The US Court of Appeals for the DC Circuit has upheld a lower court finding that the FDA lacks the authority to regulate e-cigarettes. The agency had asserted that it had jurisdication and issued warning letters to five e-cigarette manufacturers in September, 2010. Read the opinion. … [Read more...] about Court rules FDA has no authority to regulate e-cigarettes as drug/device combinations
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Decision Resources predicts Spiriva will increase market share for COPD
According to a study by Decision Resources, primary care physicians prefer Boehringer Ingelheim's Spiriva to other first-line COPD treatments, with 44% surveyed saying they would increase their use of the drug in the next few years. That percentage is down from 59% in 2009. Read the company's press release. … [Read more...] about Decision Resources predicts Spiriva will increase market share for COPD
Insmed acquires Transave and its Arikace inhaled liposomal amikacin
Richmond, Virginia biopharmaceutical company Insmed Incorporated has announced a "business combination" with Transave, making Transave a wholly-owned subsidiary. The company also announced plans for Phase 3 trials of Arikace inhalation solution for the treatment of pseudomonas infections in CF patients and for the treatment of non-TB mycobacteria lung … [Read more...] about Insmed acquires Transave and its Arikace inhaled liposomal amikacin
Gates Foundation awards $6 million grant to NanoBio for intranasal RSV vaccine
University of Michigan spin-off NanoBio Corporation has received its second grant for vaccine development from the Bill and Melinda Gates Foundation. The new $6 million grant is for development of an intranasal vaccine for respiratory syncytial virus (RSV). No approved RSV vaccines are available currently. In 2005, prior to the spin off from UM, the company received … [Read more...] about Gates Foundation awards $6 million grant to NanoBio for intranasal RSV vaccine
Pearl announces positive Phase 2b results for COPD drug
According to Pearl Therapeutics, a Phase 2b study has demonstrated that its PT003 glycopyrrolate/formoterol combination MDI provides superior bronchodilation compared to placebo, compared to its individual components, and compared to tiotropium. The trial involved patients with moderate to very severe COPD. Read the company's press release. … [Read more...] about Pearl announces positive Phase 2b results for COPD drug
GSK increases investment in Relovair development
GlaxoSmithKline has increased its share of Theravance, with which it is developing Relovair fluticasone/vilanterol COPD product, to approximately 19%. In addition, GSK is crediting a UK "patent box" proposal to encourage R&D investments with in announcing its final decision to invest in its facility in Ware, Hertfordshire for the manufacture of the new … [Read more...] about GSK increases investment in Relovair development
Verona announces successful proof of concept tests of lead product
Verona Pharma, which has been looking for a partner for its lead product RPL554, an inhaled phosphodiesterase 3 and phosphodiesterase 4 inhibitor for the treatment of asthma, COPD, and allergic rhinitis, announced that it has performed successful delivery tests by nebulizer, MDI, and DPI. Read the company's press release. … [Read more...] about Verona announces successful proof of concept tests of lead product
New asthma cure — quit Facebook?
An article published in The Lancet on November 20, 2010 describes the case of a teen-aged boy who appeared to suffer from asthma exacerbations linked to emotional distress caused by his use of Facebook. His asthma had previously been well controlled with ICS and Singulair; but after he was dumped by his girlfriend, visits to her profile page coincided with measurable … [Read more...] about New asthma cure — quit Facebook?
Clinicians told they overprescribe combination inhalers
Researchers from the Medco Research Institute presented data at the 2010 Annual Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) showing that clinicians are prescribing ICS/LABA combination treatment for two thirds of patients with mild persistent asthma and that the combination therapy has no benefit for these patients compared to ICS … [Read more...] about Clinicians told they overprescribe combination inhalers
Mannkind announces positive Phase 3 results while facing clinical trial fraud accusations
Having recently announced that it stands by its clinical trials after a former executive filed suit against the company for retaliatory termination after he raised concerns about the validity of studies conducted in Russia and Bulgaria, Mannkind has released new data from a Phase 3 bioequivalence study of its Afrezza inhaled insulin. The new data concern the … [Read more...] about Mannkind announces positive Phase 3 results while facing clinical trial fraud accusations