California-based Elevation Pharmaceuticals has announced closing of $30 million in Series B financing for development of its lead product, EP-101, a glycopyrrolate inhalation solution for the treatment of COPD. Novo Ventures, a new investor, led the round, and Elevation's previous investors, Canaan Partners, TPG Biotech, Care Capital, and Mesa Verde Venture Partners, … [Read more...] about Elevation gets funding for development of nebulized glycoprrolate
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VaryDose appoints Philippe Rogueda as CTO
UK dry powder dispensing company VaryDose has announced the appointment of Philippe Rogueda as its Chief Technology Officer. According to the company, "Philippe brings with him many years’ experience and expertise in the powder handling and pharmaceutical formulation industry. Philippe is an industry renowned product development specialist with extensive experience of … [Read more...] about VaryDose appoints Philippe Rogueda as CTO
Pharmaxis files resubmission for Bronchitol to PBAC
Pharmaxis has announced that it "filed a minor resubmission with the Pharmaceutical Benefits Advisory Committee (PBAC)" for its Bronchitol mannitol dry powder inhaler for the treatment of cystic fibrosis. According to the company, the committee's next scheduled meeting is in March 2012, at which time it will consider the submission. Bronchitol received marketing … [Read more...] about Pharmaxis files resubmission for Bronchitol to PBAC
Pulmatrix says iSperse data show superiority over lactose blends for DPIs
Pulmatrix has presented data at the 11th US-Japan Symposium on Drug Delivery Systems in Hawaii that it says demonstrate the superiority of its iSPERSE inhalation platform over lactose formulations for combination dry powder inhalers. The iSPERSE technology makes use of a "delivery matrix containing proprietary cationic salt formulations" that allows for increased … [Read more...] about Pulmatrix says iSperse data show superiority over lactose blends for DPIs
Alexza announces layoffs, possible sale of assets
Days after an FDA committee recommended approval of its lead product, Adasuve inhaled loxapine for the treatment of agitation in schizophrenia or bipolar disorder, Alexza Pharmaceuticals has announced that it is "exploring strategic options to enhance stockholder value" and has issued 60-day layoff notices to all of its employees in accordance with California … [Read more...] about Alexza announces layoffs, possible sale of assets
GSK reduces the price of the Seretide Accuhaler in the UK
Effective January 1 2012, the Seretide salmeterol xinafoate/fluticasone propionate Accuhaler 100 will cost £18 in the UK, a reduction of 42%. The price reduction is expected to save the National Health Service (NHS) £6.9 million per year. GSK suggests that the move, which equalizes pricing for the Accuhaler 100 and the Evohaler 50, "removes cost as a potential … [Read more...] about GSK reduces the price of the Seretide Accuhaler in the UK
ISTA rejects offer by Valeant
ISTA Pharmaceuticals has rejected an unsolicited, non-binding proposal from Valeant Pharmaceuticals to acquire all of its outstanding shares on the grounds that the offer "was grossly inadequate." ISTA's board voted unanimously against the proposal. The company's pipeline includes two bepotastine nasal spray candidates, one in combination with a steroid, for the … [Read more...] about ISTA rejects offer by Valeant
The FDA explains its decision on indacaterol
In an article in the December 15 issue of the New England Journal of Medicine, regulators from the FDA’s Center for Drug Evaluation and Research (CDER), with Badhul Chowdhury, director of Division of Pulmonary, Allergy, and Rheumatology Products, as lead author, detail the decision making process that led to approval of a single 75 μg dose of Novartis's Arcapta … [Read more...] about The FDA explains its decision on indacaterol
MannKind and former regulatory affairs director resolve legal issues
According to MannKind Corporation, it has completely resolved arbitration initiated by a lawsuit filed by its former Senior Director - GCP - Regulatory Affairs, John Arditi, in 2010. Arditi, who had been responsible for MannKind's GCP compliance audit program, claimed in the lawsuit that he was terminated in retaliation "for his diligence and insistence on quality … [Read more...] about MannKind and former regulatory affairs director resolve legal issues