According to Lupin, the MHRA has approved company's Lutio tiotropium bromide inhalation powder, a generic version of Boehringer Ingelheim's Spiriva Handihaler. The approval is the second for a Lupin OINDP in the UK; the MHRA approved the company's Luforbec beclometasone / formoterol MDI for the treatment of asthma and COPD, a generic of Chiesi's Fostair, in June 2021, … [Read more...] about Lupin’s Lutio tiotropium bromide DPI approved for the treatment of COPD in the UK
Regulatory
Adherium submits 510(k) for Hailie sensor use with Teva MDIs
Adherium has submitted a 510(k) application for use of its next generation Hailie inhaler monitoring sensor with Teva's ProAir albuterol MDI and its generic albuterol HFA MDI, the company said. Recently, the company filed a 510(k) submission for use of the Hailie sensor with GSK's Ventolin, Advair, and Flovent MDIs, and the FDA cleared the Hailie sensor for use with … [Read more...] about Adherium submits 510(k) for Hailie sensor use with Teva MDIs
Savara’s molgramostim for aPAP gets PIM designation from the MHRA
According to Savara, the MHRA has granted Promising Innovative Medicine (PIM) designation to the company's molgramostim inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). The PIM designation indicates that the product could be eligible for the UK's early access to … [Read more...] about Savara’s molgramostim for aPAP gets PIM designation from the MHRA
Wockhardt subsidiary Morton Grove Pharmaceuticals ordered to stop manufacturing
A US District Court has ordered Wockhardt subsidiary Morton Grove Pharmaceuticals "to stop manufacturing and distributing drugs alleged to be adulterated." The Morton Grove facility manufactured fluticasone propionate nasal sprays in addition to other products. The company has signed a consent decree agreeing to cease production, to destroy already manufactured drugs, … [Read more...] about Wockhardt subsidiary Morton Grove Pharmaceuticals ordered to stop manufacturing
FDA approves Lupin’s formoterol fumarate inhalation solution
According to Lupin, the FDA has approved the company's ANDA for a generic version of Mylan's Perforomist formoterol fumarate inhalation solution. Teva launched a generic equivalent in the US in June 2021 after expiration of the final patent covering Perforomist, and the agency approved Alembic Pharmaceuticals' ANDA for its Perforomist equivalent in November 2021. … [Read more...] about FDA approves Lupin’s formoterol fumarate inhalation solution
Nuance Pharma gets the go-ahead for clinical trials of nebulized ensifentrine in China
According to Nuance Pharma, the Chinese Center for Drug Evaluation has approved the company's IND, allowing for a Phase 3 trial of nebulized ensifentrine, a PDE3/PDE4 inhibitor for the treatment of COPD, in China. The IND also grants approval for a Phase 1 PK study in healthy volunteers that the company plans to conduct in China. Nuance acquired the Chinese rights to … [Read more...] about Nuance Pharma gets the go-ahead for clinical trials of nebulized ensifentrine in China
Harm Reduction signs supply agreement for RiVive naloxone nasal spray after getting Fast Track designation
Harm Reduction Therapeutics announced that it has signed a commercial supply agreement for its RiVive (HRT001) intranasal naloxone after the FDA granted Fast Track designation to the nasal spray, which is in development as a low cost OTC product for the reversal of opioid overdose. HRT did not name the company it contracted with but said that RiVive would be … [Read more...] about Harm Reduction signs supply agreement for RiVive naloxone nasal spray after getting Fast Track designation
Adherium submits 510(k) application for a Hailie sensor for use with Ventolin, Advair, and Flovent MDIs
Just over a week after receiving 510(k) clearance for a Hailie inhaler sensor for use with Ellipta DPIs, Adherium said that it filed a 510(k) submission to the FDA for a new Hailie sensor to be used with GSK's Ventolin, Advair, and Flovent MDIs. The new Hailie sensor measures various parameters, including respiratory flow rate, and connects to the company's Hailie … [Read more...] about Adherium submits 510(k) application for a Hailie sensor for use with Ventolin, Advair, and Flovent MDIs
Renovion announces planned Phase 3 trial of ARINA-1 inhaled mucolytic in bilateral lung transplant patients
Renovion announced that the company has gotten the go-ahead from the FDA to initiate a Phase 3 clinical trial of its ARINA-1 nebulized glutathione / bicarbonate / ascorbic acid for the prevention of bronchiolitis obliterans in bilateral lung transplant patients who have recently had a reduction in lung function. ARINA-1, which is delivered via the PARI eFlow nebulizer … [Read more...] about Renovion announces planned Phase 3 trial of ARINA-1 inhaled mucolytic in bilateral lung transplant patients
Adherium announces 510(k) clearance for Hailie sensor for use with Ellipta DPIs and new distribution deal
Hailie inhaler monitoring system maker Adherium announced that the FDA has cleared the company's new version of the Hailie sensor for use with Ellipta dry powder inhalers. Adherium submitted the 510(k) application to the FDA in March 2022. The company said that the new clearance means that Hailie is now eligible for reimbursement on 18 of the top 20 branded inhalers … [Read more...] about Adherium announces 510(k) clearance for Hailie sensor for use with Ellipta DPIs and new distribution deal