Evoke Pharma said that it has received minutes from a July 25, 2019 Type A meeting with the FDA and that the company now plans to resubmit its NDA for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis in the fourth quarter of 2019. The company initially submitted the NDA in June 2018; in April 2019, the agency issued a CRL in response to … [Read more...] about Evoke anticipates resubmitting Gimoti NDA by the end of 2019
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Nemera acquires Insight Product Development
Device developer and manufacturer Nemera has announced its acquisition of Insight Product Development, which will become the US office of Nemera's “Insight Innovation Center.” The company's other design center office is located in La Verpillière, France. Insight's capabilities include early stage development of DPIs, MDIs, and connected devices. According to Nemera, … [Read more...] about Nemera acquires Insight Product Development
George D. Behrakis joins board of AZTherapies
AZTherapies has announced that former Dooner Laboratories and Muro Pharmaceuticals CEO George D. Behrakis has joined the company’s board of directors. Behrakis sold Dooner Laboratories, which manufactured theophylline products for asthma, to Rorer in 1977 and Muro Pharmaceuticals, which marketed a number of OINDPs for the treatment of asthma and allergies, to … [Read more...] about George D. Behrakis joins board of AZTherapies
Alvogen to distribute Alvesco ciclesonide MDI in Central European countries
Alvogen has acquired marketing rights to the Alvesco cliclesonide metered dose inhaler in a number of Central and Eastern European (CEE) countries from Covis Pharma, the company said. Terms of the deal, which includes Bulgaria, Czech Republic, Hungary, Kazakhstan, Latvia, Poland, Romania, Russia and Slovakia, were not disclosed. In November 2018, Covis announced … [Read more...] about Alvogen to distribute Alvesco ciclesonide MDI in Central European countries
ISAB gets contract for nebulizer feasibility study
Inhalation Sciences (ISAB) has announced that "a leading European inhaled pharmaceutical developer" has contracted with the company for a feasibility study using ISAB's PreciseInhale aerosol generator with new nebulizer capabilities. The feasibility study is the first to use the nebulizer feature for the PreciseInhale system, which launched in February 2019, the … [Read more...] about ISAB gets contract for nebulizer feasibility study
One Drop to integrate MannKind’s BluHale inhaler monitoring device for Afrezza
The One Drop diabetes management platform has agreed to integrate MannKind’s BluHale inhaler monitoring device for the Afrezza insulin DPI, the companies said. The integration of the BluHale device will allow for monitoring of insulin doses, glucose forecasts, and other services for patients using the Afrezza inhaler. MannKind Corporation CEO Michael Castagna … [Read more...] about One Drop to integrate MannKind’s BluHale inhaler monitoring device for Afrezza
Positive Phase 2 results for ensifentrine DPI for COPD
Verona Pharma has announced that a Phase 2 trial of its RPL554 ensifentrine DPI for the treatment of COPD met all primary and secondary endpoints related to improvement in lung function. The company had previously announced positive preliminary results from the study. Phase 2 studies of nebulized ensifentrine and an ensifentrine MDI for the treatment of COPD were … [Read more...] about Positive Phase 2 results for ensifentrine DPI for COPD
Enrollment in Phase 3 study of ALZT-OP1 inhaled Alzheimer’s therapy completed
AZ Therapies has announced that the Phase 3 COGNITE study of ALZT-OP1 inhaled cromolyn/oral ibuprofen for the treatment of early stage Alzheimer’s disease has completed enrollment. The company, which announced the initiation of the study in September 2015, said that it has a special protocol assessment (SPA) agreement with the FDA regarding the trial design. … [Read more...] about Enrollment in Phase 3 study of ALZT-OP1 inhaled Alzheimer’s therapy completed
Italfarmaco to develop inhaled teicoplanin for the treatment of MRSA infections in CF patients
Italfarmaco has announced that it will pay Neupharma "a total sum up to double digits in USD millions, excluding royalties" for an exclusive option to acquire global development and commercialization rights to inhaled teicoplanin for the treatment methicillin-resistant Staphylococcus aureus (MRSA) lung infections in cystic fibrosis patients. The inhaled teicoplanin … [Read more...] about Italfarmaco to develop inhaled teicoplanin for the treatment of MRSA infections in CF patients
Mylan to acquire TOBI manufacturing facility
A spokesperson for Novartis has confirmed to OINDPnews that Mylan exercised an option to acquire a San Carlos, CA, USA manufacturing facility for TOBI inhaled tobramycin products in May 2019 and is expected to acquire the site assets in September 2019. Mylan paid approximately $463 million to Novartis for worldwide rights to TOBI Podhaler DPI and TOBI inhalation … [Read more...] about Mylan to acquire TOBI manufacturing facility