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
News
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
Aegis gets patent for osteoporosis drug formulations
US Patent No. 8,076,290 regarding stabilized formulations of parathyroid hormone (PTH) and PTH peptide analogs for various means of delivery, including intranasal delivery, has been awarded to Aegis Therapeutics. PTH and PTH peptide analogs such as PTH 1-34 (teriparatide) are used for the treatment of osteoporosis. Aegis has licensed the patent exclusively to Azelon … [Read more...] about Aegis gets patent for osteoporosis drug formulations
FDA committee recommends approval of Adasuve inhaled loxapine
After meeting to discuss concerns about the safety of Alexza Pharmaceutical's Adasuve Staccato loxapine, the FDA's Psychopharmacologic Drugs Advisory Committee voted 9 to 8, with 1 abstention, to recommend approval for a single dose in 24 hours when used with the FDA-recommended Risk Evaluation and Mitigation Strategy (REMS), for the treatment for agitation in … [Read more...] about FDA committee recommends approval of Adasuve inhaled loxapine
Intranasal norovirus vaccine capable of reducing infection
An article published in the December 8, 2011 issue of the New England Journal of Medicine describes a proof of principle study in which an intranasal dry powder vaccine significantly reduced Norwalk virus gastroenteritis and infection in study participants innoculated with Norwalk virus. LigoCyte Pharmaceuticals created the vaccine from virus-like particles since … [Read more...] about Intranasal norovirus vaccine capable of reducing infection
John Thievon named President of Dey Pharma
Mylan has appointed John Thievon as president of its subsidiary Dey Pharma, whose products include Perforomist formoterol inhalation solution and the EasyVent valved holding chamber for MDIs. Thievon was most recently President and CEO of Middlebrook Pharmaceuticals and was previously Executive VP of Commercial Operations at Adams Respiratory Therapeutics. "I am … [Read more...] about John Thievon named President of Dey Pharma
FDA committee to discuss safety of Adasuve loxapine inhalation powder
The US FDA has announced a December 12 meeting of the Psychopharmacologic Drugs Advisory Committee to discuss safety concerns related to Alexza's Adasuve loxapine inhalation powder for the treatment of agitation associated with schizophrenia or bipolar disorder. Alexza resubmitted an NDA for the product in August 2011. The company first submitted the NDA in December … [Read more...] about FDA committee to discuss safety of Adasuve loxapine inhalation powder