According to New York specialty pharmaceutical company Hi-Tech Pharmacal, sales of its generic fluticasone propionate nasal spray increased 562% during the quarter ending January 31, 2011. Total sales for the product reached $17.9 million for the quarter. The company attributes the increase to "strong unit sales at higher average prices." Read the company's … [Read more...] about Hi-Tech Pharmacal nasal spray sales more than quintuple
News
FDA committee recommends approval of lower dose of indacaterol
The Pulmonary-Allergy Drugs Advisory Committee (PADAC) of the US FDA has voted to recommend approval of the 75 mcg dose of Novartis's QAB149 indacaterol dry powder formulation for the treatment of COPD but has voted against approval of the 150 mcg dose. The vote was 13 to 4 in favor of the lower dose and 12 to 5 against recommendation of the higher dose. Trevor … [Read more...] about FDA committee recommends approval of lower dose of indacaterol
Phase 3 studies planned for nasal mist dental anesthesia
After a favorable end-of-Phase 2 meeting with the FDA, St. Renatus has announced that it plans to proceed to Phase 3 studies of its dental anesthetic, which is delivered as a nasal mist via a syringe. The nasally-administered anesthetic numbs the patient's teeth without numbing the face and lips. According to St. Renatus, the Phase 2 results showed that the nasal … [Read more...] about Phase 3 studies planned for nasal mist dental anesthesia
AstraZeneca discontinues Pulmicort MDI
AstraZeneca has announced that it will stop manufacturing the Pulmicort 100 and 200 µg/dose budesonide HFA pMDI. According to the company, the device has caused "complex manufacturing issues" and the resulting difficulty is causing it to stop production immediately. David Smith, Executive Vice President, Global Operations and IS said, “We have exhausted all … [Read more...] about AstraZeneca discontinues Pulmicort MDI
FDA briefing documents for PADAC meeting question indacaterol dosage
Briefing materials prepared by the FDA for the Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting scheduled for March 8, 2011 ask committee members to consider the safety of the higher dose of Novartis's indacaterol inhalation powder. The FDA had already issued a complete response letter in October 2009, in which it asked Novartis to consider lower doses. The … [Read more...] about FDA briefing documents for PADAC meeting question indacaterol dosage
Phase 2 study of inhaled Bimosiamose produces positive results
German biopharmaceutical company Revotar has announced that its Bimosiamose inhalation solution for the treatment of COPD met its primary endpoint in a Phase 2 study involving more than 75 patients with moderate-to-severe COPD. Bimosiamose is a pan-selectin antagonist that the company is developing for asthma and acute lung injury in addition to COPD. According to … [Read more...] about Phase 2 study of inhaled Bimosiamose produces positive results
Freeman introduces new user interface for powder rheometer
Freeman Technology will offer the new Graphical User Interface (GUI) for its FT4 powder rheometer instrument with all new instruments, and it will be available as a free upgrade for current owners. The FT4 provides data useful for optimizing dry powder flow and aerosolization characteristics by combining several different testing methodologies. With the new GUI, … [Read more...] about Freeman introduces new user interface for powder rheometer
COPD named official COPD Foundation journal
The COPD Foundation has announced that COPD: Journal of Chronic Obstructive Pulmonary Disease will be its official journal. According to John W Walsh, President of the COPD Foundation, "COPD: Journal of Chronic Obstructive Pulmonary Disease, which offers an in-depth and easy-to-access array of research findings in this field, is an ideal partner for the Foundation." … [Read more...] about COPD named official COPD Foundation journal
Insmed announces reverse stock split
Biopharmaceutical company Insmed Incorporated has announced that its shareholders have approved a one-for-ten reverse stock split and the conversion of its Series B preferred stock into common stock. Insmed acquired Transave and its Arikace inhaled liposomal amikacin in December 2010. The company is developing Arikace for the treatment of Pseudomonas aeruginosa … [Read more...] about Insmed announces reverse stock split
Shareholder opposes CPEX merger
Mangrove Partners, which holds approximately %5.7 of the outstanding shares of CPEX Pharmaceuticals, has announced that it will oppose the merger of CPEX with FCB, a wholly-owned subsidiary of Footstar Corporation. The merger was announced in early January 2011. According to Mangrove, the $27.25 per share offer for CPEX, which is developing Nasulin intranasal insulin, … [Read more...] about Shareholder opposes CPEX merger