OINDP testing experts Copley Scientific have announced the hires of Edward Brundrett, who joins the company as a technical sales executive, and Mark Lo, a mechanical engineer who is joining the company's design team. The company, which significantly expanded its Nottingham, UK headquarters in 2018, noted that its recent acquisition of Novi Systems "brings a new … [Read more...] about Copley Scientific announces hires of sales and design engineers
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Chiesi announces plans for lower carbon footprint HFA 152a inhaler by the end of 2025
Chiesi announced that the company has signed an agreement with Koura (formerly Mexichem) for supply of HFA 152a propellant as part of a €350 million plan to bring a pMDI with a 90% lower carbon footprint to market by the end of 2025. The company, which has also pledged that it would be carbon neutral by 2035, made the announcement at the Nations Climate Change … [Read more...] about Chiesi announces plans for lower carbon footprint HFA 152a inhaler by the end of 2025
Phase 2 trial of Theravance’s TD-8236 inhaled JAK inhibitor gets underway
Theravance Biopharma announced that the first patient has been dosed in a Phase 2 study of its TD-8236 inhaled dry powder pan-JAK inhibitor which the company is developing for the treatment of inflammatory lung diseases. In September 2019, the company announced positive results from a Phase 1 SAD/MAD study of TD-8236. The Phase 2 allergen challenge study will … [Read more...] about Phase 2 trial of Theravance’s TD-8236 inhaled JAK inhibitor gets underway
Ultibro Breezhaler added to National Reimbursement Drug List in China
Sosei Group has announced that the Ultibro Breezhaler indacaterol/glycopyrronium DPI has been added to the 2019 National Reimbursement Drug List (NRDL) in China for the treatment of COPD. Novartis launched Ultibro Breezhaler and Seebri Breezhaler in China in March 2019. Sosei Heptares President and CEO Shinichi Tamura commented, "We are pleased that COPD patients … [Read more...] about Ultibro Breezhaler added to National Reimbursement Drug List in China
Otitopic announces results from Phase 1 trial of its inhaled aspirin
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
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