Otitopic has announced that a Phase 1 trial of its Asprihale dry powder aspirin found that the inhaled formulation demonstrated antithrombotic effects at 2 minutes post dose compared to 30 minutes post dose for a 162 mg chewable aspirin tablet. Both the inhaled and chewable aspirin maintained maximum antithrombotic effects at 24 hours post dose. In February 2019, … [Read more...] about Otitopic announces results from Phase 1 trial of its inhaled aspirin
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Hikma submits response to FDA for its generic of Advair Diskus
Hikma Pharmaceuticals announced that it has submitted its response to the FDA's complete response letter regarding the company's ANDA for a generic fluticasone propionate/salmeterol DPI. Hikma is partnered with Vectura on the DPI, a generic version of Advair Diskus known as VR315US. The FDA issued the CRL in May 2017. In March 2018, Hikma announced that the agency … [Read more...] about Hikma submits response to FDA for its generic of Advair Diskus
UCB announces US launch of Nayzilam midazolam nasal spray
According to UCB, Nayzilam midazolam nasal spray will be available in the US as of December 2, 2019. UCB acquired the nasal spray from Proximagen in April 2018, and the FDA approved Nayzilam for the treatment of seizure clusters in epilepsy patients 12 years old and older in May 2019. The company said that Nayzilam is expected to cost $40 for a box containing two … [Read more...] about UCB announces US launch of Nayzilam midazolam nasal spray
TFF initiates Phase 1 trial of inhaled voriconazole
TFF Pharmaceuticals has announced the initiation of Phase 1 trial of its dry powder voriconazole, which the company is developing for the treatment of invasive pulmonary aspergillosis (IPA). The Phase I SAD/MAD study will be conducted in Canada and will enroll a total of 64 healthy subjects, 32 in each part. The company recently raised $22 million in an initial … [Read more...] about TFF initiates Phase 1 trial of inhaled voriconazole
Adherium names new CEO, Chief Commercial Officer
Inhaler monitoring company Adherium has named Peter Stratford as CEO and Mike Motion as Chief Commercial Officer, replacing interim CEO Jeremy Curnock Cook and interim CCO Bill Hunter. Stratford was most recently Head of Innovation at healthcare company BTG, which has now been acquired by Boston Scientific. Motion was most recently Head of Varithena, a BTG … [Read more...] about Adherium names new CEO, Chief Commercial Officer
Lupin launches Adhero inhaler monitoring device in India
Lupin has launched its new Adhero connected inhaler monitoring device in India, the company said. According to Lupin, the company collaborated with Aptar Pharma on the device, which attaches to the tops of MDIs. The Adhero sensors allow for monitoring of inhaler use, and data are uploaded to a "MyAdhero" app via Bluetooth. The usage data are also accessible to … [Read more...] about Lupin launches Adhero inhaler monitoring device in India
Chinese regulators approve IND for Penthrox
The Chinese National Medical Product Administration (NMPA) has approved an investigative new drug (IND) application for Penthrox methoxyflurane inhaler for two different indications, Medical Developments International (MVP or MDI) has announced. MVP is developing Penthrox in China for trauma pain and for procedural pain. The company said that it plans to complete … [Read more...] about Chinese regulators approve IND for Penthrox
Nebulization therapy: finding the optimum combination of performance, features, and affordability
By Jason A Suggett, Mark W Nagel, Dominic P Coppolo, and Jolyon P Mitchell A wide spectrum of options is available for delivering inhaled medications by nebulization. The challenge, either for a developer considering which delivery option to use for their new formulation, or for a clinician prescribing therapy that will be funded either privately or through … [Read more...] about Nebulization therapy: finding the optimum combination of performance, features, and affordability
Iconovo gets Japanese patent for ICOres DPI
DPI developer Iconovo has announced that the Japanese Patent Office has granted the company a patent covering its ICOres dry powder inhaler. According to Iconovo, Sweden and European patents related to ICOres have already been issued. In March 2019, Iconovo announced that CBC Corporation was taking over development responsibilities from Amneal Pharmaceuticals for … [Read more...] about Iconovo gets Japanese patent for ICOres DPI
Iliad Biotechnologies appoints Cheryl Keech as Chief Medical Officer and Executive VP of Clinical Research
Iliad Biotechnology has announced the appointment of Cheryl Keech as Chief Medical Officer and Executive VP of Clinical Research; she will be responsible for clinical studies of the company's pipeline products, including the BPZE1 live attenuated intranasal pertussis vaccine. The company said that a Phase 2b trial of BPZE1 has completed enrollment. Keech was most … [Read more...] about Iliad Biotechnologies appoints Cheryl Keech as Chief Medical Officer and Executive VP of Clinical Research