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
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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
DPT Labs acquired by Renaissance
Renaissance Acquisition Holdings has acquired Texas-based CDMO DPT Laboratories, which offers MDI and nasal spray testing and manufacturing. DPT has facilities in San Antonio, TX and Lakewood, NJ. According to the company, the management team and business will continue as before. DPT President and COO Paul Johnson commented, “Renaissance and its management team … [Read more...] about DPT Labs acquired by Renaissance
Cipla hires Frank Pieters to head respiratory business
Indian pharmaceutical company Cipla has hired former Teva vice-president Frank Pieters as Head of European Business and Head of Global Respiratory Business. Pieters was most recently Senior VP for the Region of Southern Europe at Teva. Cipla manufactures a wide range of inhaled medications. A recent article in the Business Standard quotes Cipla CFO S Radhakrishnan … [Read more...] about Cipla hires Frank Pieters to head respiratory business
Prosonix and Imperial College London to collaborate on inhaled drugs
Prosonix and Imperial College London have signed an agreement to collaborate on development of inhaled therapies based on multi-component particles (MCPs) manufactured using Prosonix's proprietary particle engineering technology. The company will coordinate with Dr. Omar Usmani of the college's National Heart and Lung Institute (NHLI) to perform in vivo and in vitro … [Read more...] about Prosonix and Imperial College London to collaborate on inhaled drugs
Results from four Phase 3 studies of GSK’s LAMA/LABA inhaler for COPD
GlaxoSmithKline and Theravance have announced results from four Phase 3 studies of its umeclidinium bromide (UMEC)/vilanterol (VI) combination DPI for the treatment of COPD. The studies include two 24-week efficacy studies and two 24-week active comparator studies comparing UMEC/VI with tiotropium. UMEC is a a long-acting muscarinic antagonist (LAMA) and vilanterol is … [Read more...] about Results from four Phase 3 studies of GSK’s LAMA/LABA inhaler for COPD