An FDA warning letter to Cipla dated November 17, 2023 cites numerous problems found in a February 2023 inspection of Cipla's metered dose inhaler manufacturing facility in Pithampur, Madhya Pradesh, India. Among the issues cited in the letter is a failure to respond adequately to more than 3,000 complaints received between April 2020 and December 2022 that reported … [Read more...] about FDA issues warning letter to Cipla citing significant problems at inhaler manufacturing facility, including continued production of defective MDIs
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Ethris gets approval for Phase 1 trial of ETH47 inhaled mRNA
According to Ethris, a clinical trial authorization (CTA) that the company submitted to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in June 2023 has been approved, and Ethris expects to initiate a Phase 1 clinical trial of its ETH47 inhaled mRNA in healthy participants before the end of the year. The company is developing ETH47 as for the … [Read more...] about Ethris gets approval for Phase 1 trial of ETH47 inhaled mRNA
FDA accepts Orexo’s NDA for OX124 intranasal dry powder naloxone for the treatment of opioid overdose
Orexo said that the FDA has accepted the company's NDA for OX124 intranasal dry powder high dose naloxone for the reversal of opioid overdose and has set a PDUFA date of July 15, 2024. The company initially announced that it had submitted an NDA for OX124 in February 2023; however, the FDA rejected that application, requesting additional information about the … [Read more...] about FDA accepts Orexo’s NDA for OX124 intranasal dry powder naloxone for the treatment of opioid overdose
US Army to evaluate Seelos’s SLS-002 intranasal racemic ketamine for the treatment of PTSD
According to Seelos Therapeutics, the US Army Medical Research and Development Command will include the company's SLS-002 intranasal racemic ketamine in an adaptive platform trial of therapies for post-traumatic stress disorder (PTSD) in soldiers and veterans. The Phase 2 Department of Defense PTSD Adaptive Platform Trial (NCT05422612), which is expected to be … [Read more...] about US Army to evaluate Seelos’s SLS-002 intranasal racemic ketamine for the treatment of PTSD
Lupin launches Vilfuro-G triple combination DPI in India
Lupin announced that the Drug Controller General of India approved the company's Vilfuro-G vilanterol / fluticasone furoate / glycopyrronium bromide dry powder inhaler for the treatment of COPD, and the company has launched the DPI in India. Earlier this year, Lupin announced the launch of its Difizma indacaterol / glycopyrronium / mometasone DPI in India for the … [Read more...] about Lupin launches Vilfuro-G triple combination DPI in India
Silo Pharma licenses Medspray’s soft mist technology for delivery of SPC-15 intranasal ketamine
Silo Pharma announced that it has signed a license agreement with Medspray Pharma for the use of Medspray's soft mist spray technology for delivery of Silo’s SPC-15 intranasal ketamine. According to Silo, the Medspray technology delivers "A formulation-specific, customized aerosol plume that is designed to allow for better deposition in the relevant region of the … [Read more...] about Silo Pharma licenses Medspray’s soft mist technology for delivery of SPC-15 intranasal ketamine
GSK announces upcoming Phase 3 trials of HFA 152a version of Ventolin salbutamol (albuterol) MDI
GSK has announced that data generated from recently early stage trials support advancing a reformulated version of its Ventolin salbutamol (albuterol) MDI using HFA 152a as the propellant into Phase 3 trials. The company said that it expects to initiate those studies in the first half of 2024 with plans to file regulatory submissions for the reformulated product in … [Read more...] about GSK announces upcoming Phase 3 trials of HFA 152a version of Ventolin salbutamol (albuterol) MDI
Altamira sells majority stake in Bentrio bentonite nasal spray
Altamira Therapeutics announced that a private investor has acquired a 51% stake in Altamira Medica, a subsidiary of Altamira that owns Bentrio bentonite nasal spray, which is sold over the counter for the treatment of allergic rhinitis. According to Altamira, the deal includes more than CHF 2 million (~$2.3 million) in cash, and the company will get 25% of future … [Read more...] about Altamira sells majority stake in Bentrio bentonite nasal spray
Ab Initio Pharma opens new R&D facility
Australian CDMO Ab Initio Pharma has announced the opening of a new R&D facility in Sydney, which the company says is "fitted out to provide state-of-the-art testing and R&D services to Australian and overseas companies developing innovative therapeutics." Ab Initio also has a GMP manufacturing facility that was granted a license by the TGA in 2022 to … [Read more...] about Ab Initio Pharma opens new R&D facility
Inhalon Biopharma gets additional funding from the US Army for development of inhaled antibody against SARS-CoV-2
Inhalon Biopharma has announced that the company received a $5.7 million contract from the United States Army Medical Research and Development Command (USAMRDC) for development of a nebulized therapy against all variants of SARS-CoV-2. The company's web site says that it received the contract for a study of "IN-007, an Inhaled ACE2-Targeting Therapeutic for … [Read more...] about Inhalon Biopharma gets additional funding from the US Army for development of inhaled antibody against SARS-CoV-2