency regulations. EMA said the court rejected the...
BC Week In Review | Apr 1, 2013
Clinical News

TOBI Podhaler regulatory update

The U.K.'s NICE issued final guidance recommending TOBI Podhaler from Novartis to treat chronic pulmonary infection caused by Pseudomonas aeruginosa in cystic fibrosis patients if nebulized tobramycin is considered an appropriate treatment. The recommendation is...
BioCentury | Apr 1, 2013
Finance

1Q Stock Wrap-Up: Out fast at opening bell

For the second year in a row, biotech put together a strong showing in the first quarter with all market segments gaining ground. The sector was led by mid-caps, which closed up 16%. Large caps...
BC Week In Review | Mar 25, 2013
Clinical News

Tobramycin inhalation powder regulatory update

FDA approved an NDA from Novartis for TOBI Podhaler to manage cystic fibrosis (CF) patients with Pseudomonas aeruginosa lung infections. TOBI Podhaler, which uses a disposable inhaler device to deliver a dry powder formulation of...
BC Extra | Mar 23, 2013
Company News

FDA approves TOBI Podhaler

FDA approved an NDA late Friday from Novartis AG (NYSE:NVS; SIX:NOVN) for TOBI Podhaler to manage cystic fibrosis (CF) patients with Pseudomonas aeruginosa lung infections. TOBI Podhaler, which uses a disposable inhaler device to deliver...
BC Week In Review | Jan 28, 2013
Clinical News

Tobramycin inhalation powder regulatory update

The U.K.'s NICE issued a final appraisal determination (FAD) recommending TOBI Podhaler from Novartis to treat chronic pulmonary infection caused by Pseudomonas aeruginosa in cystic fibrosis patients if nebulized tobramycin is considered an appropriate treatment....
BC Extra | Jan 25, 2013
Company News

NICE now backs Colobreathe, Tobi Podhaler

The U.K.'s NICE issued final appraisal determinations recommending Colobreathe colistimethate sodium from Forest Laboratories Inc. (NYSE:FRX) and TOBI Podhaler from Novartis AG (NYSE:NVS; SIX:NOVN) to treat chronic pulmonary infection caused by Pseudomonas aeruginosa in cystic...
BC Week In Review | Nov 19, 2012
Clinical News

Arikace: Completed Phase III enrollment

Insmed completed enrollment of over 300 patients in the open-label, international Phase III CLEAR-108 trial comparing once-daily 560 mg Arikace administered with the eFlow Nebulizer System from Pari GmbH (Starnberg, Germany) vs. twice-daily 300 mg...
BioCentury | Nov 19, 2012
Finance

Highlights of weekly biotech stock moves

Regulatory milestones Dynavax Technologies Corp. (NASDAQ:DVAX) lost $2.19 (47%) to $2.44 on Friday, which translates to a loss in market cap of $391.4 million, after FDA's Vaccines and Related Biological Products Advisory Committee voted 8-5...
BC Week In Review | Oct 29, 2012
Clinical News

Tobramycin inhalation powder regulatory update

The U.K.'s NICE issued a preliminary appraisal recommending TOBI Podhaler from Novartis to treat chronic pulmonary infection caused by Pseudomonas aeruginosa in cystic fibrosis patients if nebulized tobramycin is considered an appropriate treatment and the...
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