The UK National Health Service has announced that a new MDI spacer developed through Health Enterprise East (HEE), an NHS "innovation hub," will be available through Vivo Smart Medical Devices. The collapsible spacer, called the Pocketflow, is designed primarily for pediatric use but may appeal equally to adults who might use a portable spacer for their … [Read more...] about NHS announces commercialization of new MDI spacer
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Another CRL for Afrezza
MannKind Corporation has again received a complete response letter from the FDA in regards to its application for Afrezza inhaled insulin. A previous CRL was issued in March 2010, and the company resubmitted the NDA in July of that year. The FDA is now asking for additional clinical trials using the next-generation delivery device for the product and for additional … [Read more...] about Another CRL for Afrezza
Alexza says it will resubmit AZ-004 NDA in July 2011
According to Alexza Pharmaceuticals, it plans to resubmit its NDA for AZ-004 (Staccato loxapine) for the treatment of agitation in schizophrenic patients in July 2011. The company received a complete response letter (CRL) for the product from the FDA in October 2010. The FDA CRL cited safety concerns due to decreases in FEV1 after inhalation of a dose. Read the … [Read more...] about Alexza says it will resubmit AZ-004 NDA in July 2011
PharmaForm announces new hires
CMO PharmaForm, a wholly-owned subsidiary of Akela Pharma, has hired J. Blair West, formerly of Bend Research and Azo Pharma, as Vice President of Pharmaceutical Operations. In addition, the company says, Feng Zhang will become Senior Formulation Consultant. PharmaForm provides formulation and manufacturing services for a number of dosage forms, including dry … [Read more...] about PharmaForm announces new hires
Indian company gets patent for anti-emetic nasal spray
According to reports, Lincoln Pharmaceuticals of Ahmedabad, India has been awarded an Indian patent for a nasal formulation of ondansetron hydrochloride intended to prevent nausea and vomiting for chemotherapy patients. The company says that it will begin marketing the product in India within the next few months and intends to market it internationally in the … [Read more...] about Indian company gets patent for anti-emetic nasal spray
PecFent nasal spray approved for use in Scottish national health system
According to Archimedes Pharma, the Scottish Medicines Consortium has approved the company's PecFent fentanyl pectin nasal spray for the treatment of breakthrough cancer pain for use in NHS Scotland. The product received marketing authorization in the European Union in September 2010 and is under review by the FDA for use in the US. Read the company's press release. … [Read more...] about PecFent nasal spray approved for use in Scottish national health system
Dance and Aerogen developing inhaled insuin product
Aerogen has licensed its OnQ nebulizer technology to a San Francisco, California company, Dance Pharmaceuticals for development of a new inhaled insulin solution product. Dance founder John S. Patton was a co-founder of Inhale Therapeutics, which later became Nektar and developed Exubera inhaled insulin. Read the companies' press release. … [Read more...] about Dance and Aerogen developing inhaled insuin product
US asthma rate continues to increase
According to a new report by the National Center for Health Statistics of the US Center for Disease Control (CDC), the 2009 US asthma rate rose to 8.2% of the population, a historic high. The report includes data from several national surveys. Nearly 96% of patients surveyed reported that they had been taught how to use an inhaler. Read the complete report. … [Read more...] about US asthma rate continues to increase
Alkermes pulmonary delivery spin-out Civitas gets $20 million
Civitas Therapeutics has obtained $20 million in Series A financing for development of its lead product, a DPI intended for the treatment of Parkinson's disease. The assets Civitas has licensed from Alkermes include a pipeline, delivery technology, and a manufacturing facility. Management of the new company includes Glenn Batchelder, CEO; Richard Batycky, Chief … [Read more...] about Alkermes pulmonary delivery spin-out Civitas gets $20 million
Catalent adds DPI filling capacity
With the addition of new Harro Höfliger Omnidose filling equipment at its Research Triangle Park facility, Catalent now has the ability to provide DPI filling from clinical manufacturing through commercial manufacturing, according to the company. The new microdosing equipment can fill a range of DPI types, including both capsule and blister-based devices. Read the … [Read more...] about Catalent adds DPI filling capacity