Aptar Pharma has announced the official opening of its new 7,000 sq m manufacturing facility in Mumbai, India. Aptar has been manufacturing MDI valves and pumps at the site since 2012. According to Aptar, the capabilities there "have now been expanded to offer more innovative product solutions and ensure increased manufacturing capacity to pharma customers in South … [Read more...] about Aptar Pharma opens new manufacturing facility in Mumbai
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FDA extends review period for Optinose’s sNDA for Xhance fluticasone propionate nasal spray for the treatment of chronic sinusitis
The FDA has extended the review period for Optinose's sNDA seeking approval of Xhance fluticasone propionate nasal spray for the treatment of chronic sinusitis in patients without nasal polyps, Optinose said. Xhance was originally approved by the FDA in 2017 for the treatment of nasal polyps. The agency originally accepted the sNDA in May 2023 and set a PDUFA goal … [Read more...] about FDA extends review period for Optinose’s sNDA for Xhance fluticasone propionate nasal spray for the treatment of chronic sinusitis
Recipharm announces appointment of Simon Gardner as Business Development Specialist, partnership with Oz-UK on LGWP MDIs
CDMO Recipharm announced that it has hired former Koura Global Business Development Director Simon Gardner as Business Development Specialist for pMDIs to assist customers with the transition to LGWP propellants. Recipharm President, Advanced Delivery Systems, Chris Hirst commented, "Vital to a successful transition for our customers is having access to a team of … [Read more...] about Recipharm announces appointment of Simon Gardner as Business Development Specialist, partnership with Oz-UK on LGWP MDIs
Nasus reports results from second PK trial of FMXIN002 intranasal dry powder epinephrine
Nasus Pharma said that in a second PK study of FMXIN002 intranasal dry powder epinephrine, 91% of subjects who received a 4 mg dose of the nasal formulation reached the clinical threshold for plasma exposure at 6 minutes post dose compared to 51% who received a dose of epinephrine from an EpiPen. The company reported results from the initial PK study in June 2021. … [Read more...] about Nasus reports results from second PK trial of FMXIN002 intranasal dry powder epinephrine
Kindeva and Koura partner on conversion of existing MDI to HFA 152a
Kindeva Drug Delivery and Koura Global parent company Orbia Advance Corporation announced that they have partnered to convert a currently marketed metered dose inhaler to use Koura's HFA 152a (Zephex 152a), a lower global warming potential (LGWP) propellant. According to the announcement, the collaboration "aims to facilitate conversion of pMDI products to the … [Read more...] about Kindeva and Koura partner on conversion of existing MDI to HFA 152a
FDA contracts with Aptar for LGWP propellant study
Aptar said that the company has won a contract worth up to $6 million from the FDA for a study "designed to provide the FDA with information related to the formulation, manufacture, device design and quality aspects related to low-GWP propellant MDIs and their utility to replace existing propellant MDIs." According to Aptar, the study is part of the FDA's development … [Read more...] about FDA contracts with Aptar for LGWP propellant study
Acadia announces initiation of Phase 3 trial of ACP-101 carbetocin nasal spray for hyperphagia in PWS
Acadia Pharmaceuticals said that it has initiated the Phase 3 COMPASS PWS study of ACP-101 carbetocin nasal spray for the treatment of excessive hunger in people with Prader-Willi syndrome (PWS). Acadia acquired the carbetocin nasal spray (formerly LV-101) when it acquired Levo Therapeutics in June 2022 and announced plans to develop ACP-101 for hyperphagia in PWS … [Read more...] about Acadia announces initiation of Phase 3 trial of ACP-101 carbetocin nasal spray for hyperphagia in PWS
1nhaler raises £2 million for development of its single-use cardboard DPI
Scottish device company 1nhaler has raised £2 million for development of a credit-card sized dry powder inhaler in a funding round led by Archangels, the investment firm announced. The 1nhaler device is made out of cardboard, contains a single dose of carrier-free API deposited on a membrane, and is breath-activated. According to the announcement, 1nhaler was … [Read more...] about 1nhaler raises £2 million for development of its single-use cardboard DPI
BiomX says it plans to move forward with development of BX004 inhaled phage cocktail based on data from second half of Phase 1b/2a trial
Based on results from Part 2 of the Phase 1b/2a trial, BiomX said that it plans to advance its BX004 nebulized phage cocktail for the treatment of chronic P. aeruginosa lung infections in cystic fibrosis patients into a Phase 2b/3 trial "subject to regulatory feedback and availability of sufficient funding." The study data demonstrated limited efficacy, with culture … [Read more...] about BiomX says it plans to move forward with development of BX004 inhaled phage cocktail based on data from second half of Phase 1b/2a trial
Qnovia reports results from Phase 1 trial of QN-01 inhaled nicotine replacement therapy
Qnovia (formerly Respira Technologies) has announced results from a Phase 1 trial of its QN-01 inhaled nicotine replacement therapy, which is based on the company's RespiRx vibrating mesh nebulizer platform. In September 2022, the company announced that it had raised $17 million for development of the nicotine replacement product. The Phase 1 PK study enrolled 12 … [Read more...] about Qnovia reports results from Phase 1 trial of QN-01 inhaled nicotine replacement therapy