Opiant Pharmaceuticals said that it has terminated an agreement for the use of Bespak's Unidose Xtra device for delivery of its OPNT003 intranasal nalmefene for the treatment of opioid overdose and has entered into a new agreement with Aptar Pharma for the use Aptar’s Unit Dose System (UDS) to deliver OPNT003. Opiant already uses the UDS for delivery of its Narcan … [Read more...] about Opiant switches to Aptar’s UDS for delivery of its intranasal nalmefene
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Sorrento presents positive preclinical data for its intranasal neutralizing antibody against COVID-19
Sorrento Therapeutics said that its intranasal Covi-Drops (STI-2099) neutralizing antibody reduced the effects of SARS-CoV-2 infection in a hamster model, and the company is planning to submit an IND for a clinical trial of Covi-Drops this month. Hamsters receiving the intranasal antibody lost less weight than hamsters in the control group at day 5 post infection, and … [Read more...] about Sorrento presents positive preclinical data for its intranasal neutralizing antibody against COVID-19
Inhalation Sciences gets US patent for its PreciseInhale system
Swedish inhalation research equipment company Inhalation Sciences (ISAB) announced that it has received notification that a US patent covering the aerosol generating technology in its PreciseInhale laboratory aerosol dosing system will soon be issued. In May 2019, ISAB announced that it intended to validate the PreciseInhale for clinical use. The new patent is … [Read more...] about Inhalation Sciences gets US patent for its PreciseInhale system
Positive Phase 1 trial results for PIMS-E’s epinephrine DPI
PureIMS subsidiary PIMS-E has announced that a Phase 1 clinical trial of its epinephrine DPI demonstrated that the dry powder epinephrine was well tolerated with no serious adverse reactions and produced peak plasma concentrations at levels that should be effective within 5 minutes post inhalation. PIMS-E is developing the epinephrine inhaler for the treatment of … [Read more...] about Positive Phase 1 trial results for PIMS-E’s epinephrine DPI
EC approves Arikayce for the treatment of MAC lung infections in non-CF patients
The EC has granted marketing authorization to Insmed's Arikayce nebulized lipsomal amikacin for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC) in adult patients without cystic fibrosis who have limited treatment options, Insmed said. In the US, the FDA approved Arikayce for the treatment of NTM lung … [Read more...] about EC approves Arikayce for the treatment of MAC lung infections in non-CF patients
Ampio initiates Phase 1 trial of inhaled Ampion in COVID-19 patients
Ampio Pharmaceuticals has announced the initiation of a Phase 1 trial of an inhaled formulation of its Ampion anti-inflammatory biologic; the company had announced plans for the trial in September 2020 after having said in March 2020 that it intended to develop nebulized Ampion for the treatment of respiratory distress due to COVID-19. The trial is expected to … [Read more...] about Ampio initiates Phase 1 trial of inhaled Ampion in COVID-19 patients
FDA clears Neuronasal IND for intranasal N-acetylcysteine
According to ATAI Life Sciences, the FDA has cleared an IND submitted by Neuronasal Inc. for its N-acetylcysteine (NAC). In January 2020, ATAI announced that it had partnered with Neuronasal on development of intranasal NAC for the treatment of mild traumatic brain injury (mTBI, or concussion) and expected a pilot study to begin the next month. The pilot study has … [Read more...] about FDA clears Neuronasal IND for intranasal N-acetylcysteine
Experic adds TFF thin film freezing manufacturing capability
CDMO Experic is adding a thin film freezing manufacturing line based on technology owned by TFF Pharmaceuticals at its Cranbury, NJ, USA cGMP facility, according to TFF. Completion of Experic's TFF line, which adds a third cGMP manufacturing site for TFF, is expected in the second quarter of 2021. In September 2020, TFF announced that it will advance its … [Read more...] about Experic adds TFF thin film freezing manufacturing capability
Proveris Scientific announces new hire for Applications Laboratory Manager
According to Proveris Scientific, Lynn Jordan has joined the company as Applications Laboratory Manager. Proveris offers laboratory services for development and analysis of a wide range of OINDPs, and the company launched new cGMP compliant testing services earlier this year. Jordan was most recently a Technical Sales Representative with Biotage and has held … [Read more...] about Proveris Scientific announces new hire for Applications Laboratory Manager
Lonza to increase capsule manufacturing capacity at eight sites
Lonza has announced that it will invest CHf 85 million (~$94 million) at 8 of its Capsugel manufacturing sites around the world to expand its capsule manufacturing capacity by 15%, or 30 billion capsules per year. The expansion will involve multiple lines of capsules, including the Zephyr range and other DPI capsules. Lonza acquired Capsugel in 2017, and the … [Read more...] about Lonza to increase capsule manufacturing capacity at eight sites