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Medical

PhRMA report lists more than 50 drugs in US COPD pipeline

According to a new report by the Pharmaceutical Research and Manufacturers of America (PhRMA), American pharmaceutical companies have 54 COPD medications in their pipelines. The list of drugs in development includes all dosage forms, including a large number of inhaled medications. PhRMA President and CEO John J. Castellani commented, “Early detection of COPD is … [Read more...] about PhRMA report lists more than 50 drugs in US COPD pipeline

Recall of acetylcysteine inhalation solution

Bedford Laboratories has announced a national (US) voluntary product recall of acetylcysteine solution manufactured for Roxane Laboratories. The recall was initiated on December 20, 2011 due to a visible glass particle in a vial of solution from lot 1877093. According to the company, no adverse events have been reported. The company warned that "Use of an inhaled … [Read more...] about Recall of acetylcysteine inhalation solution

MHRA announces recall of contaminated saline nasal spray

Manufacturer Church & Dwight UK has informed the Medicines and Healthcare products Regulatory Agency (MHRA) of possible bacterial contamination of its Sterimar Isotonic 100ml saline nasal spray, which is available over the counter in the UK. The company has recalled two batches, numbers FE1248b and FE1249, identifying Pseudomonas stutzeri and Sphingomonas paucimobilis … [Read more...] about MHRA announces recall of contaminated saline nasal spray

Inverseon to focus on smoking cessation, COPD programs

California pharmaceutical company Inverseon has announced that it will redirect its development program for INV102, an inverse beta agonist, to focus on smoking cessation and COPD rather than asthma, although it is continuing to seek grants for development of the product as a treatment for asthma. Inverseon founder and Chair William Garner explained, “The … [Read more...] about Inverseon to focus on smoking cessation, COPD programs

Many patients with mild-to-moderate asthma may not respond to ICS

According to an article published online in the American Thoracic Society’s American Journal of Respiratory and Critical Care Medicine, only about a third of asthma patients not using an inhaled corticosteroid (ICS) and 17% of those using ICS had eosinophils in their sputum, an indicator of inflammation that suggests they would likely respond to ICS treatment. The … [Read more...] about Many patients with mild-to-moderate asthma may not respond to ICS

St Renatus gets funding for Phase 3 development of nasal spray dental anesthesia

An unnamed angel investment group is providing up to $3.5 million dollars to St. Renatus for Phase 3 clinical trials of its nasal mist dental anesthesia. St. Renatus announced in March 2011 that it had had a successful end-of-Phase 2 meeting with FDA regulators and planned to move ahead with Phase 3. The product, delivered to the nasal cavity, numbs only the upper … [Read more...] about St Renatus gets funding for Phase 3 development of nasal spray dental anesthesia

GSK says “totality of the data” gives it confidence to submit applications for Relovair

GlaxoSmithKline and Theravance have announced the completion of Phase 3 studies of their Relovair fluticasone furoate/vilanterol DPI for COPD. One Phase 3 study for the treatment of asthma remains to be completed. Despite the fact that the studies failed to produce statistically significant improvements in a number of measures, GSK says that it will submit … [Read more...] about GSK says “totality of the data” gives it confidence to submit applications for Relovair

Pearl ready to begin Phase 3 studies of PT003

According to Pearl Therapeutics, it has completed two Phase 2b clinical studies of PT003, its inhaled combination bronchodilator for the treatment of moderate-to-severe COPD, and is "on-track to commence Phase 3 program in 2012." One of the trials was a dose confirmation study of various doses of PT003 compared to its components, PT001 and PT005; the other was a … [Read more...] about Pearl ready to begin Phase 3 studies of PT003

Positive Phase 1 results for inhaled L-dopa

Civitas Therapeutics has announced positive results from a Phase 1 clinical study of its CVT-301 inhaled dry powder formulation of levodopa (L-dopa) for the treatment of Parkinson’s disease. According to the company, the study showed that all of the doses tested were well tolerated, and sufficient plasma levels of L-dopa were achieved in healthy volunteers who inhaled … [Read more...] about Positive Phase 1 results for inhaled L-dopa

Phase 2 study of ISTA’s bepotastine-steroid nasal spray begins

ISTA Pharmaceuticals says that it has initiated a Phase 2 study of its Beposone bepotastine besilate/steroid combination nasal spray for the treatment of seasonal allergic rhinitis. Approximately 600 patients with allergic rhinitis caused by mountain cedar pollen are expected to take part in the randomized, placebo-controlled, parallel-group environmental study, which … [Read more...] about Phase 2 study of ISTA’s bepotastine-steroid nasal spray begins

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