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
Business
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
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
Aradigm gets patents for inhaled ciprofloxacin formulations, announces plans for Pulmaquin Phase 3 trials
The United States Patent and Trademark Office has issued US Patent No. 8,071,127 regarding formulations of inhaled liposomal and free ciprofloxacin to Aradigm Corporation. The patent covers the company's lead candidate, Pulmaquin dual release ciprofloxacin for inhalation, and should provide exclusivity for the product until October 22, 2027. Aradigm now plans to take … [Read more...] about Aradigm gets patents for inhaled ciprofloxacin formulations, announces plans for Pulmaquin Phase 3 trials
Decision Resources predicts flat asthma drug market through 2020
A report from research firm Decision Resources predicts no growth in the asthma drug market through 2020, in large part due to incursions by generics and greater competition. According to the company, "The overall asthma drug market will decrease slightly from $14.6 billion in 2010 to $14.4 billion in 2020 in the United States, France, Germany, Italy, Spain, the … [Read more...] about Decision Resources predicts flat asthma drug market through 2020
NanoBio to collaborate with Merck on intranasal RSV vaccine
Merck and NanoBio will conduct preclinical studies to evaluate a vaccine combining Merck's respiratory syncyctial virus (RSV) antigen with NanoBio's NanoStat adjuvant. NanoBio has already conducted studies that showed the induction of immunity by a NanoStat-adjuvanted RSV vaccine "without eliciting the enhanced respiratory disease that has caused other RSV vaccine … [Read more...] about NanoBio to collaborate with Merck on intranasal RSV vaccine
Meda gets patent related to Astepro nasal spray
Swedish pharma company Meda released a statement regarding a new patent for its Astepro nasal spray that reads in its entirety: "The United States Patent and Trademark Office (USPTO) today issued a patent related to Astepro (azelastine) nasal spray. This patent will be listed in the FDA's Approved Drug Products List (the Orange Book). The Astepro patent is valid … [Read more...] about Meda gets patent related to Astepro nasal spray