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Sativex spray now available in Spain

Almirall has launched Sativex oro-mucosal spray for the treatment of spasticity in multiple sclerosis patients in Spain. Sativex is an endocannabinoid modulator that contains THC and cannabidiol developed and manufactured by GW Pharmaceuticals. According to the company approximately 75% of the 40,000 MS patients in Spain suffer from spasticity. The product will be … [Read more...] about Sativex spray now available in Spain

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

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