Marina Biotech will pay up to $95 million in milestone payments, plus a "mid-single digit" royalty, in addition to 53 million Marina common shares to acquire Turing Pharmaceutical's intranasal ketamine program, including all existing product, clinical development plans, and intellectual property rights. The acquisition is expected to be completed by July … [Read more...] about Marina Biotech to acquire intranasal ketamine from Turing Pharmaceuticals
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EMA review finds that all ICS products carry similar risk of pneumonia but that benefits outweigh the risks
An EMA Pharmacovigilance Risk Assessment Committee (PRAC) review of published data from controlled clinical trials, observational studies, and meta-analyses has concluded that all inhaled corticosteroid (ICS) products appear to carry a similar risk of pneumonia when used to treat COPD patients but that the benefits of ICS treatment for COPD outweigh the risks. … [Read more...] about EMA review finds that all ICS products carry similar risk of pneumonia but that benefits outweigh the risks
FDA approves ProAir RespiClick for pediatric use
The FDA has approved Teva's supplemental NDA for ProAir RespiClick albuterol breath-activated DPI for the treatment or asthma in children aged 4 to 11, the company has announced. The sNDA filing was accepted by the FDA in September 2015. ProAir RespiClick has been approved by the FDA for patients 12 years old and older since March 2015. Erwin Gelfand, Chairman, … [Read more...] about FDA approves ProAir RespiClick for pediatric use
Nanopharm announces launch of dissolution testing for inhaled drugs using its UniDose collection system
OINDP analysis and development specialist Nanopharm is now offering dissolution testing services using its proprietary UniDose aerosol collection apparatus, the company said. UniDose allows analysts to conduct dissolution testing that is independent of the collected dose. The system deposits the entire dose at a low impaction velocity onto a high surface area … [Read more...] about Nanopharm announces launch of dissolution testing for inhaled drugs using its UniDose collection system
Phase 3 trials of Sunovion’s nebulized glycopyrrolate meet primary endpoints
Sunovion has announced that the GOLDEN-3 and GOLDEN-4 Phase 3 clinical trials of SUN-101 glycopyrrolate inhalation solution for the treatment of moderate-to-very severe COPD both met their primary endpoints. SUN-101, delivered via the PARI eFlow handheld nebulizer, demonstrated statistically significant improvement in FEV1 versus placebo after 12 weeks for both the 50 … [Read more...] about Phase 3 trials of Sunovion’s nebulized glycopyrrolate meet primary endpoints
Aradigm announces private placement of $23 million to fund continued Pulmaquin development
Aradigm Corporation has announced the first closing of a private placement of $23 million in senior convertible notes that mature in 2021 and warrants to purchase 263,436 shares of common stock at $5.21 per share, "beginning on the later of 180 days after the date of issuance or the date the company issues a press release announcing data related to the ORBIT-3 and … [Read more...] about Aradigm announces private placement of $23 million to fund continued Pulmaquin development
AstraZeneca’s Bevespi Aerosphere MDI approved by the FDA
The FDA has approved AstraZeneca's Bevespi Aerosphere glycopyrrolate/formoterol fumarate MDI (formerly PT003) for the treatment of COPD, the company has announced. The product is AstraZeneca's first to use the Co-Suspension technology patented by Pearl Therapeutics in 2012. AstraZeneca acquired Pearl in 2013. Data from the Phase 3 PINNACLE trial, which was … [Read more...] about AstraZeneca’s Bevespi Aerosphere MDI approved by the FDA
FDA issues product-specific draft guidances for four more inhalation products
The US FDA has issued four new product-specific draft guidances in April 2016 for inhalation products, including three dry powder products and one MDI. The documents include recommendations on establishing bioequivalence for generic versions of Breo/Relvar Ellipta, Arnuity Ellipta, Arcapta Neohaler/Onbreez Breezhaler, and Asmanex HFA, Read the new guidances for … [Read more...] about FDA issues product-specific draft guidances for four more inhalation products
Aytu acquires US rights to Acerus’s Natesto nasal testosterone
Aytu BioScience has acquired US rights to Natesto testosterone nasal gel from Acerus (formerly Trimel) for $8 million up front, including $2 million on signing and an additional $6 million by the end of FY 2017, the companies have announced. Under the deal, which extends through at least February 2024, Aytu will pay milestones of up to $37.5 million. Aytu will also … [Read more...] about Aytu acquires US rights to Acerus’s Natesto nasal testosterone
3M DDS launches Intelligent Control Inhaler
3M Drug Delivery Systems has announced the launch of the 3M Intelligent Control Inhaler, a connected, breath-actuated inhaler that provides instructions to the patient via a screen integrated into the device and provides feedback to both the patient and health care providers via an associated app. According to the company, the inhaler minimizes inspiration errors … [Read more...] about 3M DDS launches Intelligent Control Inhaler