Powder characterization specialist Freeman Technology has established a US subsidiary, Freeman Technology Inc., to handle the growing North American demand for its FT4 powder rheometer. Newly-hired National Sales Specialist Mike Delancey and Applications Specialist John Yin will work with US customers. Freeman Technology Managing Director Tim Freeman explained: … [Read more...] about Freeman Technology launches US subsidiary
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Mylan to appeal invalidation of inhalation solution patents
On March 1, Judge John Koeltl of the US District Court for the Southern District of New York issued a partial summary judgment in Mylan's patent infringement suit against Sunovion Pharmaceuticals, invalidating 5 of the 7 patents regarding Brovana arformoterol tartrate inhalation solution cited in the suit filed by Mylan's subsidiary Dey against Sunovion (formerly … [Read more...] about Mylan to appeal invalidation of inhalation solution patents
Teva announces positive Phase 3 results for QNASL dry nasal aerosol
Teva Pharmaceutical has announced positive results from four Phase 3 clinical studies of QNASL beclomethasone dipropionate HFA nasal aerosol for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). Previously released data demonstrated that treatment with QNASL improved nasal symptom scores over the first 30 weeks of a 52-week … [Read more...] about Teva announces positive Phase 3 results for QNASL dry nasal aerosol
Positive Phase 3 results for Meda’s Dymista nasal spray
Meda has announced positive results from three studies of its Dymista azelastine hydrochloride/fluticasone propionate nasal spray for the treatment of seasonal allergic rhinitis. The company filed both an NDA for the product, currently known as MP29-02, and an MAA in 2011. One long-term study showed that the product is well tolerated, with fewer than 3% of patients … [Read more...] about Positive Phase 3 results for Meda’s Dymista nasal spray
FluMist Quadrivalent intranasal vaccine gets FDA approval
The FDA has approved MedImmune's FluMist Quadrivalent for the prevention of influenza, making the intranasal vaccine the first approved quadrivalent flu vaccine in the US. FluMist Quadrivalent contains two type A strains and type B strains from both B/Yamagata and B/Victoria. All other currently approved seasonal flu vaccines are trivalent. University of Kentucky … [Read more...] about FluMist Quadrivalent intranasal vaccine gets FDA approval
NEJM: 200 years of asthma treatment
To celebrate its 200th anniversary, the New England Journal of Medicine (NEJM) is publishing a series of special articles reviewing progress in medicine since 1812. As part of the series, an article in the March 1, 2012 issue titled "A Patient with Asthma Seeks Medical Advice in 1828, 1928, and 2012" presents a fictionalized series of doctor's notes on the treatment … [Read more...] about NEJM: 200 years of asthma treatment
Caffeine nasal spray launched in US
A company called GSC Products has launched what it says is "the world's first caffeine nasal spray" in the US. GSC says that the product, called Turbo Snort, was introduced on the Internet in January and is now sold in more than 500 independent convenience stores. GSC CEO Wayne Perry said, "By delivering caffeine through the nose, it bypasses the systemic processes … [Read more...] about Caffeine nasal spray launched in US
European marketing approval for Forest’s Colobreathe dry powder inhaler
Forest Laboratories has received EMA approval to market Colobreathe dry powder colistimethate sodium inhalation powder for the treatment of P. aeruginosa infections in cystic fibrosis patients aged 6 years and older, according to the company. The company already markets a colistimethate sodium inhalation solution for nebulization under the brand name Colomycin in the … [Read more...] about European marketing approval for Forest’s Colobreathe dry powder inhaler
FDA advisory committee recommends approval of aclidinium bromide inhalation powder
The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 12 to 2 in favor of approval for Forest Laboratories' and Almirall's NDA for a 400 μg twice daily dose aclidinium bromide inhalation powder to treat COPD. Although the briefing materials for the advisory committee meeting raised questions about the safety of inhaled long-acting muscarinic agents … [Read more...] about FDA advisory committee recommends approval of aclidinium bromide inhalation powder
FDA posts 2011 warning letter to MDI spacer marketer
Among the warning letters posted to the FDA website on February 21, 2012 is a letter to FSC Laboratories dated June 9, 2011 detailing violations related to quality controls for the manufacture of the E-Z Spacer collapsible holding chamber for metered dose inhalers. According to the letter, a March 2011 FDA inspection found that the company "is a virtual company that … [Read more...] about FDA posts 2011 warning letter to MDI spacer marketer