Amiko Digital Health has announced that Portuguese health care group Luz Saúde has signed an agreement for the use of Amiko's Respiro inhaler monitoring platform for asthma and COPD management. Earlier this year, Amiko announced that the Respiro platform received the CE mark for use with Spiromax, Nexthaler, and Ellipta inhalers, and the company had received a … [Read more...] about Luz Saúde partners with Amiko Digital Health
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Catalent acquires Juniper Pharmaceuticals
Catalent has announced that it will acquire Juniper Pharma Services (formerly Molecular Profiles) along with its parent company Juniper Pharmaceuticals. Catalent will pay $11.50 per share to acquire all of Juniper Pharmaceuticals' stock. Juniper Pharmaceuticals acquired CDMO Molecular Profiles in 2015 and changed its name to Juniper Pharma Services. Juniper has … [Read more...] about Catalent acquires Juniper Pharmaceuticals
Menarini to market Orion DPIs in Asia-Pacific region
Menarini Asia-Pacific Holdings has signed a multi-year licensing agreement with Orion Corporation for distribution and commercialization of Easyhaler DPI products in China, Hong Kong, Philippines, Malaysia, Indonesia, Thailand, Singapore, Vietnam, Taiwan, and South Korea, the companies said. In 2016, Menarini and Orion announced that Menarini would co-market … [Read more...] about Menarini to market Orion DPIs in Asia-Pacific region
Stevanato Group to manufacture and sell Iconovo’s ICOcap inhaler
Swedish DPI developer Iconovo has announced a manufacturing, sales, and distribution agreement with Stevanato Group for its ICOcap dry powder inhaler. The capsule-based ICOcap device will be manufactured by Stevanato Group subsidiary Balda. According to the announcement, Stevanato Group has a sales and marketing presence in more than 150 countries. Iconovo CEO … [Read more...] about Stevanato Group to manufacture and sell Iconovo’s ICOcap inhaler
US appeals court affirms ruling on validity of Zomig nasal spray patents
Amneal Pharmaceuticals announced that the US Court of Appeals for the Federal Circuit has upheld a March 2017 ruling finding that Lannett infringed on US patents 6,750,237 and 7,220,767, which are related to Zomig zolmitriptan nasal spray. Impax Laboratories, an Amneal subsidiary, and AstraZeneca filed suit against Lannett after Lannett filed an ANDA for a generic … [Read more...] about US appeals court affirms ruling on validity of Zomig nasal spray patents
Copley Scientific introduces new equipment for IVIVC testing
Copley Scientific has announced the introduction of a new air compressor, compressed air manifold, and automated compressed air flow controller for improved in vitro-in vivo correlation (IVIVC) testing of OINDPs. The new equipment is designed to balance air flow through a test set-up with a breathing simulator coupled to a cascade impactor through a mixing inlet, … [Read more...] about Copley Scientific introduces new equipment for IVIVC testing
FDA clears IND for Oyster Point’s OC-01 nasal spray for dry eye disease
Oyster Point Pharma has announced that its investigational new drug application for OC-01, a nicotine acetylcholine receptor (nAChR) agonist nasal spray, has been cleared by the FDA. OC-01 and another nAChR nasal spray, OC-02, are both in Phase 2 development for the treatment of dry eye disease. The company said that an IND for OC-02 was cleared in October 2017, … [Read more...] about FDA clears IND for Oyster Point’s OC-01 nasal spray for dry eye disease
Pulmatrix announces results from Phase 1/1b trial of its Pulmazole itraconazole DPI
According to Pulmatrix, a recent Phase 1/1b study of its Pulmazole (PUR1900) itraconazole DPI for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in asthma patients with asthma showed that total systemic exposure in healthy volunteers was significantly lower than historical levels for oral itraconazole and that the drug was well tolerated at all doses … [Read more...] about Pulmatrix announces results from Phase 1/1b trial of its Pulmazole itraconazole DPI
Impel plans for Phase 3 study of intranasal DHE for migraine
According to Impel NeuroPharma, the FDA has given the company a notice to proceed with clinical study of INP101 intranasal dihydroergotamine (DHE) for the treatment of acute migraine. A Phase 3 study is expected to begin enrolling patients in the second half of this year. The company said that it had recently submitted an investigational new drug application to the … [Read more...] about Impel plans for Phase 3 study of intranasal DHE for migraine
Levo Therapeutics to restart development of intranasal carbetocin for Prader-Willi syndrome
Levo Therapeutics has announced that it plans to initiate a Phase 3 trial of LV-101 intranasal carbetocin for the treatment of Prader-Willi syndrome (PWS) before the end of 2018. The company said that it acquired rights to the formulation from Ferring Pharmaceuticals in August 2017 and is now publishing results from a Phase 2 study sponsored by Ferring that concluded … [Read more...] about Levo Therapeutics to restart development of intranasal carbetocin for Prader-Willi syndrome