CDMO Bespak, which spun out from Recipharm earlier this year, and device company H&T Presspart have announced that a new pilot-scale GMP line for filling MDIs with lower global warming potential (LGWP) propellants HFA-152a and HFO-1234ze is ready to begin manufacturing at Bespak's Holmes Chapel, UK, site. The two companies announced in April 2024 that they had … [Read more...] about Bespak and H&T Presspart launch new GMP pilot-scale MDI filling line for LGWP propellants
Products and Services
Aero Pump and Resyca launch Ultra Soft Nasal Pump Spray device
German spray pump manufacturer Aero Pump and soft mist inhaler developer Resyca have announced a partnership for the development and launch of a device called the Ultra Soft Nasal Pump Spray, which is now available for licensing. In January 2024, Resyca parent companies Recipharm (now Bespak) and Medspray announced that they had added development of soft mist nasal … [Read more...] about Aero Pump and Resyca launch Ultra Soft Nasal Pump Spray device
ARS launches Neffy nasal epinephrine nasal spray in the US
ARS Pharmaceuticals has launched Neffy epinephrine nasal spray in the US, the company said. In Auguest 2024, Neffy was approved by the FDA for the treatment of anaphylaxis in patients who weigh 30 kg or more. Earlier this month, ARS submitted an sNDA for a lower dose of Neffy for the treatment of anaphylaxis in children weighing 15 to 30 kg (33-66 lbs). European … [Read more...] about ARS launches Neffy nasal epinephrine nasal spray in the US
Iconovo reports positive feedback from the FDA regarding its ICOpre DPI and reacquisition of rights to the ICOone device
DPI developer Iconovo said that the FDA "has issued a positive guidance regarding the generic substitutability of the company's proprietary inhaler ICOpre with the original drug Breo Ellipta with respect to external design and operating principles" and indicated that the device is suitable for an ANDA for a generic of Breo Ellipta fluticasone furoate/vilanterol DPI. … [Read more...] about Iconovo reports positive feedback from the FDA regarding its ICOpre DPI and reacquisition of rights to the ICOone device
Ritedose to manufacture Verona’s Ohtuvayre inhaled ensifentrine
CDMO Ritedose Corporation announced that it will manufacture Verona Pharma's Ohtuvayre nebulized ensifentrine, which was approved by the FDA in June 2024 for the treatment of COPD. Also in June 2024, Ritedose announced that it was adding blow-fill-seal (BFS) capacity for an additional 180 million unit doses at its manufacturing facility in Columbia, SC, … [Read more...] about Ritedose to manufacture Verona’s Ohtuvayre inhaled ensifentrine
Serán Bio gets $200 million investment to support new commercial manufacturing facility
CDMO Serán Bioscience announced "a strategic growth transaction" led by Bain Capital Life Sciences that is worth more than $200 million, with the funds intended to support completion of a new commercial-scale manufacturing facility in Bend, Oregon, where the company is headquartered. According to Serán Bio, the commercial-scale facility, which is expected to be … [Read more...] about Serán Bio gets $200 million investment to support new commercial manufacturing facility
Vectura to be acquired by Phillips Medisize parent Molex
Inhalation CDMO Vectura has been sold to Molex for £150 million up front and up to an additional £148 million in potential payments, the companies have announced. Following the acquisition, Vectura will be operated by Phillips Medisize, which was acquired by Molex in 2016. The sale is expected to close by the end of this year. According to the Vectura Fertin press … [Read more...] about Vectura to be acquired by Phillips Medisize parent Molex
TFF Pharmaceuticals partners with Emory University on mRNA-based antiviral DPI with BARDA funding
TFF Pharmaceuticals announced that it will study the feasibility of formulating Emory University's mRNA-based Cas13a antiviral for the treatment of SARS-CoV-2 and influenza A and B as a dry powder using the company's thin film freezing technology. Funding for the study is provided by the Biomedical Advanced Research and Development Authority (BARDA) as part of its … [Read more...] about TFF Pharmaceuticals partners with Emory University on mRNA-based antiviral DPI with BARDA funding
Aptar Pharma to offer services for development projects based on Pulmotree’s Kolibri nebulizer platform
Aptar Pharma announced that it has signed a development and promotion agreement with Pulmotree related to Pulmotree's Kolibri mesh nebulizer, which it refers to as a non-propellant liquid inhaler (NPLI) platform. The company says that its subsidiaries, including inhalation CRO Nanopharm and human factors specialist Noble, will support Kolibri development projects for … [Read more...] about Aptar Pharma to offer services for development projects based on Pulmotree’s Kolibri nebulizer platform
Bespak joins IPAC
According to Bespak, the company has joined the International Pharmaceutical Aerosol Consortium (IPAC), which is the parent organization of the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS). Earlier this year, Bespak spun out of Recipharm, which joined IPAC-RS as a member in 2022. Bespak will be represented on the IPAC board … [Read more...] about Bespak joins IPAC