Alexza Pharmaceuticals has announced that it has issued 80,429 shares of common stock to Azimuth Opportunity as the two companies have reached an agreement for a committed equity financing facility under which Alexza has the option to sell Azimuth up to $20 million of its registered common stock over 2 years. The two companies entered a similar agreement in May 2010 … [Read more...] about Alexza gets $20 million in new funding
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UK supermarket chain to begin selling inhalers over the counter
Supermarket chain Asda says that it will become the first retailer in the UK to sell asthma reliever inhalers over the counter when its pharmacies begin offering salbutamol (albuterol) inhalers for sale on July 24. Asda has pharmacies in 218 stores. Patients over the age of 16 will be able to purchase two inhalers for £7 after filling out a simple questionnaire. … [Read more...] about UK supermarket chain to begin selling inhalers over the counter
Alexza submits answers to Day 120 List of Questions for Adasuve
According to Alexza Pharmaceuticals, the company has submitted responses to the Day 120 List of Questions it received from the EMA's Committee for Medicinal Products for Human Use in March 2012 regarding its marketing application for Adasuve inhaled loxapine. The company says that it expects to receive a Day 180 List of Outstanding Issues for the MAA by the end of … [Read more...] about Alexza submits answers to Day 120 List of Questions for Adasuve
Safety study of inhaled alpha1-proteinase inhibitor for CF to begin this year
Grifols has announced that its inhaled alpha1-proteinase inhibitor received orphan drug designation from the FDA in April 2012 and that the company will begin a safety study of the drug by the end of the year. Grifols markets intravenous alpha1-proteinase inhibitor, derived from human plasma, as Prolastin-C as a treatment for alpha1-antitrypsin (AAT) deficiency and is … [Read more...] about Safety study of inhaled alpha1-proteinase inhibitor for CF to begin this year
Private investment firm to acquire Par Pharmaceutical
Par Pharmaceutical's board of directors has voted unanimously in favor of acquisition by private investment firm TPG for $1.9 billion, with Par shareholders getting $50 cash per share of Par common stock. Par and its subsidiary Strativa market several OINDPs, including Nascobal cyanocobalamin nasal spray and Miacalcin calcitonin nasal spray. Par Chairman and CEO … [Read more...] about Private investment firm to acquire Par Pharmaceutical
IPAC-RS offering free human factors webinar
The Device Working Group of the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) is offering a webinar on July 19 from 11:30 a.m. to 12:30 p.m. Eastern Time dealing with human factors assessments in the development of OINDPs. Julian Dixon, Director of Human Factors at Team Consulting, will present the webinar, which "will provide … [Read more...] about IPAC-RS offering free human factors webinar
FDA issues form 483 to Exemplar (Updated)
The FDA has issued a 483 to Exemplar citing observations regarding problems with MDI filling from its March 21, 2012 inspection of the company's Massachusetts facility. Exemplar is referring inquiries about the issue to MAP Pharmaceuticals, which recently met with the FDA to address manufacturing problems with its Levadex inhaled dihydroergotamine cited in a Complete … [Read more...] about FDA issues form 483 to Exemplar (Updated)
FDA approves Asthmapolis inhaler sensor and app
The FDA has granted 510(k) clearance to Asthmapolis's asthma sensor system and mobile app. The sensor attaches to the top of an MDI canister, records data from an accelerometer and GPS receiver, and transmits the data wirelessly to a patient's smart phone. The device uses GPS data to record where and when the inhalers are used, providing information to public health … [Read more...] about FDA approves Asthmapolis inhaler sensor and app
Gerresheimer adds inhaler manufacturing capability in the Czech Republic
Gerresheimer is adding 3,500 square meters to its medical plastics facility in Horsovsky Tyn, Czech Republic, at a cost of about €18 million, adding to a previously announced expansion at the site. According to the company, it will hire approximately 200 more personnel over the next two years to handle increased production of inhalers and other devices at the site. … [Read more...] about Gerresheimer adds inhaler manufacturing capability in the Czech Republic
Hi-Tech Pharmacal attributes sales increase to nasal sprays
Hi-Tech Pharmacal has reported a 10% increase in net sales of generic products for the quarter ended April 30, 2012 compared to the same quarter in 2011, an increase due primarily to a sales increase for fluticasone proprionate nasal spray. According to the company, sales of fluticasone propionate nasal spray were up from $26.9 million in the same period last year to … [Read more...] about Hi-Tech Pharmacal attributes sales increase to nasal sprays