Contract development company MedPharm has announced a new fast track service for topical formulation development, including for respiratory delivery. The company offers development services for a variety of OINDP formulations, including MDIs, DPIs, inhalation solutions, and nasal sprays. According to the announcement, the service "produces a safe and stable, but … [Read more...] about MedPharm offers new fast track service
News
Tobramycin inhalation solution gets tentative FDA approval
According to the FDA, the agency has issued a tentative approval of an application by PulmoFlow, Inc. to market tobramycin 300 mg/5 ml inhalation solution. PulmoFlow, Inc. was established in Virginia in 2013. The company's web site is a single page that says "PulmoFlow is a newly established company currently focused on solutions to improve the lives of patients … [Read more...] about Tobramycin inhalation solution gets tentative FDA approval
Civitas gets $55 million for Phase 3 development of inhaled L-dopa
Civitas Therapeutics has announced that all of its existing investors, plus seven new investors, participated in a $55 million Series C financing round. The company is developing products based on respiratory delivery technology acquired from Alkermes in 2011 and originally developed by AIR. Civitas President and CEO Mark Iwicki commented, “The proceeds from this … [Read more...] about Civitas gets $55 million for Phase 3 development of inhaled L-dopa
Medicon Valley Inhalation Consortium announces new CEO
The Medicon Valley Inhalation Consortium (MVIC) has announced that Ola Nerbrink has succeeded Orest Lastow as CEO. Nerbrink was previously MVIC's VP of Business Development. Lastow, who founded MVIC in 2012, left the position in May 2014 to become CEO of device developer Iconovo. That company has now entered into a collaboration agreement with MVIC, Nerbrink … [Read more...] about Medicon Valley Inhalation Consortium announces new CEO
Molins Technologies now offering checkweigher for DPI blister disks
Molins Technologies has announced the addition of the disk format µ-check to their µ-check line of check weighers. The standard µ-check can weigh individual DPI blisters alone or in blister strips. The new µ-check machine weighs the contents of each individual blister in a DPI disk. According to Molins, the disk µ-check weighs 10 pockets/minute with a repeatability … [Read more...] about Molins Technologies now offering checkweigher for DPI blister disks
Airflusal Forspiro approved in Mexico
Sandoz has announced that the Mexican health authority, COFEPRIS, has approved the company's marketing application for the Airflusal Forspiro salmeterol/fluticasone DPI for the treatment of asthma and for COPD. Three dosage levels were approved: 50-100 µg, 50-250 µg and 50-500 µg. The product will be marketed as IrFlosol Forspiro in Mexico. The Mexican approval … [Read more...] about Airflusal Forspiro approved in Mexico
FDA approves GSK’s fluticasone furoate DPI, Arnuity Ellipta
GlaxoSmithKline has announced that it has received FDA approval for its fluticasone furoate DPI, to be marketed as Arnuity Ellipta, for the maintenance treatment of asthma. The approval is for 100mcg and 200mcg doses and for patients age 12 and older. GSK submitted the NDA for Arnuity Ellipta in October 2013. GSK Senior VP and Head, GSK Global Respiratory … [Read more...] about FDA approves GSK’s fluticasone furoate DPI, Arnuity Ellipta
Boehringer Ingelheim files NDA for tiotropium/olodaterol Respimat
The FDA has accepted Boehringer Ingelheim's New Drug Application for its tiotropium/olodaterol Respimat soft mist inhaler for the treatment of COPD, the company has announced. BI's Striverdi Respimat olodaterol SMI was approved by the FDA at the end of July 2014, and the agency's Pulmonary-Allergy Drugs Advisory Committee (PADAC) recently voted in favor of … [Read more...] about Boehringer Ingelheim files NDA for tiotropium/olodaterol Respimat
USP awards fellowship for DPI research
The United States Pharmacopeial Convention (USP) has announced three recipients of its 2014–2015 Global Fellowship Awards. One of the recipients of the $30,000 fellowship, Ahmed Shalash of Alexandria University in Alexandria, Egypt, is researching carriers for dry powder inhaler formulations. According to USP, "The research deals with investigation of the role of … [Read more...] about USP awards fellowship for DPI research
Fresenius Kabi launches acetylcysteine 10% solution
In addition to its 20% acetylcysteine solution products, Fresenius Kabi is now offering 4 ml, 10 ml, and 30 ml vials of acetylcysteine 10% for oral use or inhalation in the US. Acetylcysteine is a mucolytic used to thin mucous in the lungs of patients with conditions such as cystic fibrosis, bronchiectasis, and pneumonia. The drug was on the FDA's drug shortage list … [Read more...] about Fresenius Kabi launches acetylcysteine 10% solution