The FDA has approved Boehringer Ingelheim's sNDA for the use of Spiriva Respimat to treat asthma in patients aged 6 and older and has granted pediatric exclusivity for the product, the company announced. Spiriva Respimat was approved for the treatment of asthma in patients 12 and older in the US in September 2015. Boehringer Ingelheim Pharmaceuticals Senior VP, … [Read more...] about Spiriva Respimat approved by FDA for pediatric use
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FDA exempts Evoke’s Gimoti metoclopramide nasal spray from human factors requirement
Evoke Pharma has announced that the FDA will allow the company to move forward with an NDA for its Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis without a human factors validation study, exempting the product from requirements set out in the 2016 guidance titled "Applying Human Factors and Usability Engineering to Medical … [Read more...] about FDA exempts Evoke’s Gimoti metoclopramide nasal spray from human factors requirement
Paul Kippax of Malvern Instruments answers questions about MDRS
Using morphologically-directed Raman spectroscopy (MDRS) for generic nasal spray development. Q:Last year, the FDA published an article titled “The FDA Embraces Emerging Technology for Bioequivalence Evaluation of Locally Acting Nasal Sprays” in which the FDA’s Bing Li said that the agency was very happy to have accepted MDRS data in lieu of a clinical endpoint BE … [Read more...] about Paul Kippax of Malvern Instruments answers questions about MDRS
Prevacus announces plans for Phase 1 study of PRV-002 intranasal therapy for concussion
Prevacus has announced that it plans to initiate a Phase 1 clinical trial of its PRV-002 intranasal product for the treatment of mild traumatic brain injury (mTBI) by the middle of 2017. According to the company, pre-clinical studies showed that intranasal administration of PRV-002 positively impacted memory, sensory-motor function, cerebral edema, anxiety and … [Read more...] about Prevacus announces plans for Phase 1 study of PRV-002 intranasal therapy for concussion
Hikma to market Orion’s budesonide/formoterol Easyhaler in the Middle East and North Africa
According to Hikma Pharmaceuticals, the company has signed a licensing and distribution agreement with Orion Corporation for marketing rights to a budesonide/formoterol Easyhaler DPI for the treatment of asthma and COPD throughout the Middle East and North Africa (MENA). Hikma Vice Chairman and CEO of MENA and Emerging Markets Mazen Darwazah commented, “We are … [Read more...] about Hikma to market Orion’s budesonide/formoterol Easyhaler in the Middle East and North Africa
Insmed announces new US patent for Arikayce inhaled amikacin
The United States Patent and Trademark Office (USPTO) has granted Insmed Incorporated US Patent Number 9,566,234, titled, "Systems for treating pulmonary infections," the company said. The patent's claims relate to the use of Insmed's Arikayce liposomal amikacin inhalation solution for the treatment of nontuberculous mycobacteria (NTM) and other pulmonary infections. … [Read more...] about Insmed announces new US patent for Arikayce inhaled amikacin
Penthrox methoxyflurane inhaler launched in France and Belgium
According to Medical Developments International (MVP), Mundipharma has launched the company's Penthrox methoxyflurane inhaler for or the treatment of moderate to severe pain in trauma patients in France and Belgium, triggering a milestone payment of $2.0 million to MVP. Mundipharma owns the rights to Penthrox in most of Europe outside of the UK and Ireland, where … [Read more...] about Penthrox methoxyflurane inhaler launched in France and Belgium
GSK launches OTC Flonase Sensimist fluticasone furoate nasal spray in US
GSK Consumer Healthcare has announced the US launch of Flonase Sensimist fluticasone furoate nasal spray for the once-daily treatment of seasonal and perennial allergy symptoms. The FDA approved Flonase Sensimist, an over-the-counter version of Veramyst, in August 2016. GSK has been marketing an OTC fluticasone propionate nasal spray as Flonase Allergy Relief in … [Read more...] about GSK launches OTC Flonase Sensimist fluticasone furoate nasal spray in US
Propeller Health to provide sensors for Novartis’s Breezhaler
Inhaler monitoring company Propeller Health has announced that it will develop an add-on sensor for Novartis's Breezhaler DPI. The sensor, which will be used on COPD products Ultibro, Onbrez, and Seebri Breezhaler in Europe, will record patient use data and transmit that data through the Propeller platform. The company is already partnered with a number of … [Read more...] about Propeller Health to provide sensors for Novartis’s Breezhaler
Impel NeuroPharma announces agreement with Camargo Pharmaceutical Services
According to intranasal drug developer Impel NeuroPharma, the company has signed service agreements with 505(b)(2) development specialist Camargo Pharmaceutical Services. Camargo will provide development services for products based on Impel's Precision Olfactory Delivery (PODTM) intranasal delivery platform. In December 2016, Impel announced that it had raised up … [Read more...] about Impel NeuroPharma announces agreement with Camargo Pharmaceutical Services