On November 1, 2019, Aquestive Therapeutics filed a citizen petition asking the FDA to stay approval of a 505(b)(2) NDA submitted by Neurelis in September 2018 for Valtoco diazepam nasal spray for the treatment of cluster seizures in epilepsy. Aquestive, which is developing a diazepam buccal oral film for the treatment of breakthrough seizures, says the agency … [Read more...] about Aquestive files citizen petition asking FDA to delay approval of Valtoco nasal spray
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Insmed announces appointment of new board member, promotions of two executives
Insmed Incorporated has announced the appointment of Clementia Pharmaceuticals President and CEO Clarissa Desjardins to its board of directors and the promotions of Roger Adsett to Chief Operating Officer and Drayton Wise to Senior VP, Head of United States. The company also recently announced the appointment of Martina Flammer as Chief Medical Officer and provided an … [Read more...] about Insmed announces appointment of new board member, promotions of two executives
Inhaler sensor company Adherium gets $1.1 million in new financing round
According to Adherium, the company has received $1.1 million in a second round of secured debt note financing, and the subscriber for this round is new strategic investor Trudell Medical Limited, parent company of respiratory device companies Trudell Medical International, Monaghan Medical, and NasoNeb. Adherium said that the funds would be used for working … [Read more...] about Inhaler sensor company Adherium gets $1.1 million in new financing round
AZTherapies names Ernest Penachio VP of Manufacturing Operations and CMC
AZTherapies has named Ernest D. Penachio to the newly created position of VP of Manufacturing Operations and CMC to oversee clinical and pre-commercial manufacturing, scale-up, and CMC content development for the company's ALZT-OP1 inhaled cromolyn/oral ibuprofen combination therapy for the treatment of Alzheimer's disease, which is in Phase 3 development. … [Read more...] about AZTherapies names Ernest Penachio VP of Manufacturing Operations and CMC
Iconovo and Crystec sign collaboration agreement for DPI development
Device maker Iconovo and particle engineering specialist CrystecPharma have announced a non-exclusive collaboration agreement for development of dry powder inhalers. The companies say that they plan to develop engineered particles using CrystecPharma's modified supercritical anti-solvent (mSAS) technology for delivery via one of Iconovo's devices. According to the … [Read more...] about Iconovo and Crystec sign collaboration agreement for DPI development
OINDP specialists win big at CPhI Pharma Awards
Many of the winners at this year's CPhI Pharma Awards, held on November 5 at the 2019 CPhI Worldwide meeting in Frankfurt, Germany, offer significant expertise in inhaled and nasal drug delivery, including Lonza, which was named Pharma Service Company of the Year. Lonza Capsugel was also a finalist in the Excellence in Pharma: Formulation category for the Capsugel … [Read more...] about OINDP specialists win big at CPhI Pharma Awards
Kind Consumer launches Voke nicotine inhaler in the UK
Kind Consumer has announced the UK launch of its breath activated Voke 0.45mg nicotine inhaler, which will be available to consumers by direct online purchase at a price of £11.99. The Voke inhaler was approved by the MHRA for general sale for the relief or prevention of nicotine cravings and withdrawal symptoms in September 2014. In January 2017, British American … [Read more...] about Kind Consumer launches Voke nicotine inhaler in the UK
Rick Batycky joins Pulmatrix board of directors
Inhaled drug developer Pulmatrix has announced the appointment of Nocion Therapeutics CEO Rick Batycky to its board of directors. Batycky was a founder of Civitas Therapeutics, which developed Inbrija inhaled levodopa and which was acquired by Acorda in 2014. Prior to serving as Chief Scientific Officer at Civitas and then Chief Technology Officer at Acorda, Batycky … [Read more...] about Rick Batycky joins Pulmatrix board of directors
MannKind gets 2nd development milestone payment for dry powder treprostinil
MannKind Corporation said that it has reached the second milestone in its development of Treprostinil Technosphere (“TreT”), a dry powder formulation of treprostinil for inhalation that the company is developing for the treatment of pulmonary arterial hypertension in partnership with United Therapeutics. In April 2019, MannKind announced that United Therapeutics had … [Read more...] about MannKind gets 2nd development milestone payment for dry powder treprostinil
Insmed appoints Martina Flammer as Chief Medical Officer, provides update on Arikayce
Insmed has announced the appointment of Martina Flammer as Chief Medical Officer, effective mid-December 2019. Flammer was most recently Senior VP Customer Value at Boehringer Ingelheim and her previous positions include VP Medicine, Regulatory Affairs & Pharmacovigilance at BI Canada; VP Clinical Development & Medical Affairs of BI's Specialty Care Business … [Read more...] about Insmed appoints Martina Flammer as Chief Medical Officer, provides update on Arikayce